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.
SEWN MEDICAL SOLUTIONS
PRO-TECH Design provides custom sewn solutions to meet the needs of medical device customers. 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.
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
SEWING CAPABILITIES
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. We employ a wide variety of materials and sewing techniques depending on the project.
Product Design
We offer complete design solutions using the latest design software, 3D printing, and rapid sample prototyping. Using our extensive experience in developing medical device wearables, we design solutions that provide functional, yet stylish sewn products that 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
MARKETS SERVED
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:
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- Patient Monitoring
- Diabetes Care
- Chronic Pain Management
- Parkinson’s
- Incontinence
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
EXAMPLES AND MATERIALS
- Soft Sided
- Device Wear Items and Garments
- Pressure Formed
- Event Monitoring
- Sales Presentation Kits
- Belt Clip Cases and Harnesses
- Nylon
- Lycra
- Polyester
- Neoprene
- Leather
- Vinyl
Please Contact Us today to design a solution to meet your unique needs.
THE PROCESS
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.
SEWN MEDICAL PRODUCTS
Custom-fitted wearable optionsSITUATION
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.Frequently Asked Questions
What type of sewing services does PRO-TECH Design & Manufacturing offer?
PRO-TECH specializes in a wide variety of sewn medical products, including carrying cases, accessories, wearables, and sales presentation kits. We offer the flexibility of manual or automated custom sewing operations at US or OUS medical device manufacturing facilities. We provide custom designs based on years of experience creating the perfect sewn solution for any customer need.
What sets PRO-TECH’s medical device contract manufacturing process apart?
With decades of extensive experience in medical sewn products, PRO-TECH combines a wealth of experience, cutting-edge technology, and a skilled workforce to deliver best-in-class manufacturing solutions. We are also one of the few sewn medical products companies that are ISO 13485 certified.
What materials does PRO-TECH use for sewn medical products?
We work with a wide array of materials including Nylon, Lycra, Polyester, Neoprene, Leather, and Vinyl. We tailor the material choice and each product solution to meet the unique needs of our customers and we have the flexibility and experience to design wearable products that meet their budget and timing requirements.
How does PRO-TECH ensure the quality and precision of contract sewing services?
We are an ISO 13485-certified contract manufacturer – one of the few with that certification in the sewn medical industry. That means that we must adhere to strict quality standards and sewing processes and the customer can be assured that we will deliver a quality product. In addition, we have years of experience designing custom solutions to the highest quality standards and have a reputation in the medical industry for creating unparalleled custom-sewn solutions.
What industries benefit from PRO-TECH’s sewing capabilities?
PRO-TECH serves a variety of industries within the medical field, offering sewn solutions for medical device companies in Patient Monitoring, Diabetes Care, Chronic Pain Management, Parkinson’s, and Incontinence among others.
Can PRO-TECH handle custom medical device sewing projects?
Yes, PRO-TECH routinely develops custom-sewn solutions for customers. Our experienced team of engineers and designers works closely with medical device companies to design and produce dependable products, ranging from custom-fitted wearable devices to sales presentation kits.
Do you manufacture in the U.S. or overseas?
PRO-TECH has the capability to produce its sewn medical products in the U.S. at our own facility or overseas, where we have long-standing partnerships with our suppliers. So, depending on the customer’s requirements, budget, and timeline, we have the flexibility to produce their item either in the U.S. or OUS.
What additional services does PRO-TECH offer alongside sewing and manufacturing?
In addition to our extensive history in medical sewing services, PRO-TECH also provides contract packaging, cleanroom assembly, sterilization services, and validation testing for medical devices. We offer a comprehensive suite of solutions to protect our customer’s medical device products. If you want to learn more, feel free to reach out to us at our contact phone or via email address.