Case Study: From Prototype to Clinical Trials

November 12, 2020 / Case Studies

How our focus and experience in the prototyping process helped this customer to develop their high-performance valve delivery sheath for clinical trials.


Proof of Concept

Our customer had strong product IP position in mitral valve technology. To further support their IP position and to strengthen their investment proposition and activities, they required a proof of concept device (POC) to demonstrate their technology.


For the POC, ICS Medical Devices fabricated a batch of 5 prototypes meeting the priority functional requirements defined by the customer, including in this instance the hub connection to adapt the sheath with the customer’s valve geometry. The materials used by ICS replicated the targeted requirements and were either stored in-house or sourced with a <1-week lead time. From here we were able to prototype a braided construction within 3 days.


Further Iterations

Our customer successfully received funding allowing them the opportunity to further develop their concept. Over the following six months we prototyped seven different iterations, fine tuning performance and features and adding requirements identified in testing with their KOL’s. Functional and physical testing was completed at the ICS Medical Devices facility and bench, clinical and KOL testing was completed by the customer in parallel.

ICS engineer working on the concept design prototype stage

Prototype iteration 4, 5 & 6 were used in animal trials and batch 7 used in GLP trials. Where required, the prototypes are built with full design history, traceability, and controls.

Within 9 months of the first POC request, the customer achieved design freeze and is now gearing up for First-In-Man clinical trials with a robust and tested design.


Our Experience

With years of accumulated experience our engineering team at ICS Medical Devices is well positioned to address your catheter prototyping and development needs. Our experience has been accumulated over many years and a wide a variety of projects.

We are firm believers in ‘fail early, fail often’ and we apply this mantra to the projects we work with our customers on. To learn more about our prototyping process, read our blog on it here.

If you are in need of design or prototyping support, reach out to us today to speak directly to one of our engineers –

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