[CASE STUDY]

Early Design Assistance Aids Innovative
Urinary Self-Catheter Med Device


For people with spinal cord injuries, diabetes, spina bifida, multiple sclerosis and other conditions, self-inserting a disposable urinary catheter is a difficult task.

A private manufacturer based in the western United States sought to provide an easier method for people with limited finger dexterity to perform those intermittent self-catheterizations while simultaneously reducing potential infections. For individuals with normal dexterity, the medical device is likely the easiest and most convenient catheter they’ll have ever used, according to our customer.

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CHALLENGE

Our customer, who was facing volume and delivery issues with an overseas-based supplier on a liquid silicone rubber (LSR) and two plastic parts, contacted NPI/Medical for assistance. The overseas molder was unable to supply timely delivery or ample quantities of parts.

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SOLUTION

Upon receiving product files and samples, NPI/Medical identified part and tool design issues. The plastic part design was inappropriate for high-volume production and the tool was only able to mold about 100 parts per day.

NPI/Medical provided design guidance and assistance to convert the part to a two-piece design, built prototype molds, and molded and assembled test units. Testing by our customer determined 100 percent acceptable function.

The customer also wanted to make the LSR part in a thermoplastic elastomer. NPI/Medical helped explore material alternatives, built a prototype mold and determined via testing that the original LSR candidate was the correct material, preventing high-capital investment in a production mold that would never run. After the prototype phase to determine optimal parts designs, material selection and less than six months of testing, all parts were approved and NPI/Medical was given the go-ahead to build one multi-cavity LSR mold and three multi-cavity plastic production molds.

The customer’s desire for high-quality, low-cost parts and willingness to pay for superior quality molds helped ensure success in supplying the lowest cost of assemblies and on-time deliveries.

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RESULTS

After 12 years of research and development, the self-catheterization product hit the market and has been making an impact on thousands of lives since. In fact, our customer calls it “the most significant advancement in intermittent urinary catheters since the closed-system was created.”

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“The most significant advancement in intermittent urinary catheters since the closed-system was created.”

- NPI/Medical’s Customer
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NPI Medical

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