Med-Tech Innovation Expo preview: Three simple questions
We set some of our speakers from across the three stages at this year’s expo a task – to answer three crucial questions. Their responses demonstrate the broad cross-section of stakeholders attending this year’s Med-Tech Innovation Expo.
1.What are the current challenges in medtech?
Alistair Walker, owner and consultant, Lorit Consultancy: One of the biggest challenges the sector faces is companies keeping up to date with the massive framework of international standards, as well as directives from different markets, in order to ensure their products are compliant with safety regulations. The lack of standardisation internationally is a huge burden on medical device companies and navigating the regulatory landscape can be very complex. This can even be prohibitive when it comes to international expansion as different markets have different standards you must adhere to should you want to trade in that geography.
Michael Branagan-Harris, CEO, Device Access UK: The NHS is under enormous strain and device manufacturers really need to present their device differently as a solution for the patients and hospital in a way that’s beyond using the words “saving money” or “innovative” which does not work, as does pointless downward price negotiation with procurement.
Steve Cox, 3D tech consultant, Amfori Consulting: I think the challenges are similar to those facing most other sectors in that people are expecting more solutions, they are expecting better solutions, but we need to be delivering those solutions somehow with less. I work as a consultant with Autodesk and “More, Better, Less” is a strapline that they have adopted as a challenge that they want to meet with the software and solutions that they offer in the design and manufacturing sector.
Oli Hudson, content director, Wilmington Healthcare: Aggregating procurement, value pricing, transparency, the burden of proof on outcomes, and demonstrating a whole-system benefit.
Michael Kipping, Innovation Lead, Innovate UK: The Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) usher in important changes to the EU regulatory environment and increase the requirements on companies. Challenges for medtech companies include: how to assess regulatory gaps in current product portfolios, finding a Notified Body that will accept them as a client, where to seek regulatory advice from and evaluating whether it is commercially viable to re-certify to MDR/IVDR, lack of awareness of the need to comply e.g. digital technologies, combination products etc.
2. What are the opportunities?
Michael Branagan-Harris: The NHS have never needed technological innovation as much as they do now. In 2014 The King’s Fund advised NHS England to build 22 x 800 bed hospitals before 2022 to meet current demand, and the building work has not started yet.
New technologies that reduce length of stay, reduce complications and readmissions, treat and diagnose patients faster with greater accuracy with less staff are things that the system needs like never before.
Alistair Walker: There is an opportunity to learn from other high risk, highly regulated sectors such as automotive, rail and aviation. We tap into knowledge of different industries to support the guidance we give to clients as there is great benefit in taking this approach. While other sectors have their own unique challenges, they are far more standardised than the medtech sector; currently the medtech sector can even find different definitions of commonly used words across standards causing a lot of confusion and inefficiencies.
Steve Cox: New digital technologies and 3D capabilities are providing new tools for use in the sector, and those solutions are able to deliver more effective, and in some cases, more bespoke solutions but at an economic cost
Michael Kipping: Drawing together the fragmented support mechanisms in the UK and supporting SMEs to comply with new regulations and develop opportunities in non-UK markets.
Oli Hudson: I’d say the big opportunities lie within innovation tariffs, faster evaluation under NICE, investment in technology under the long-term plan, and the medtech funding mandate.
3. How are changes to the regulatory landscape affecting the sector?
Michael Kipping: The softening of the stance by FDA combined with the increased requirements of the EU MDR/IVDR mean that some companies are now looking to the US first for regulatory approval rather than the EU.
Alistair Walker: There has been a lot of talk regarding MDR, however this is not saying anything new. It is purely tidying up what was already available and presenting it in one large document. From a regulatory point of view this is a positive step forward however in reality when you scratch beneath the surface there is nothing new – just a different format and more rigour as a result.
Michael Branagan-Harris: Over regulation stifles innovation. If the EU Government continues to move the goalposts, then sadly technology research and trials will end up in other parts of the world which have easier regulations, like South America, and we won’t have them first.