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PRIME Faraday Technology Watch

Medical Devices

The UK Industry and its Technology Development

Medical-device technology is saving and improving the quality of life by detecting diseases earlier and improving diagnosis, treatment and patient monitoring. Furthermore, medical devices are reducing healthcare costs, through earlier diagnosis, more effective treatment and relieving the pressure on skilled staff and hospital resources.

Much has been written of the UK medical-device market, which is driven by the National Health Service and the needs of an increasingly health-aware population. But little attention has been focused upon understanding the UK's indigenous medical-device industry as opposed to the world players who supply into the UK market from overseas.

This report describes the indigenous UK industry, classifies its products and drivers, and explores the opportunities for technology development.

David Topham

Arts & Science

Prime Faraday Partnership

ISBN 1-84402-027-4 Medical Devices: The UK Industry May 2003

Medical Devices: The UK Industry and its Technology Development

Published in 2003 by PRIME Faraday Partnership

Wolfson School of Mechanical and Manufacturing Engineering Loughborough University, Loughborough, Leics LE11 3TU http://www.primetechnologywatch.org.uk

© 2003 Loughborough University

ISBN 1-84402-027-4

Whilst the advice and information in this publication is believed to be true and accurate at the time of publication, neither the author nor the publisher assume any legal responsibility or liability for any error or

omission that may have been made.

Comments on this publication are welcomed. Please send them to <[email protected]

Prime Faraday Technology Watch – May 2003


Contents 1 Introduction........................................................................................................................... 1

1.1 Methodology and Acknowledgements........................................................................... 2 2 Application Areas ................................................................................................................. 3

2.2 Classification ................................................................................................................. 4 3 The UK Medical-Device Industry.......................................................................................... 5

3.1 World, European and UK markets................................................................................. 5 3.2 International Comparisons ............................................................................................ 8

3.2.1 Imports and Exports ............................................................................................. 8 3.3 UK Companies ............................................................................................................ 10 3.4 UK Output – Financial and Employment Characteristics ............................................ 11

4 Technology and Product Development .............................................................................. 16 4.1 Drivers and Technical Issues ...................................................................................... 16 4.2 The Current World Scene............................................................................................ 17

4.2.1 In-Vitro Diagnostics ............................................................................................ 17 4.2.2 Endoscopy and Minimally Invasive Surgery....................................................... 18 4.2.3 Wound Management .......................................................................................... 19 4.2.4 Infusion Devices ................................................................................................. 20 4.2.5 Inhalation Therapy.............................................................................................. 21 4.2.6 Implantable Devices ........................................................................................... 22 4.2.7 Surgical Devices................................................................................................. 23 4.2.8 Patient Monitoring and Patient-Related Instrumentation.................................... 23

4.3 Patent Survey .............................................................................................................. 25 4.4 Regulation, Craft and Skills ......................................................................................... 27

4.4.1 Regulation .......................................................................................................... 27 4.4.2 Skill, Craft and Scale .......................................................................................... 28

5 Future Directions for UK Medical Devices ......................................................................... 29 5.1 UK Foresight................................................................................................................ 29 5.2 Technology Development............................................................................................ 30

5.2.1 Endoscopy and Minimally Invasive Surgery....................................................... 31 5.2.2 Implants .............................................................................................................. 31 5.2.3 Infusion Therapy................................................................................................. 31 5.2.4 Manufacturing Inspection ................................................................................... 32 5.2.5 Microengineering and MEMS Technology ......................................................... 32 5.2.6 Non-Invasive Monitoring..................................................................................... 32 5.2.7 Surgical Instruments........................................................................................... 33 5.2.8 Untethered Technologies ................................................................................... 33 5.2.9 Wound Management .......................................................................................... 34

5.3 Research Programmes ............................................................................................... 34 5.4 Technology Integration................................................................................................ 35

Appendix A Medical Device Listing........................................................................................ 37 Appendix B A Note on Specifications .................................................................................... 46 Appendix C Sources of Information and Advice .................................................................... 47 References .................................................................................................................................. 49

Prime Faraday Technology Watch – May 2003 iii


1 Introduction

This report examines the indigenous UK industry sector responsible for the design and manufacture of medical devices, and goes on to explore the current and potential future technological developments which will result in new products and business opportunities. The report differs from the more usual market study in that it strives to exclude those UK activities primarily concerned with importing goods to the home marketplace and with distribution. It is expected that the work will be of value not only to those primarily engaged in the sector, but also to the supply chain, to government and corporate strategists, and to researchers and research organisations supporting the sector.

Medical devices represent an extraordinarily varied product group, ranging from simple disposable supplies such as face masks, catheters and syringes through to surgical implements, patient-treatment and monitoring instruments and ultimately encompassing high-technology beds, laboratory equipment and capital-intensive body-scanning and radiotherapy plant. To assist in understanding this vast subject area this document maps and classifies the application of medical devices and identifies their UK manufacturers along with their staffing levels and financial scale.

Interdisciplinary in nature, medical devices require design, engineering and manufacturing expertise from a diverse range of technology areas including electronics, mechanical engineering, polymer science, chemistry and biochemistry, as well as fluid engineering, sonics, optics, magnetics and software.

There is a temptation in describing a manufacturing industry and the technological aspects of its products to discount the simpler products which are often low-cost disposable products. This report is inclusive of these items, for the following reasons:

• The safety and regulatory aspects of the medical devices market impose special constraints upon even simple items. Accordingly, the materials used in their manufacture and distribution will have been selected with exceptional care, and the processes used in their design and manufacture will be rigorously controlled.

• The threat of deadly cross-infection has been recognised. This means that there is a move from multi-use surgical instruments to disposable types. In making this move, much will be learned from the manufacturers of more traditional disposables.

• 'Smart' technologies are being integrated into to traditionally low-cost disposable products in every market. The medical device sector is no different.

A common thread of intrinsic safety and regulatory measures runs through the business and technology aspects of the sector. It will be seen that on the one hand this stabilises the industry whilst on the other it introduces high business risk for the adoption of new developments.

The report is divided into four main sections. In the firs, the reader is introduced to medical devices and their application areas, and the classifications adopted by the report. The second section concentrates upon the business aspects of the sector, putting the UK market into its world context, then analysing the financial and employment patterns of the companies operating in the UK. The third section examines technology development, with particular reference to the drivers, regulatory and technology integration issues that characterise the sector. The final section illustrates the technology challenges and opportunities facing the UK medical-devices industry and the development directions and programmes that will assist in their realisation.

Prime Faraday Technology Watch – May 2003 1


1.1 Methodology and Acknowledgements

The research supporting this report has striven to apply insight to codified data available from public sources. Although SIC codes provided an initial cut of medical-device companies as classified in official returns, a supplementary selection benefited from searches of activity descriptions. Finally, all information was corroborated where possible by Internet research, not only into companies' own claims but also by seeking out cross-references from published reports, and press and analysts' commentaries. Inestimable value was contributed by industry interviewees who brought their personal knowledge and experience to the project whilst at the same time reviewing the framework of data and observations that support the report in its final form. To these generous and knowledgeable individuals the authors give their thanks.



2 Application Areas

The application areas of medical devices are summarised in Table 1.

Table 1 Application areas of medical devices



2.2 Classification

A comprehensive list of the very many medical devices deployed across the foregoing application areas is provided in Appendix A. To assist in later analysis, a consistent classification system has been adopted as below. The categories are by no means industry standards as they have been selected to aid later discussion in this report.

Table 2 A classification of medical devices

Anaesthesia Ranging from face masks through the administering equipment to patient monitoring and monitoring of the operating theatre environment

Endoscopy/laparoscopy A very wide range of implements and equipment concerned with internal inspection and minimally-invasive surgery

Hearing aids & audiometry Instruments to aid hearing and to diagnose and characterise hearing loss

Hospital capital plant Fixed plant such as body scanners, linear accelerators and x-ray apparatus

Hospital supplies & disposables A huge range, including disposable supplies such as catheters, bags and syringes through to sterilisers and autoclaves

Implantable devices Miniaturised instruments such as pacemakers

In-vitro diagnostics & kits Typically ‘lab-in-a-box’ including reagent liquids or strips

Infusion & inhalation therapies Instruments to dispense drugs or nutrients through the airways or circulatory system

Instruments – treatment, clinical and laboratory

A wide range of electronic instruments

Invasive surgery Surgical tools – largely sterilisable instruments, but increasingly including electro- items, items with 'smart' content and disposables

Patient monitoring Instruments usually connected to the patient via invasive probes or non-invasive sensors or electrodes

Prosthetics and artificial joints Passive implants or limb replacements usually customised to the patient

Ultrasound Imaging, diagnostic and treatment devices depending upon ultrasonic transducers

Wound management Dressings, including alginate, foam and hydrocolloid dressings together with transparent film and hydrogel dressings



3 The UK Medical-Device Industry

This section describes the business aspects of the UK medical-device industry in terms of:

• The financial and employment patterns of companies operating in the UK • Their involvement in the product categories classified in the previous section

K-derived manufacturing and design output. This report is not concerned with UK consumption, neither is it concerned with the proportion of

atisfy UK consumptiothat pass through UK compan lue.

eeding tin its world context, including some

an and UK markets

drepresenting the medical technolo billion, with Europe

f that total. T h that used for this report, encompasses aids for the disabled, active implantable devices, anaesthetic respiratory

lectrom phthalmic and optical devices, passive implantable devices, single use devices and surgical (reusable)

rld market, totalling €160 billion in 2000

It is important to see this review as focusing upon U

imports that s n, nor is this report concerned with overseas-produced items ies to other territories with no significant added va

Nevertheless, before proc o describe the UK activity, the UK market is briefly examined international comparisons.

3.1 World, Europe

The world market for medical evices in 2000 as reported by Eucomed, the organisation gies industry in Europe, stood at €160

accounting for 25% o he Eucomed definition, broadly in line wit

devices, dental devices, e edical instruments, imaging, in-vitro diagnostics, o

instruments.

Table 3 Wo

ry % Share Market value

24.50 39

USA 41.50 60

f World 19 36.5

urce: Eucomed member estimates, HIMA; Jan-Feb 2000 data

Count(€ billion)

Europe

Japan 15 24.5

Rest o

So

Table 4 European market, totalling €39 billion in 2000

Country % Share Market value

(€ billion)

Germany 36 14.3

France 19 7.6

UK 10 3.9

Source: Eucomed member estimates, HIMA; Jan-Feb 2000 data

Moving forward into 2001, information sourced from Espicom, the industry research organisation that specialises in medical-device research, shows figures that follow a very similar trend to the Eucomed figures for 2000. Here the global market for medical devices, as



measured by total manufacturer sales, is sta

Germany2%

Portugal2%

Netherlands

Table 5 UK medical-device market 1999-2003

ted as $132.8bn (€151.7bn) in 2001 with the European total being $29.9bn (€34.1bn). Espicon estimate that in the four-year period from

any 1999 to 2003 the UK medical device sector will grow by 20%, compared with a rate for Germof 16.9%, for France of 12.5% and for Italy of17%.

UK12%

France12%

Austria3%

Spain8%

Belgium3%

Denmark2% Finland

1%Sw itzerland

5%Sw eden

2%

Figure 1 Western European medical-device market – % by country 2001

Norw ay

Ireland1%

Italy12%

28%Greece2%

5%

Source: Espicom

Espicom's view of the UK market in isolation shows that approximately 7% of GDP goes on health expenditure, with spending growing 5% year on year for the next two years. See Table 5.

1999 2000 2001 2002 2003 Market (US$ million) 3,365 3,500 3,675 3,860 4,050 Per capita (US$) 62 65 69 57 59

8

tory sterilisers

By Product Sector Bandages & other medical supplies 312 324 340 357 375 Medical X-ray film 8 91 96 101 106 Gloves, surgical of rubber 85 88 93 97 102 Medical, surgical or labora 19 19 20 21 22 Wheelchairs 28 29 31 32 34 Contact lenses 77 80 84 88 93

1,709 1,777 1,866 1,960 2,057 Medical equipment 435 457 479 Electromedical 398 414

Syringes, needles & catheters 400 417 437 459 482 Dental instruments & appliances 88 96 101 106 92

ts and app s 53 56

138 144 531 553 329 342

Ophthalmic instrumen liance 58 61 64 Other instruments and appliances 768 799 839 881 925

Therapy apparatus 151 159 167 Orthopaedic/prosthetic goods 580 610 640 X-ray apparatus 359 377 396 Medical furniture 50 52 54 57 60

Source: Espicom

Worldwide, the leading industry participants are predominantly US companies. Of the top 40 manufacturers, according to the journal Medical Device and Diagnostics Industry (MDDI), only 7



companies are based outside the US. The only UK company in the top 40 is Smith and Nephew, ranked 18th in the table with sales of $1.6bn and a workforce of over 10,000 (of whom the vast majority are employed at overseas sites). See Table 6.

The structure of the medical-device industry has been changing due to acquisitions and mergers, with multinational manufacturers consolidating to establish a strong presence around

, most of the largest medical-device companies have a number of significant subsidiaries. Johnson & Johnson’s include, for example, Ethicon, DePuy, Cordis, J&J Medical and Critikon; Boston Scientific’s include SciMed, Microvasive, Schneider and EP Technologies; Baxter’s include IV Systems, Edwards Division, Hyland Division, Clintec and Renal Therapy; and Tyco International’s include Kendall, Sherwood Davis & Geck and U.S. Surgical.

Table 6 Top 40 world players

the world. According to Frost and Sullivan, the international market research company

Source: MD&DI



3.2 International Comparisons

A few countries – Germany, Ireland, Italy and the UK – dominate exports of medical devices from the EU. 20% of UK production is exported outside the EU, Germany exports 17% and

Table 7 Comparative imports and exports

Ireland exports 35% of its €385m output.

3.2.1 IMPORTS AND EXPORTS

One way of ascertaining the strength of a country's medical-device industry is to compare the level of relevant imports and exports. See Table 7.

Imports 1995 (US$ million)

Imports 1999 (US$ million) % Change

Exports1995 (US$ million)

Exports 1999 (US$ million) % Change

USA 5568 9379 68.4 10100 13985 38.5

UK 2023 2712 34.1 2450 3103 26.7

Germany 4351 5073 16.6 7254 7172 -1.1

France 3075 3540 15.1 2292 2977 29.9

Source: Espicom

Looking at the historic trends of imports and exports among the major medical-device nations, US imports of medical devices have increased by nearly 70% between 1995 and 1999 whereas their exports have increased by 38%. The US medical-device trade deficit of $4.5bn in 1995 has remained practically stationary over the period, and in real terms this represents a narrowing. UK imports increased 34% over the same period, with exports rising 27%. In 1995, the country enjoyed a modest $427m trade surplus in medical devices, reducing to $391m in 1999.

Germany and France differ dramatically. Germany had a massive medical-device trade surplus of $2.9bn in 1995, and even though imports rose some 17% and exports stayed static over the next 4 years, the surplus remained at over $2bn in 1999. France, however, is a net importer of medical devices. In 1995 the trade deficit was $783m, narrowing to $563m in 1999, with imports increasing at a lesser rate than the other countries compared and exports increasing by a significant 30%.

Industry overviews from the US Dept of State Country Commercial Guide provide further useful insight into the conditions within different nations' markets. The following quotations come from its assessments for the financial year 2000.

Of the UK:

American industry supplied 25 percent of imports and accounted for 12 percent of the total $3.4 billion medical equipment market in Britain last year. Current market growth has been slow, and the lack of domestic investment in new product development in recent years has created a demand for imported high-tech equipment. Requirements include lasers, endoscopes, medical imagery and dental equipment.



The principal purchaser of medical equipment in the UK is the National Health Service (NHS), which provides about 85 percent of Britain’s health care. Private hospitals and

The U.K. market is regulated by EU directives that set out the requirements for e rmance and safety of medical devices, and procedures for ensuring compliance. The

three main directives are the EU Medical Devices Directive and the Active Implantable

ll be fully implemented in December 2005.

Of Germany

The market for medical devices in Germany is estimated at USD 12.5 billion for the year 2000, a 3 al health expenditures. There are roughly 1,200 local m dica fac pr a 8

999. The major consumer group e in-pa hospital , accoun USDthe ou nt sector d at USD on(e).

lt of health 2000 and cost-contain t measures, local production is expeccrease only rately by 1. cent, w e total ma ize estim grow

5.5 percent in the year 2000. Experts consider medical devices a growth market with excellent potential for U.S. suppliers of innovative and price-competitivmedical device exporters to Germany hold a 30 percent market share and, with CE marked

French medical costs are reimbursed a factor that has led to a widespread tendency to

France, the medical equipment sector is highly dependent on imports, mainly from the U.S., followed by Germany, Japan and Italy.

.

assisted living. Areas of projected stronger demand include products used in providing home health care services and medical information systems for telemedicine. American firms will also continue to see

residential care currently account for almost $400 million of medical expenditure. The private medical sector presents additional opportunities, as more U.K. consumers move toward private medical treatment.

p rfo

Medical Devices Directive, which are both fully implemented, and the EU In-Vitro Diagnostic Medical Devices Directive, which wi

pproximately 1l device manu

percent of totturers, which e oduced medical devices v lued at USD billion in

1 is th tient, sector ting for 7.5 billion(e) in the year 2000, followed by t-patie value 5 billi As a resu reform men ted to in mode 3 per ith th rket s ated to by

e products. U.S.

products, will continue to find excellent potential in Germany and other European countries.

Of France:

The French medical sector continues to grow, reflecting the increase in population and longer life expectancy. The emergence of new technologies, such as same-day surgery, has generated a new market for home health care equipment. Approximately 70 percent of alloveruse medical services. Any attempt to control medical costs creates strong opposition from the public, and from medical professionals. This attitude persists in spite of the fact that an increasing number of French people agree that some savings must occur in order to save the French social security (medical insurance) system.

Since June 1998, as in the rest of Europe, all medical devices sold in France must bear the CE Mark. In

Market size of the medical equipment sector in 2000 was $4.089 billion versus $3.942 billion in 1999 and $3.891 billion in 1998

Of Japan:

Overall, Japan’s market for medical devices is expected to exhibit slow growth in 2001. This is attributable primarily to government efforts to control healthcare spending. While a strong emphasis on cost containment will continue for the foreseeable future, this will be counter-balanced by the needs of Japan’s rapidly aging population and the construction of a large number of new facilities for nursing home care and



bright sales prospects in areas they currently dominate. This will remain especially true in the more technologically sophisticated product categories such as pacemakers, advanced interventional cardiology products, artificial implants and digital imaging equipment.

Still, there are signs that demand, even for the most advanced medical devices, may be tempered by Japanese Governments efforts to control healthcare expenditures. The impact

e major product categories (arterial (PTCA) catheters, pacemakers and orthopedic implants),

S. firms hold roughly 75% of the market. In October 2000, Japan will implement

mpanies

Befoand examancom

Tab

of these cost cutting efforts are evidenced in recent policy initiatives taken with regard to several categories of innovative medical devices. Every two years, the Ministry of Health and Welfare revises the reimbursement prices for medical devices and products covered under the national health insurance system. During the most recent biennial price revision, undertaken in April 2000, an average price reduction of 4.5% was implemented for thre

where U.changes to the system by which these three categories of medical devices are priced. American firms are concerned that the new system will discourage product innovation by pricing devices incorporating incremental, but medically significant changes, at the same level as older, less sophisticated technology.

American firms hold a dominant position in the Japanese market among foreign producers, accounting for two-thirds of all imports. The U.S. share of the overall Japanese medical device market has increased from 20% in the early 1990s to one-quarter of the market presently. American firms accounted for roughly $4.5 billion of Japan’s $18 billion device market in 1999.

3.3 UK Co

re considering the financial and employment patterns of companies operating in the UK their involvement in the product categories upon which this report is based, it is useful to

mine Espicom's review of what they consider to be the UK's leading medical-device ufacturers. See Table 8. The research behind this report indicates that many of these panies source by no means all of their products from UK manufacture.

le 8 Leading UK medical-device manufacturers

Company Main Business Areas ington Surgical Cardio-vascular, general surgery, ENT & orthopaedic

nced Medical Solutions Wound care

Accr

Adva

Aortech Heart valves

ak Drug-delivery systemBesp s

Blease Medical Respiratory & anaesthesia equipment

Brandon Medical Surgical lamps, control panels & emergency power systems

Chelsea Instruments Incubators, DNA-analysis equipment

ent Clarke Int. Ophthalmic & respiratory equipment

Medical Orthopaedic implants & instrumentation

Medical Aids Rehabilitation products

x Ultrasound equipment

ed Lasers Surgical lasers

Clem

Corin

Days

Delte

Diom



Dixons Surgical Surgical instruments, portable autoclaves & operating-table accessories

mic Imaging Ultrasound scanners, dopplers, portable linear scanners

tro Medical Equipment Respiratory & diagnostic products

Dyna

Elec

Eschmann Operating tables, autoclaves & electrosurgery units

ris Asthma, respiratory, cardio-respiratory, ECG & monitoring equipment

llands Medical apparatus, ENT sets, ophthalmoscopes, laryngoscopes

leigh Technology Hospital beds, hand-held dopplers & foetal monitors

guard Diabetes-care products

surgical Anaesthesia devices, breathing filters, HMEs & HMEFs

vascular Research Intravascular ultrasound equipment

Replacement Instru. Orthopaedic implants

l Interventional cardiology & radiology, critical-care & renal products

rsk Medical Critical care, operating room equipment, wound care & infusion therapy

ue Plc. Ultrasound bone densitometers

ys Medical-gas distribution &

Ferra

Gow

Hunt

Hypo

Inter

Intra

Joint

Kima

Mae

McC

Med patient-environment systems

Mediplus Catheters & lesion location sets

x Instruments Surgical, diagnostic & dental instruments & electromedical equipment

Electric Medical suction products & nebulisers

o Medical Respiratory equipment, spirometers & gas monitors

r Instruments

Medi

MG

Micr

Moo Laser doppler blood-flow monitors & imagers

Neville Instruments Dental forceps

Oak Medical Tourniquets & vascular-diagnosis equipment

Osmetech Plc. In-vitro diagnostics

Owen Mumford Ltd. Blood sampling, insulin delivery, eye care & diagnostic equipment

Oxford Instruments Neurology, neurophysiology, cardiology & obstetric equipment

Seward Ltd. Obstetric & neonatal, laboratory, medical & surgical equipment

Shield Medicare Ltd. ENT, orthopaedics, vascular surgery & sterile services

Smith & Nephew Wound care, orthopaedic implants & endoscopy

SIMS Single-use kits, operating tables, monitoring, infusion & respiratory products

SSL International Surgical & examination gloves, condoms, wound care & continence care

Surgicraft Orthopaedics, spinal & obstetrics

Sutures Ltd. ruments Sutures, ophthalmic inst

Swann Morton Surgical blades

Vernon-Carus Surgical instruments

Vitalograph ers, spirometry systems and lung-function testing equipment Peak flow met

The indigenous U al-device manufacturing industry300+ compan of around £2.9bn in the manufacturiThese figures we ted from financial dat2002. mpanies claiming exbased on a 0k turnover

Source: Espicom

3.4 UK Output – Financial and Employment Characteristics

K medic employs some 27,000 people in ies with sales ng and design of its own output.

re calcula a in the latest company returns as at February Figures for small co emption from full reporting were extrapolated

ratio of £10 per employee. Note that no company has a UK manufacturing turnover greater than £300m, which is a small fraction of the quoted sales of the




major multinationals. No co in t bulk of U with a few dozen

ve um. However, it is multinationals that responsible for

around the country, gures ow. (Recall that erseas is

excluded, as also are UK business activities solely devoted to sales or distribution.)

Turnover of U

mpany has more than 2,000 employees concerned adding valuethe UK. The vas K medical-device output comes from SMEs each employees and turning o r a few million pounds per annare largely the geographical employment concentrations to be found in several locales in particular in and around Leeds, Sheffield and Oxford. See Fi2 to 6 bel imports, trading in and distribution of items produced ov

Figure 2 K companies

Figure 3 Em by UK companies

200

0

50

100

150

200

250

10 - 99 100 - 999 1000+

Employees

Num

ber o

f com

pani

es

ployment

250

<10

12

100

150

Num

ber o

f com

pani

es

0

50

<£1m £1m - £9m £10m - £99m £100m +

Turnover



Figure 4 UK companies: geographic distribution

Sheffield

Leeds

West

Oxford

Cambridge

Greater Guildford And Woking

3 - 5

0 - 2

4 - 6

10+

7 - 9

Number of companies


Figure 5 Geographical distribution of UK employment

Sheffield Hull

Oxford

Thetford

Greater

Hythe

100 - 499

0 - 99

500 - 999

1000+

Number of employees

Cardiff andBridgend

Wokingham andBasingstoke



Figure 6 - UK medical-device output by categories


5 companies

6 companies

7 companies

7 companies

9 companies

12 companies

13 companies

13 companies

14 companies

20 companies

22 companies

25 companies

28 companies

25 companies

£110m

£21m

£200m

£29m

£20m

£81m

£60m

£200m

£67m

£79m

£240m

£53m

£520m

£170m

810 employees

260 employees

2100 employees

170 employees

200 employees

1300 employees

740 employees

1800 employees

860 employees

910 employees

1400 employees

610 employees

2200 employees

4200 employees

Endoscopy

Anaesthesia equipment

Wound management

Ultrasound

Design & development

Prosthetics

Implantable devices

Infusion & inhalationtherapy

Hearing aids &audiometry

Invasive surgery

Hospital capitalequipment

Laboratory instruments

Infrastructure, comms,beds, etc

In vitro diagnostics &kits

Note: The companies total exceeds the UK national total as some companies have multiple interests. Turnoverand employees have been distributed between these companies' activities.

50 compani

mpanies£200m

10m

1900 employees

7300 employees

Patient monitoring

Hospital supplies &disposables

95 co

£8

es

15


4 Technology and Product Development

This section examines technology and product development, with particular reference to the drivers – regulatory and technology integration issues that characterise the sector. A tabulation of the drivers that affect medical-device development is followed by a synopsis of word developments, reference to the UK Foresight activity and then a review of patent activity. The section concludes with a discussion of the interaction of regulation, crafts and skills, which dominates the design, development and manufacture of medical devices i

4.1 Drivers and Technical Issues

Table 9 illustrates the relative importance of the main drivers across the medical-device clas-sifications chosen for this report (defined in Table 2 and listed by device type in Appendix A).

Table 9 Drivers

n the UK.

DRIVER

Nor

mal

ised

rank

ing

acro

ss a

ll de

vice

cat

egor

ies

Wou

nd m

anag

emen

t

In-v

itro

diag

nost

ics

& ki

ts

Endo

scop

y/La

paro

scop

y

Impl

anta

ble

devi

ces

Pros

thet

ics

and

artif

icia

l joi

nts

Hea

ring

aids

& a

udio

met

ry

Inva

sive

sur

gery

Hos

pita

l sup

plie

s &

disp

osab

les

Inst

rum

ents

- tre

atm

ent,

clin

ical

an

d la

bora

tory

Hos

pita

l cap

ital p

lant

Hos

pita

l inf

rast

ruct

ure

(incl

. co

mm

s, b

eds,

etc

.)

Ultr

asou

nd

Anae

sthe

sia

Patie

nt m

onito

ring

Infu

sion

& in

hala

tion

ther

apie

s

Regulation and safety 5.0 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5

Cost to make 4.1 5 5 3 2 3 5 5 5 4 3 4 4 5 4 5

Efficient use of trained personnel

3.5 5 5 3 0 3 3 4 3 4 4 3 4 4 4 4

Cost to use (e.g. energy, time)

3.0 3 2 3 4 2 3 0 3 3 5 2 3 4 4 4

High i 2.7 0 4 3 5 2 5 ntegration

balisation/ss

0 3 2 0 0 4 5 3 4

Glomaavailability

2.5 5 5 2 2 3 4 4 4 0 0 0 0 0 4 5

Smart structures 2.2 2 4 3 3 2 3 2 2 0 0 2 4 0 3 3

Cost (use of real estate & infrastructure)

1.7 0 0 0 0 0 0 0 3 4 5 4 3 2 4 0

Minimal invasion 1.0 0 5 5 0 0 0 0 0 0 0 0 0 0 5 0

= Increased future importance 0 = Unimportant 5 = Vital



The following observations are worthy of note:

• Regulatory matters and safety are hugely relevant across all sectors – a point reported by all the contacts who contributed to this report.

• In those sectors where minimal invasion is important, it is supremely important. • Smart structures are already moderately important across all categories today and promise

to become more important in the future across a wide cross section of device categories.

A checklist of technical issues pushed by the drivers is given in Table 10.

Table 10 Technical issues

Imposed environments

EMI & EMC Issues

Electro/opto/ mechanical integration

Gas/liquid/ sensor interfaces

(incl. membranes)

Electrodes Bio-interfaces / implantation

Cross-discipline design



Cross-discipline design Mass Bio-compatibility

Sterilisation ECG signals very weak

Fixtures and fasteners Electrical isolation Size Toxicity

Sluice/wash/steam/disinfect

Instruments must not interfere with

each other

Design for inspection

Contamination of patient Contact reliability Immunity to

rejection

High magnetic fields near MRI

Instruments must be tolerant of

electrical/magnetic noise

Servicing Thermal isolation Comfort

Integrity of interface to

encapsulated device

Stressed people Choice of

communications standards

Effects of voids (reliability, infection)

Contamination of sensor or

membrane

Potential for wire-free

Integrity of interface to nerve

or tissue

Selective screening (EMC

compliance whilst still able to

transmit & receive)

Materials compatibility – temperature,

aging, electrical effects …

Selective encapsulation

(protecting sensors yet

allowing sensing)

Overall robustness External control

Privacy of data Adhesives Disposability of parts Power supplies

Localised precision Overall robustness Monitoring

Manufacturing contaminants Overall robustness

Overall robustness

4.2 The Current World Scene

The following sub-categories have been chosen as being of specific interest.

4.2.1 IN-VITRO DIAGNOSTICS

ular testing. More and more companies are developing automated instrumentation, which simplifies testing and requires less human manipulation and intervention. Increases in automation lead to increases in productivity and decreases in manpower. This has a dual positive effect in light of recent laboratory

Increased automation Although automation in the laboratory is not perfect, it is well on its way. This is especially true with new technologies such as molec



personnel shortages. Obstacles expected to be conquered in the near future by this trend are high costs and throughput issues.

cles – such as sensitivity issues when dealing with extremely small sample volumes – before it reaches the finish line and microfluidics and miniaturisation become seamlessly integrated into diagnostics.

lthcare industry in general is moving towards assigning

ng their own health awareness. As this trend develops, the patients may have more of an impact by imploring doctors to use or consider ingenious technologies. In other words, patients are

tive in their own personal healthcare issues instead of just passive participants.

The European IVD Directive This dire was legall s ted in December 1999. The Directive is d gned to require medica vi and in agnost upplies/reagents t in compliance with predetermined national standards. The adoption of the directivprotracted, spanning about seven years before complete implementation occurs.1

4.2.2 ENDO Y D IM Y A S E

oscopy equipment In European countries, sales of endoscopy equipment are g at on nu . M nu tur s a experiencing llin

the board. Only technological advances have the potential to push market growth. Suppliers are relying on service agreements to maintain revenues. Developments that may help this market

autoclavable flexible endoscopes, disposable endoscopes, more robust rigid es and microendoscopic devices.

or s ss cc so s h e wn b om the largest sector of the market almost everywhere, partly because accessories are not capital-intensive items and partly

mo c so s e po ble an req re eq t pla me . les f have risen since the Medical Devices Directive outlawed the widespread practice of

g dispo e ms he en m et ow er, not led by the sale of accessories. Its claving regulations have led to a rapid expansion of the replacement market for rigid es. c rep se 2 % f t European market, second only to Germany's

ems Many European countries have installed robotic systems for a variety of appli n t se G a is e l es ar t fo ob c s gic sy ms n herlands, widespread use of minimally invasive techniques is evident, including

ndoscopic surgery, laser technology and imaging devices. The Leiden University Hospital own s system in Europe – a clinical laboratory automation system. The

ajor European countries – France, Germany, the UK, Italy and Spain – have installed robotic surgical systems.

Microfluidic and miniaturisation technologies These have made a substantial impact in the in-vitro diagnostic industry. They have reduced the volume of specimen required for testing and have made widespread point-of-care testing a reality. In combination with automation, microfluidics and miniaturisation are moving towards being the accepted standard across the entire in-vitro diagnostics industry. However, the trend will meet with various obsta

Increased patient responsibility The heapatients increased responsibility regarding their personal conditions. This trend is still young but has the potential to be far-reaching. Patients continue to become more sophisticated regardi

becoming more interac

ctivel de

SIVE

y in-vitr

tituo di

IVDo bee is

esi

SCOP

ces

URG

ic s

AN MIN ALL INV RY

Sales of endgrowin ly 4% an ally a fac er re fa g revenues and profits across

grow includeendoscop

The access y bu ine A es rie av gro to ec e

because st a ces rie ar dis sa d ui fr uen re ce nt Sa odisposablesreusinstrict auto

sabl ite . T Fr ch ark , h ev is

endoscop Fran e re nts 2.5 o he 25.5%.

Robotic systsurgicalthe Net

catio s. A pre nt, erm ny th arg t m ke r r oti ur al ste . I

es the first hospital robotic

m



Endoscopic neurosurgery Also on the horizon for endoscopy is same-day brain surgery. A fully

pro e point of entry is through the nostril, there is l procedure

Oph ic surgery. A proximity sensor that alerts surgeons to the location of retinal tissue when they are performing endoscopic eye procedures is being developed at the Microsurgery Advanced Design Laboratory at Johns Hopkins University, Baltimore. With the monoscopic endoscopes

rgery, the surgical visual field appears flat, and surgeons may have difficulty discerning the distance between their instruments and the retina. Accordingly, the dev lates ce b edle and the re d ht refl om the face. Th ice has a small fibre passing through the endoscope bore that transmits light to the retina and collects the reflected light. The r a th o it is c ted in l signal with a voltage level dependent upon the distance between the endoscope's needle and the

e end n o s ed lly invasive endoscopic surgery, in which the surgical team can easily and precisely view endoscopic ima ol operating equipment. A typical endosuite has two video s ca d bo oth the e. Videocassette recorders and assorted monitors often rest in staggered modules the s u iti w e teaching tools for practising surgeons. Such speci ed operating rooms help solve the fundamental cha im su ow to work in a confined space, deliver ght with ea ide o ren f tissues and o o ns can use endoscopic MIS techniques to treat gastro-oesophageal disease ernias, heart disease, colorectal disease and breast disease.

4.2.3 WOUND MANAGEMENT

Composite dressings These have evolved since the early 1980s and have been designed to incorporate physically distinct components into a single dressing that provides multiple functions. These functions must include but are not necessarily limited to: a bacterial barrier; an

rent or non-adherent property over the wound site; and an adhesive border. Composite dressings often combine the appropriate features of different

sion and wound visualisation as necessary.

e have also been developing since the late 1980s and offer the practitioner the ability to manage painful wounds by the use of a thin, vented, transparent film

endoscopic procedure utilises a tiny endoscope 4 mm wide and 20cm long with angled tips to vide a panoramic view of the brain. Because th

no scarring and the brain is undisturbed. Both the time required for the actual surgicaas well as the overall recovery time are dramatically reduced.

thalmologic endoscopic sensors New technology is improving endoscopy in ophthalmolog

that must be used for ocular su

ice calcuetection of lig

the distanected fr

etween the retinal sur

endoscope's nee dev

tina based on

eflected light p sses through e fibre to a ph todiode where onver to an electrica

retina.

Video-assisted ndosuites An osuite is a perating room pecially design for minima

ges and contrsuspended fromcreens, each ntilevere oms, facing b sides of surgical tabl

belowcreens. All eq ipment is pos oned exactly ithin the room.

ally designEndosuites ar also important

llenges of minout attendant h

rgans. In video

ally invasivet and prov

-assisted end

rgery, i.e., hptics that

suites, surgeoli der an exact representation o

, gallstones, h2

absorptive layer; either a semi-adhe

dressing types to tailor absorption, moisture vapour transmission, adhe

Contact-layer dressings Thes

layer that will not adhere to the wound. These dressings are used to line the entire wound and are not intended to be changed with each dressing change. Typically, they are changed weekly. The doctor has the option to use any preferred dressing over a contact-layer dressing, knowing that the contact layer will not interfere with the function of the primary dressing.



Speciality absorptive dressings Speciality absorptive dressings represent a category of simple, primarily one-piece wound dressings designed to reduce the frequency of dressing change and thereby save nursing time while reducing pain and trauma to the wound site. They also lower

The main developments in infusion pumps support devices becoming smaller, lighter in weight and portable. One driving force is the fact that the space

risation is the rapid development of the ambulatory healthcare sector, where infusion pumps are necessarily lightweight and portable, and easy to handle. Patient safety is very important especially with

therapies, including intravenous anaesthesia and

gly required to fit into this electronic environment. This is leading devices to have an

, often a patient requires further treatment such as regular intravenous

total dressing cost. Their primary feature is superior absorptivity compared to other gauze-type dressings. The major benefit is that one dressing eliminates the need for the use of a sterile sponge, tape, non-adhering layer and scissors. Also, extended wear is a major benefit for the home healthcare patient.3

4.2.4 INFUSION DEVICES

Some 80% of hospitalised patients receive intravenous (IV) infusions in one form or another. However, it is important to bear in mind that in some countries all inpatients are routinely fitted with a catheter for IV access for potential use, whereas in other countries IV access is only established if actually required. The technological development of the medical devices has been influenced by a variety of factors.

Infusion-pump technology trends

beside a hospital bed is precious, especially around acute or high-dependency beds where an infusion pump has to share the space with other medical equipment, including also other infusion pumps. As a result, new product types now include stacking systems, which stack a number of pumps vertically in order to save space. A second factor driving miniatu

pumps that are managed by the patient.

The capabilities and features of infusion pumps are generally increasing, but the market has been developing two ways. Firstly, pumps used in general hospital wards on a daily basis need to be relatively simple. Medical personnel are often under time pressure, so highly sophisticated devices with many features and settings may lead to apprehension and confusion. Simplification also applies to ambulatory pumps, where the pump is often handled by an elderly patient or care giver. However, pumps used for specific paediatrics, require sophisticated features for highly accurate drug-delivery mechanisms and controls to avoid medication errors.

Patient data management system (PDMS) PDMS is becoming increasingly important and necessary. It includes the paperless documentation and administration of patient data, which is required by law and also necessary for reimbursement and quality-management purposes. PDMS consists of a microprocessor unit at each patient's bed that is connected to a central unit allowing input, transfer and storage of data. Infusion pumps and other bedside devices will be increasinelectronic interface to input, transfer and store patients' data.

Shift away from the hospital environment The market for outpatient intravenous therapy is growing rapidly in most European countries. The main reasons are reforms affecting healthcare sectors leading to cost containment in hospitals and declining average inpatient stay times. In many European countries, the number of hospital beds has been declining. Surgical procedures and therapies have become more sophisticated, cutting the time a patient needs to spend in hospital. However



infusions that can take place outside the hospital in an alternative care site or the patient's home. This shift away from the hospital environment has led to a general trend towards smaller and lighter infusion devices with power-saving control circuitry. Despite this shrink in size and power, infusion pumps have become smarter, offering features such as the patient control, which allows patient controlled analgesia (PCA).

The whole segment of ambulatory devices is set to grow much quicker than devices only used in the hospital. This trend has become evident as most manufacturers of infusion devices have extended their ranges to include ambulatory and portable products. At the same time, these devices are characterised by easy-to-handle features and functions. The future of infusion devices is likely to further cater for outpatients, especially older patients.

Development of telemedicine Telemedicine exploits two-way telecommunications technology, multimedia and computer networks to deliver or enhance healthcare. It is aimed at the improvement of the quality of healthcare for those who live in remote or isolated areas where access to quality healthcare may be a problem. The move towards decentralised healthcare systems in sparsely populated regions is driving home infusion therapies that are delivered via remotely programmable or remotely controlled infusion pumps. Whilst the initial investment in new technologies is expensive, there are significant long-term advantages. In particular,

Pulmonary insulin delivery systems These are progressing through clinical trials. Inhale Therapeutics, in collaboration with Pfizer, has an inhalable insulin product in phase III clinical trials. Aradigm, collaborating with Novo Nordisk AG, has an inhaled-liquid system, which has

e is collaborating with Eli Lilly on a product now in phase II testing.

Reproductive hormones Pulmonary technology is also being investigated as a means of

front, Aviron, in

patients using these new devices will enjoy a greater sense of independence leading to better patient self-management. In turn, this is likely to mean reduced costs if fewer visits by medical personnel are required.4

4.2.5 INHALATION THERAPY

Pulmonary delivery of therapeutic agents offers the advantage of increased concentration of a drug at the site of action without the problems of systemic side effects. Historically, the treatment and control of asthma has been the overwhelming driver of low-cost, reliable, mass production. Now other therapies and applications are being introduced.

compl ted phase II trials. ElanAlkermes is developing an inhaled-insulin product that is delivered in single-dose, disposable packets. Aerogen is working with Becton Dickinson, which is developing a patient-adjustable container for use with Aerogen's insulin product.

Osteoporosis Eli Lilly is collaborating with Inhale Therapeutics on an inhaled bone-forming treatment for osteoporosis. The companies anticipate that this inhalable product will be the first to use Inhale's new pocket-sized inhaler technology, which is in phase I trials.

delivering reproductive hormones to treat female infertility. This market is estimated at over $600 million annually. Alkermes is in phase I trials with its product, EstroLast, a pulmonary-delivered generic estradiol for oestrogen-replacement therapy.

Viral protection An inhaled influenza vaccine will soon be on the market. Aviron, in collaboration with Wyeth-Lederle, has completed clinical trials on FluMist. Still on the viral



conjunction with SmithKlineBeecham, is developing a vaccine for Epstein-Barr virus, a source of mononucleosis. Alkermes is also developing an inhalable monoclonal-antibody treatment for respiratory syncytial virus.

Other developments Aradigm, in collaboration with Genentech, is developing an inhalable treatment for Genentech's cystic fibrosis drug, which is scheduled to go into phase IIb trials in late 2001. Aradigm is also partnering with SmithKline Beecham for inhaled morphine in cancer patients with breakthrough pain. The product recently entered phase IIb trials.5

4.2.6 IMPLANTABLE DEVICES

, polysulfone or ceramics. Stainless steel, even though less expensive, has become less popular as it can interfere with scanning procedures such as

nd marketed by Berlex Laboratories. It consists of a T-shaped polyethylene frame with a steroid reservoir around a vertical stem. The reservoir

cetate formulation utilising Atrix's Atrigel technology. It is injected as a liquid and, after solidification into an implant, releases a controlled systemic

eed-implant radiation therapy.

Ports Since the development of the first implantable venous access device, different manufacturers have designed their own types of port. However, most are similar in design, function and application. The devices mostly differ in the choice of material used. Ports can be made from stainless steel, titanium

magnetic-resonance-imaging (MRI) scans. For these reasons, the port material should therefore be non-conductive and non-magnetic, but during an x-ray procedure the port should clearly show up. The most commonly used device across Europe is a plastic port with a titanium reservoir (chamber) or at least a titanium base. Ports fully made from plastic have gained popularity due to their lower costs compared to metal devices.6

Contraceptive implant products Recently introduced to the U.S. market, these include: Mirena and Nuvaring. Mirena is a levonorgestrel-releasing intrauterine system, approved in December 2000 for contraception for up to 5 years a

consists of a cylinder made of a mixture of levonorgestrel and silicone, covered by a silicone membrane. Nuvaring is a self-administered intrauterine device. It comprises a flexible plastic device inserted monthly, fitting around the cervix to release a steady flow of both progestogen and oestrogen to prevent conception.

Implant-delivery cancer therapeutics has spawned a number of products with a variety of mechanisms of action. Atrix Laboratories has developed Leuprogel for the treatment of prostate cancer. Leuprogel is a leuprolide a

therapeutic dose. A product that will soon be used to treat brain cancer is DepoCyt, a suspended-release injectable microsphere from SkyePharma, which eliminates repeated injections and reduces toxicity. DepoCyt has received preliminary FDA approval. For early-stage prostate cancer, UroMed has applied to the FDA for approval of its iodine-125 seeds. These radioactive-isotope seeds are implanted into the prostate during an hour-long outpatient procedure and provide localised radiation therapy. The implant therapy lowers rates of impotence and incontinence. Theragenics is also developing s

Intraocular implants are being developed to treat various eye diseases, such as retinitis, a viral infection that occurs in nearly 30% of late-stage AIDS patients and up to 60% of organ-transplant patients. The implants, which deliver a sustained drug dose for 4 to 8 months, would eliminate the need for daily or weekly intravitreal injections. Control Delivery Systems, Inc. has developed a technology for an implant that delivers an antiviral drug into the vitreous of the eye.



Chiron IntraOptics, a business unit of Chiron Corp., has licensed the technology and plans to assume sponsorship of the phase III clinical trials, which are presently under way.

Drug-delivery implants are also under development for many other disease targets, including heart disease, diabetes, dental caries and various 7 cancers.

pump surgery is being hailed as the next revolution in cardiac surgery. Mounting research evidence is supporting the

s Between 4% and 5% of revascularisation procedures can result in procedure-related stroke. Protection devices have now been designed to capture debris during an interventional procedure. Medtronic's subsidiary, PercuSurge, develops and manufactures

ices. The company's PercuSurge GuardWire Plus comprises a

tem (PAES) to protect

em is designed to apply less pressure on the diseased blood vessel and to maintain balanced blood-flow rates.8

nt-related instrumentation has to share the space with other medical equipment. Further afield, light weight and portability is

4.2.7 SURGICAL DEVICES

Off-pump devices There is a growing trend towards performing coronary artery bypass graft (CABG) surgery on a beating heart, also known as off-pump CABG. Off-

belief that performing the procedure in this manner, as opposed to the conventional method of stopping the heart and using a heart-lung machine, has major benefits for patient outcome. An estimated 20% of bypass procedures are now performed using off-pump techniques.

Off-pump surgery requires some or all of the following: stabilisation systems; access devices for allowing easy access to vessels near the rear of the heart; immobiliser systems; suction appendages which conform to the surface of the heart and allow the surgeon to position the heart as desired; aortic and other sutureless connectors. Robotics and minimally invasive techniques are also an important part of the CABG revolution.

Embolic-protection device

interventional protection devballoon-tipped guide wire, which is inflated briefly to occlude blood flow and captures any material dislodged during the procedure. This material is then withdrawn using the PercuSurge export aspiration catheter.

ArteriA Medical Science has developed the Parodi Anti-Emboli Sysagainst emboli during carotid-artery angioplasty. A catheter is inserted into the femoral artery and guided to the common artery, where the balloon is inflated. Meanwhile, another balloon is positioned to block off the external carotid artery. The system works on the basis of reversing the blood flow in the target vessel so fragments of plaque flow away from the brain and can be filtered from the blood flowing back into the body. A different approach, the Angioguard, is marketed by Cordis. The device resembles an open umbrella when positioned in the artery, with micro openings to filter out the debris. The syst

4.2.8 PATIENT MONITORING AND PATIENT-RELATED INSTRUMENTATION

Technology trends Trends in patient monitoring and patient-related instrumentation follow similar drivers to those in infusion pumps: reduced size and weight, greater portability and more and more highly featured while remaining simple to use in a busy and often stressful environment. At the bedside, patient monitoring and other patie

taking the instrument to the patient within the hospital, within clinics and in the home.



For reasons that are reviewed in the next section, medical-device companies are coy about their forthcoming product developments, but a useful set of examples is published by the NHS Regional Medical Physics Department, which is inviting commercial exploitation for its developments, as follows:

rrence of kidney reflux. This device is used as a diagnostic tool and is worn like a belt on the patient allowing freedom of movement.

Peripheral pulse measurement This is a non-invasive vascular measurement system for the

cs and sport and fitness centres as potential sites where the instrument might be used.

em monitors the swaying motion of a standing subject to assess postural stability. While the subject stands within a weak magnetic field (produced by the

e. Other applications include the assessment of burns, use in diabetic clinics, in vascular surgery

restoration is usually achieved by fitting a small prosthetic valve between the trachea and oeso-

Kidney reflux system Kidney reflux is a medical condition that results in urine going back up into the kidneys. This device is primarily aimed at young patients and hinges on a new highly sensitive radiation detector, which is linked to a data logger to analyse the occu

initial screening of peripheral arterial disease. This system compares multi-site pulse waveforms obtained from various different body sites and also compares each site with normative pulse data in order to determine if significant vascular disease is present. The multi-site pulse approach also shows promise for the assessment of peripheral arterial ageing and for the assessment of autonomic function. The product is currently undergoing clinical evaluation and promises simplicity of application and ease of data collection. Additionally, it has benefits for screening patients in GPs’ surgeries and other primary-care establishments in that it allows de-skilled staffing and quick peripheral vascular assessments to be made, along with speed of diagnosis and low resource overheads. Interestingly, and as a pointer for other instruments, the Regional Medical Physics Department also cites home diagnosti

Programmable cardiac stimulator The Cardiac Stimulator is a versatile, portable instrument designed for use in cardiac electrophysiology investigations. The instrument can be easily integrated into electrophysiology recording systems. The interface, described as ‘user friendly’, gives control over many stimulator features, allowing a comprehensive range of provocation sequences to be performed.

Sway-magnetometry system The syst

system), movement of the body is monitored by measuring the magnetic field using small detectors placed on a belt around the hips. The prospects for this instrument show how medical-device development and technology could grow into much wider markets. In addition to applications in biomedicine (audiology, ENT and drug assessment), in neurology (examination and surgical appraisal), rehabilitation, geriatrics, orthopaedics (rehabilitation assessment and surgical appraisal), the Department also sees applications with the disabled and sports science. But furthermore, they also have the vision to see applications in computer control and in balance assessment for aviators

Skin oxygen-level imaging system (SOLIS) This has particular applications in imaging and reconstructive surgery, detection and monitoring of the progress of peripheral vascular diseas

and trauma. SOLIS is quick and easy to use, unique and non-invasive. A prototype has been constructed to evaluate the concept of oxygen imaging. Early results show promise in the clinical area.

Tracheal air-pressure measurement For patients who have undergone laryngectomy, voice



phagus. The device developed measures the air pressure in the trachea while the patient speaks and displays it on an array of coloured LEDs, giving valuable information to the speech and language therapist and providing biofeedback to the patient. The pressure meter can be

UV phototesting wand Measuring the sensitivity of a patients' skin to ultraviolet (UV) radiation before they undergo UV treatment for a skin disease can improve the treatment. This ‘phototest’

e reas of skin to increasing doses of UV radiation and noting the smallest dose that results in a slight redness of the test site 24 hours after exposure.

ze, power consumption and cost are reduced and reliability is improved. These benefits ensure that more

connected to a PC. Software written in-house allows the data to be displayed graphically.

involv s exposing small a

Ultrasound Smaller, portable machines are becoming available. Image quality is dramatically improved. Real-time imaging is now possible, and solutions are being found for those patients that were previously difficult to image. Developments in digital electronics and transducer technology, for example the use of application-specific integrated circuits (ASICs), mean that one super-chip can now replace several boards of electronics. This means that si

computing power can be packed into a machine of standard size or that the same performance can be obtained from a smaller machine. This is epitomised by the portable high-performance SonoSite scanner. The miniaturisation achievable with digital electronics makes good image quality and power Doppler possible in a relatively inexpensive hand-held unit.9

4.3 Patent Survey

A search was made for patents granted during 1999–2001 to UK inventors and held by UK companies. Similar searches were made for patents with German, Japanese, US and French inventors and owners respectively. Only IPC categories A61b, A61c, A61g, A61h, A61m and A61n were covered; they fit best the medical-device field covered by this report. See Table 11.

Table 11 Patents granted 1999–2001

IPC Category A61b A61c A61g A61h A61m A61n

gnos

is, s

urge

ry,

entif

icat

ion

ntis

try,

ora

l or

ntal

hyg

iene

nspo

rt o

r m

mod

atio

n fo

r pa

tient

s

ysic

al th

erap

y pa

ratu

s, a

rtifi

cial

ira

tion r i

ntro

-in

g m

edia

into

b

ody

ther

apy,

to

ther

apy,

n

ther

apy,

ou

nd th

erap

y

Dia

id De

de Tra

acco

Ph ap resp

Dev

ices

fodu

cor

ont

o th

e

Elec

tro

mag

nera

diat

ioul

tras

France* 1220 183 139 185 732 196

Germany 6342 2286 1152 825 4064 919

Japan 10617 1361 2146 2895 3524 1105

United States 9911 889 568 347 6017 2293

Great Britain 905 111 521 169 962 76

Total number 28995 4830 4526 4421 15299 4589

% 46% 8% 7% 7% 25% 7%

* For France, data on granted patents were unavailable; the data here are for patent applications.



UK patents are fewer than might be expected from a comparison of GDPs. The UK’s GDP is about one-tenth of the US’s, a ratio reflected in the patents granted. In France, which has a GDP slightly greater than that of the UK, patent applications are slightly more numerous than granted patents in the UK. In Germany however, where GDP is around 50% up on that of the UK, the number of patents granted in this sector is many times the UK figure. In Japan, with a GDP one quarter of the US’s, the most patents were granted. Perhaps the preponderance of German patents aligns with that country's very healthy trade surplus in this sector.

Further analysis of the content of the UK patents yielded the data in Table 12.

Table 12 Analysis of GB Patents registered 1999-2001

IPC Category A61b A61c A61g A61h A61m A61n

Number of patents 905 111 521 169 962 76

% 33% 4% 19% 6% 35% 3%

Number having significant equipment content

75 0 2 2 44 11

Assignee origin assumed as UK

34% 0 0 100% 39% 36%

Assignee origin assumed as non-UK

33% 0 50% 0 31% 28%

Assignee origin not determined

32% 0 50% 0 30% 36%

There is a preponderance of ‘equipment’ interest in IPC categories A61b (diagnosis and surgery), A61m (drug and other media introduction into the body) and A61n (therapies involving electrical, magnetic, radiation or sound waves). It is thought that none of the categories include patient monitoring per se, because such equipment will be classified for patenting purposes as

ipment' patents

‘instrumentation’.

Non-UK assignees represent a significant proportion of GB patents. It is possible that where the origin of the assignee of a UK patent has not been ascertained it could still be in the UK. However, because of the way the selection was made, these assignees are unlikely to be either commercial or university bodies.

An analysis of the 49 patents having UK corporate assignees yielded the data in Table 13.

Table 13 Ranking of UK 'equ

Category Number of patents

Category Number of patents

smart catheter 8 ultrasonic apparatus 3

implantable technology 5 smart bone fixture 3

infusion 5 electromagnetic treatment 3

non-invasive monitoring 5 endoscopy 2

smart electrode 4 imaging - optical 2

inhalation 4 Other (non-clinical) 5



4.4 Regulation, Craft and Skills

During the course of the study a picture emerged of a sector whose dynamics are characterised by regulatory effects upon relatively small-volume manufacturers, themselves highly dependent for their success upon multi-disciplinary skills and craft. The domination of regulatory

elopment resources and the economies of manufacturing scale.

• increased business risk, firstly as competitive products may be launched during the delay and, secondly, because regulations may require prototypes to be produced on the volume

isaged for mass manufacture, which accordingly may need to be built o guarantee of eventual commercial operation

An easy guide to the MDD is available at www.qualitydigest.com:

one of four classes of increasing risk to the patient according to their properties, function and intended purpose. The level of control is

to the of ris nsure ction ent h ighte es classify medical devices that require understanding and interpretation, as there are no clear-cut categories

• Class I devices are those that pose a low risk to atient e products or measuring devices, can be self-certif m re speaking, these es do ter in t o it .

• Class IIa devic of a ris y r se t the ISO 9000/EN46000 standards. These es are ive in t teracti ith the human body, but the methods of invasion are limited to natural body orifices. The category may also include therapeutic devices used in diagnosis or in wound mana t.

• vice of a medium risk th ay requ sesse lity sy to 0/EN 0 stand third-p ertification is required. They are either ota ntable the h body, ay m e biological or

chemical composition of body fluids.

conformance in conjunction with the imponderability of 'craft' discourages UK medical-device companies from pursuing the now more usual subcontracting of development, design and manufacture. Accordingly companies are not only held back by the delays and risks arising from regulation; they are insulated from the benefits of access to a breadth of outside dev

4.4.1 REGULATION

The FDA in the US is recognised not only throughout the huge local market, but also across the developed world. In the EU, the Medical Devices Directive (MDD) applies. According to the class of device, producers need to ensure conformance with non-trivial sets of rules from design through manufacture. The effects of regulation bring:

• long delays (of several years) to product introduction

production lines envpre-emptively with n

• a philosophy of incremental product development, or, in the limit, no development at all unless absolutely necessary

One company contacted employs a full-time Regulatory Affairs Manager as a senior role.

The MDD places all medical devices into

proportionate level k to e prote of pati ealth. E en rul

.

devic

es are

the pied by ther interact w

equire as

and, excanufactu

h the body

ssed quali

pt for steriler. Generally

y systems to

not en

medium

to contac

k that madevic invas heir in on w

gemen

Class IIb de s are at m ire as d qua stems the ISO 900 4600 ards; arty cpartially or t lly impla within uman and m odify th



• Class III devices are of high risk and require design/clinical trial reviews, product certification and an assessed quality system. All third-party product and system certification must be conducted by a European Notified Body (or designee through formal agreement). Generally speaking, these devices affect the functioning of vital organs and/or life-support systems.

Medical device classification may also be affected by the time period in which the device performs its intended function. Three definitions for duration of use apply to the directive:

utes), short-term (normally intended for continuous use of 30 days or less) and long-term (normally intended for continuous use of more than 30 days).

4.4.2 KILL RAFT AND SCALE

Skill, craft and scale convey the following fur charac tics upo secto

eir very ure requ a multi-disciplinary approach. Even a relatively simple piece of tubing will require input from medics, polymer scientists, moulding engineers

d ster kaging e erts. • The combined demands of maintaining such skill sets and satisfying regulatory

r with perils of ailure in why fo examp en 'simple' disposables do not become commodity items imported from low-cost economies.

• Mu n des ten outstresult, depending upon the emphasis of the organisation, electronics design might for instance be performed by chemists, or mechanical design by electronics engineers, etc.

nd subassemblies may well be sub-contracted. Individually they exhibit little potential for IPR: the value is in the integration.

not possibly audit such 'x' factors, and when something works long

and risky delay.

ility of fully eliminating ‘x’ factors through specifications.)

transient (normally intended for continuous use of less than 60 min

S , C

ther teris n the r.

• Medical devices by th nat ire

and safety, quality an ile-pac xp

conformance togethe the f expla r le ev

ltiple disciplines i ign of rip the capabilities of small organisations. As a

This will lead to non-optimal products. • Those medical devices requiring the physical integration of technologies tend to be

manufactured in relatively small quantities. Integration is therefore performed by the hand assembly of parts and subassemblies rather than through truly integrated manufacture. These parts a

• Hand assembly and integration through craft skills is difficult to characterise, leaving important factors unaccounted for which can and do hamper the consistency of manufacture, and in particular impede its transfer between facilities.

• Conformance inspections cancompanies are very reluctant to change, especially when such a change may invoke a

(See Appendix B for a note explaining the impossib



5 Future Directions for UK Medical Devices

The UK Foresight Programme brings together the voices of business, government, science and t might happen in the future and what needs to be done now to secure

long-term competitive advantage and enhanced quality of life for all. Each Foresight panel has

e healthcare panel's ‘Healthcare 2020’ n on health engineering contains the

g of biological behaviour,

body functions and the clinical applications of genetics will draw heavily on engineering in areas such as microstructure and microarray development, imaging

ation of physical and chemical

y viable in vivo robotic systems, whilst still some way off, are a likely end re

35re d, structure-coimfoapoxvascular pathology and thrombosis. Cardiovascular diagnosis and treatment will make use of smfoenfa ocused ultrasound.

This final section commences with an extract from the UK Foresight Programme healthcare panel's vision of the future for 2020, then examines the imminent course of medical-device technology development. This is followed by a review of UK development programmes before concluding with a discussion regarding technology integration – a thread that has coursed through the whole study.

5.1 UK Foresight

others to look at wha

looked at the future for a particular area, identifying the challenges and opportunities that the country is likely to face over the next 10 to 20 years and beyond. The panels’ reports provide the basis from which panels and others are working to help turn the recommendations into action at national, regional and sectoral level. Thdocument was published in December 2000. The sectiofollowing predictions.

35.1 Physical and engineering sciences will play a pivotal role in the further development of biology, medicine and health care in areas such as whole systems engineering, mimicry of natural sensor/effector pathways, image analysis, predictive modellinand clinical decision support. Physical sciences will be drawn on to understand how molecular processes translate to whole

and data mining.

35.2 Improved patient surveillance will result from miniaturissensing devices, along with smarter biohybrid (‘biosensor’) structures. Advances in device miniaturisation will permit lower cost solutions to techniques such as magnetic resonance, ultrasound, chromatography and mass spectroscopy. These will be used in the near-patient context, as is currently the case for bedside electrophysiological and biochemical monitoring systems. New tools in endoscopic surgery, particularly those with a feedback link to navigation will emerge. Clinicall

sult of progress in areas such as microfabrication, material science and biointerfacing.

.3 Advances in enhanced image resolution, and extension into both 3-dimensional and al-time domains are occurring now and these will provide the basis for targetenformal therapies, as robotic surgery and metabolic imaging initiated in PET scanning. New aging modalities and improved resolution from existing methods will also lead to techniques r non-invasive tissue microscopy and tissue architecture visualisation, transforming current proaches to tissue diagnosis. Full 3-dimensional tomographic scanning of flow, perfusion, ygenation distribution, and probably also endothelial function, will be available to investigate

aller, higher resolution endoscopes including endoscopes that are remote-guided by a cused magnetic field, intelligent stents, for example with drug release based on local vironment, plasma oxygen carriers and the targeted release of anticoagulants/angiogenesis ctors for example from liposomes using f



35decliasult assessed alongside any other health technology in regard to clinical benefits. It could be an important means of enhancing mass screening,

The

gether the NHS, Research Councils, industry and other relevant interests including the Royal College of Surgeons and Royal Academy of Engineering. Under an independent Chair it would be given the remit of developing without d for health engineering, including the identification of new interdisciplinary opportunities for scientists, engineers and doctors.

RECOMMENDATION 34 We recommend that ways of creating better integration between

isciplinary activities. We highlight here a

they are

terials science and biology. The future will see an

NHS is not produced by

The NHS should stimulate rather than be apprehensive of engineering technologies,

here are engineering solutions that are relevant to NHS interests and usable by less affluent countries.

5.2 Technology Development

The following pointers and examples of current, imminent or required technology development were collected during interviews with industrialists and researchers in the medical-device sector, from Internet announcements and other news commentary.

.4 Commercial work with high throughput screening for drug discovery already places mands on computational data processing methods and these should be applicable in the nical sphere. Nano-bioreactors have been developed for diagnostics allowing thousands of say wells to be incorporated into centimetre scale platforms. Whatever its technical power, imately data processing will need to be

disease risk assessment and predicting individual prognosis.

document also contains two recommendations relevant to the UK Medical devices sector:

RECOMMENDATION 33 We recommend the establishment of a Health Engineering Consortium. The consortium would bring to

elay a national strategy

mathematics, biology, medicine and engineering/physical sciences should be addressed by government, funding bodies, and universities. In recommendation 18 we point to the need for clearly established processes to facilitate cross-dparticular need:

The interfaces between these fields of research and others including chemistry and social sciences, should be tackled by medical schools, by the universities with whichassociated, and by the Higher Education Funding Councils. Relevant to this is curriculum design in schools, faculty structures and curricula of universities and the organisation and funding criteria of research funding bodies.

Currently there is a gulf between maemphasis on implantable materials that are bio-active rather than bio-compatible. Such materials will influence tissue responses for example by incorporating growth factors. Integration on site is needed to bring the relevant disciplines together and to associate this with technology transfer and training. At least two more UK centres are needed to take advantage of the opportunities.

Incentive structures are needed to link research with prototype engineering developments and commercially viable products. Given the fertility of ideas and prototype developments in the UK and the fact that the vast bulk of equipment purchased by the UK companies, the challenge of building a new relationship between biomedicine, health care, engineering/physical sciences and industry must have high priority.

particularly engineering solutions that could have wider applicability and export potential. Important



5.2. ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 1

• The US scene is very conservative. Even though endoscopes have evolved to replace light

• Future technical developments are indeed predicted to include the integration of other sensor systems into the endoscope head and to incorporate tele-manipulated instruments,

erforming combined inspection, diagnosis and surgery in one pass. Far-s will see remote ‘Fantastic Voyage’ robotic probes.

nted in the mastoid and laser-welded to the incus bone of the middle ear. Th

• Oa orca

• A patients until suitable donor hearts are found. The implantable heart pump, the DeBakey velit

5.2.3

• ‘Csi tion. Developments in multi-parameter sensing are likely to be needed to provide fail-safe op

• Inthofcous

• Thupmw

guides with miniature cameras, the allied surgical tools remain primitive and purely mechanical.

• Current technical issues are safety, sterilisation and miniaturisation, the latter to reduce invasion.

all in the hope of pfuture development

• The world centre for endoscopic development is not the US; it is the German Black Forest region, with its clock-making craft base.

5.2.2 IMPLANTS

• A new implantable hearing aid is under clinical study at the University of Tübingen, Germany. A sound receiver is implanted in the wall of the ear canal, the battery and processor are implanted subcutaneously behind the ear and an electro-mechanical transducer is impla

e different elements of the hearing aid are housed in titanium capsules. ne topical issue is what happens to implanted devices after they have been in the body for number of years. Recovery studies are not the norm, partly because of the difficulties of ganising these systematically, also because of the ethical problems of dealing with daveric recovery. device has successfully been used to support and improve prospective heart-transplant

ntricular assist device, is positioned in the left ventricle and boosts blood flow to 10 res/minute in cases with congestive heart failure.

INFUSION THERAPY

losed loop’ infusion therapy, whereby the dose is automatically controlled according to gns sensed from the patient, is anticipated but will need to proceed with cau

eration. sulin-delivery pump maker MiniMed is testing MEMS sensors for an implantable device at will monitor and regulate glucose levels. In ongoing tests with human subjects as part the federal regulatory process, a tiny intravenous sensor has shown that it is able to ntinuously and accurately read glucose levels. The next generation of insulin pump will e the sensor to control the delivery of medicine automatically. e US Georgia Institute of Technology has developed a new drug-delivery system based on a patch only a few millimetres square, on which an array of very fine needles is

ounted. Liquid drug can be pumped through the needles into the outermost layer of skin ithout pain.



5.2.4

• Thw

• In• Fa

• Rsi

• i-Spapa

• NanoPass Ltd has developed a MEMS-based disposable micro device – smart patch – wsk

• Udrthat allow the transducer to vibrate and stimulate the bones in the middle ear. As a result, flu

• A Uincochlear implants only use between 8 and 22 electrodes.

• Apinch

• Seimemitting diode near a separate photodiode receiver. It is encapsulated into a pill-shaped st

• Mac

• Mm dice in neonates without th

• Minth stimulates the brain in order to reduce the neuromuscular tremors associated with Parkinson's disease.

5.2.6 NON-INVASIVE MONITORING

ar meter for use at home, and that the product would ideally be the size of a pocket calculator and use only high-frequency electromagnetic fields to measure glucose levels through the finger or elsewhere.

MANUFACTURING INSPECTION

ere are issues with the rigorous inspection of integrated medical devices – devices that ill contain concealed 'smart' features. spection will need to be performed at production-line speeds ilure analysis will be more difficult. Acoustic microscopy?

5.2.5 MICROENGINEERING AND MEMS TECHNOLOGY

ADI Medical Systems AB in Uppsala are producing very small surface-micromachined licon pressure sensors developed for use in catheters. TAT has developed a hand-held automated blood analyser capable of performing a nel of commonly ordered blood tests on 2–3 drops of blood in just two minutes at the tient's side.

hich will enable withdrawal of biological fluid samples or the delivery of drugs through the in without the assistance of medically trained personnel. S company Otologics LLC has developed an auditory MEMS device whereby a tiny hole is illed into the incus and a transducer inserted. The system contains microscale bellows

id in the inner ear vibrates and stimulates the auditory nerve. second-generation, low-power cochlear implant is being developed by a team at the

niversity of Michigan. They are incorporating an array of 128 electrodes that will be serted into the inner ear (or cochlea) to electrically simulate the auditory nerve. Currently,

plied Digital Solutions already sells an implantable microchip called Verichip that contains formation about its wearer, such as allergies or medical conditions. A combined sensor-ip device is in development nsors For Medicine Inc. is attempting to develop a glucose sensor that would be planted under the skin for a full year. Their novel approach uses an extremely tiny light-

ructure about the size of a medicine capsule icroParts is now testing a radically different inhaler that uses micronozzles and a sprint-tivated micropump to replace the propellant-gas technology prevalent in today’s inhalers. icroParts has also developed a microspectrometer in conjunction with an American anufacturer, SpectRx. One application is early recognition of jaune need for a blood sample. edtronic Inc. has developed an implanted ‘deep brain stimulator’ based on an electrode serted in the brain. A miniature generator implanted in the chest cavity sends signals to e electrode, which

• Diabetes Services Inc. (www.diabetesnet.com) reports that research and development firms are trying to develop a portable, non-invasive blood-sug



• Diabetes Services Inc. also reports that the Canadian company CME Telemetrix has a non-

techniques to the emerging light, the concentration of various blood analytes

whereby Motorola purchased a 5% interest in CME in exchange for a worldwide

• rely on predictable

4 precisely selected frequencies, it is hoped that glucose can be accurately measured with little risk of user error.

• US Cygnus Inc. has spent well over 10 years developing a transdermal glucose sensor. It e a cons able transdermal pad, called an AutoSensor, which adheres to the skin and n ins a b sensor connected to a ‘GlucoWatch’. Normal dermis does not allow glucose

, who can be distracted by conventional ECG electrodes.

5.2.

• In invasive surgical products, the move is from multi-use sterilisable products to single-use disposable products.

• is osability ust m an low cost, but, released from the constraints of durability and e isability, esigns an be more effective and incorporate better features.

• -disposable element will be needed.

•

5.2.

• Electrocardiograms can be uncomfortable and intrusive to wear. The principal source of this discomfort is the wires connecting the electrodes to the recording instrument. Wireless technologies such as Bluetooth are being investigated to obtain ECG data using wireless

invasive monitor called GlucoNIR, which, uses near infrared light. A beam of light in the near-IR range is focused on a person’s finger for about half a minute. By applying mathematicalincluding glucose can be determined. On May 15, 2000, CME announced an alliance with Motorola, (excluding Japan) licence to CME's non-invasive medical devices for measuring glucose and other diabetes-related analytes. Radio Wave Technology is another approach described by Diabetes Services Inc. They report that glucose sensing through the use of radio waves could alterations in how ionic solutes like sodium respond to alternating electromagnetic fields in the presence of glucose. By using 3 or

us s umco ta ioto leak out, but skin can be forced open by electrical stimulation. The AutoSensor brings glucose through the skin by a small electrical charge in a process called reverse iontopharesis, and then triggers an electrochemical reaction that generates electrons from which glucose levels are estimated. The AutoSensor is manufactured in conjunction with Dupont.

• Developments in pulse oximeters will be aimed at producing ambulatory instruments. The problem is not trivial. Seiko are integrating the optics into a glove. MIT are working on a prototype ring, complete with servo and inflating pump. Ambulatory pulse oximeters will be popular with athletes

7 SURGICAL INSTRUMENTS

D p m est ril d c

• Avoiding sterilisation paves the way for smart instruments with integrated electronics and other ‘vulnerable’ technologies. An alternative approach will be instruments with disposable heads. Attention to the interface with the non

• The increased uptake of barrier approaches to infection control will put greater emphasis upon tele-mechanics and haptic feedback. A Bulgarian company is seeking to commercialise a combination of cryotherapy with electrophoresis, where the active electrode is shaped from a block of ice obtained by freezing a solution of a chosen drug.

8 UNTETHERED TECHNOLOGIES



el ctrode patches. This nuisance e also limits the cardiologist’s ability to obtain essential

• artment of Information Technology and Electrical ) is developing miniaturised

signal processing and signal transmission on the same chip, thereby reducing mechanical and electrical artefacts. All parts are developed in a standard low-cost CMOS technology.

Care Cent r, Koshigaya Hospital, Dokkyo University on with the Nihon Kohden Corporation a

trode was also evaluated during

• standard) or one of a plethora of radio standards is not easy. Bearing in

e ubiquitous.

5.2.

• The University of Rochester in the US has developed a hi-tech dressing to help doctors tell

teria, such as salmonella, listeria and E. coli. The ‘smart

5.3

Theseems to be the Cinderella of medical research funding. Of the 1600+ current MRC grants only

profunmedical devices administered by Quo-Tec Ltd on behalf of the Department of Health. This programme has now closed, but the 30 or so of its projects that were current in 2000 were all relevant to equipment-related medical-device development.

The Department of Health has now announced a new programme, Health Technology Devices

comtech

diagnostic data. The Electronics Laboratory in the DepEngineering at the Swiss Federal Institute of Technology (ETHactive wireless electrodes integrating signal acquisition,

• In Japan, the Trauma and Critical eSchool of Medicine has developed in associatismall wireless ECG module (size: 3 cm × 10 cm) consisting of a battery-operated telemeter equipped with two electrodes. The wireless ECG eleccardiopulmonary resuscitation and was operative even during DC shock. Untethered – infra-red or radio – is very much a flavour for the future but the decision to adopt IR (IRDAmind the gestation period imposed by regulation, a decision has to be made which will intercept with the future. One thought is that device manufacturers should determine the standard to be used by PDAs, which are expected to becom

• Both IR and radio, if they proliferate, will change the environment of use, either in the home, the clinic or on the person. EMC issues will be exacerbated. It is easy enough to screen a 'dumb' instrument, but to selectively screen something that must communicate reliably is another matter.

9 WOUND MANAGEMENT

the difference between types of bacteria and send the results to a PC. The team at Rochester are hopeful that they can improve their silicon sensor, the size of a pinhead, to identify different types of bacdressing’ picks out the lipid A molecule, which is found on the surface of the cells of gram-negative bacteria. The researchers have created another molecule, which binds with lipid A to make a subtle colour change.

Research Programmes

‘equipment’ (as opposed to biomedicine) subsector of the UK's medical devices activity

16 are relevant to the field. Similarly, only 2 of the 10 grants under EPSRC's IntHeTech gramme have relevance to the development of medical devices per se. An impending new ding programme has however been identified. MedLINK was the LINK programme for

(HTD), which will follow on from MedLINK. The mission of the HTD programme is to stimulate, mission and monitor collaborative research projects on new and improved health-nology devices. More specifically the programme plans to:



• commission 40 to 55 projects (dependent on modality), at least 2 of which will be concerned with trauma care and at least 2 of which will be concerned with tissue engineering (with a total public investment of at least £1m) involve at least 65 companies (75% of which will be SMEs) involve at least 35 science-base research groups achieve post-project collaboration in 50% of projects ensure that 80% of projects achieve the objectives stated in their proposals by the time of completion

• • • •

•

• least 125 participants, to

• •

•

HTD will be open to applications in mid- to late-May 2002 and is expected to close to new

end

5.4 Technology Integration

r d that p mpted and an through the study behind this report is that medical devices logies and disciplines. A premise to be tested by the study was

figu of medical devices, and that there should be opportunities to optimise

the anies' abilities

sectors such as information technology, telecommunications and consumer goods – all of which

instruments, is that production volumes are relatively low.

• ompanies typically design only on rectangular PCBs and adopt simple solutions. Integration takes place through skilled, intricate and often manual assembly processes. Individual subassemblies that do not cross technology

u aries are ub-contracte , and companies add value through their proprietary s bly (techn gy-integratio ) processes.

• ensure that the results of at least 50% of projects are taken up by companies other than the project participants within 3 years of project completion ensure that 15% of projects succeed in delivering new medical devices for use by health services within 5 years of project completion hold 5 seminars to disseminate project results, each involving atinclude 20 SMEs deliver 70 papers published in refereed scientific journals, reports and case studies deliver 70 patents (as a direct result of work done under the programme) that strengthen the IP position of the patentee organisations ensure that the results of 50% of the projects add to the commercial potential of the industrial participants within 3 years of the completion of the relevant project.

applications at the end of January 2008. The HTD programme itself is expected to close at the of January 2011 with the completion of the final projects.

The th ea ro rsit at a unique meeting of technothat new juxtapositions of materials, mechanisms, electronics, fluidics and photonics would

re in the development the integration of these technologies. Whilst the study confirmed the premise, it also revealed

overriding influence of regulatory forces. Regulatory matters constrain compto make the same sort of rapid progress that would be expected in other high-technology

also overcome issues of technological integration and convergence.

A further factor that colours UK medical-device development, especially in the case of

The following observations concern technology integration encountered during the study.

Cost is a strong driver. Accordingly, c

bo nd s das em olo nThere is a strong opportunity to analyse dextrous assembly processes and to match them with the automation features that are routine in other industries.



•

•

and implementing 'fashion'

•

•

s means that small organisations with small technology teams will almost certainly have a single overriding skill. This can lead to electronics engineers designing mechanical parts and vice versa, chemists tackling fluidics, etc.

roper UK supply chain of the valuable disciplines which are

With long product life cycles, rapid design is not needed, but products have a very high craft content. If this craft could be captured and built into the one-time activity of design then real progress could be made.

Another design-related issue is that some personal ambulatory products, notably insulin pumps, are becoming lifestyle (fashion) items. Medical-device companies have little experience in capturing needs.

Although mass-market technologies and components may not be optimum for small-scale manufacture, through industry globalisation the trend is that these are becoming the only technologies and components that are available. Medical-device companies need assistance to assimilate the consequences of this.

A further factor brought about by the abundance of 'high-street' technology, particularly in relation to sports and 'well-being' products, is that they will bring price pressure to bear. Mass-market products may prompt hospital financiers to question the costs of 'professional' equipment.

• Medical devices are used as part of a medical intervention. On the macro scale their development, design and manufacture has to take into account the whole system, including the patient. On the detail scale there needs to be the cooperation of many disciplines. Unfortunately thi

There needs to be a pdistributed across the sector.



Appendix A Medical Device Listing

The following provides a comprehensive list of the very many medical devices in use. The en selected to aid discussion in

technology issues associated with each

Tab ical device listing

Primissu

categories are by no means industry standards as they have bethis report. A key is provided to indicate the primaryclass of device.

le 14 Med

ary technology es Electro-mechanical

integration Gas/liquid/sensor interfaces Electrodes Bio-interfaces

PRIM

AR

Y D

EVIC

E TY

PE

SUB

SET/

CO

ound

man

agem

ent

Endo

scop

y/la

paro

scop

y

Impl

anta

ble

devi

ces

Inva

sive

sur

gery

nd la

bora

tory

Hos

pita

l cap

ital p

lant

omm

s, b

eds,

etc

Ultr

asou

nd

Patie

nt m

onito

ring

MM

ENTS

In-v

itro

diag

nost

ics

& k

its

W a Hos

pita

l inf

rast

ruct

ure

incl

. c

Anaesthesia environment

monitoring

Pros

thet

ics

and

artif

icia

l joi

nts

Hea

ring

aids

& a

udio

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ry

Hos

pita

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tre

atm

ent,

clin

ical

Ana

esth

esia

Infu

sion

& in

hala

tion

ther

apie

s

Anaesthesia machines

Anaesthesia Gaseous- patient phase gas

monitoring analysers

Anaesthesia patient Monitoring

Invasive blood gas

Anaesthesia Patient monitoring

Non-dispersive infrared (NDIR)

Anesthesia patient monitoring

Non-invasive blood gas

Anesthesia Other (e.g.

patient aural)

monitoring stimulation – EEG monitoring

Apnea Rely on monitors electrodes

and/or pressure sensors

iometers s and bed

tems

Aud

Bedsys



Primary technology es issu Electro-mechanical


PR

IMA

RY

DEV

ICE

TYPE

SUB

SET/

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anag

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t

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dis

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a Hos

pita

l inf

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ruct

ure

incl

. c In

fusi

on &

inha

latio

n th

erap

ies

Biof

ture, heart , skin

eedback Monitors and presents back to the patient some or all of EMG, EEG, EKG, temp-erarateconductance, blood press-ure and respiration

d-flow itors

Ultrasound reflects from moving particles

d-

Bloomon

Bloopresmon

sure itoring

Body-composition analysers

e.g. weighing scales contain electrodes and so measure impedance and weight, interpolate to fat

Bone-growth stimulators

Cardiac monitors

Cardiac pacemakers

Cell-size analysers

Laboratory analysis

Chromato-graphs

Laboratory analysis

Cold/hot-therapy products

Various, incl. phase-change packs

Compression hosiery

Elastic support hosiery, mat-ernity sup-ports, back and abdominal supports, sports med-icine supports and other orthopaedic products



Primary technology issues Electro-mechanical

integration Gasinte

/liquid/sensor rfaces Electrodes Bio-interfaces

PR

IMA

RY

DEV

ICE

TYPE

SUB

SET/

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MM

ENTS

Wou

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nd

Ana

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or sis

al

urge oys tith u

coe

tr

pain relief

Defibrilla

Diagnostic kits y Allerg

Diagnostic kits typing Blood Diagnostic kits Cancer

Choleste

Diagnostic kits specific

Disease-

Diagnostic kits c Drug-specifi Diagnostic kits Fertility

Pregnancy

Diagnostic kits Ovulationtesting

Blood-glucmonitoring

Dialysis equipment

Body worn

Dialysis equipment

xed/bedside Fi

Hos

pita

l sup

plie

s &

dis

posa

bles

nstr

umen

ts –

tre

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apita

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nt

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eds,

etc

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sion

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apie

s

Continuous passive motion (cpm) equipment

For rehabil-itation, and long-term unconscious-ness paraly

Cornetopography

Cranial nerve electrodes

Cryos ry Destr is-sue w ltra-

ld pellets; specially for

non-radio-active cancer

eatment, fibroids and

tors Implantable Defibrillators External

Diagnostic kits rol

Diagnostic kits

Diagnostic kits ose

Diathermy equipment




integration

Ultr

asou

nd

Patie

nt m

onito

ring

Disposables Incl. syringes, catheters, vessels, band-ages, face masks etc.

Measures and charts cardiac activity, detected via skin probes.

ECG

Electrodes EEG Neuro-stimulatio

Electro-enephalograph(EEG)

c-s

easures and charts brain activity,

.

M

detected via skin probes or electromag-netic sensors

Electrically-enhanced instruments for ca

n

,

Endoscopes cysto-urethro-

pes, laryngo-

s

s

s,

Includes

scopes, oto-scopes, amnioscopes,arthroscopes, sinosco

scopes, hysteroscope& laparo-scopes; and all kinds of instrumentused with endoscopes, light sourceetc.

Gas/liquid/sensor interfaces Electrodes Bio-interfaces

PRIM

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s

Electrocardio-graphs (ECG)

Electrodes

Electrodes n

Electrosurgery

oagul-tion, and

microsurgical procedures, eurosurgery,

ophthalmologyplastic and

reconstructive microsurgery





PR

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DEV

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TYPE

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aids

& a

udio

met

ry

Inva

sive

sur

gery

Hos

pita

l sup

plie

s &

dis

posa

bles

nstr

umen

ts –

tre

atm

ent,

clin

ical

an

d la

bora

tory

Hos

pita

l cap

ital p

lant

Hos

pita

l inf

rast

ruct

ure

incl

. co

mm

s, b

eds,

etc

Ultr

asou

nd

Ana

esth

esia

Patie

nt m

onito

ring

Infu

sion

& in

hala

tion

ther

apie

s

Gastrointest-inal-motility analysers

Hearing aids Implanted

External

Holter monitoring

Process signals and

ore data from skin

systems st

electrodes

Provides high oxygen-content environmenmonitors exhaled gasetc.

surgery and forth-coming remote-controlrobotics

ultrasound,

therapy

Infusion pumps

Ambulatory

Infusion pumps

Bedside

Infusion pumps

me High volu

Infusion pumps

Implantable

pumps Patient-controlled analgesia

Infusion pumps

Portable

Infusion pumps

Syringe drivers

Inhalers

Hearing aids

Hyperbaric chambers

t;

Image-guided Laparoscopy

Imaging Doppler,

MRI

Incontinence

Infusion





PR

IMA

RY

DEV

ICE

TYPE

SUB

SET/

CO

MM

ENTS

Wou

nd m

anag

emen

t

In-v

itro

diag

nost

ics

& k

its

Endo

scop

y/la

paro

scop

y

Impl

anta

ble

devi

ces

Pros

thet

ics

and

artif

icia

l joi

nts

Hea

ring

aids

& a

udio

met

ry

Inva

sive

sur

gery

Hos

pita

l sup

plie

s &

dis

posa

bles

nstr

umen

ts –

tre

atm

ent,

clin

ical

an

d la

bora

tory

Hos

pita

l cap

ital p

lant

Hos

pita

l inf

rast

ruct

ure

incl

. co

mm

s, b

eds,

etc

Ultr

asou

nd

Ana

esth

esia

Patie

nt m

onito

ring

Infu

sion

& in

hala

tion

ther

apie

s

Intracranial-pressure monitoring systems

Implanted sensor

(keyhole surgery, also

Uses a smalvideo camera and a few customisinstruments toperform surgerminiminjury. Camerand inments ainserted intothe abdomeor chest through smalskin cutsallowing the surgeon to explore the whole cavity without the need to maklarge incisions.

Cuts and cauterises

patient

Typically bedside vital-signs mon

Electrical waveforms applied through electrodes to activate muscles

andportable

Laparoscopy

see Endo-scopes)

l

ed

y with al tissue

a stru-

re n

l

e

Laser surgery

Microscopes Microtomes Multi-parameter

monitoring itors

Muscle stimulators

Nebulisers Fixed





PR

IMA

RY

DEV

ICE

TYPE

SUB

SET/

CO

MM

ENTS

Wou

nd m

anag

emen

t

In-v

itro

diag

nost

ics

& k

its

Endo

scop

y/la

paro

scop

y

Impl

anta

ble

devi

ces

Pros

thet

ics

and

artif

icia

l joi

nts

Hea

ring

aids

& a

udio

met

ry

Inva

sive

sur

gery

Hos

pita

l sup

plie

s &

dis

posa

bles

nstr

umen

ts –

tre

atm

ent,

clin

ical

an

d la

bora

tory

Hos

pita

l cap

ital p

lant

Hos

pita

l inf

rast

ruct

ure

incl

. co

mm

s, b

eds,

etc

Ultr

asou

nd

Ana

esth

esia

Patie

nt m

onito

ring

Infu

sion

& in

hala

tion

ther

apie

s

Needle-free drug delivery

.g. a micro-thin stream of liquid that

the

into

e

penetrates skin and is depositedthe sub-cutaneous(fatty) tissue

Nerve stimulators for

on

sia &

g general anaesthesia

Pulse generator nerve locatiduring regional anaesthemonitoring of neuromusc-ular block durin

and intensive care

Neurosurgical therapeutics

e.g. nerve amplifiers

Ophthalmo-scope

Ophthalmdiagnostiimaging

ic c

Ophthalmic diagnostic

d ultrasoun

Ophthalmic lasers

Orthopaedic Huge range devices

Pacemakers External Pain reliealso infuspumps)

f (see ion

re

ectrical nerve stim-ulation (TENS) devices

Milliampetranscut-aneous el

Neuromus-cular stimulators

Pacemakers Implantable





PR

IMA

RY

DEV

ICE

TYPE

SUB

SET/

CO

MM

ENTS

Wou

nd m

anag

emen

t

In-v

itro

diag

nost

ics

& k

its

Endo

scop

y/la

paro

scop

y

Impl

anta

ble

devi

ces

Pros

thet

ics

and

artif

icia

l joi

nts

Hea

ring

aids

& a

udio

met

ry

Inva

sive

sur

gery

Hos

pita

l sup

plie

s &

dis

posa

bles

nstr

umen

ts –

tre

atm

ent,

clin

ical

an

d la

bora

tory

Hos

pita

l cap

ital p

lant

Hos

pita

l inf

rast

ruct

ure

incl

. co

mm

s, b

eds,

etc

Ultr

asou

nd

Ana

esth

esia

Patie

nt m

onito

ring

Infu

sion

& in

hala

tion

ther

apie

s

Photo therapy es ome

light-deficiency

Light sourcto overc

disorders

Prosthetics

Ranges from customisedfoam mould-ings to implantedstructures such as artific-ial hip joints

A probe attached to the flesh emitsand detects two beams of light which are absorbed by haemoglobin in amounts which differ depending onwhether it is saturated with oxygen

Radiation therapy

Typically lacapital plan

rge t

Radiology (X-ray)

emilluminatoralysers for images

Spinal fusion rs

stimulato

Spirometers Peak flow

Volumetri

Stents Inserted intblood vesseto preven

o ls

t collapse

Pulse oximeters

Inca

cludes librators,

xposure onitors,

s/an

Spirometers c Splints

Sterilisers Stethoscopes





PR

IMA

RY

DEV

ICE

TYPE

SUB

SET/

CO

MM

ENTS

Wou

nd m

anag

emen

t

In-v

itro

diag

nost

ics

& k

its

Endo

scop

y/la

paro

scop

y

Impl

anta

ble

devi

ces

Pros

thet

ics

and

artif

icia

l joi

nts

Hea

ring

aids

& a

udio

met

ry

Inva

sive

sur

gery

Hos

pita

l sup

plie

s &

dis

posa

bles

nstr

umen

ts –

tre

atm

ent,

clin

ical

an

d la

bora

tory

Hos

pita

l cap

ital p

lant

Hos

pita

l inf

rast

ruct

ure

incl

. co

mm

s, b

eds,

etc

Ultr

asou

nd

Ana

esth

esia

Patie

nt m

onito

ring

Infu

sion

& in

hala

tion

ther

apie

s

Surgical instruments

May now include small motors, rotadrills and saw blades

ry

Temperaturemonitoring

(thermometry)

Medical aications of dig-ital infrared thermal imaging are extensive

Transcutan-eous electrinerve stim-ulation (TEN

cal

S)

Ultrasound imaging

Ultrasound therapy

.g. pulverises kidney stones e

Vascular products

Apply alternating pressure to

imulate blood flow st

Vascular vein-r

Attaches to e end of a

standard

the needle

blood vessel

entry indicatodevice

th

catheter.; signals when

penetrates a

Ventilators Voice simulators

Tagging Telemetry systems

Thermal imaging

ppl-

-

Traction equipment

Wheelchairs & mobility aids



Appendix B A Note on Specifications

Researchers, designers and prototypers often suppose that they themselves could manufacture in volume, but even with instructions that are 'precise' (although there will necessarily always be some leeway) they still will often be unable to do it. This is because they do not have the background experience to be manufacturers and they will not have gained the craft skills to be manufacturers. Even if they can make something once, they do not necessarily have the proper ability to replicate it time after time.

Specifications are generated initially from first principles and then developed by experiments which feed back to refine the principles. Some of this may be by simulation. At some stage there is release for manufacture, but if production does not work repeatedly the remedy is often by either changing things or condoning things (relaxing the specification)

As a matter t, normally accepted industrial specifications and instructions are less than rigorous in that they usually call for absolute range limits (or bounds of activity) without either

th l ist ty) ith t r ge Pr er manufacturing limits should allow any distribution (or change of rout e) ithi the , u es the distribution or behaviour within the limits is expressly specified. Rigorous designs ought not to depend on interpretation – i.e. skill – but there is a divergence between design and manufacturing engineers. Design engineers see limits as quanta within which anything may take place at random without perturbing the overall performance of the product in terms of its

ed op boun arie . Manu ctu ing engineers see limits and procedures as boundaries within which there is licence to tweak (use skill). They will also know things such as, for example, that components specified as ±5% may be received in ranges -5% to -1% and +1% to +5%, while components within the middle tighter tolerance ±1% have been selected out of the batch by the manufacturer and sold for a higher price.

A manufacturing engineer potentially brings both knowledge and understanding, but it is not possible to fully document manufacturing techniques which are based on skill or background. There are therefore 'x' factors that never feed back into design, and even the tightest specification is undermined by such ‘interstitial skill’.

of fac

specifying e statistica d ribution (or the details of activi win

inw

hen

anm

. nl

ops

intend erating d s fa r



Appendix C Sources of Information and Advice

Table 15 Medical device links

LINK COMMENT URL

Association of British Health-care Industries (ABHI)

Industry association with resourceful web site

http://www.abhi.org.uk/

Brown Eyed Sheep

Chatty & useful list of medical equipment and

pplie

http://www.browneyedsheep.com/medicalequipment.h

su rs

Centre for Biomedical Engineering,

ity of

i-disciplinary ch group with

members drawn from mechanical, electrical and electro c en ine ingorthopaedic surgery, rheuma log andrehabilitation

http://www.dur.ac.uk/~des0www2/Research/biomedic

UniversDurham

A multresear

ni g er ,

to y

DepartmHealth R&D p

ent o o pre ens e R D ce

http /www.doh.gov.uk/researchf age

Very creferen

m h iv & :/

Slightl

Health Technology

nt

The na nal &Dprogramme for the NHS (includes priorities)

http /www.hta hsweb.n s.uk

Assessme

tio R :/ .n h /

Health Technology Portal

The new route to funding under the Health Technology Devices (HTD) Programme. This portal will

ima interface for ment of Health

nce nd chn logfer.

http://www.healthtechnologyportal.org.uk/

be the pDepart

r ry

scietrans

a te o y

Technology Information

Catcomto toptraresearsocidepar

ni n v in

Institute of Physics and

ing in )

Well classified site deals with several disciplines represented as special interest groups

http /www.ipe .org k/

EngineerMedicine (IPEM

:/ m .u

tm

al_engineering.html

Foresight Healthcare

y outdated http://www.foresight.gov.uk/default800.htm

Hospital alogues medical-device pa es a d gi es l ks

ical developments, de associations,

ch associations, eties and government

tments

http://www.hospital-technology.com/



Medcatalog.com Free information on medical http:/ products and supplies;

roduct images, link to company

/www.medcatalog.com/

Products A-L and Products M-Z – clicking on these links will show you a list of 100+ product headings; select any product heading to view company p

sites etc.

Medical Device Institute Scotland

Trade body with activities and directories

http://www.mdis.org/

Medical Device Good portal for all medical- http://www.devicelink.com/

Link device topics; supplier directory unfortunately lists only suppliers to the device industry rather than the industry itself

Medical Device Resource Centre

Good collection of links http://www.geocities.com/medicalequipmentdirectory/

Medical Devices Directive

Easy guide http://www.qualitydigest.com/sept97/html/ce-mdd.html

Medical Equipment Technology

Huge resource http://www.themedweb.co.uk/

Medical Research Council

Provides an overview and a searchable database of

http://www.mrc.ac.uk/

research.

MedLINK project information

Lists the 33 projects active in 2000

http://www.quotec.co.uk/medlink/medlink projects.htm

MedMarket.com e-business portal http://www.medmarket.com/

NHS Regional Medical Physics Department

Excellent product innovation resource

http://www.rmpd.org.uk/innovation/technology_transfer.htm

Open Directory Project

Links to medical device manufacturers, with short descriptions

http://dmoz.org/Business/Industries/Healthcare/Products_and_Services/Medical_Equipment/Manufacturers/

Product Code Classification Database

Lists FDA product codes http://www.fda.gov/cdrh/prodcode.html

Research findings register

Excellent research references

http://tap.ccta.gov.uk/doh/refr_web.nsf/basicsearch?OpenForm

UK Medical Devices Agency

Government department responsible for the sector

http://www.medical-devices.gov.uk/

US Medical Device Approvals

Lists new approvals http://www.fda.gov/cdrh/mda/index.html



References 1Frost and Sullivan, World in Vitro Diagnostic Technologies Market, January 2002

py Markets, August 2001 3 Business Communications Company, Standard, Markets for Advanced Wound Care Technologies - Introduction, Summary, Overvi e And Value of Wound T d S em4 ivan g: European Intravenous Therapy Devices Markets (introduction, executive summary, glossary, industry challenges and research methodology), Market Engineering: German and French Intravenous Device Markets, December 2001 5 ration ologys y, drug deli ion, drug delivery, transdermal drug delivery, inhalation and implant drug delivery), June 2001 6 Sullivan g: Euro( execu sary, in nd research methodology), M ering Intravenous Device Markets, December 2001 7 ation y: U.S. Markets and Developments (executive summary, drug delivery industry, introduction, oral drug delivery, transdermal drug delivery, inhalation and implant drug delivery), June 2001 8 PJB Publications, ces for Cardiovascular and Heart Disease, Vol. 1: Cardiac Surgery, MICS and Interventional Procedures (executive summary, clinical trial acronyms, i de y9 l epartment, Newcastle General Hospital, Westgate Road, Newcastle upon Tyne, NE4 6BE, UK [http://ww

2 Theta Corporation, World Endosco

ew, Products, Volumechnologies an Frost and Sull

ynthetic Dressings, Nov, Market Engineerin

Theta Corpoummar

Drug Delivery Technvery industry, introduct

: U.S. Markets and Developments (executive oral

Frost and introduction,arket Engine

Theta Corpor

, Market Engineerintive summary, glos, German and French Drug Delivery Technolog

Clinica: New Devi

pean Intravenous Therapy Devices Markets dustry challenges a

ntroduction and Regional Medica

vices for surgery), JanuarPhysics D

ber 2001

2002

w.rmpd.org.uk/]


http://www.browneyedsheep.com/medicalequipment.htm

http://www.browneyedsheep.com/medicalequipment.htm

http://www.dur.ac.uk/~des0www2/Research/biomedical_engineering.html

http://www.dur.ac.uk/~des0www2/Research/biomedical_engineering.html

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