Advances in Bionic Prosthesis and Orthosis

(Technical Insights)

Assistive Products to Aid in Achieving Human-like Stability, Strength,

and Speed

2012

D2F7-TI

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Contents

Section Slide Numbers

Executive Summary 5

Research Scope 6

Technical Insights–Research Process and Methodology 7

Key Findings 9

Snapshot 10

Overview 11

Application Areas 12

Global R&D Network Analysis

Value Chain Assessment 13

Existing R&D Networks 14

Stakeholder–R&D Focus Areas 17

Emerging Business Model 19

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Contents (Contd…)

Section Slide Numbers

Global R&D Network Analysis

Environmental Assessment 21

Key Technology Drivers 22

Key Business Drivers 23

Regulatory, Geo-Political Factors/Standards Compliance 24

Strategic Management of R&D

Industry Trends and Requirements 29

Technical Resource Competency 30

R&D Intensity 31

Infrastructural/Facility Demands 33

Funding 34

R&D Effectiveness Measurement 36

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Contents (Contd…)

Section Slide Numbers

R&D Management Strategy 37

Technology Strategy 38

R&D Strategy 39

New Product Development (NPD) and Commercialization Strategy 40

IP Protection Strategy 41

Patents 42

Contact Details 46

Appendix 49

Decision Support Database 53

About Frost & Sullivan 58

Scope of Research

5

Source: Frost & Sullivan.

This research service will cover the following key sections in the Orthotics and Prosthetics industry:

• Global R&D network assessment with analysis of R&D focus areas and emerging business models.

• Global environmental assessment with emphasis of the drivers and regulatory factors and geo-political

compliance.

• Strategic management of R&D section including technical resource competency, funding, and infrastructural

facility demands.

• New product innovation and technology management strategies.

• Key contacts within the industry.

• Decision support database (DSD) tables.

The field of Orthotics and Prosthetics (O&P) has changed dramatically in the past two decades. Practitioners

today work in a variety of settings and use innovative materials and techniques to restore function and provide

relief for various impairments. This research service (RS) is a study on the advancements in the O&P industry

from an R&D management perspective. There is an ever-increasing demand for O&P devices and new

innovations and inventions needs to be compliant with the ever-changing regulatory scene. There is a lot of

competition in the industry today and this RS tries to guide the reader in selecting the optimal path for speedy

commercialization, strengthening existing technologies/products, and enhancing future growth. The industry is

bound to undergo a change in its outlook as technologies are increasingly converging which will result in

fostering a diverse platform for our aging/disabled population.

Key Findings

6

Source: Frost & Sullivan.

Technology

Orthotics and Prosthetics technologies and products can aid in mimicking lost limbs and show promise in transforming the

outlook of disability. The advances in software, hardware, materials, and structures have enabled many different O&P

appliances, such as microprocessor knees, Hytrel – polyester elastomer material for O&P devices, solar powered cochlear

implants, targeting different parts of the body enhancing mobility and stability for disabled people. Today’s O&P industry is

characterized by the convergence of different technologies and sciences, such as neuroscience, electrical engineering,

cognitive science, signal processing, battery design, and nanotechnology among others.

Market

There is an increase of O&P products required as there is an exponential rise in amputee and elderly population. Similarly,

there is a leap of technological advancements in cosmesis and aesthetically attractive orthosis and prosthesis, which has

increased amputee acceptance and hence more usage of O&P devices. A good example is the livingskin prostheses from

TouchBionics which are hand crafted from high definition silicone and hand painted to match skin tone and appearance. The

development and usage of non-surgical and minimally-invasive devices also translates to giving patients better ease and less

utilization of resources, such as emergency rooms, out-patient visits, and readmissions.

Strategies

Organizations have played a vital role in collaborating and bringing together the technology prowess and product

commercialization to the masses. This strategy of bringing like-minded players under one umbrella and addressing the

market has helped complement existing technologies and explore other new technologies. A few examples being the National

Commission on Orthotic & Prosthetic Education encouraging all residents to create a Legacy Project such as to create a chart

of weight limits for prosthetic knee components and so on, which would aid in the future improvement of experience,

education and patient care. Similarly the American Board for Certification in Orthotics, Prosthetics & Pedorthics have created

and implemented a practice analysis study of mastectomy fitter profession, the results of which will provide updates and bring

about much needed changes in the delivery of care, items and services available, and the technology in use today. The

collective learning in the organization aids in coordinating diverse production skills and integrate multiple streams of

technologies. Additionally, a strong R&D network also allows the uninterrupted funding and technology transfer between

partners to enhance the value of the developed technology/product.

Existing R&D Networks

7

Source: Frost & Sullivan.

Orthotics and Prosthetics is a specialized healthcare profession, combining a unique blend of clinical and technical skills. The

professions of O&P have advanced together, as the same skills and knowledge base are necessary to evaluate for and design

custom orthoses and prostheses. A strong R&D network can result in the technology/product reaching the target audience in a

short span of time. Additionally, the network also allows the uninterrupted funding and technology transfer between partners to

enhance the value of the developed technology/product.

Patient Care

Facilities

Associations/

Organizations

R&D Institutes/

Universities

Funding

Companies

Orthotics and Prosthetics

Regulatory

Body

Existing R&D Networks (Contd…)

8

Source: Frost & Sullivan.

Stakeholders Names

Patient care Facilities• Alliance Orthotics and Prosthetics LLC

• OPGA Patient Care Clinics

• Stellar Orthotics and Prosthetics Group

• Collier Prosthetic Orthotic Care

Associations/Organizations• International Society for Prosthetics and

Orthotics

• National Association for the Advancement of

Orthotics & Prosthetics

R&D Institutes/Universities

• School of Health and Rehabilitation

Sciences, University of Pittsburgh

• The Northwestern University Prosthetics-

Orthotics Center

• Biomechatronics group, MIT Media

Laboratory

• Rehabilitation Institute of Chicago

Companies

• iWalk

• Ossur Hf

• Otto Bock Healthcare GmbH

• Argo Medical Technologies Ltd.

• TouchBionics Inc.

• Ekso Bionics

Regulatory Bodies

• Food and Drug Administration, USA

• Therapeutic Goods Administration,

Australia

• Ministry of Health, Labour and Welfare,

Japan

• State Food and Drug Administration, China

Funding Agencies• National Science Foundation

• National Institutes of Health

• National Center for Research Resources

• Paralyzed Veterans of America

Key Business Drivers

9

Dri

ve

rs

Low Source: Frost & Sullivan.

DescriptionImpact

High LowImpact

Reduced

hospital stay

Development and usage of non-surgical and minimally-

invasive devices translates to lesser utilization of health

resources, such as emergency rooms, out-patient visits,

and readmissions. These factors will allow patients to

reduce heavy financial burden and also not jeopardize

their limited resources.

Amputee/Elderly

Population

Advancements in cosmesis and aesthetically attractive

prosthesis enhance amputee acceptance. Apart from

functionality improving, end-users are increasingly

conscious of how they look and are keen to blend in with

mainstream society.

Technological developments augment quality orthosis

and prosthesis instigating market growth. Increasing

innovations and technology uniqueness offers a

competitive benchmarking factor that leaves options to

the physicians to decide on suitable therapy for patients.

An increasingly inactive lifestyle and mounting work

pressure are escalating the number of people

succumbing to diseased states. Additionally, there is also

an increasing incidence of amputee and baby boomer

population which necessitates increased sales of O&P

devices. Advanced

Technology

Cosmesis

Long

Term

(6-10 years)

Medium

Term

(3-5 years)

Short

Term

(1–2 years)

High

Regulatory, Geo-Political Factors/Standards Compliance

10

Source: Frost & Sullivan.

. The US Food and Drug Association (FDA) is an agency within the US Department of Health and Human Services responsible

for protecting and promoting public health. FDA assures the safety, effectiveness, and security of human and veterinary drugs,

vaccines, and other biological products, medical devices, food supply, cosmetics, dietary supplements, and products that give off

radiation- not required, please delete. Under the FDA, the Center for Devices and Radiological Health (CDRH) regulates orthotic

and prosthetic devices, which fall under 21 CFR Part 890 (Physical Medicine Devices).

FDA

(CDRH)

Class I

Class III

Class II

High

LowCo

mp

lexity

Microprocessor Knee, Brace, Multiarticulating Hand

Prosthetic hands via implanted neural sensors

Cranial remolding helmets

• According to 21 CFR Section 807.65(i) O&P retail patient care facilities are not required to register with the FDA as

manufacturer. However, aspects of FDA regulations can be applied to O&P patient care, including certain manufacturer

obligations.

• Class I is the lowest classification in terms of patient risk and the degree of regulatory control required.

• FDA prefers companies to have a person whose sole function is quality management and regulation (QMR).

• There is difference of opinion among some quarters stating that an FDA approval would reduce individualized nature of

care provided. Additionally, there is also the case of facilities accreditation where The American Board for Certification in

Orthotics, Prosthetics & Pedorthics (ABC) and Board of Certification/Accreditation, International (BOC), provide

accreditation. This makes the need for an FDA approval to be considered as an unnecessary additional layer of

regulation.

Regulatory, Geo-Political Factors/Standards Compliance

(Contd…)

11

Source: Frost & Sullivan.

The Health Insurance Portability and Accountability Act (HIPAA) privacy regulations, with which O&P is concerned, involves

the use and disclosure of personal health information. The Department of Health and Human Services (DHHS) Office of Civil

Rights is responsible for the enforcement of the HIPAA privacy rule, and there are both civil and criminal penalties for

violations.

Single Use Device (SUD)

• An entire third-party reprocessing industry has evolved to assist hospitals with reusing medical devices. SUD

reprocessing is controversial in both hospital and non-hospital settings.

• The level of regulation and oversight of reprocessed SUDs is determined by the FDA device classification and the risk

associated with the use of the refurbished device.

• Most OEMs resist SUD reprocessing for many reasons, primary among them being that they believe the device is for

single use, and reuse has an adverse impact on new product sales. Supporters of reprocessing, such as hospitals,

focus on lower cost.

• OEMs are subject to heavy FDA regulations when marketing new medical devices, while refurbishers and reprocessors

of those devices were unregulated. However, with a new act (Enforcement Priorities for Single-Use Devices

Reprocessed by Third Parties and Hospitals) brought around by FDA for SUD, reprocessors are also subject to the

same regulatory standards as OEMs.

Recycling SUDs make a high impact especially in countries where the danger of unexploded ordnance continues to take a

heavy human and economic toll. There are over 70 landmine-affected countries, Afghanistan and Cambodia being some of

the worst affected countries. There is no proper system to collect statistical data, hence lack of knowledge on the existing

situation, such as rehabilitation services, and so on. In some instances, governments have taken initiative to develop a

social service system to cover the requirements of disabled people. However, it is a hard task considering that the

law/regulations are ambiguous and the overall system is fragmented and insufficient to cover the complete rehabilitation

services. Additionally, there is no adequate education system, regulations and career opportunities in such countries, which

result in the difficulty for O&P technicians to obtain new techniques.

Infrastructural/Facility Demands

12

Source: Frost & Sullivan.

Factors to be considered when choosing a fabrication facility

• Minimum turn-around time of the manufactured device

• Warranties entertained and complaint resolution protocol if there is a problem

• Number of shifts and their timing

• Are there existing templates for the device or can the clinicians establish their own templates

• Details of shipping protocols and their speed of delivery

• Does the fabrication facility do all the work on the premises or are items outsourced

• Do they offer volume discount

• Players have to decide on time spent fabricating against time spent marketing and attending to other business

needs.

• Most players rely entirely on outsourcing for its fabrication needs, thereby increasing patient treatment options and

outcomes.

• The flexibility of outsourcing provides managing satellite offices with non-technical staff with optimal office space.

High-quality devices are manufactured with no additional investment in additional equipment and training.

• It is advantageous to be an extension of the surrounding medical community, where physicians and other medical

personnel within the center can rely on one another to make the patient experience efficient and comprehensive.

• Computer-aided design (CAD) and computer-aided manufacturing (CAM) allow businesses to create and produce

orthotic and prosthetic devices. These programs help create a design based on specifications gathered by the

practitioner and then manufactured with the production system’s built-in tools. This enables the business to

efficiently communicated with central lab facilities.

• The items are modified on the premises; outsourcing however allows time to focus on other business aspects.

• A dedicated wing should be assigned to establish that the company’s protocols fulfill the federal government’s

requirements.

Funding for Bionics and Orthotics Segment (Contd…)

13

Source: Frost & Sullivan.

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

NIH funding (Jan – Jul 2012)

Fun

din

g in

US

Dolla

rs

Positive Factors for an Investor

• Diversified product and service

offering

• Ability of the company to meet

demand with current

infrastructure and resources

• No pending regulatory, legal or

government action

• New

technology/products/services in

the pipeline

• Strong management team with

few key personnel

• Weak competitors and healthy

market share for the candidate

company

• Favorable O&P industry trends

Investors prefer a clear roadmap to

control costs and guide

reimbursements.

Patents (Contd…)

14

Publication NumberPublication

DateAssignee Name Title

US 2009/0192619 A1 July 30, 2009Orthocare Innovations

LLC, OK (US)Passive electro-magnetically damped joint

The present invention comprises an apparatus, system and method utilizing a passive electro-magnetically damped joint for

orthotics and prosthetics. Such a system may be controlled through changing the resistive nature of the circuit in which a

braking or damping mechanism can sufficiently replicate and augment biomechanical movement. This may be accomplished

through electronic circuitry means only, or through the use of intelligent control through a microprocessor and dynamic

ambulation replication algorithms.

US 2012/0130508 A1 May 24, 2012Chas A. Blatchford & Sons

Limited, Hampshire (GB)Lower Limb Prosthesis

Invention relates to a lower limb prosthesis comprising a shin component, a foot component, and an ankle joint mechanism

interconnecting the shin and foot components. The ankle joint mechanism is arranged to allow limited damping pivoting

movement of the shin component relative to the foot component. The wall of the cylinder has a cylindrical outer bearing surface

for a sleeve which is translationally displaceable relative to the piston and cylinder assembly according to the axial load, the

sleeve being resiliently mounted by a compression spring which extends axially within the sleeve and has an integral end

portion forming an upper bulkhead of the cylinder.

Source: Frost & Sullivan.