Posts categorized as“Business”

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 […]

5 tips to a successful academic-industrial partnership Costs are rising for research so how do you maximize your biotech R&D budget? Form an academic-industrial partnership. Perhaps you are working on a disruptive technology and need an expert to assess that your assay is better than the accepted standard? Or maybe you’ve had a pet research […]

For insight into Infectious diseases Point of Care (POC) assay industry trends I’ve summarized several leading sources for trends including the World Health Organization, the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting key topics, and an Ipsos Mori poll published by the Bill and Melinda Gates Foundation.

With an enforcement date of May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) is about to impact medical device manufacturers. Though similar to the U.S. Health Insurance Portability and Accountability Act (HIPAA), the new GDPR requirements will influence medical device data services by enhancing privacy and security for EU citizens.

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 […]

Blockchain technology introduces new secured measures for keeping authentic and anonymously real time personal data in decentralized manner. It can be expected that upon maturity the blockchain technology behind Bitcoin will gain the required trust and be used extensively by partners of the highly regulated healthcare ecosystems: patients, regulators, clinics, pharmacies, insurers, laboratories, technology developers […]

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 […]

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 […]

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 […]

Saturday night I won the Technology category of the EY Entrepreneur Of The Year™ 2017 Pacific Awards ceremony held in Vancouver BC. I’m sharing my acceptance speech video with our blog readers who are entrepreneurs or about to embark on the journey.  To me, the award is a team award for what we’ve achieved together because StarFish and ViVitro are […]

Build an Input Pyramid to support your medical device development As a medical device designer, I see clients balancing cost and feedback in a daily struggle to decide when to get clinical feedback, from whom, and how much weight to give that input. KOLs (Key Opinion Leaders) and individual designer experience can take a product well […]