Although they are experts in designing medical devices, medtech companies are often not well-versed in assembling and packaging those devices to deliver safely to the end customer while meeting FDA requirements. As a result, PROTECH’s role is to design packaging, assembly, and sterilization solutions that protect their device from initial receipt to patient. Besides, they advise which materials would be most effective, which sterilization methods are most appropriate, and which approaches would be the most cost-effective. These challenges have only increased with changing regulations, COVID-related supply chain disruptions, and customer uncertainty. Because of this, PRO-TECH has seen its role evolve into a consultant working with customers further upstream to help them navigate and adapt to changing conditions.
PRO-TECH is a full-service FDA, and ISO 13485 registered medical device contract packaging company. Founded in 1980 by CEO Pamela McMaster, PRO-TECH is a woman-owned business. Together, Pam and her son Aaron Swanson, President, lead the company and guide it’s future direction. Aaron is the rare combination of scientist, operations expert, and general manager. He is a microbiologist by training, and he understands the science at the microscopic level. He has been working in medical device packaging for nearly 20 years and has a deep, hands-on understanding of the operational elements required to assemble devices and their packaging in a cleanroom environment efficiently. Combining these skills has transformed PRO-TECH from a small, family-owned packaging firm to one of the leading contract packaging companies in the medical device sector.
“One of the pain points that our customers have experienced is the long-lead times and cost of packaging validation tests. As a result, during the pandemic, we undertook the process to achieve ISO 17025 accreditation for our laboratory,” says Swanson. “Even in normal times, achieving accreditation is a fairly involved, complex process. Add to that the challenges of a remote audit and conversations with a governing body that was working largely from home, and it became a monumental task.” Swanson adds, “we are very pleased to share that our Quality Assurance and Laboratory teams rose to the occasion and achieved full accreditation. We are now able to offer our customers additional validation expertise in-house as part of the medical device packaging services we provide. Additionally, we can reduce the lead times and costs associated with validation since we have the control and expertise in-house.”
PRO-TECH offers a full contract sterilization service, including validation and cycle development. Integral to PRO-TECH’s packaging and assembly services are the coordination and recommendation of appropriate sterilization services. The company has long-standing relationships with several sterilizers who utilize Ethylene Oxide and Gamma sterilization methods, and they work with them closely to determine the appropriate sterilization methodology, cycle times, and load configurations. “Our formula for success is pretty simple. As a family-owned business, we pride ourselves on developing and maintaining close relationships with our customers,” says Swanson. “Many of them have been with us for a decade or more. In fact, our original customer is still a customer 40 years later! So, for us, Customer First is not just a phrase.” Swanson and his team strongly believe that to be effective they must genuinely understand the customer’s business to create customized solutions unique to their situation.
We are now able to offer our customers
additional validation expertise
in-house as part of the medical device
packaging services we provide
We are now able to offer our customers additional validation expertise in-house as part of the medical device packaging services we provide
The company pays strict attention to quality. “With most of our customers, their devices will be implanted inside a patient. As a result, we take our role in protecting that device very seriously and through 40 years of experience, we are adept at designing packaging that will keep the product safe all the way to the end patient,” explains Swanson. “We believe that flexibility is a key ingredient to our success today and in the future. Case in point, with the abrupt change in the business environment last year due to COVID, we were able to nimbly adjust to the changing conditions and were still able to do the same.”
PRO-TECH had a potential customer approach them during the pandemic, saying that their existing packaging supplier couldn’t handle their business. The customer only had 45 days of inventory on hand, and once that ran out, they would have no product to ship. They needed a qualified supplier to be up and running within a few weeks to ensure that they maintained a consistent supply to their customers. Once they approached PRO-TECH, they were quickly assigned a cross-functional team to coordinate an action plan. Without hesitation, the team worked with the customer to understand their needs and unique situation. By responding quickly, PRO-TECH assembled to their specifications, ordered parts, identified a suitable pre-validated packaging solution, and ramped up production to replenish their inventory. This all happened within their timeline, and they never missed a beat shipping product to their customers-all during the pandemic.
According to Swanson, PRO-TECH’s future looks bright. They continue to see growth in the medical device sector, and there will continue to be a strong need for custom packaging solutions. In the near term, Swanson expects that technology innovation will play a greater role in enhancing medical devices’ impact. This, in turn, will require new packaging and sterilization solutions to safeguard them along the journey to the final patient. “For PRO-TECH, that means continued flexibility and adaptation to changing conditions and requirements, which we think is already a strength and one we plan to enhance through innovation in both technology and processes,” adds Swanson.
PRO-TECH Design & Manufacturing, Inc. is a fullservice, contract manufacturer that specializes in packaging, assembly and sterilization services for the medical device industry.