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 FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. The workshop is scheduled for Wednesday, November 29, and Thursday, November 30, 2023, from 10:00am-2:00pm ET.
Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.
The MedTech industry has grown too comfortable with “essential use” exemptions and is ignoring the growing liability, supply chain and regulatory risk of PFAS use in medical devices and manufacturing facilities.
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.
RFID and IoT technologies can strengthen the medical device supply chain and improve workflows. The following real-life examples illustrate the benefits that can be achieved.
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.
AdvaMed has filed comments with the EPA regarding proposed regulations of ethylene oxide and their impact on patient care.
Maria Shepherd, president and founder of Medi-Vantage and co-founder of MedExecWomen, discusses her career in the medical device industry, what led her to launch her own company and the joy of “finding her tribe” among fellow female executives committed to bringing up the next generation of women leaders in MedTech.
The UK is an appealing market for MedTech businesses, but there are some important issues that companies will need to be familiar with to ensure they fully understand the UK regulatory landscape. The role of the UK Responsible Person is one of the most important.