Episode description
This is the audio from RQM+ Live! #51, recorded 24 March, 2022.
In this session, our panel of clinicians (including a neurosurgeon and anesthesiologist) will discuss ways that they work with regulatory affairs teams to improve outcomes for submissions, including the following:
- Scoping intended use/purpose and clinical indications (incorrect scoping is currently the biggest issue notified bodies are findings in IVDR submissions)
- Scoping state of the art from a physician's perspective, ensuring it truly represents what clinicians do on a daily basis
- Identifying clinical risks and mitigations clearly across risk, CER/PER and PMCF/PMPF documentation
- Clearly defining the clinical roadmap for ease of understanding and review
- Writing CERs/PERs that are comprehensive and will withstand review by clinical experts in regulatory authorities
- Responding to post market surveillance challenges
- Reviewing claims and guiding responsible marketing
- Being part of cross-functional teams from device development through the entire device lifecycle
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Sally Sennitt, MBBS, FRCA – Medical Director
- Andrew Tarnaris, M.D. MD(Res) FRCS(NeuroSurg) – Medical Director
- Dulciana Chan, M.S.E. – Principal Consultant
Questions:
1:50 -- What are the areas of the regulatory process where you think we could be leveraging medical directors more?
5:23 -- Have you found other reasons why else it is important to involve clinicians in your submission process?
10:18 -- As an FDA reviewer (to Dulciana), could you see submissions that involve clinicians vs. not, or where intended use is off-base?
11:03 -- Do you think there is going to be a problem with titling these indications, and therefore... clinicians being used to their old ways... using devices almost off label?
14:47 -- How can you include your external medical experts in your QMS processes and training to be able to participate in an organization's procedures for risk management and clinical evaluation?
17:27 -- Scoping State of the Art has been a huge challenge. How could clinicians help with that?
23:07 -- Can you use the designing surgeons to be part of the process?
27:37 -- One process for early understanding of the level of clinical data needed for MDR certification is through ‘proposed clinical path review’ by the NB. But the same NB glut and delays observed for cert. are similar for this vehicle (NB clinicians appear to be too busy with cert. to even address clinical path review). Are there other approaches for companies to understand what level of clinical evidence is needed prior to submission of a full application?
39:57 -- Could you enlighten us on where the border between consulting and providing information stands?
41:57 -- Where is that line when it comes to FDA?
44:25 -- What's your opinion on software as a medical device, trends on classification, and how to take help from clinicians for scoping?
47:36 -- What about CERs and PERs, specifically?
52:30 -- Are there any key takeaways to wrap up? (includes commentary on PMCF and an overall summary)