Posts by Dana Trousil

Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]

Dana Trousil

Why an early PFMEA is important

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 […]

Dana Trousil

Off the shelf components in medical devices

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.

Dana Trousil

Prototype vs Production tooling

“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?”

Dana Trousil

Calculating Medical Device manufacturing costs

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 […]

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