Newsletter | June 12, 2025

06.12.25 -- Tips From A Biomedical Engineer For Medical Device Innovation And Compliance

FEATURED EDITORIAL

Tips From A Biomedical Engineer For Medical Device Innovation And Compliance

Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

INDUSTRY INSIGHTS

How Knowles Powers Precision Miniaturization In MedTech

Knowles offers advanced miniaturization solutions—like micro coiling, molding, and electronics integration—designed to optimize MedTech device performance.

Cheat-Sheet For Developing Innovative Bone Grafts

Bone grafting is a growing market with challenges in traditional materials. A new EBM platform offers a unique, inductive biomaterial with potential for improved handling and predictable regeneration.

How Recent Trends Impact Bringing Your Molecule To Market

With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

The 5 Ws Of A Human Factors Strategy

A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

ARTICLES YOU MAY HAVE MISSED

When To Outsource — And How To Pick The Perfect Clinical Trial Partners

Protecting Intellectual Property In The Genomics Revolution

AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 2

Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis

Unlocking Business Value In Digital Health Solutions In Pharma

RESOURCES

Laser Rotary Encoders For Highly Accurate Angle Sensing

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