“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.
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StarFish Medical videos are created to help viewers learn about medical device design, development and manufacture. They are also a great way to get a better sense of the people you will be partnering with at StarFish.
Four new medtech blogs and three new authors joined our 2018 “most read” list. Regulatory was the most popular topic, followed by electrical engineering, software, and supply chain.
Anyone who has taken a signals and communications course has likely heard of 
When choosing a manufacturer to launch your medical device, there are 
Many entrepreneurs underestimate the importance of ramping up medical device manufacturing in a small and controlled way – sort of a slow ramp. They often overestimate how quickly they’re going to require high volume and underestimate the value of post-release design changes and the effort that will be required in early launch.
The most common question supply chain professionals get from clients is “How can we reduce the cost of this project?” Cost reduction is always a challenge – especially in a low volume, complex manufacturing environment.
When most people think of Lean Manufacturing, they think of large, gleaming, gazillion square foot manufacturing spaces where every surface is clean, meticulously labelled and taped off. Happy workers reach for their conveniently placed tools on their shadow boards and work on mistake-proof assembly stations. They think of Toyota, or Boeing, or any manner of billion dollar businesses that have invested a lot into leaning out their operations. That can be quite intimidating for small companies on tight budgets with little headroom to get their Lean for small volume manufacturing journey started.
We asked our new product introduction (NPI) team to reflect on their collective experiences transferring medical devices from design to production. Their top tips for production readiness are listed below.
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