Offering preclinical trials for medical devices as a service: an examination of the initial requirements to make this business model work.

Abstract

Orsi Academy is an institute for education on robotic and minimally invasive surgery located in Melle, Belgium. Because of their unique location, infrastructure, facilities, and people, there are possibilities for them outside the educational scope. They have close connections with the MedTech industry on the one hand and even stronger ties with the academic world on the other. This puts them in a very interesting position. Being involved in R&D is something that is included in the mission statement since the inception, and this project could be seen as a big step in that direction. The researchers, two Master students Innovation and Entrepreneurship from Vlerick Business School have a medical background. They obtained a Master’s degree in Rehabilitation Sciences and Physiotherapy at Ghent University. This consultancy project investigates if offering preclinical trials as a service would be a course of action that Orsi Academy should pursue, and what the requirements to offer this service would be. Methodology: To solve this complex question, different kinds of data were collected. The first kind forms the backbone of this study and consists of qualitative, primary data collected through 39 interviews with industry experts. The second kind is qualitative and quantitative, secondary data from industry reports, European legislation concerning the MDD, MDR, CE-mark, and ISO norms. Secondary data was mostly consulted when unknown concepts were encountered in the interviews. Interviewees are divided into seven different categories based upon the key roles in the MedTech ecosystem. For each of these seven categories, four different questions were composed as a basis to gather information during the interviews. These interviews generally lasted 30 minutes to one hour. Notes taken during the interviews were later summarized. Weekly meetings with both Orsi Academy’s management and the Vlerick project promotor were organized to report progress, ask additional questions, and determine the focus of the study. Results: In the results, the findings of this consultancy project are explained. Out of the interviews with Orsi’s staff and management, a summary of Orsi’s assets and points of improvement was made. To give Orsi insights in the market they will try to enter, an overview of the current Medical Device industry is portrayed. The general process of developing a medical device, the accreditations, and legislations that play a role and the market size is presented here. After this the ecosystem, with the roles and interactions between the different key players, is schematized and explained. Lastly, Orsi’s position in this ecosystem is compared with the current alternatives for their service. The specific questions that were composed for each category of people are analyzed and summarized in the “interview analysis” section. This forms a strong basis for the recommendations made. Lastly, two different preclinical trial invoices were analyzed to give Orsi Academy an idea for their price setting. This model is based on very limited data but can serve as a first guideline. Recommendations: From all the information gathered in the past eight weeks, the researchers formulated recommendations in order to make this project as successful as possible. These recommendations cover the following topics: assets, human capital, focus, market overview, accreditations, legislations, and marketing strategy. Conclusion: For Orsi Academy to offer preclinical trials in the medical device market might prove a challenging and complex task. They will need to balance the needs of a lot of different parties whilst staying within budget and holding too tight deadlines. Nonetheless, we are convinced they can bring added value to the market with their unique assets and innovative mindset. If they wish to pursue this project, they should not treat it as a side project but fully commit, strive for excellence, and learn from the best.