Executive Exclusives

Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

Philips CEO Roy Jakobs talks to Medtech Insight about the medtech firm’s decade-long history of embedding AI into its products and what he expects from the newly released draft framework by the National Academy of Medicine, which he helped develop as co-chair of the Steering Committee.

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

Jasmine Balloch, chief of staff at generative AI medtech startup Tortus, reflects on opportunities for women to succeed and repackage success, providing advice on how to succeed as a woman in medtech.

Medical device cybersecurity is a part of a larger ecosystem that should not—and cannot—be ignored.

HSS Spine co-chair Sheeraz Qureshi can envision a future where HSS will use AI chatbots, like ChatGPT, to help educate patients, but it will never replace shared clinical decision-making between doctors and patients.

Counterfeit copies of LifeVac Europe’s anti-choking devices have been registered on the EU’s EUDAMED database and continue to be sold on third-party platforms. Medtech Insight asked director of sales and marketing Matthew Banagan how the company deals with fake devices and what the authorities must do.

Medtech Insight spoke to Brian Anderson about creating standards for responsible AI and the policy developments he’s looking forward to in 2024. 

Medtech Insight spoke to QliqSOFT executive Bobbi Weber about the advantages of collecting patient data though chatbots, and how the technology can make conversations at the doctor’s office a little more manageable. 

“We have the power to drive innovation, improve patient outcomes, and shape the future of healthcare, as women in medtech,” Daniela Delledonne, vice-president and general manager at BD Biosciences, told Medtech Insight. We spoke to Delledonne about her experiences of the medtech industry in honor of International Woman’s Day and Women’s History Month.