SteriLabs: Advancing Medical Device Testing in Canada’s MedTech Ecosystem. LSO Success Stories 2024

 COMPANY OVERVIEW

Established in 2016, SteriLabs is a trusted provider of laboratory testing and advisory services, specializing in microbiology and analytical chemistry for the medical device and pharmaceutical industries. Operating within a state-of-the-art, 20,000-square-foot facility, the company utilizes FDA and Health Canada-approved equipment to conduct rigorous testing. SteriLabs’ laboratory is accredited to ISO/IEC 17025 standards and licensed by the Public Health Agency of Canada, ensuring the highest levels of quality and safety. SteriLabs has worked on a wide range of complex medical devices, validating cleaning, disinfection, sterilization, and packaging procedures. Their expertise includes simulating use cycles and assessing the effects of repeated reprocessing on device performance. These studies are crucial for manufacturers to demonstrate to regulatory bodies, including the FDA and Health Canada, that their devices are safe for patient use. The company supports device manufacturers and research institutions through every stage of the product lifecycle, from design and validation to regulatory approval. Each test is customized to the specific device and complies with the latest global standards. SteriLabs is dedicated to delivering precise, reliable results, recognizing that the accuracy of every test is essential to ensuring the safety and efficacy of products entering the market.

WHAT ARE YOU DOING THAT’S UNIQUE? WHAT PROBLEMS ARE YOU SOLVING, AND WHAT IS YOUR IMPACT BEYOND YOUR COMPANY’S WALLS?

Before the establishment of SteriLabs, Canadian medical device manufacturers had to rely on U.S.-based laboratories for specialized testing in cleaning, disinfection, and sterilization validation. This created challenges, including the logistical complexity of shipping devices across the border, lengthy turnaround times, and limited collaboration opportunities. Manufacturers often found it difficult to effectively engage with U.S. labs when issues arose, as they could not easily visit the facilities to contribute to problem-solving. SteriLabs addressed these challenges by creating a world-class, ISO 17025-accredited testing laboratory in Canada, specialized in medical device testing. This has provided Canadian manufacturers with the ability to conduct validation studies locally, reducing costs, shortening turnaround times, and enabling direct collaboration with SteriLabs’ team of scientists, engineers, and consultants. By offering faster, more accessible testing services, SteriLabs has significantly streamlined the validation process for Canadian companies, fostering innovation and efficiency within the industry.

BARRIERS TO SUCCESS

One of the biggest challenges SteriLabs faces is engaging medical device manufacturers that have traditionally worked with overseas laboratories. While organizations often resist change, SteriLabs has maintained a 100% customer return rate. Once manufacturers experience the lab’s efficient and effective processes, they consistently choose to return for future testing and validation services. Another significant barrier is the limited number of Canadian-based MedTech conferences since the pandemic, which makes it harder to network with potential clients in the local industry. Looking ahead, the increasing complexity of medical devices—combined with more stringent regulatory requirements—will likely raise the costs of testing and validation. This is particularly challenging for startups with limited funding, who may struggle to afford the comprehensive testing necessary to gain market access

KEY WINS

SteriLabs has successfully collaborated with numerous medical device manufacturers, helping them complete critical testing and validation studies. The company has built strong relationships with key partners in the Canadian MedTech ecosystem and has been invited by incubators and industry organizations to connect with emerging MedTech startups and manufacturers. The SteriLabs team is actively involved in the development of standards and guidance documents published by AAMI, ISO, and ASTM, which regulate the industry. In addition, SteriLabs has expanded its ISO 17025 accreditation to include new, in-demand testing methods, further broadening its service offerings. The company continues to grow, bringing in scientists, engineers, consultants, and interns from diverse backgrounds to strengthen its expertise and capabilities.

LOOKING FORWARD

SteriLabs aims to become the first choice for all Canadian medical device manufacturers seeking microbiology and analytical testing, as well as validation services, to meet regulatory requirements in the Canadian, U.S., and European markets. By continuing to expand its capabilities and services, SteriLabs is committed to playing a pivotal role in strengthening the Canadian MedTech ecosystem. Over the next five years, the company plans to deepen its relationships with key industry players, both locally and internationally, while staying at the forefront of evolving regulatory standards. SteriLabs envisions becoming a go-to partner for manufacturers, not only for testing and validation but also for offering expert guidance throughout the entire product lifecycle—from research and development to regulatory approval and market launch. Additionally, SteriLabs is dedicated to continuous innovation, expanding its scope of services, and investing in new technologies to support the testing of increasingly complex medical devices. By doing so, the company seeks to provide manufacturers with viable, cost-effective options that accelerate their path to market, fostering greater innovation within the MedTech sector and ensuring Canadian companies remain competitive on the global stage.

LSO Success Stories 2024.