Posts categorized as“Manufacturing”

Henry Ho

First-to-Market strategy, trade-offs and tips for medical devices

In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival.  To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy. FTM product commercialization carries a much higher overall project risk […]

Astero StarFish

Avoid these 11 costly medical device development mistakes

There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple […]

Astero StarFish

Medtech resolutions for 2018

The New Year brings reflection and desire to improve.  We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered. Here is their list of 2018 resolutions and smart things to do that would speed […]

Astero StarFish

Top 10 StarFish Medical blogs of 2017

The top 10 StarFish Medical blogs of 2017 feature a heady mix of regulatory, engineering, and practical information and advice. Seven of the blogs are perennial favorites with high ranking on Google and other search engines. The remaining three are from new writers and hint of new evergreen standards in the works.  New or tried […]

Astero StarFish

Readers’ Choice: Top 10 StarFish Medical newsletter items of 2017

The StarFish Medical newsletter features a monthly collection of medical device articles, images, events and videos. We aim to share our knowledge and expertise to all levels of medical device colleagues. Once a year we share what was hot with our readers. Just in case you missed that issue. Below are our Top 10 reads […]

Astero StarFish

Top 10 StarFish Medical videos of 2017

We love creating StarFish Medical videos to help viewers learn about medical device design, development and manufacture.  We also appreciate the opportunity to showcase our talented team. It’s a great way to get a better sense of the people you will be partnering with at StarFish. The top 10 viewed Starfish Medical videos for 2017 […]

Taimoor Khan

Qualifying and Managing RoHS and REACH suppliers

Companies manufacturing equipment or consumer parts that use hazardous materials in the manufacturing process must comply with RoHS and REACH environment regulations. RoHS and REACH are two regulations that require compliance if a company intends to sell in the European Union, China, Korea and some parts of the United States and Canada. Therefore it is […]

Kathryne Young

Establishing Supply Chain Controls to de-risk your supply chain

As a medical product moves through development to production stage, establishing  supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate […]