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Manufacturing Execution

Featured Articles

April 18, 2025

The Agile MedTech Lifecycle:
Rethinking Regulatory Adoption in a Time of Global Disruption

By Arjunvasan Ambigapathy

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.

April 4, 2025
titanium

Titanium:
biocompatibility, durability and cost-efficiency continue to improve

By Kim Crabtree

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of rejection. Its non-ferromagnetic nature makes it MRI-safe, and its durability supports better healing outcomes compared to materials like stainless steel. Though more expensive, titanium’s costs are becoming more manageable, and demand is expected to surge with the aging population. Innovations like beta-titanium alloys, surface treatments, and 3D-printed implants continue to expand its medical potential.

April 4, 2025
Interoperability

What’s Missing in MedTech Innovation? The Journey Toward Plug-and-Play Device Interoperability

By Dr. Charles Jaffe, Todd Cooper

For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a vendor-neutral framework to finally achieve plug-and-play interoperability—unlocking scalable, AI-powered MedTech innovation and improving patient outcomes.

February 7, 2025

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

January 21, 2025

Public Health Impact of Medical Device Supply Chain Vulnerabilities

By Michelle Tarver, M.D., Ph.D.

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.

January 10, 2025

Sustainable from Start to Finish

By Dr. Max Rehberger

The European Commission’s Green Deal sets specific sustainability targets across the EU, while policies like the German Supply Chain Act (LkSG) of 2023 are setting standards domestically. TÜV SÜD explains how hospital operators and medical device manufacturers can position themselves sustainably in the market.

January 2, 2025

CMMS Software:
Enhancing Regulatory Compliance

By Donal Bourke

Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining compliance with regulatory requirements.

December 19, 2024

Software Intensive Medical Devices, Costly Development Pitfalls

By Tim Bowe

In the medical device industry, engineering quality is paramount. This is a high-stakes field, and the FDA has zero tolerance for violations. A robust development process not only enhances quality, compliance and efficiency but also boosts profitability.

View More Operations Articles »

News & Views

  • Medtronic Acquires Nano Surface Technology Assets from Nanovis

  • AAMI Updates Materials Compatibility Guidance for EO, Other Modalities

  • APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare

  • MEDICA & COMPAMED 2024: Adapted Hall Layout for Even Better Integration of Trade Fair and Ancillary Program

  • Soaring Medical Device Scrutiny: How is the Market Adapting?

  • Pusan National University Researchers Explore the Interplay Between High-Affinity DNA and Carbon Nanotubes

  • SURVEY: Managing global regulatory strategy and compliance – assessing status, gaps, and needs.

  • FDA publishes long-awaited clinical trial diversity guidance

  • Ricoh launches innovative Point of Care 3D medical device manufacturing facility at Atrium Health Wake Forest Baptist

  • Flex Recognized as a 2024 World’s Most Ethical Company

Upcoming Events & Webinars..

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On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024 – 1:00 pm – 2:00 pm
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024 – 10:00 am – 11:00 am
Decoding global regulatory pathways: How to classify your Medical Device






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

Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

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