In short. A pharma company asked us to develop a proprietary continuous glucose monitoring patch: a skin-worn, single-use electrochemical sensor with its own needle and chemistry, a two-week wear target and Bluetooth. We delivered it in eight phases to a clinical-ready prototype: 11,600 engineering hours over one and a half years, about $1.5 million of engineering for a program of this type plus $20,000 to $40,000 of materials. The device is now in clinical trials.
The challenge
Two players hold about 85% of revenue in this market, largely because the needle sensor and the processing are proprietary. A new entrant needs a patch that is accurate, comfortable for two weeks on the skin and cheap enough to throw away. The client was a corporation, but it needed the same thing a startup needs: a golden sample that fully meets the functional requirements before certification and manufacturing are priced.
The eight phases
Discovery, proof of concept, design
Requirements, proof of the core function and the design for the first prototype.
Prototype 1
Electronics, firmware and enclosure; a batch of 100 units; bench testing and accuracy work.
Prototype 2
Optimization, the applicator, tissue and model testing, and small trials to find a design that does not irritate the skin during long wear.
Prototype 3
The clinical-ready version that goes into the study.
Clinical phase about 2,000 hours
About 30 devices; we covered the software, the protocol, support during the study and analysis of the results.
Prototype 4
Updated on the clinical findings.
What comes next
Certification, design for manufacturing and manufacturing are priced separately, after the clinical results. For this level of complexity design for manufacturing is estimated at another 5,000 to 7,000 engineering hours: assembly sequence, test strategy, tooling support, second sources and process validation.
Lisa Voronkova described this program in detail on the Global Medical Device Podcast.
Of course, in the state you cannot sell it as a medical device or make any clinical claims, but it’s enough to understand do you want to invest more on that or not really. But for startups, this is the most useful artifact to open the next round.
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Sources
Client names are not disclosed. Updated on October 9, 2026.