Post Market
Clinical Surveillance
View from Industry

2nd Qserve Conference
18-19 November, 2013
Stefan Menzl, PhD
Directo...
Content of the Presentation 1/2
• What is Post Market …
– Surveillance?
– Clinical Follow-Up / Surveillance?

• Requiremen...
Content of the Presentation 2/2
• Elements of Post Market (Clinical) Surveillance
– PM(C)F Plan
– Vigilance (incl. Trendin...
Post Market (Clinical) Surveillance / Follow-Up
 Post-market follow-up, ... is a continuous
process …and
shall be part of...
MDD
Requirements for Post Market (Clinical) Follow Up
MDD, new Annex X, 1.1c
Requirement to actively update clinical asses...
MDD
Post Market (Clinical) Surveillance / Follow-Up
MDD (93/42/EEC) requires PMS and PMCF

Additional requirement to compl...
New Medical Device Regulation
Proposal Post Market Clinical Follow-Up
″ ... PMCF shall be performed pursuant to a
document...
MEDDEV 2.12-2
Post Market (Clinical) Surveillance / Follow-Up
MEDDEV 2.12-2
Definitions
PMCF study: a study carried out fo...
QMS ISO13485
Post Market (Clinical) Surveillance / Follow-Up
Requirements of Quality-management System (Annex II.3)
• Know...
Elements of Post Market (Clinical) Surveillance / Follow-Up
Post Market Surveillance Plan
Featured prominently
in the prop...
Elements of Post Market (Clinical) Surveillance / Follow-Up
Post Market Surveillance Plan
• PMCF should be conducted for a...
Elements of Post Market (Clinical) Surveillance / Follow-Up
Post Market Surveillance Plan
 The data shall be reviewed at ...
Elements of Post Market (Clinical) Surveillance / Follow-Up
Post Market Surveillance Plan- Content
The plan shall define t...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Vigilance (New Medical Device Regulation)
″ ... Europea...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Literature Review (New Medical Device Regulation)
″ The...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Registries (New Medical Device Regulation)
 Options – ...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Studies (New Medical Device Regulation)
 Options
Smal...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Studies
When to do a PMCF study
• Presence of residual ...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Studies
Elements of a PMCF study
• PMCF plan:
– Researc...
Elements of Post Market (Clinical) Surveillance / Follow-Up
PMCF – Studies
Outcome
• Conclusions to be part of the clinica...
Post Market Clincal Follow Up
Role of the Notified Body
• The Notified Body will review the PMCF procedures and plans as
p...
Practically meeting post-market requirements
The Challenge of non-harmonized Requirements
The challenge to meet internatio...
Practically meeting post-market requirements
Challenges besides Regulations – the “human factor”

Stefan Menzl 2013

23
Practically meeting post-market requirements
Other Challenges (than diverse regulation)
• The available information is dif...
Ensuring safety data is consistently up-to-date
Elements in addition to complaint handling and vigilance

• Literature rev...
Ensuring safety data is consistently up-to-date
Literature reviews

• Proactive measure for PMS
• Which journals

• Abstra...
Ensuring safety data is consistently up-to-date

Stefan Menzl 2013

27
New Medical Device Regulation
PMCF - Conclusion
 PMS under new Medical Device Regulation
More stringent and controlled
...
New Medical Device Regulation
Post Market Surveillance – Potential Consequences
 PMS plan itself
 Product Improvements
...
AMO Products covered by the PMS/PMCF program
Vision. For Life.
AMO’s strategy is to deliver advanced life-improving vision...
Three Integrated Businesses Provide
Vision. For Life.
Eye Care Professionals
Corneal

Refractive

Cataract

Proprietary fo...
Abbott Medical Optics
3,700+ employees worldwide
• Direct sales in 29 countries & presence in more than 60 countries

Russ...
Cataract -- IOL Platforms
• Tecnis® IOL
– Monofocal, aspheric IOL designed to correct spherical
aberration to zero

• Tecn...
Cataract -- Phaco and Visco Platforms
• Healon® Viscoelastics
– Family of viscoleastics that provides a range
of viscosity...
Refractive Technology Suite
• iFSTM Laser
– Femtosecond laser that focuses pulses of light
below the surface of the cornea...
Corneal Products
• RevitaLens Ocutec Multipurpose Disinfecting
Solution
– Next-generation multipurpose disinfecting
soluti...
Post Market Clinical Follow-UP

“Everything should
be made as simple
as possible, but not
simpler”

Stefan Menzl 2013

37
Stefan Menzl 2013

38
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Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - Abbott Medical Optics (Qserve Conference 2013)

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Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - Abbott Medical Optics (Qserve Conference 2013)

  1. 1. Post Market Clinical Surveillance View from Industry 2nd Qserve Conference 18-19 November, 2013 Stefan Menzl, PhD Director, International Regulatory Affairs, Abbott Medical Optics
  2. 2. Content of the Presentation 1/2 • What is Post Market … – Surveillance? – Clinical Follow-Up / Surveillance? • Requirements for Post Market (Clinical) Surveillance – Current Medical Device Directive – New Medical Device Regulation – MEDDEV 2.12-2 – QM-System (ISO13485) Stefan Menzl 2013 2
  3. 3. Content of the Presentation 2/2 • Elements of Post Market (Clinical) Surveillance – PM(C)F Plan – Vigilance (incl. Trending) – Literature Review – Registries – Studies • Challenges for Industry to meet Requirements – Non harmonized requirements worldwide – The ‚human factor‘ – Language –… Stefan Menzl 2013 3
  4. 4. Post Market (Clinical) Surveillance / Follow-Up  Post-market follow-up, ... is a continuous process …and shall be part of the manufacturer's postmarket surveillance plan  To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorized to bear the CE marking, within its intended purpose ... with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence Stefan Menzl 2013 4 PMCF definition Emphasis on the proactive nature of the program PMCF plan mandatory unless duly justified
  5. 5. MDD Requirements for Post Market (Clinical) Follow Up MDD, new Annex X, 1.1c Requirement to actively update clinical assessment with data from ‘Post Market Surveillance’ ACTION Required update of risk assessment and clinical assessment in defined frequency Consider PMS data (incl. Events and Literature) Requirement to have PMS-Plan for every Product-family Stefan Menzl 2013 5
  6. 6. MDD Post Market (Clinical) Surveillance / Follow-Up MDD (93/42/EEC) requires PMS and PMCF Additional requirement to comply with ‚state of the art‘ Literature-screening as part of PMS, clinical assessment and PMCF Clinical assessment required for all classes of devices (2007/47/EEC) ER (6a) • Safety & Effectiveness • Beneficial risk/benefit ratio Stefan Menzl 2013 6
  7. 7. New Medical Device Regulation Proposal Post Market Clinical Follow-Up ″ ... PMCF shall be performed pursuant to a documented method laid down in a PMCF plan ... ″ specify general methods and procedures, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data ... ″ The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.” Stefan Menzl 2013 7
  8. 8. MEDDEV 2.12-2 Post Market (Clinical) Surveillance / Follow-Up MEDDEV 2.12-2 Definitions PMCF study: a study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (residual risk) of a device when used in accordance with its approved labeling PMCF plan: the documented, proactive, organized methods used to collect clinical data from actual use in humans on a specific CE marked device (or device group) with the aim of confirming long term clinical performance and safety, the acceptability of identified risks, and to detect emerging risks on the basis of factual evidence Stefan Menzl 2013 8
  9. 9. QMS ISO13485 Post Market (Clinical) Surveillance / Follow-Up Requirements of Quality-management System (Annex II.3) • Known risks (e.g. from literature or event reporting) need to be addressed in Risk-Management-Process and have to be considered in clinical assesssment • Remaining risks need to be addressed in labeling • Medical benefit needs to outweigh remaining risk (risk-benefit ratio) Stefan Menzl 2013 9
  10. 10. Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan Featured prominently in the proposal of MD regulations released on Sept 26 Importance of Post Market Clinical Follow Up Importance to apply the concept throughout the life-cycle of the device Stefan Menzl 2013 10
  11. 11. Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan • PMCF should be conducted for any device that has used clinical data from equivalence devices alone as the basis for the clinical evaluation. • The plan should ensure that residual risks identified for the equivalent devices are addressed Stefan Menzl 2013 11
  12. 12. Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan  The data shall be reviewed at regular intervals  The plan shall define: – Frequency of review to ensure continuous monitoring of benefit/risk ratio (including patient quality of life and public health impact) – By whom – Trending methodology: identification of trend and need for preventive/corrective action Stefan Menzl 2013 12
  13. 13. Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan- Content The plan shall define the source of data and the means to collect those data and shall be proportional to the risk of device/device family The plan may include: – Complaints Handling – Return Product Analysis – Vigilance Reports – Literature Review – Registry Review – PMCF – Regulatory Feedback Stefan Menzl 2013 13
  14. 14. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Vigilance (New Medical Device Regulation) ″ ... European system for the notification and evaluation of incidents and field safety corrective actions ...  Advantage Existing company system Low additional cost  Challenges Reactive Issues late in the game Stefan Menzl 2013 14
  15. 15. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Literature Review (New Medical Device Regulation) ″ The process of reading, analyzing, evaluating, and summarizing scholarly materials about a specific topic.”  Options Review relevant sources at regular intervals, e.g. PubMed Conferences Journal alerting Services  Advantage Relatively cheap Access to data world wide  Challenges Reactive Data typically limited and heterogeneous Stefan Menzl 2013 15
  16. 16. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Registries (New Medical Device Regulation)  Options – several Paper/ EDC forms Single/ multi center ...  Advantages Value for money Low site threshold ...  Challenges No efficacy/ added value data Stefan Menzl 2013 16
  17. 17. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies (New Medical Device Regulation)  Options Small scale single arm RCT  Advantages Efficacy and/ or added value RCT is gold standard  Challenges Not daily practice Huge investment Blinding Stefan Menzl 2013 17
  18. 18. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies When to do a PMCF study • Presence of residual risk that may impact the benefit/risk ratio • To examine long term performance and/or safety • To examine the performance and/or safety of the device in a more representative population of users and patients • PMCF study is expected, a justification needs to be given when not performed, e.g. medium/long term safety is already known from previous use, other appropriate PMS activities provide sufficient data to address the risks Stefan Menzl 2013 18
  19. 19. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies Elements of a PMCF study • PMCF plan: – Research questions, objectives and related endpoints – Scientifically sound design with appropriate rationale and statistical analysis plan • Implementation of the study according to plan • Analysis of the data • Appropriate conclusions Stefan Menzl 2013 19
  20. 20. Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies Outcome • Conclusions to be part of the clinical evidence report • Depending on the conclusions, an update of the Essential Requirements checklist and risk assessment may be appropriate • Changes could result in corrective/preventive actions like – Labeling changes – Changes to manufacturing process – Design changes – Public health notifications Stefan Menzl 2013 20
  21. 21. Post Market Clincal Follow Up Role of the Notified Body • The Notified Body will review the PMCF procedures and plans as part of design review (class III) or tech file review and – Verify compliance of the plans to Annex X, meddev guidance and standards – Evaluate the need for a PMCF plan – Assess the appropriateness of the PMCF plan – Assess the justification given for not conducting a specific PMCF plan – Verify that data from PMCF plans is used to update the clinical evaluation Stefan Menzl 2013 21
  22. 22. Practically meeting post-market requirements The Challenge of non-harmonized Requirements The challenge to meet international Vigilance requirements • Country specific requirements • Other challenges Possible solutions to meet the challenge • Harmonization • Company internal processes and systems Stefan Menzl 2013 22
  23. 23. Practically meeting post-market requirements Challenges besides Regulations – the “human factor” Stefan Menzl 2013 23
  24. 24. Practically meeting post-market requirements Other Challenges (than diverse regulation) • The available information is different from country to country and from customer to customer • The language barrier • Cultural approach to the reporting of complaints • Availability of technical expertise in every country • Different classification of products (drug / device) depending on country regulation • Responsibility for reporting are different from country to country (subsidiary or distributor) Stefan Menzl 2013 24
  25. 25. Ensuring safety data is consistently up-to-date Elements in addition to complaint handling and vigilance • Literature reviews • Post market clinical follow up, Post market clinical studies • Customer surveys • Feedback from technical service •… Stefan Menzl 2013 25
  26. 26. Ensuring safety data is consistently up-to-date Literature reviews • Proactive measure for PMS • Which journals • Abstracts • Presentations at conventions • ‚yellow press‘ (e.g. BSE crisis) • Define the process !!! • Responsibility & Frequency Stefan Menzl 2013 26
  27. 27. Ensuring safety data is consistently up-to-date Stefan Menzl 2013 27
  28. 28. New Medical Device Regulation PMCF - Conclusion  PMS under new Medical Device Regulation More stringent and controlled  Various Options Literature Review Registries Randomised Controlled Studies ….. Stefan Menzl 2013 28
  29. 29. New Medical Device Regulation Post Market Surveillance – Potential Consequences  PMS plan itself  Product Improvements  Extend, maintain or reduce PMCF/registry  Product Labeling / IFUs  Extend, maintain or reduce Product Training / User Training  Update of Risk Management  FSCAs Stefan Menzl 2013 29
  30. 30. AMO Products covered by the PMS/PMCF program Vision. For Life. AMO’s strategy is to deliver advanced life-improving vision technologies for people of all ages
  31. 31. Three Integrated Businesses Provide Vision. For Life. Eye Care Professionals Corneal Refractive Cataract Proprietary formulations designed to protect and lubricate ocular surfaces Advanced laser technologies designed to deliver freedom from eyeglasses Leading products for intraocular procedures that optimize visual function
  32. 32. Abbott Medical Optics 3,700+ employees worldwide • Direct sales in 29 countries & presence in more than 60 countries Russia Sweden Canada Ireland Netherlands Spain United States Japan China Mexico India Puerto Rico Africa Singapore South America 3 Mfg/R&D sites 3 Mfg sites 1 Global R&D site 4 Regional hubs Australia
  33. 33. Cataract -- IOL Platforms • Tecnis® IOL – Monofocal, aspheric IOL designed to correct spherical aberration to zero • Tecnis® Toric IOL – Toric IOL designed to correct preexisting corneal astigmatism • Tecnis® Multifocal IOL – Diffractive, aspheric IOL that provides near, intermediate and distance vision with exceptionally high spectacle independence – Enjoys premium pricing and patient-shared billing in the U.S.; co-pay in several markets outside U.S. • Synchrony® Accommodating IOL – Addresses presbyopia in cataract patients – Dual optic accommodating IOL designed to allow patients to see near, intermediate and distance vision – Approved in Europe; pending FDA approval in U.S.
  34. 34. Cataract -- Phaco and Visco Platforms • Healon® Viscoelastics – Family of viscoleastics that provides a range of viscosity to satisfy different surgical needs • WhiteStar Signature™ Phacoemulsification System • Ultrasonic device that emulsifies and extracts a cataractous lens using less heat and turbulence and FusionTM Fluidics to optimize outcomes • Ellips™ handpiece provides longitudinal combined with transversal motion
  35. 35. Refractive Technology Suite • iFSTM Laser – Femtosecond laser that focuses pulses of light below the surface of the cornea to create the flap before a LASIK procedure is performed • WaveScan WaveFront System – Diagnostic device that captures unique imperfections in each patient’s eyes and creates a personalized treatment plan – iDesignTM system is next generation technology • Star S4 IR Laser System – Computer-driven excimer laser that corrects refractive errors by reshaping the cornea – Performs Advanced CustomVue procedure, which corrects unique imperfections in each patient’s eyes and is capable of treating the industry’s broadest range of refractive conditions
  36. 36. Corneal Products • RevitaLens Ocutec Multipurpose Disinfecting Solution – Next-generation multipurpose disinfecting solution for silicone hydrogel and conventional soft contact lenses • Complete Multipurpose Solution – Convenient, single-bottle solution formulated to effectively clean and disinfect contact lenses • Oxysept Ultracare System – Hydrogen peroxide system that provides powerful disinfection efficacy for contact lenses • Blink Tears – Family of lubricating eye drops designed to provide relief to dry eye patients
  37. 37. Post Market Clinical Follow-UP “Everything should be made as simple as possible, but not simpler” Stefan Menzl 2013 37
  38. 38. Stefan Menzl 2013 38

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