Posts categorized as“Business”

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 […]

Is Device Generated Data part of your medical device plans? We live in a digital era, and if you are in the medical device design and development business, it may be wise to think digital health. There is an undeniable shift from stand-alone technology to integrated systems even for devices with specialized functionality. Granted, devices with […]

The interview process was surprising to me when I applied to StarFish Medical for an administrative role six years ago. I was brought in for two rounds of interviews. In years past, I had only ever had a single interview with a company before being offered a position. Looking back on that now, I was naïve in […]

Medtech companies that innovate with value-based care in mind will be well positioned  In a video interview published by MDDI, Omar Ishrak, the CEO of Medtronic, describes the biggest threat to the medtech industry is not “acknowledging that in the end patient outcomes is the most important criteria and therefore helping move payment incentives both […]

This is the second blog in series of three that cover our recent experience with FDA inspections of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing. The first blog outlined our inspection preparation strategies (very different for each one!), while this one discusses inspection outcomes. The last blog will cover lessons learned.