A Viewpoint from Preeti Choudhary – Key trends in the Medical Device Industry in 2018
As a result of better quality of lifestyle, life expectancy has increased and therefore there has been a significant rise in people aged 65 and over. Globally we’re expected to see a surge in demographical changes of 15% and 20%, which has been a massive driver in the growth of the medical device industry last year, boosting its sales to somewhere between 5% and 10%.
As I look forward to an exciting and busy year for my business, working with Procorre and the medical device industry as a whole, I want to take the opportunity to look back at some of the key market trends over the course of the last 12 months.
Changes in regulatory requirements across the globe (Harmonisation)
Due to increased demand and awareness in the industry, regulatory requirements are getting more stringent. Transition from MDD to MDR is one of the key examples. The main focus and the key driver for the changes is harmonised standards across the globe, which will support higher quality products and make trade less complex.
EU MDR is changing, and is now more oriented towards the following:
- Clinical evidence and continuous assessment for device performance
- Improvement on technical documentation content
- Increased surveillance, vigilance and PMS (Post Marketing Surveillance) changes
- Requirements for UDI (Unique Device Identification) in terms of both device and production
- The introduction of the European Database for medical devices, distributor and importers requirements
New Product Development
As a result of an increase in regulatory requirements, a big trend observed in 2018 was plans across the industry to invest in New Product Development. These products are consumer focussed and huge investments have gone into major projects to attract new markets.
Digitalisation, data safety and management, cyber security
As we are moving into the SMART world, digitalisation has impacted the medical device industry massively. Management and security of data (patients, employees, users etc.) has become a huge concern due to the introduction of the new data protection regulation GDPR. Accurate and better management of bigger data now plays an important role as huge amounts of information is generated and gathered. Hence the introduction of data management, security and analytics became a hot topic over the course of the last 12 months.
Increased Focus on Patients and end user
Patient safety first is obviously a main focus for the industry across the globe, and there has been a number of changes in labelling, IFU/user manual requirements for various markets and changes in regulatory requirements at market level. 3D printing of labels was also another key trend in 2018.
Unique Device Identification (UDI)
Introduction of UDI for both production and design was another big talking point and the upcoming 2020 deadline is going to impact the regulatory framework to work towards the new UDI requirements.
Determining the policies and agreement for the impact of Brexit on the medical device industry was the most talked about topic of 2018. This discussion will continue long into this year as the the UK’s exit date approaches. The current update from UK government is that they intend to recognise the EU MDR for the foreseeable future. The role of authorised representatives for medical devices supplied to the EU was also widely talked about.
These are just a few of the trends and issues that stuck in my mind from last year. Stay tuned for my predictions on what will be the hot topics for 2019!