I had the opportunity to attend, chair and present at the IQPC Combination Products Forum in Munich on 24 and 25 October. Many thanks to Romy Tuin and the team at IQPC for organising the event.
I presented on The Implications of the New EU Medical Device Regulations on Combination Products. I discussed how the regulations of medical devices and In vitro diagnostic devices are undergoing the most significant change for decades. I outlined the objectives that the legislation seeks to address and the challenging timelines for implementation. I also explained how the legislation impacts the whole lifecycle of medical devices that are marketed in Europe and the complex group of actors impacted. It is clear the legislation introduces some significant changes to the way the EU marketed MD/IVD lifecycle needs to be managed and it will present a number of challenges to products that are within scope.
The presentation can be accessed via the following link: The Implications of the New EU Medical Device Regulations on Combination Product Packaging
Other presentations from the event included:
Beyond the Molecule – Optimising Combination Product Development Using the E-Health Wave
Steve Dew, Associate Director Combination Products and Medical Devices, Biogen
Steve presented on how digital health is expanding and how this needs to be built into the development of your combination products. Some of the topics covered included:
- Data and connectivity are providing added value for patients and healthcare providers.
- Adding electronics to products is a growing trend – both for clinical trials and commercial products.
- Patient-centric solutions will drive the integration of devices, pharmaceuticals and technology.
- Combination products can make products more convenient and easier to use.
- Connected medical devices can collect data to demonstrate health outcomes, compliance and persistence.
Steve also presented a number of examples of combination products being developed by healthcare providers.
Platform Technologies For Antimicrobial and Potential Next-gen Ophthalmic and Cancer Fighting Drug-Devices
Drew Rogers, Global Director for Healthcare & Medical, Trelleborg Sealing Solutions and Mark Paulsen, President, Silicone Consulting LLC
Drew and Mark presented on the use of silicone in the medical device industry. They talked about the use of implantable silicone devices impregnated with drug product to support different applications. They provided an overview of two studies they have been involved in, testing the effectiveness of impregnating silicone tubes with various drug products to help enhance the effectiveness of the impregnation process.
MHRA Perspective: Understanding The Regulatory Landscape For Combination Products
Dr Stefania Ragone, Pharmaceutical Assessor Licensing Division, MHRA
Stefania presented on the regulatory environment for combination products in Europe. She drew attention to two significant aspects of the European regulations:
- Medical devices are certified by Notified Bodies whereas pharmaceutical products are registered by the Competent Bodies.
- There is not a definition for combination products in Europe (as there is in the US).
Stefania discussed the requirements of the regulations and, through a number of examples, some of the pitfalls to avoid when preparing submissions.
Using Design Control to Aid in the Development of Combination Products
Margaret Kelly, Device Development Project Leader, Novartis
Margaret presented on the use of design controls in a medical device development process. She walked through a typical development process to show how this would fit to a design control framework and how you can use the design history file to collate the information gathered in the development of the device. This led to a conversation on how the device and drug development processes interlink and how they should be managed.
Cockpit’s Guided Compliance For Medical Device And Combination Product Development
Edwin Schumacher, Managing Partner, Synergio
Edwin demonstrated Synergio’s guided compliance tool for product development – Cockpit.
Edwin provided an overview of the product’s key features and benefits and, by way of a specimen project, demonstrated the functionality of the system.
Optimising and De-risking Device Development of Combination Products
Peter Czuczman, Global Project Leader Drug Device Product Development, BTG
Peter presented on the work he is undertaking in BTG to de-risk device development for combination products. Initially Peter gave an overview of the legislative environment and the implications presented for product development. He then discussed how you can take the regulatory frameworks to develop your drug and device development processes, de-risking the processes by making sure the regulatory requirements are built in.
To conclude, Peter explained which standards support which parts of the development process and how a suite of standard tools can underpin the process and make it more repeatable.
Applying The TRIZ Methodology To Medical Device Innovations
René Dathe, Head of Quality Medical Devices Shared Function, Novartis
René’s presentation covered the use of the TRIZ methodology in Novartis and how it can be applied to medical device innovation.
The TRIZ methodology is an alternative problem-solving methodology that was originally developed in Russia and can be applied to technology driven problems.
René explained a case study they used to test the methodology using an auto-injector product design.
Harmonizing the Integration of Drug Developments and Device Approaches
Lori-Ann Woodard, Senior Manager Quality Compliance Combination Products, Teva Pharmaceuticals
Lori-Ann presented on how to align the legislative requirements for devices and drug products. In particular Lori-Ann looked at what you need to do to have one comprehensive QMS in your company, depending on whether you base your QMS on the requirements for drug products or devices.
Lori-Ann also looked at how key milestones in the drug products and device development methodologies can be aligned to give one seamless development approach.
Navigating the Different Regulatory Pathways for Combination Products Across the EU and US
Lars Hyveled-Nielsen, Regulatory Project Director, Regulatory Affairs, Zealand Pharma
Lars’ presentation focussed on which regulations apply to medical devices and drug products in the EU and US.
Lars explained how single-use devices and multi-use devices have different regulatory approaches in the EU. Lars explained the different requirements for each.
Lars also explained the regulatory requirements for combination products in the US and how these differ from the EU.
Human Factors Engineering for Combination Products
Heidi Manijeh Mehrzad, Principal Human Factors Specialist, HFUX Research
Heidi provided a comprehensive and wide-ranging presentation on the requirements for human factors studies in medical devices. Heidi explained the requirements for such studies and how they fit into the overall device development process.
Heidi highlighted the benefits from a well-thought-out human factors study approach and discussed numerous best practices to consider, in defining your human factors study approach.
How to Compile a Clinical Evaluation for Combination Products
Florian Tolkmitt, Independent Regulatory Affairs and Clinical Evaluation Expert
Florian talked about the clinical evaluation requirements for combination products. Florian provided an overview of the requirements for clinical trials in the new EU MDR regulations.
Florian outlined the processes and documentation requirements that companies will need to apply to their clinical evaluations through the new regulations and discussed a number of challenges that companies will need to meet.
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