During the past five years, myriad developments have shaken the medical device industry, from the revision of ISO 13485 to the introduction of the Medical Device Single Audit Program, not to mention the incoming EU Medical Device Regulations. At the consumer level, FitBits have become a common sight on the wrists of fitness-conscious people across the globe. With the pace of change showing no sign of slowing, we look to the second half of 2019 and discuss emerging trends for the year ahead.
1. Breakthroughs in heart surgery
Open heart surgery is risky and invasive. Advances in medical devices are allowing surgeons to pioneer new surgical techniques such as mitral and tricuspid valve replacement that provides access to the heart through a catheter in the skin. It has been proven to save lives, reduce recovery times and re-admissions, and several companies are now competing to get their products to market.
2. Use of medical devices to tackle drug addiction
Illicit drug use can ruin lives, strain public services, and decimate communities. In the US, the FDA is attempting to tackle addiction through the innovative use of medical device technology. Approved plans include a transcranial magnetic stimulation device and VR therapy.
3. Wearable tech becomes pervasive
Wearable devices continue to grow in popularity. Last December Gartner predicted the sales of wearables to increase by 26% worldwide, with shipments reaching 225 million in 2019. As wearables become more common, medical applications of wearable technology will also become steadily more prevalent.
4. Wearables used in clinical trials
With the prevalence of wearable devices and smartphones comes huge data-gathering potential. Currently, there are some 600 clinical trials underway across the globe incorporating wearable tech. Expect that number to increase as the scope of wearables becomes more apparent.
5. Monitoring the safety of medical devices
How do you ensure the ongoing safety and efficacy of medical devices that are used in patient welfare? The FDA is leading the way thanks to the creation of a national system for gathering real-world data and clinical evidence on everything from devices used in tissue closure procedures to spinal repairs. The findings may well determine the relationship between patients and medical devices for years to come.
6. Consumer goods companies entering the industry
Apple was granted two De Novos earlier this year to work on its ECG monitoring capabilities on the Apple Watch. We’ve also seen Bose working on technology to improve hearing aids. Non-medical device companies participating in medical technology will become more common in 2019, as Apple and Bose are going to be joined by other companies that identify opportunities to apply their technology in the healthcare sector.
7. Challenges of EU MDR
The EU’s new Medical Device Regulations require all medical devices, from scalpels to pacemakers, to be individually coded and tracked throughout the EU member states. This change to regulations presents a massive challenge to manufacturers, who must now ensure accurate application of traceability amongst their products.
We’re in the last year of the three-year transition period to allow companies to prepare for EU MDR coming into force, and yet only two-thirds of Notified Bodies that have been accredited by the MDD and AIMDD have applied for the EU MDR accreditation. That puts huge pressure on manufacturers who currently cannot get new products to market, starving the health sector of innovation.
Additionally, the technical specification of EUDAMED isn’t due to be issued until the end of 2019, only half a year before the databank registration deadlines for Class 2 and Class 3 products. 2019 will certainly see the challenges of conforming to the new framework becoming apparent.
What next?
The most significant and noticeable trend moving forward is likely to be the growing prevalence of wearable devices. With smartwatches leading the charge, devices that can record data about ourselves and facilitate preventative action will bring huge benefits. The challenge looms, however, that wearables classified as medical devices will be subject to the EU MDR. Manufacturers will have to remain mindful of the May 2020 deadline and ensure that new and existing products can be effectively tracked.