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CUSTOMER CASE STUDIES

Sewn Medical Products

Custom-fitted wearable options

PRO-TECH has been designing and fabricating sewn goods both in the USA and overseas for over twenty years. As an FDA registered contract manufacturer of medical devices, PRO-TECH understands the needs and requirements of the medical market.

SITUATION

A large pharmaceutical company developed a combination drug/pump therapy to change the lives of patients with a chronic medical condition.  To receive sufficient therapy, patients needed to wear a large infusion pump at all times.  This limited patient mobility and made the therapy less tolerable. 

The company needed a wearable device to house the pump, enhance mobility, and allow the patient to program therapy without removing the device. 

As the wearable device is considered part of the combination drug therapy, the manufacturer of the sewn medical product needed to be FDA registered, ISO 13485 certified and needed to provide a finished device with UDI compliant labeling.

ACTION

PRO-TECH’s design team worked with the company to develop a range of wearable options for the patients, including vests and options to wear around the waist or shoulder. 

PRO-TECH produced prototypes for human factors trials, durability testing, and performed risk analysis on the product. 

Once all testing was successfully completed, PRO-TECH performed a full production ramp up to support the worldwide market.

RESULTS

The sewn device was successfully launched in the USA and worldwide.

 After two successful years on market, PRO-TECH and the customer are using patient feedback to further enhance designs and continually improve the patient experience.

ADDITIONAL CUSTOMER CASE STUDIES