Strategies for expanding your medical device & diagnostic - PowerPoint PPT Presentation

Strategies for expanding your medical device & diagnostic business in Europe www.md101consulting.com Mathieu Charleux San Diego, California, USA 10 February 2015 1

Quick Bio www.md101consulting.com • Mathieu CHARLEUX, CEO – 15 years experience in international business – Great knowledge of medical imaging and orthopedic/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 European Market Entry Strategy 2 10 February 2015

www.md101consulting.com EUROPEAN POTENTIAL 3

European Union www.md101consulting.com • 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 European Market Entry Strategy 4 10 February 2015

European Union www.md101consulting.com • 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) European Market Entry Strategy 5 10 February 2015

European Union www.md101consulting.com • 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 European Market Entry Strategy 6 10 February 2015

European Union www.md101consulting.com The market is changing and is more and more challenging BUT still many opportunities to grasp!! European Market Entry Strategy 7 10 February 2015

www.md101consulting.com REGULATORY 8

Regulatory Environment www.md101consulting.com • 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 European Market Entry Strategy 9 10 February 2015

Regulatory Environment www.md101consulting.com • 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!! European Market Entry Strategy 10 10 February 2015

Regulatory Environment www.md101consulting.com • 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 European Market Entry Strategy 11 10 February 2015

Regulatory Environment www.md101consulting.com • 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 European Market Entry Strategy 12 10 February 2015

Regulatory Environment www.md101consulting.com European Market Entry Strategy 13 10 February 2015

Regulatory Environment - summary www.md101consulting.com !"#$%&'()'*(+,' 3+01$4*' -".$/01'."2$/"' 5##+,0&/"' 6'740&.0,.#' :(#4=>0,?"4' :,(.+/<(&' :,(.+/4#' 8' 9' 7+,2"$110&/"' ()'*(+,'-".$/01' ;"%$#4",".' ' ."2$/"' 701"#'8'#",2$/"' ;"%+104(,*' 8'-0$&4"&0&/"' >0&0%"-"&4' !"#$%&'()*)+('#+'%,)'-./&&01-/2#+'#3'%,)'()40-)' European Market Entry Strategy 14 10 February 2015

Regulatory Environment – New EU Regulation to be approved www.md101consulting.com • Proposed EU regulations for medical devices and IVD devices – Harmonization of the EU regulation with replacement of former EU directives 90/385/CE, 93/42/CE, 98/79/ CE – Votes by EU parliament in 2015 and applied within 3 years European Market Entry Strategy 15 10 February 2015

Regulatory Environment – New EU Regulation to be approved www.md101consulting.com NOW is a good time to enter Europe to start getting acquainted with the regulations and start grasping market shares European Market Entry Strategy 16 10 February 2015

Regulatory Environment – New EU Regulation to be approved www.md101consulting.com • 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!! European Market Entry Strategy 17 10 February 2015

Regulatory Environment – New EU Regulation to be approved www.md101consulting.com – 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. European Market Entry Strategy 18 10 February 2015

Regulatory Environment – New EU Regulation to be approved www.md101consulting.com • 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 European Market Entry Strategy 19 10 February 2015

Regulatory Environment – New EU Regulation to be approved www.md101consulting.com • Patient safety vs. innovation – Increased time-to-market with new EU regulation – More and more importance of clinical data in pre-market phase !!!!!!! European Market Entry Strategy 20 10 February 2015

www.md101consulting.com CLINICAL 21

Clinical Environment www.md101consulting.com • 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 European Market Entry Strategy 22 10 February 2015

Impact of regulatory/clinical www.md101consulting.com • When to deal with regulatory? @&$<04"' 4B(+%B4' A,(/"##' :,(4(4*A"' ;"#"0,/B'5/<2$<"#' ;"#"0,/B' @."0' @&.+#4,$01$D0<(&' !"#$%&C'."2"1(A-"&4' E#4'F04/B' :,(4(4*A"' G0+&/B'()' G0+&/B'()' ,"%+104(,*' /1$&$/01' A,(/"##' European Market Entry Strategy 23 A,(/"##' 10 February 2015

www.md101consulting.com CONCLUSION 24

Take-Home Message www.md101consulting.com 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) European Market Entry Strategy 25 10 February 2015

Take-Home Message www.md101consulting.com 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…) European Market Entry Strategy 26 10 February 2015