Strategies for expanding your medical device &amp; diagnostic [PDF]

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Mathieu Charleux San Diego, California, USA 10 February 2015

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Strategies for expanding your medical device & diagnostic business in Europe

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Quick Bio

European Market Entry Strategy 10 February 2015 2

Mathieu CHARLEUX, CEO

– 15 years experience in international business – Great knowledge of medical imaging and

rthopedic/spine markets

– Relevant experience in various startup companies and large size organizations – Today focus on assisting medical device companies on QA/RA/Clinical Affairs/ Reimbursement/Business Development aspects to enter the EU

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EUROPEAN POTENTIAL

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European Union

28 member states
Population of 500 million
25’000 medical technology companies
500’000 people employed
95% of SMEs (less than 50 people)
Biggest community of companies in

Germany, UK, Italy, Switzerland, Spain and France

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European Union

EU market worth €100b
Top 3: Germany (27%), France (16%), UK

(11%)

US companies are the largest foreign

suppliers of medical devices in EU (65% in 2012)

Expenditure on medical technology per

capita = 195€ (vs. €310 in the US)

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European Union

Few good distributors
Not really any master distributor model like in Brazil or

Russia although some form of alliances exist:

Increased competition from Asia
Low prices in many countries like Germany
Market structure in Germany is changing
References: Eucomed & WHO Global Health Expenditure Database

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European Union

The market is changing and is more and more challenging BUT still many

pportunities to grasp!!

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REGULATORY

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Regulatory Environment

90/385 CE, Active implantable medical devices
93/42 CE, Medical devices
98/77 CE, IVD devices
2000/70 CE, Devices incorporating blood derived

substance or human plasma

2005/50 CE, reclassification of articular prosthesis

(hip/knee/sholder)

2007/47 CE, modification of the directives 90/385

& 93/42 & 98/8 on biocides products

And also:

– 89/686 CE, Individual Protection Equipements, – 2006/42 CE, Machines

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Regulatory Environment

ISO 13485 = gold standard in Europe for medical device manufacturers

to assess the organisation

– ISO 9001 – Quality manual – Responsability & engagement of management – Processes approach:

Documentation management
Back-office, HR, training
Infrastructure, general services
Regulatory affairs: vigilance, post-market, recall
Design, developpement, management of modifications
Purchases, production
Measures and improvements
Non-conformities, Corrective & Preventive Actions
Marketing, sales, customer feedback, service

– Risks management ! ISO 14971

Easy for a US company with 21CFR to put in place!!

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Regulatory Environment

The current directive defines classes of

medical devices = level of risks

– Europe CE: 4 classes:

I = non invasive, surgical instruments
IIa = diagnostic instruments, surgical devices
IIb = active medical devices
III = surgical implants or biodegradable, in contact with

CNS, combined devices with drugs…ie drug eluting stents

Determination of the classification of your

devices is based on technical criteria

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Regulatory Environment

CE vs. FDA
Class III = Pre-Market Approval

– 3 years minimum, clinical trials

Class II = 510(k) Pre-Market Notification

– 3 months minimum

Class I = registration to FDA

– Immediate, no submission of files

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Regulatory Environment

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Regulatory Environment - summary

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European Market Entry Strategy 10 February 2015

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Regulatory Environment – New EU Regulation to be approved

Proposed EU regulations

for medical devices and IVD devices

– Harmonization of the EU regulation with replacement

f former EU directives

90/385/CE, 93/42/CE, 98/79/ CE – Votes by EU parliament in 2015 and applied within 3 years

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Regulatory Environment – New EU Regulation to be approved

NOW is a good time to enter Europe to start getting acquainted with the regulations and start grasping market shares

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Regulatory Environment – New EU Regulation to be approved

Impact of EU regulation on classification of IVD

and Medical Devices

– Harmonization of borderline products classification – Some medical devices upgraded to class III (ortho/ spine implants…) – Classification of IVD devices according to risks they represent – Reinforcement of clinical evaluation (notion of clinical performance for IVD devices and PMS for other medical devices) – Former EU directive: 80% of IVD were not audited by NB, with new EU regulation, 80% WILL be audited!!

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Regulatory Environment – New EU Regulation to be approved

– IVD devices definition will be extended to include “lifestyle tests”. The definition will include “indirect medical purpose” and “prediction” – Risk-classification for IVD developed by Global Harmonization Task Force (GHTF) vs. positive listing or self-testing (Class A = low risk which does not require NB involvement except when intended for near-patient testing, has a measuring function or is sold sterile; Class B, C, D = high risk with involvement of NB) – Clinical performance studies will be required proportional to the assigned risk level.

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Regulatory Environment – New EU Regulation to be approved

Changing role of Notified Bodies

– Hence a careful choice of your NB is important as they are going from 80 to 1 per country – Unannounced inspections of manufacturing processes (once every 3 years) – Category of special notified bodies to certify high risk devices

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Regulatory Environment – New EU Regulation to be approved

Patient safety vs. innovation

– Increased time-to-market with new EU regulation – More and more importance of clinical data in pre-market phase !!!!!!!

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CLINICAL

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Clinical Environment

Post-market clinical follow-up mandatory
Requirements for clinical evidence will

increase substantially thus increasing costs

In-house regulatory compliance manager

mandatory

Periodic safety reports filed once a year

for first 2 years for class III devices

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Impact of regulatory/clinical

When to deal with regulatory?

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European Market Entry Strategy 10 February 2015

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CONCLUSION

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Take-Home Message

1/ The regulatory environment must not be a burden for your business plan but must be considered highly 2/ Europe is attractive but you must have a clear strategy 3/ Changing EU regulations is an incentive to enter now the market and comply with existing norms (specificities like insurance in different countries like Spain, CZ…need to be considered too)

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Take-Home Message

4/ Think about your reimbursement and value-based approach of the market as this takes time 5/ Different countries in EU with possible different strategies 6/ Easier and cheaper to setup clinical studies in EU also as wider acceptance for innovative devices and possible subsidies/grants (PHRC…)

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Take-Home Message

7/ Countries like France offer:

great subsidies for R&D,
tax exemptions,
access to some of the top KOLs in Europe (especially Provence

Alpes Côte d’Azur with the help of: http://www.investincotedazur.com/en/

http://www.investinprovence.com/
http://www.eurobiomed.org/en/
http://www.sattse.com/?lang=en
FrenchBioBeach (http://bit.ly/1EMhnqH)
key geographical location to approach the EU

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Take-Home Message

8/ Choose wisely your notified body 9/ Do not look for stocking distributors (understanding payment structure of markets like Italy where distributors can wait up to 2-3 years to get paid) 10/ Establish reference centers in key countries and think of a EU MAB

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Take-Home Message

11/ Onsite office will reassure distributors and other partners and send positive sign to scientific communities 12/ Onsite office can help to manufacture locally and reduce significantly your costs 13/ Onsite office can help you tap in local know-how and IP for partnerships (i.e. SATT Sud-Est in PACA- France)

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Take-Home Message

14/ Take time to understand the market and different cultures (ie. Dutch

vs. Latin countries)

15/ Complete required clinical studies within the next 3 years and conformity assessment by your notified body 16/ IVD companies need to plan ahead by assessing the type of clinical evidence they need, how much time they will need to generate it, and

btain slot from notified body (whom are going to be overwhelmed thus

impacting the time-to-market even more) 17/ All devices on the market will need to be reevaluated and certified under the new regulations when the existing certificates expire. ISO13485 is highly recommended to facilitate the transition phase.

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CONTACT

Mr. Mathieu CHARLEUX

Phone (France): +33603179245 mathieu.charleux@md101consulting.com https://fr.linkedin.com/in/mcharleux https://twitter.com/MD101consulting www.md101consulting.com

21 Nov. 2012 MD101 Consulting - Homologation Dispositifs Médicaux 31

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European Market Entry Strategy 10 February 2015

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