Leadership

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.

Medtech Insight spoke with René Quashie, vice president of digital health at the Consumer Technology Association (CTA), about what to expect at this year’s CES show.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

Our dozen-plus experts from across the medtech sector agreed that 2024 was the year when AI went mainstream. They expect it to continue shaping the sector into 2025 and also hope for increased international harmonization, a more business-friendly US government, and increased investment.

From regulations to technology to market dynamics, 2024 was a year of change for the device sector. We asked 14 experts from industry, regulators and other stakeholders to tell us which changes were welcome, and which they’d like to leave in the past.

Key challenges for 2025 remain enforcement, political issues and potential deregulation, while improved reimbursement and emerging markets offer major advantages. See what else was top of mind for experts contacted by Medtech Insight.

The incoming second Trump administration promises changes for medtech that include both the potential benefits of deregulation and the risks of tariffs. See what a dozen-plus industry experts had to say.

Scotland has a strong foundation of medtech research, but to reach the ‘tipping point’ where it has gained critical startup mass, it must overcome funding challenges and foster corporate startup partnerships.

The medtech sector in the UK, Switzerland, and Germany face a challenging 2025, heads of national trade groups say. Competition and access to innovation remain key concerns across the board, with collaboration with the EU and US planned in Switzerland while Germany focuses on approaching elections.

Medtech Insight asked three leading AI experts, Verily’s Andrew Trister, Ferrum Health’s Pelu Tran and Hologic’s Jennifer Schneiders, to offer their perspectives on the future of AI in health care.

Jerome Trividic, CEO of Swiss company Spineart, believes that by solving pain points felt by orthopedic surgeons performing spinal procedures, it can improve patient outcomes. He thinks the firm’s innovative approach, which focuses on partnership deals as well as developing its own products, will give it a competitive edge in the spinal surgery market.

While medtechs still find the investment environment difficult, good companies will continue to get funded. So says Taylor Wessing partner Ross McNaughton, adding that UK life sciences innovators should in the longer-term benefit from more funds going into VC and PE under The Mansion House Compact.

Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.

Jonathan Kamerman, ambulatory monitoring and diagnostics, national sales leader at Philips, discusses leveraging and managing patient data to solve hospital pressure points.

Santhosh Nair, president of Thermo Fisher Scientific's ImmunoDiagnostics , talks to Medtech Insight about Thermo Fisher's "secret sauce,” the Allergon company, and what is next for Thermo Fisher.

PharmStars CEO Naomi Fried spoke with Medtech Insight about the Boston-based virtual accelerator, which brings together digital health-focused start-ups with pharmaceutical companies to accelerate deals. Executives from Elemeno Health, Head Diagnostics and JOGO Health who participated in the PharmaU program and final pitching event to PharmStars’ pharma members talked about their experiences, the value proposition and challenges in securing a pharma deal.

After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.

Guardant Health expects to break even by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.

Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.