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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

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.

January 20, 2026
Balancing Cyber Risk

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

January 20, 2026
ChatGPT

How ChatGPT Health is rewriting patient engagement

By Christoph Lippuner

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026
Medical Device R&D Bottleneck

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

January 6, 2026
Superemployees - AI human evolution

How is AI Enabling Darwinian growth for Life Science Professionals?

By Ivor Campbell

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.

December 4, 2025

The Hidden Complexities of Medical Needle Design

By Kelly Peterson

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

December 4, 2025
Smart Critical Care

Using AI and LLMs to fill in fragmented data gaps within complex critical care

By Dimitar Baronov, PhD

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or de-escalation of treatment and enhances patient outcomes. These technologies also help reduce staffing issues and prevent clinician burnout by continuously monitoring patient risk and supporting decision-making in busy ICU settings.

View More Combination Products Articles »

TOPICS

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

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