Posts categorized as“Manufacturing”

Nigel Syrotuck

XYZs of Medical Device Vibration Testing

Medical devices, especially complex ones with electronics, almost always undergo shipping testing before they are considered safe enough for market. We use 3rd party testing services to run typical load profiles on devices in their packaging. These usually include impact, drop and vibration testing, amongst others. Vibration testing is a particularly interesting subject, which we’ll […]

Nigel Syrotuck

What do Mil-Spec Anodizing Types and Classes Mean?

Let’s talk about what an anodized finish actually is.   A core finishing technique around the world, anodizing is highly valued in the medical industry to promote longevity of devices. It is a finishing process that can be applied to a few different materials, the most common being aluminum (in fact, this blog will only discuss […]

Nathan Muller

3D Printed Parts Streamline Development Process

This blog provides a context for designers to streamline their development process using 3D printed parts as a part of their market-ready medical devices. 3D printing is disruptive. It challenges the way that designers consider product development. Contrasted with traditional fabrication methods, 3D printing offers several benefits along with certain limitations. Regulatory agencies are providing […]

Nigel Syrotuck

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated […]

Astero StarFish

Our Top 10 medical device development videos in 2020

Our top 2020 medical device development videos include 6 new videos. They join favorites from previous years and cover subjects including 2020 updates, COVID implications for research and POC devices, optimizing founder value, manufacturing for NPI, IVD insights, and working at StarFish.

Alex Gunson

5 LEAN Manufacturing Techniques for Medical Device NPI

Waste in manufacturing drives up product costs affecting both short term profitability and the long-term adoption curve. LEAN Principles that reduce waste are widely adopted to improve high volume manufacturing, but how can they be applied to New Product Introduction (NPI) for medical devices? This blog shows how applying these 5 LEAN Manufacturing Techniques for […]

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