PRO-TECH Design & Mfg, Inc. : Unparalleled Medical Device Assembly, Sterilization, and Packaging

More often than not, medical device manufacturers and contractors don’t consider packaging design and validations until the very end of the product development process. However, amidst the COVID-19 pandemic and an increasingly challenging technological and regulatory landscape, they are starting to realize the value in determining the best packaging and sterilization solutions early in the design process to ensure device protection and patient safety. As such, medical device manufacturers need to design cost-effective packaging that protects their devices from damage and potentially harmful microorganisms throughout the supply chain. However, they struggle to find the right combination of packaging material, sterilization method, and safety tests to achieve this effectively. They also lack packaging design expertise in-house as a core competency. This is where PRO-TECH Design & Mfg, Inc. positions itself to serve medical device manufacturers and contractors.

As a family-owned and operated full-service FDA and ISO registered medical device contract manufacturing and packaging company, PRO-TECH has established itself as a prominent leader in the industry. The company specializes in medical device assembly and packaging, contract manufacturing, validation, sterilization, and sewn products. Apart from providing full-service contract manufacturing services to the medical device market, including contract assembly and contract packaging in its ISO 13485 registered facilities, PRO-TECH also offers full contract sterilization services, including validation and cycle development. “We are known for being customer-focused and deploying a customer-first approach,” says Aaron Swanson, President at PRO-TECH Design & Mfg, Inc. “We holistically look at the overall process from packaging design to sterilization and then assist our clients develop a reliable solution as per their requirements. We help them reduce costs and improve speed to market, while ensuring strict attention to quality standards and regulatory requirements,” he adds.

Notably, PRO-TECH has over 6,000 square feet of certified Class 10,000 Cleanroom space dedicated to medical device packaging, assembly, and kitting. This enables cleaning, assembling, packaging, and labeling products in the same facility, ensuring the highest level of quality. With its 100,000 square feet of manufacturing and warehouse space, PRO-TECH can serve the needs of both large and small customers. Furthermore, PRO-TECH has both in-house and managed third-party laboratory support. “We’ve also just gotten our laboratory approved ISO 17025 certified to conduct biologics testing, other than Bioburden and Endotoxin testing. We keep adding new capacity and testing to our internal laboratory in order to meet the needs of our customers in-house,” mentions Swanson.

PRO-TECH provides its customers 24/7 access to order and inventory status via custom web portals and allows them to have products stocked and shipped from its dedicated distribution facility. The company’s team comprising microbiologists specializing in medical device sterilization and packaging experts with experience in automated and manual assembly is well-led by Swanson.