· 2017. 7. 5. · - new draft regulation published by ec in 2012 => ivdr • may 5, 2017:...
TRANSCRIPT
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.
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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.
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Timing in regulation of IVD products
5 years …
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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!
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Definitions
Notified Body
+ issues certificates
+ audits
+ monitors CAPA
+ PMS
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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:
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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
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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
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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
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
in vitro Dx Matchwww.ivdmatch.com
Actions
• Portfolio analysis
• Gap analysis
• Make transition plan
• Re-assess market viability and profitability potential per product
Which changes may affect your current business
Change:
• > 1 Person responsible for regulatory affairs
• A Unique Device Identification (UDI) system/database will be introduced starting with highest risk devices
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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 …
Which changes may affect your current business
Change:
• reinforcement of the criteria for designation and processes for oversight of Notified Bodies
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Action
• Start early and get your products on the waiting lists
Effect
• Reduction of number of NBs
• Increased workload hence waiting times
Which changes may affect your current business
Change:
• Authorized Representatives to IVD manufacturers will be held "jointly and severally liable" for defective devices
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Action
• Discuss and re-negotiate with AR
Effect
• AR will screen potential manufacturing partners more strictly
• AR may (have to) charge additional insurance
Which changes may affect your current business
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.
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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.
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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
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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
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Shake out
• Products
• Notified bodies
• Distributors
• (Authorized Representatives)
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Shake up in distribution chain
Quality management along distributionchain:
• Manufacturer to suppliers, OEM partners
• Manufacturer to importer, distributor
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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
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Opportunities
• Product shake-out
• Stronger (clinical) validationreports
• Fewer competitors, more focus
• Better product differentiationby better understanding *
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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
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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)
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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
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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 …
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Your supporting organizations
Registration specialists
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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
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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
in vitro Dx Matchwww.ivdmatch.com
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?
in vitro Dx Matchwww.ivdmatch.com
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