· - new draft regulation published by ec in 2012 => ivdr • may 5, 2017: regulation (eu)...

www.ivDMatch.com

Changing Requirements for Market Access of IVD Products into the EU:

How to Match and How to Market Effectively?

J UNE 1 1 , 20 17

Anton PruijssersPersonal Introduction

25 years of marketing and sales in commercial healthcare/consulting

• Including regulatory affairs, market access, (WHO) pre-qualification …

• BM/Roche Dx; Lab systems; NL, Germany; VP in global marketing

• Roche Pharma NL; institutional clients including pharmaco economics

• Consultant to: Hitachi PHVC (J), InTec (China), US companies,

• mostly in POC

• 3,5 years in NGO, developing healthcare in Africa, DALYs

• 5 years in executive search & interim management search in health

in vitro Dx Matchwww.ivdmatch.com

Opportunities and threats in vitro Dx Matchwww.ivdmatch.com

- Which changes may affect your current business,

- Which changes will require new build-up of technical files

- For newcomers: how to enter the EU IVD market under the new

conditions

- How is the relationship between manufacturer, importer,

distributor, AR and NB expected to materialize and finally,

- How can APMG and its associated network assist you in finding

the right partners to become successful.


Questions I intend to answer

- IVD Directive introduced in ‘98 … identification of weaknesses, scandals

- New draft regulation published by EC in 2012 => IVDR

• May 5, 2017: Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (repealing Directive 98/79/EC and Commission Decision 2010/227/EU)

• The new rules will only apply after a transitional period, namely 5 years after entry into force (spring 2022).

• Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.


Timing in regulation of IVD products

5 years …


Definitions: Competent Authorities

Entities enforcing IVDD at the national level in each EU member state

• 27 member states plus European Free Trade Association members (Norway, Switzerland, Iceland, Liechtenstein)

• N.B. Brexit!• Population of >500 million people• 23 languages

• From Directive to Regulation!


Definitions

Notified Body

+ issues certificates

+ audits

+ monitors CAPA

+ PMS


The role of a Notified Body is to conduct a conformity assessment under the relevant EU Directives/Regulations.

The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the device, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device.

Definitions

Notified Body, examples:


The majority of IVDs currently self-certified will now require the services of a Notified Body in the conformity assessment process to ensure the safety and performances of IVDs placed on the EU market.

Definitions

Authorized Representative

• Name on package/IFU

• Could be your distributor as well, but not to be advised for reasons of flexibility


Required for any company without a location in the EU

• Liasing between manufacturers andCompetent Authorities

• Notifying Competent Authorities of manufacturers’and devices’names

• Keeping Technical Files available forreview

• ParticIpating in PMS procedures

Which changes may affect your current business

Change:

• New Global Harmonization Task Force (GHTF) recommendations for IVD device risk-based classification A, B, C, or D


ClassificationExamples

• D: Blood screening

• C: Companion diagnostics

• B: Pregnancy tests

• A: Specimen receptacles

Effect

• Now: 20% of products require involvement of NB

• 2022: 80%+ of products will require involvement of NB


Change:

• New Global Harmonization Task Force (GHTF) recommendations for IVD device risk-based classification A, B, C, or D


Actions

• Portfolio analysis

• Gap analysis

• Make transition plan

• Re-assess market viability and profitability potential per product


Change:

• > 1 Person responsible for regulatory affairs

• A Unique Device Identification (UDI) system/database will be introduced starting with highest risk devices


Action

• Skilled staff will become scarce => Early hiring!

• UDI assignment, packaging

• Implement/adapt traceability processes

New, risk-based classification in vitro Dx Matchwww.ivdmatch.com

• Many manufacturers will need to improve QMS processes (ISO13485:2016)

• Many IVDs which have currently been classified as self-certified will be classified as higher risk, requiring much more elaborate technical files, most likely more validation studies and certainly more investment

• CE certificates will remain valid for a maximum of two years following final implementation of the new regulations, i.e. spring 2024

• Class D scrutiny: NBs will have to inform Competent Authorities about all new CE Mark certificates issued to Class D IVDs; CAs may at their discretion appoint experts to evaluate clinical data for such devices

• Near-patient tests considered as different from self-tests

matching clinical evidence with product CLAIMS !

• Remote diagnosis and medical apps …


Change:

• reinforcement of the criteria for designation and processes for oversight of Notified Bodies


Action

• Start early and get your products on the waiting lists

Effect

• Reduction of number of NBs

• Increased workload hence waiting times


Change:

• Authorized Representatives to IVD manufacturers will be held "jointly and severally liable" for defective devices


Action

• Discuss and re-negotiate with AR

Effect

• AR will screen potential manufacturing partners more strictly

• AR may (have to) charge additional insurance


Change:

• Clinical evidence * required to be accumulated and assessed throughout the market lifetime of the device, i.e. including PMS

• Health Technology Assessment is next?

• Vigilance procedures will require trend reporting for some classes of IVD device.


Action

• Hire/assign resources to collect data and to perform new tasks

• Introduce/adapt PMS procedures *

• Assess the organization’s capability to match EU style of collecting and presenting scientific evidence

Which changes may affect your current business: supply chain

• Responsibilities for a newly defined range of ‘economic operators’ will provide legal impact on supplier management and partnering contracts.


Cooperation in terms of:• Traceability• Unique Device Identification• Registration• Complaints• Vigilance

(courtesy of )

Basic steps to CE compliance & sales

• Implement QMS in compliance with ISO13485• Choose AR and Notified Body• Identify Regulations appling to (combinations of) products• Classify products

Prepare basic technical file and competitive analysisVerify market viability in target market (against local competitors!)Verify options for reimbursement

If market potential is sufficient, define market access strategy,including clinical evidence and competitive profiling

Execute clinical trials and/or method comparisonStart of local KOLmanagementCompile all components of technical file


Basic requirements

Basic steps to CE compliance & sales

Have NB review technical files and/or audit your QMSRegister the device with Competent AuthorityPrepare Declaration of Conformity and affix CE marking to products

Get input from local marketing expertsDefine local channel, marketing and sales strategy

Finalize marketing documentation, battle plan

Recruit right partners in channel, marketing and salesTrain partners

Execute, sell, sell, sell


Shake out

• Products

• Notified bodies

• Distributors

• (Authorized Representatives)


Shake up in distribution chain

Quality management along distributionchain:

• Manufacturer to suppliers, OEM partners

• Manufacturer to importer, distributor


All the above

Threats and work

• Loss of business from existing products

• Higher barrier of entry for new products

• Additional cost in staffing, consulting, supporting services

• Waiting times

• Risks

• Work, work, work


Opportunities

• Product shake-out

• Stronger (clinical) validationreports

• Fewer competitors, more focus

• Better product differentiationby better understanding *


Opportunities

• Focus on your best franchises • Own your franchise

• Dominate your market segment

• Be closest to your KOLs and end-users

• Understand their medical practiceneeds and how you can contribute


Opportunities

• Staffing

• Logical and justified reasons tore-negotiate with distributionchain partners

• Get the best people now and/or engage the best consulting/interim management partners now

• Suppliers of components, OEM partner

• Importers/Distributors

• (Authorized Representative)


Opportunities with distributors, if applicable

• Logical and justified time torenew distributor vetting;

Fight for the right distributor(s) will intensify!!

• Logical and justified time toreview pricing strategy

• Review current and new distributors in terms of e.g.

• Market knowledge

• Quality System, includingPMS/vigilance

• Review current product pricing and pricing strategy for new product introductions


Opportunities

• From mere market access toHealth Technology Assessment?

Be the first and the best

• Start understanding your products’ real added value in the clinicalsetting/market

• Describe and quantify your value in clinical decision making terms

• Present to public authorities, reimbursement institutions, insurers, consumers …


Your supporting organizations

Registration specialists


Legal specialists

Strategy consultants

CROs for medical devicesRecruitment firms

Interim management firmsMarketing/PR agencies

Authorized Representatives

Market research firms

Distributor management firms

Re-think their best possible role for you!

Reimbursements specialists

background


2003: Executive search, interim management and consultancy for healthcare companies (Pharma, Medical devices, CROs etc)

2008: foundation of daughter company, distribution company:

2009: association with GMBC-DX in the US2016: started discussion on association with LOK corporation for IVD

hundreds of interim professionals, thousands of distributors

2016: association with PerSelectief Interim for Interim management processes2016: association with Suzhou Innovation Service Centre of Medical Devices

2017: ivDMatch.com, building on network of interim professionals, specialized in IVD

How can APMG assist in managing the threats and grabbing the opportunities


Registration specialists

Legal specialists

Strategy consultants

CROs for medical devicesRecruitment

Interim managementMarketing/PR agencies

Authorized Representatives

Market research

Distributor management

New players: one-stop shopping, one primary contactWe can work with you to manage your interests with stakeholders:

YOU

Reimbursement specialists

How can APMG assist: tailor in vitro Dx Matchwww.ivdmatch.com

Or: you work with specialized organizations directly• CROs for medical devices• Registration specialists• Reimbursement specialists• Authorized representatives• Legal specialists

And work with APMG op selected topics:• Market research• Pre-marketing with Key Opinion Leaders through interim professionals• Recruitment services • Screening and selection of suitable distribution partners

How can APMG assist in vitro Dx Matchwww.ivdmatch.com

Market research, can the product actually be successful in the market?

• Panel questionnaires• Focus Group Discussions, • Price sensititvity analyis• Product positioning

=> Co-create market access strategy as part of strategic marketing planning

How can we assist in vitro Dx Matchwww.ivdmatch.com

(pre-) marketing with KOL & stakeholders:

Contract the right IVD interim professionals/interim managers from our network to:• Pre-market with KOL• Guide KOL management throughout multi-center evaluation and/or clinical

validation stages

• Review, optimize product positioning and marketing materials to local markets

How can we assist in vitro Dx Matchwww.ivdmatch.com

Recruitment of local staff

• Select business development/sales professionals (staff or ad interim)• Select marketing professionals

• Other staff

How can we assistin vitro Dx Matchwww.ivdmatch.com

Manage your interests with distributors:

• Draft selection criteria• Recruit the best possible fit distributors• Contract the distributors• Manage the relationship and optimize your business

• Act as EU general distributor through ProDiag

How can we assistin vitro Dx Matchwww.ivdmatch.com

Or, in case of the desire to set up an affiliate:

• Assist in finding legal, tax, office, warehousing, production partners• Recruit (commercial) staff

and/or payroll them• Hire and manage temporary sales teams

Thank you for listening!Want to discuss and find out more?


Welcome to talk after the presentation, let’sdiscuss your specific needs and how we cantailor to them

• Contact me at: [email protected]• Call me at +31 6 15 118 118• Or fill out the contact form at

www.ivdmatch.com

• Or contact Suzhou Innovation Service Centre of Medical Devices:

Miss Ivy Chen: +86-512-62 91 67 60

mailto:[email protected]

http://www.ivdmatch.com/

· - new draft regulation published by ec in 2012 => ivdr • may 5, 2017: regulation (eu)...

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