Mixed messages at the Vonlanthen drug-device combination product conference 2019

The thoughts of Matthew Jones of DCA’s Medical Sector team on the 3rd Drug/Device Combination Products conference in Amsterdam 10th – 11th April 2019:

The first paper of this lively conference struck a confident note, presenting predictions that put the growth rate in the combination devices market at 8% a year well into the 2020s, fuelled in large part by combinations for the injection of large volume biologic drugs.

Two of the most engaging papers of the conference were from representatives of big pharma companies.  They both pointed out that with healthcare increasingly moving out of the clinic and the hospital, and into the home or onto the body, the importance of designing combination products that patients like to use and like to look at is more critical than ever.  It was an exciting viewpoint from a part of the industry that often pays the product development bills and that has often set these design considerations low down the priority list.  Ultimately, that’s got to be good news for patients and their compliance with treatment regimens. 

As the conference continued, some of the papers and discussions struck a more negative note but were no less valuable for it.  On the second day, which in part had a regulatory focus, a number of concerns were raised regarding the end of the transition period for the new Medical Device Regulation (MDR) which happens in May 2020.  Chief among them was that most notified bodies are still undergoing the designation process under the MDR and that process is far from complete.  Meanwhile, the overall workload for notified bodies is greatly increased both because of the requirements for recertification and the additional work of using the MDR for the first time. 

The upshot is that the industry should expect significant delays in new product approvals and that will undoubtedly mean bad news for patients, with delays in treatment using new products, and bad news for the industry, with products taking longer to reach the market. 

In one of the panel discussions, while all the contributors to the discussion agreed that the field of drug-device combinations is on the precipice of a digital revolution, many expressed fears regarding the risks of this new world.  They particularly focussed on data management – what data should be collected, how privacy should be protected, what new risks are created, to mention just a few.  It’s an understandable concern given the potential magnitude of change to the way products interact with patients and HCPs and given the number of high profile data breaches outside the world of medical devices that have hit the news in recent years.  However, one contributor was able to cut through the concerns and he made the point that data management is no different from any other risk; it needs to be considered in a well informed and structured risk analysis process.  At DCA, we clearly see this in our developments of smart and digital medical devices and systems.  The important thing is that the development is carried out by people that are experienced in undertaking these risk assessments and implementing design solutions to eliminate or mitigate them.  The medical device industry should look forward with positivity because, as an industry, it is good at handling risk.

Whether positive or negative, the papers and discussions at this edition of the conference were valuable and interesting.  We’ll be back!