SEWN MEDICAL PRODUCTS
In addition to our medical device assembly and packaging capabilities, PRO-TECH Design is also an ISO 13485 certified medical sewing contractor. We specialize in wearable medical devices and carrying cases. We handle product development from design to sample production to full-scale manufacturing to meet the unique needs of medical device OEMs and their patients.
We provide custom solutions tailored for different sectors of the medical device market. Most of our customers require complex sewn assemblies to support custom wearable medical devices and cases that safely and securely hold monitoring devices, continuous medicine delivery pumps (insulin pumps) and neuromodulation treatments. We are one of the few contract sewn manufacturers in the industry who are also ISO 13485 certified to meet the demanding standards of the medical device industry.
Some of the medical markets we serve include:
- Patient Monitoring
- Diabetes Care
- Chronic Pain Management
For medical wearables products, where the device must be worn continuously to be effective, patient comfort is key to successful treatment. Therefore, it’s critical to partner with an experienced medical contractor who is adept at human factors when creating custom sewn solutions that works seamlessly with life-saving medical devices.
From medical device wear and carry accessories to sales presentation kits, we design and produce a broad range of sewn products that are stylish, functional and durable and we employ a wide variety of materials and sewing techniques.
- Product Design
Starting with Product Design, we offer complete design solutions using 3D printing, rapid sample prototyping and extensive experience in developing medical device wearables to design a solution that provides a functional yet stylish product to compliment your medical device.
We can handle small runs or large scale jobs. Our sewing capabilities include:
- Manual and automated sewing
- Specialty stitching, custom embroidery and screen printing
- Laser and Die cutting
- Custom foam inserts
- Foam/Plastic Thermoforming
- Pad Printing
- Label and IFU printing
- Ultrasonic Welding
COMMITMENT TO QUALITY
Our domestic sewing facility in Santa Fe Springs, CA is ISO 13485 and FDA registered, ensuring only the highest quality standards.
- U.S. and OUS Facilities
- Total Project Management software
- Customer tracking portal – provides ongoing project transparency to customers
Our skilled engineers and sample makers work hand-in-hand with you to create products that satisfy your specific requirements. We use your device, solid models, drawings and sketches to generate fast turnaround concept samples to meet your timing requirements. We work with you through every step of the process to ensure your patients receive a final product that works with their lifestyle.
EXAMPLES & MATERIALS
Style and Case Examples
- Soft Sided
- Device Wear Items and Garments
- Pressure Formed
- Event Monitoring
- Sales Presentation Kits
- Belt Clip Cases and Harnesses
CUSTOMER CASE STUDIES
Sewn Medical Products
Custom-fitted wearable options
PRO-TECH has extensive experience in designing and fabricating sewn goods both in the US and overseas. As an FDA registered contract manufacturer of medical devices, PRO-TECH understands the needs and requirements of the medical market.
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.
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.
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.