A Viewpoint from Preeti Choudhary: 2019 Predictions for the Medical Device Industry
Following my last blog where I outlined some of the key trends over the course of 2018, I thought I’d share my predictions for 2019.
There’s certainly going to be some challenges in the industry towards the awareness and usage of smart medical devices by the general consumer; as our personal lives become busier, we want everything to be easily accessible. – Typical examples include smartwatches and sports equipment. Gone are the days when you had to go to a physician to measure your pulse and blood pressure; the availability of smart devices has made this so much easier, we can measure our vitals and health from the comfort of our own home.
Although these smart changes in lifestyle empower the user, this trend has ramifications for the medical device industry and I predict that this is something that’s going to greatly impact the industry over the course of this year, therefore the challenges could be huge. With the increasing demand, users now have options available to buy these items online, hence this will cause the medical device industry to review the regulatory pathways to market, which are virtual in many instances, and this will start a whole new movement across the globe.
As the transition deadline approaches, it is creating more panic and becoming increasingly challenging for the industry. With more stringent requirements, industries are struggling to translate the MDR regulations into workable actions as strategies are being developed. Part of the challenge is understanding the strict new requirements and implementing them within the tight deadlines, which is causing an impact on time, resource and cost. It’s not only challenging for the industry but equally complex for notified bodies and regulatory experts. Everyone is still in the learning process. My advice is don’t wait and start preparing for changes now if you haven’t already!
Risk Management – Revision of ISO14971
Another big stir on the horizon is changes to risk management standards, the 14971:2018 version, which is very much still in the draft stages. As a RA/QA consultant, I am really looking forward to the new edition; it’s going to be far more detailed and brings more clarity. The new edition also aims to deliver harmonisation with MDD/AIMDD/IVDD and MDR/IVDR. But don’t panic just yet, my advice is wait for the outcome of the technical committee!
21 CFR 820 (QSR) harmonization with ISO13485:2016
Another major trend for the medical device industry is the FDA’s consideration to adopt ISO13485:2016 in line with 21 CFR 820. This is a good option in my view as looking at the details, they are not too far from the requirements point of view. The challenge is how they plan to sync two sets of requirements together and make it feasible in a harmonised way.
To summarise, 2019 is going to be another challenging yet exciting year for the medical device industry. It will continue to move at a very fast pace which will drive manufacturing and innovation in order to meet patient demand.
A Blog by Preeti Choudhary