While the road ahead might be unpredictable, the core dynamics of the life sciences sector and the coming expiry of patents worth over $100 billion are poised to drive a renaissance in biotech mergers and acquisitions.
Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.
The recent Supreme Court ruling in Amgen v. Sanofi reminds patent practitioners that the scope of disclosure defines what has been enabled and that purely functional claiming can be problematic.
A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President, U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how other companies can get started.
Device manufacturers may see the EU MDR extension as an opportunity to take their collective feet off the gas. But slowing down or pausing a device’s testing program could jeopardize a successful transition and exacerbate the problem the deadline extension was designed to fix.
The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
There are several tactical approaches to design that can help medtech manufacturers inspire patient confidence in their products and ensure proper usage. Following are three ways you can help ease the burden of delivering and receiving quality care through product design.
As 3D printing gains a more prominent place in the manufacture and protoyping of medical devices, advances in technology and materials are expanding indications. We spoke with John Kawola, CEO of Boston Micro Fabrication (BMF), about the move toward micro 3D printing and how this technology is supporting the drive for miniaturization and minimally invasive medical treatments.
