As technology continues its journey of relentless evolution, one thing is abundantly clear: Intersectoral collaboration between the medtech and pharmaceutical industries will have a critical role to play in confronting the future’s unmet medical needs.
On September 8th, BioTalent’s own Louise Cleland attended the annual Medtech and Pharma Platform (MPP) conference to explore one of the most pressing topics in the life sciences space – How combined products address health challenges.
Held in Basel, Switzerland, the MPP conference acts as a forum to exchange knowledge, collaborate in technology & regulatory areas, and to promote product development & innovation.
Attended by experts from a wealth of life sciences sectors and tech industries, (including representatives from Novartis, Roche, and IBM) the conference was aimed at the nature of combined products, the regulatory framework that governs them, and their impact on the wider community.
Here are our key takeaways from a day overflowing with profound insight.
Digital Health is Going to be the Future of the Medical Device Space
Technological integrations will continue to greatly influence the realm of digital health, as seen already in the form of wearable tech and other forms of mobile health products.Innovative startups with lofty visions keep appearing in this space, and many big companies, like Google, Deloitte, and Capgemini are establishing subsidiaries in order to keep up.
Communication Between Manufacturers and Notified Bodies is an Ongoing Challenge
Communication is critical to meaningful progression, particularly in highly regulated industries. This still appears to be an ongoing challenge for manufacturers and the notified bodies, an issue that’s been exacerbated in some part by the EU’s new MDR and IVDR reforms.
The new reforms (designed to better protect the health of the patient) give notified bodies more control over manufacturers, a sign of the irrevocable regulatory changes taking place in the life sciences today.
Careful implementation of this legislation is crucial, and clear communication and understanding will decide it’s effectiveness.
This could present some new challenges for the world of regulatory compliance recruitment, as companies will likely need to look to a new set of talented professionals to pilot their process life cycle under the new legislation.
There is some confusion surrounding legal frameworks and the MDR/IVDR timeline – clear processes need to be put in place to rectify this, and to establish the harmony between the AI act and the devices using AI. Regulatory recruitment solutions will have a large part to play in the future of this space.
Combining Software and Hardware
It is more challenging to get regulatory approval when combining software and hardware (SaMD + medical device) that it is to get it for a single device. One of the ways this could be improved is if contact with the FDA was established during the early phase of device development.
There was Real Passion on Show During the Conference
The conference had no shortage of passionate people, all of whom had gathered to engage in meaningful discussion and drive collaboration in the industry, as Louise noted:
‘You could feel the genuine passion just talking to people about what they do & what exciting things they’re working on, and it was inspiring, I loved the whole experience, and I can’t wait for the next one.’
Quotes from the Day
Bao Phan, Vice President, Global Head of Oncology Therapeutic Group/Global Regulatory Affairs:
‘This is still a new field that is moving, and the regulatory environment is evolving so early, engagement with regulators is important. It is also important that pharma companies build capabilities to support their ambitions’
Antoine Bourrier, Speaker, Senior Solution Manager, Capgemini Engineering:
‘I really enjoyed getting to meet many people from different companies, backgrounds, and responsibilities. The talks were very informative and gave a good overview of the actual challenges HealthCare industries face these days.’
Rahal von Rohr, Speaker, Senior Consultant, anteris helvetia:
‘It was a great day, with a very diverse selection of presentations and many exciting encounters. I was particularly inspired by the panel discussion, where representatives from industry and regulators exchanged their views on the regulatory challenges combination products face. A call for all of us to work together to expedite effective, safe, and innovative solutions for patients.’