Sometimes radiopacity is required to visualize the location of your device during a procedure, or perhaps to make sure it’s where you left it. When x-rays are utilized with metallic objects, the image can suffer from shadowing effects due to the strong contrast with the surrounding tissue or bone. An ideal radiopaque solution is a […]
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Throughout the development of a product there are technology-related project risks that have the potential to negatively impact budget and timeline. At StarFish, our development process defines medical device proof-of-concept (POC) prototypes to mitigate these risks, either by resolving the uncertainty one way or the other, or by testing the use of a new or […]
I have taken part in a large number of brainstorming sessions with a variety of techniques. In general I am usually disappointed with the quality of the solutions that are generated. As a facilitator I will exit the brainstorm with a fist full of ideas and then spend time dissecting them and more often than […]
Hacking (gaining access to a device through unintended means) commonly has negative connotations, but it need not imply an intent to destroy data or harm hardware. I’ll use the term Hacking in this blog, with the acknowledgement that when malicious intent is involved, a better term is Cracking. Hacking medical devices is not new, but […]
Around 10 years ago, I set up a company with the entrepreneurial Professor from my PhD. After recruiting an MBA as chief executive and performing very many pitches, we eventually secured seed funding then series A funding to develop a novel medical device technology. The development was a new application of an existing technology and […]
Think back to your last job interview… in all likelihood you were asked to describe a difficult situation you faced and how you tackled it, or to explain your greatest weaknesses, or a major failure you encountered in your career. You squirm in your chair and try to think of a positive way to spin […]
Developing a complex medical device spans a significant period of time and a significant expertise spectrum. Early ideation and technology development through transfer to volume manufacturing covers a tremendous range of skill sets. Staged product development as employed by StarFish has some unique benefits for dealing with the changing skill sets required throughout the development […]
We’re all probably familiar with the following scenarios from sometime in our careers. Maybe we’ve just powered up the first populated sample of our new prototype PCB; it all seems to work fine. Two weeks later something smokes and we subsequently discover that one of the boost converters is unstable and killing downstream parts.
During the development of electromechanical products there is a natural transit from unconstrained to highly constrained design. The initial ideation phase of the development is often very fluid and not only can the shape of the product change markedly and rapidly but so too can the architecture itself. This is not a reflection of the […]
*Guest post by Annelies Tjebbes Picture this, it’s product verification time. Today you are going to start testing your product. You have put together a plan, thought of everything that could go wrong, and planned for it: you are ready. You read over the first few sections of the Verification Plan to refresh on the […]
A quick survey of available project management tools yields some interesting findings: 1. There are many of them 2. Some are expensive, and not worth the investment 3. Some are free, and still not worth the investment 4. Most are Gantt variants, and Gantt charts don’t tell the whole story Gantt charts are the […]
First principles calculations are the best way to give a design concept a reality check and worthy fluid dynamics books have a wealth of reference information on drag coefficients, major/minor losses, hydraulic diameter calculations, and a trusty Moody diagram. However, sometimes the problem is less intuitive… For example, non-Newtonian fluid flow, actual flow from a fan, […]