08 Mar Q&A with President and CEO Trevor Gascoyne and Senior Biomedical Engineer Sara Gustafson from Orthopaedic Innovation Centre (OIC)
The Orthopaedic Innovation Centre (OIC) in Winnipeg, Canada, is a multidisciplinary facility that houses state-of-the-art technology for orthopaedic medical device testing and clinical research services for a large international client base.
And that multidisciplinary approach has resulted not just in the development of several disruptive intellectual properties but also initiatives including a dedicated, on-site bioskills lab and implant retrieval and analysis programme.
It has also led to the successful spin-off of sister business Precision ADM, which combines traditional manufacturing methods with cutting-edge additive manufacturing technology.
We spoke to President and CEO Trevor Gascoyne and Senior Biomedical Engineer Sara Gustafson about the growth of the business over the past 12 months, exciting changes they are seeing within the industry and challenges on the horizon impacting medical device manufacturers.
Trevor and Sara, thank you for joining us. Tell us more about the OIC and what makes it unique.
Trevor Gascoyne: Our core business since 2003 has been orthopaedic clinical research. In 2010 we set up the medical device testing side of our business and over the past decade we’ve been running a wide variety of orthopaedic implant tests from joint simulation wear testing, biomechanical testing, as well as fatigue, static, and torsion testing on all types of joint replacement devices for the hip, knee, shoulder, extremities, and spine – and we’re really the only lab in Canada that does this.
We’re a non-profit, which sets us apart from other labs. It allows us to focus on clients with unique products and to work more closely with them to offer a tailored service that adds more value.
How has the business grown in the past 12 months and what are your ambitions for future success?
Trevor Gascoyne: As well as investing in our team, which has grown by nearly 50 per cent, we’ve been investing in our quality system achieving our ISO 17025 accreditation in March last year.
Having started with hips and knees we’re now performing ankle, shoulder and spine device tests while expanding our scope into other subspecialties.
We’ve begun collaborations with testing labs in Germany as well as universities in the US and Canada and are always looking for more international collaboration. In the next two years we are looking at perhaps another initiative similar to the Precision ADM spin-off that may see us dive into the tissue engineering realm and standardised testing thereof.
Sara Gustafson: We have recently purchased additional load frames to keep up with our increasing clientele and testing demand, allowing us to complete more projects in a timely manner, while increasing overall testing capabilities.
How do you see the market developing in the next five years?
Sara Gustafson: We’re seeing more medical device companies develop implants made from different biomaterials rather than your typical metals, ceramics or polymer materials. Some of these new implantable materials can be absorbed in the body, alleviating the need for implant removal and reducing the likelihood of revision surgeries.
We’re also seeing a big increase of smaller start-up companies coming out with unique spine products, and while outside the scope of what we test, more robotics for surgery and preoperative planning technologies.
Trevor Gascoyne: We do see manufacturers moving more towards virtual testing, with some common device tests done virtually instead of physical testing. But I think it is going to take some time before confidence levels are established and someone will have to take the lead in order to present acceptable results.
You’re exhibiting at AAOS in Las Vegas next month. What sort of companies will you be interested in speaking to?
Sara Gustafson: We can test for any type of medical device company that markets orthopaedic implants, but we enjoy working with start-ups and growing companies that don’t necessarily have the right equipment in-house or regulatory knowledge. That’s where the OIC comes in to help develop and execute appropriate test protocols that will gain them the regulatory data they need to achieve market approval efficiently and effectively.
Our engineering team of experts are very good at developing custom test methods, while considering the recommended recognised standards. We especially enjoy working with clients that are developing innovative implant designs or devices holding new technology that wouldn’t exactly fall under the cookie cutter test methods. Ultimately, our goal is to perform effective test protocols that are accurate to the client’s needs at hand.
Most importantly, we work closely with our clients to develop strong relationships starting from the planning phase through to project completion and beyond towards up and coming products of the future.
What challenges do you see in the market currently?
Trevor Gascoyne: We have a pretty substantial clinical database, with over 20,000 patients and surgeries in the last 15 years.
This has been extremely helpful for some of those companies going through the MDD to MDR transition in obtaining that crucial long-term data.
We also see a growing trend of companies based internationally but prioritising the US market as the regulations are currently less onerous.
More and more we are seeing added complexity in the process of standardised testing with devices needing to be pre-conditioned, artificially aged, and/or fully sterilised and packaged before they are sent to us for testing. This affects the final device materials and thus impacts testing timeframes. Good planning is key.
Thank you both for joining us.
The OIC team will be exhibiting at the AAOS Annual Meeting in Las Vegas (Booth 1222) from March 7 to 11 and at OMTEC in Chicago (Booth 249) from June 13 to 15.
For more information on the OIC or to get in touch email email@example.com or visit www.orthoinno.com.
Read our previous #OrthoInsider interview with Michael Cheetham, Founder of Tenacity Sales Training here.