2018 Trends in Medical Device Regulation
- The continued trend of consumer tech disruptors entering MedTech via partnerships may indicate that MedTech wants to leverage the established consumer-centric mindset rather than develop its own. Zimmer Biomet and Apple teamed up to study the Zimmer Biomet’s mymobility app, which relies on the Apple Watch, and its impact on patient outcomes and overall costs for joint replacement patients. ResMed and Google’s Verily inked a new joint venture deal aiming to develop software solutions to improve diagnosis, treatment and care for sleep apnea and other breathing related sleep disorders. Insulet and Samsung are partnering up to develop an Omnipod insulin delivery system that would allow users to control their insulin pump therapy with a Galaxy smartphone.
- FDA has made a great effort this year to improve regulatory processes to help continue innovation and safety in medical devices. FDA proposed an update to the 510(k) regulatory review pathway with more of a focus on predicate medical devices that are 10 years old or less. A proposed De Novo Classification Process would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. Safety and Performance Based 510(k) Pathway will allow a company to demonstrate that their novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles. Safer Technologies Program (STeP) intended to encourage device tech that significantly improves safety as compared to current devices on the market.
What to look for in 2019
- FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with ISO 13485:2016. FDA plans to leverage MDSAP (product of IMDRF) for its nationwide adoption of the globally agreed upon standard on device oversight as the audits are conducted against 13485 under this program. CDRH intends to roll out its revised quality system regulation by April 2019. The revisions are intended to reduce compliance and record keeping burdens on device manufacturers by harmonizing domestic and international requirements.
- NEST v1.0 – the envisioned network of data collaborators for the advancement of real-world evidence (RWE) generation— is set to launch before the end of 2019. NESTcc should at least be able to answer questions around clinical evaluations and payer reimbursement decisions by next year.
- Increased FDA focus on cybersecurity and post-market surveillance processes to better protect patient safety.
This year end blog was written by Amaris Ajamil, PhD, Simbex Research Engineer. A story’s inclusion does not imply endorsement by Simbex, LLC.