Decentralized Trials Are Here To Stay; What Challenges Do They Face?

Decentralized trials took a leap in popularity over the past few years, in part thanks to the COVID-19 pandemic. Medtech Insight spoke to two executives at clinical research technology companies about running decentralized clinical trials to discuss the benefits and limitations of trials run remotely.

drug bottle on a trial form with a syringe
• Source: Shutterstock

Decentralized clinical trials, which use communication technology to avoid forcing patients to visit a central lab or clinic, are changing how drugs and devices are developed. 

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Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push, UK Pilots

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.

When It Comes To Spine, Incumbents Are ‘Not Listening To Surgeons,’ Says Spineart CEO Jerome Trividic

 

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.

EU Pilots Streamlined Approach To Multinational Combination Product Trials

 
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EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

Deloitte 2025 Life Sciences Outlook Report Finds Medtech Leaders Focus On AI, GenAI Adoption Across Value Chain To Increase Efficiencies, Cut Costs

 
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The Deloitte 2025 Life Sciences Outlook report highlights cautious optimism among life sciences and medtech executives, with 75% expressing confidence in revenue growth despite challenges. AI and digital transformation are central to their strategies, enabling cost savings and operational efficiencies. Medtech Insight also spoke with Deloitte’s US Consulting Medtech Practice Leader, Sheryl Jacobson, about her medtech outlook for 2025.

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Bayer Expands Into IBS Market With HiDoc Technologies Acquisition, Cara Care App

 
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Bayer Consumer Health snaps up digital therapeutic Cara Care for its Precision Health business with an eye to developing its self-care capabilities.

Penetration Testing Strengthens Medical Device Security Against Emerging Threats

 
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Penetration testing, which involves ethical hackers identifying vulnerabilities before malicious actors can exploit them, is crucial for securing medical devices against cyber threats. The process is essential for compliance with regulations, preventing financial losses, and ensuring patient safety, cybersecurity experts say.

Deloitte 2025 Life Sciences Outlook Report Finds Medtech Leaders Focus On AI, GenAI Adoption Across Value Chain To Increase Efficiencies, Cut Costs

 
• By 

The Deloitte 2025 Life Sciences Outlook report highlights cautious optimism among life sciences and medtech executives, with 75% expressing confidence in revenue growth despite challenges. AI and digital transformation are central to their strategies, enabling cost savings and operational efficiencies. Medtech Insight also spoke with Deloitte’s US Consulting Medtech Practice Leader, Sheryl Jacobson, about her medtech outlook for 2025.