Posts by Dana Trousil

It behooves designers to look at the assembly processes early, with a focus on how we can stop critical faults or those that are likely to happen. Process Failure Modes and Effects Analysis (PFMEA) is a tool to assess potential process failure points during assembly and how the failures could be felt or observed by […]

When developing a medical device, it’s easier both in time and effort not to reinvent the wheel. Sometimes, off-the-shelf (OTS, or COTS – commercial off the shelf) components don’t meet the device needs, and usually these deficiencies are obvious. The problem arises when we unconsciously ask for more than the original widget design requires.

“What’s the difference between production tooling vs prototype?” and “What quality can I expect?” are often questions that I get asked from development or clients. The best answer begins with other questions: “What quality do you really need?”, and “How many are you making?”

CAUTION:  Overhead ahead One of the biggest mistakes start-up companies can make is underestimating manufacturing costs.  The tendency is to focus on the cost of the components, i.e. Bill of Materials (BoM) costs.   They’re important, but costs don’t stop at the BoM.  Depending on the nature of the device, other/overhead charges can overshadow the costs of […]

We prototype to learn, but also to communicate ideas and concepts.  While undoubtedly 3D printing is an exceedingly useful tool, there are a number of low fidelity prototyping methods that can help launch a successful product. As medical device developers, we are often faced with making design decisions under tight budgetary constraints.  Prototyping medical devices should […]

Garbage In, Garbage out…    StarFish manufactures medical devices, and one of the coatings we see from time to time is anodizing.  Anodizing creates a durable coating that can be a great coating for medical device parts.  If aesthetics matter, it’s important not to think of anodizing in isolation, but also consider the inputs into anodizing.