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Ultimate Posts

IVDR

IVD Intended Purpose: Why it matters more than ever under IVDR

March 21, 2025 6:59 am | By Rich West

Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies? Read more →

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Featured Articles

March 1, 2026

Why Digital Tool are Needed to Cope with Increasing Pressures in MedTech Innovation

What is driving the need for increased transparency across the MedTech organization relative to product innovation, development and commercialization?

February 26, 2026
MedTech Commercialization

Decision Criteria for Technology Commercialization of Medical Devices in 2026

By Partha Anbil

Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.

February 26, 2026
Vivalink Cardiac RPM

Continuous Cardiac Monitoring: Redefining the “End” of a Clinical Study?

By Cecilia Xi, Ph.D.

While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient care.

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

February 9, 2026
navigating regulatory strategy

Navigating the Global Regulatory Landscape: A Foundation for Medical Device Commercial Viability

By Partha Anbil

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.

February 3, 2026
Mental Health Reimbursement

Demand for Non-Pharmacological Mental Health Needs a Delivery System

By Allan Gobbs

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.

February 3, 2026
Safety of AI in Medical Devices

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

January 20, 2026
Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

View More Combination Products Articles »

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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