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Nov 29
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08:30 - 09:00 30 mins
09:00 - 09:10 10 mins
Chairperson’s Opening Remarks
  • Philip Clay - Director, Chorley Consulting Ltd.
09:10 - 09:45 35 mins
Current and Future Methods for Irritation and Sensitization Testing
  • Kelly Coleman, Ph.D., DABT, ERT, RAC - Distinguished Toxicologist, Technical Fellow/Bakken Fellow, Medtronic plc

Currently medical device irritation testing is conducted using a rabbit skin irritation test, while sensitization is evaluated primarily by the guinea pig maximization test. This presentation will briefly review these two animal methods, present the current status of in vitro alternatives, and provide an update on the ISO 10993-10 and ISO 10993-23 standards.

09:45 - 10:20 35 mins
Challenges with Biocompatibility in Wound Care Devices
  • Beau Rollins - Director, Quality Services, ConvaTec, USA
  • Appropriate tests for hydrogels
  • Effects of negative pressure therapy
  • Incorporating anti-microbials
  • Hurdles of porous dressings  
10:20 - 10:50 30 mins
Linking ISO 10993-17 and ISO 10993-18: Connections Between a Chemical Characterization (18) and a Subsequent Toxicological Assessment (17)
  • Annelies Vertommen - Team Leader, Medical Device Chemical Characterisation Testing, Nelson Labs (part of Sotera Health), Belgium
  • From TTC to AET
  • Importance of correct compound identifications and how to achieve them

10:50 - 11:20 30 mins
Coffee & Networking Break
11:20 - 12:00 40 mins
Biocompatibility Pitfalls from a Notified Body Perspective
  • Christina Reufsteck - Product Specialist, TÜV SÜD Product Service GmbH, Germany
  • Discussing the common biocompatibility pitfalls in industry and how they can be avoided
  • Typical standard requirements that are often not met
  • Necessary depth of chemical characterization
  • Evaluation approaches for new devices vs. marketed devices
  • Case examples
12:00 - 12:30 30 mins
The Evaluation of Chemicals for Potential Endocrine Disrupting Activities in Medical Devices
  • Dr. Anna Müller - Professional Biological Safety Medical Devices, Knoell Germany GmbH
  • Understanding the impact of the Medical Device Regulation
  • Compounds of concern and how to deal with them
  • Can the current ISO 10993 standards be used in this evaluation or are other tests necessary?
12:30 - 14:00 90 mins
14:00 - 14:35 35 mins
FDA Guidance on Biocompatibility Dossiers
  • Ron Brown - Toxicologist, US FDA (retired)
  • Discussing the FDA guidance on the previous ISO 10993
  • Will the new updates be addressed?
  • A guide to biocompatibility testing for successful market approval
15:10 - 15:30 20 mins
Coffee & Networking Break
15:30 - 16:00 30 mins
Panel Session: Expectations for Global Submissions
  • Kelly Coleman, Ph.D., DABT, ERT, RAC - Distinguished Toxicologist, Technical Fellow/Bakken Fellow, Medtronic plc
  • Ron Brown - Toxicologist, US FDA (retired)
  • Dr. Robert Przygoda - Research Fellow (retired), Johnson & Johnson, USA
  • Christina Reufsteck - Product Specialist, TÜV SÜD Product Service GmbH, Germany
  • Comparing the similarities and differences in biocompatibility across regions
  • The steps taken to harmonisation of ISO 10993 standards in the EU, US and China
  • Discussing the challenges faced during submission processes across the globe
16:00 - 16:35 35 mins
3-D Printed Medical Devices – The future or a multi-dimensional problem?
  • Philip Clay - Director, Chorley Consulting Ltd.

Additive manufacture, also known as 3-D printing, has a huge potential in the development and production of small scale or personalised medical devices.  The technology is gaining acceptance in the production of surgical planning models and medical device prototyping.  There are however presently very few 3-D printed medical devices which contact the body approved for market.  One of the areas of concern for such devices is how to assess the biological safety of the device and the additional risks introduced by the materials and printing process. I will discuss recent guidance provided by US FDA and other regulatory bodies and also present a case study of how an authority’s concerns over biological safety were addressed when seeking clinical trial approval for a 3-D printed device.

16:35 - 16:40 5 mins
Chairperson’s Closing Remarks
16:40 - 16:45 5 mins
End of Conference