Close
Highlighting important considerations during the "Design & Development" stage of the Medical Devices translational pathway.
IDEA:
Target Product Profile (TPP) – captures the ‘benefit’ of the proposed medical device and key considerations in the strategic development of the product (incl. technical, scientific and medical information required to satisfy regulators and industry partners).
Key considerations for adoption include:
- Intended use - ‘Unidentified’ opportunities for clinical benefit/use (e.g.arising from creative discussion with expanded audience)?
- Device description - Ergonomics / ease of use
- Contraindications - Destined for stand alone use or routine employment alongside/in combination (e.g. consider comorbidities)?
- Testing - Usability testing assumes device is used as ‘imagined’; Replicate/engineer testing in ‘work as done’ context; Design in ‘Resilience’ (i.e. minimum service adaption to enable adoption and diffusion, regardless of context)
UCL Support:
The Translational Research Office (TRO) have extensive knowledge of the medical devices landscape, and can provide advice on early considerations such as intended use and device descriptions etc, to guide development, as well as longer-term considerations for adoption i.e. help you produce and develop your TPP.
UNMET CLINICAL NEED:
As part of the TPP, comprehensively research and define the potential for benefit of the proposed medical device over current ‘standard of care’.
Understand the patient and clinician ‘pull’ – are they clearly aligned or conflicted?
UCL Support:
The Translational Research Group (TRG) within the Translational Research Office, will help define the project plan to how your project successfully meets the unmet clinical, ensures costs are accurately calculated to cover the project sufficiently, identifies suitable funding streams and helps with the application. Importantly these funding streams require active project management which the TRG can provide throughout the entire project.
INTELLECTUAL PROPERTY (IP):
Engage with Business experts to ascertain if you have a novel invention, ensure freedom to operate and to protect foreground/arising intellectual property.
UCL Support
If you believe you have an innovative, patentable technology, it’s important you contact UCLB before any form of public domain disclosure.
UCLB are experts that provide confidential support for researchers at UCL, to understand the value of your invention and the best approach to protecting your intellectual property (IP), advising on strategies to commercialise your research such as through forming a spin out company or licensing to a third party.
All researchers with potentially commercialisable research results should fill out a confidential Invention Disclosure Form (IDF) and submit it to their UCLB Business Manager: http://www.uclb.com/for-researchers/do-you-believe-you-have-a-novel-invention/
DOCUMENTATION:
Regulators require appropriate documentation detailing medical device design, manufacturing, specifications, quality measures, usages, safety and impact.
It is necessary to keep and update records throughout the entire lifetime of the device, It is not something that can be done at a later date, when ready for regulatory submission
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system to standardize the documentation process (e.g. approval and review, version control, availability).
Hospital in-house development is now covered by MDR (May 17-21), therefore requiring appropriate QMS, although it remains unclear where in-house academic devices fall since these technically do not constitute institutes treating patients.
Oxford Global Guidance have developed an excellent digital tool aimed at people working in the area of medical devices, helping researchers to navigate device and IVD regulations: https://www.oxfordglobalguidance.com/
UCL Support:
The Devices & Diagnostics Therapeutic Innovation Network (TIN) is implementing a lean QMS to meet the basic regulatory requirements at the early stage of medical device development (i.e. ISO 13485-aligned). The QMS does not provide the documentation required, only the processes needed to be followed to deliver the required documentation (incl. review, approval, version control, access, design & decision traceability).
Join the Devices & Diagnostics TIN
Additionally, the UCL Translational Research Office have been involved in a number of discussions involving the new Medical Device Regulations (MDR) for 2021, to help provide clarity on the applicability of the MDR to academic and partner health institutes.
If you have questions relating to the new guidelines and how they may affect you, please contact Dr Simon Eaglestone.