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.

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

With a rich background in sterilization, microbiology, and biocompatibility, Swanson oversees all aspects of medical device assembly, packaging, and sterilization in the company.

He explains that PRO-TECH has always been at the forefront of technical knowledge, which has helped the company stay ahead of an evolving regulatory landscape while effectively working with its clients. “Given our background and expertise, our customers often come to us for advice on regulatory submissions and validation packages. We are flexible enough to align our services according to the customers’ needs and build strong customer relationships,” states Swanson. “We take pride in the fact that several of the customers that we started with 40 years ago are still with us today,” he asserts.

After onboarding a customer, the company brings a dedicated team together that oversees the product in terms of packaging, sterilization, and quality. From being a consultant and supplier for companies that need the guidance and expertise, taking them through the regulatory processes, to putting their operational pieces together, PRO-TECH does it all. For over 40 years, PRO-TECH has been successfully providing unequaled quality, value, reliability, and customer service to its clients in the medical device industry.

Swanson shares a customer success story that best exemplifies PRO-TECH's value proposition. The customer in question had been using PRO-TECH’s stock packaging systems to package orthopedic implants. As the sales grew, they wanted to reduce the packaging footprint and achieve a more enhanced look. This situation called for a fully customized packaging system. PRO-TECH's Engineering team designed a system that accommodated three distinct products, each with over a dozen sizes. The solution used a common inner/outer tray and box with retainers and interior foam to meet individual product needs. The company’s development team wrote and executed validation protocols for the new packaging to ensure safety and compliance. As a result, all implants were successfully transitioned into the new dual tray system with no loss in quality and compliance, and validations were completed on time. The customer currently enjoys a new design for their medical device packaging, and PRO-TECH’s production team continues to clean, package, label, and sterilize all implants.

Having scripted several such success stories, PRO-TECH has carved a unique niche in the space. Looking ahead, the company aims to continue on its growth curve. They have created aggressive expansion programs to meet the capacity issues prevalent in the market nowadays. In fact, PRO-TECH is doubling the cleanroom capacity in its FDA-Registered facilities located in Santa Fe Springs and Arlington to attain flexible production capabilities. The company has recently purchased land in Texas as well to meet its future production requirements. “Our five-year plan is to be considerably bigger company than we are now. We are ensuring that we leave no stone unturned in terms of addressing the requirements around infrastructure, primarily equipment, and more to stay ahead of the competition,” notes Swanson.