The lecture
On 22 February 2022, Anastasios Gkiokas and Norbert Farkas from CENTIVIS delivered a live lecture on Diagnostics Market Access to the participants of the CAS CARAQA Program (Clinical, Regulatory, Quality Affairs) at the University of Applied Sciences and Arts Northwestern Switzerland (FHNW).
The CAS CARAQA Program
The program is offered in collaboration with regulatory consulting agency Medidee* and is attended by people with long standing experience in the industry, focusing primarily on quality assurance, compliance and auditing, clinical and regulatory affairs, and research. As such, our focus was to provide them with practical aspects of Market Access and share our perspective on how interconnected our respective fields are.
Why would an early joint Market Access and Regulatory strategy make a difference?
Certain internal and external challenges call for a joint Market Access and Regulatory strategy:
From the internal perspective, defining an intended use/Target Product Profile early on in product development is pivotal, but often neglected. Many Medical Device/IVD companies and start-ups tend to focus more on the technological aspects of their solution, and less on fulfilling an unmet medical need. Closer to launch they often realize that the medical device/diagnostic solution:
1. Has already many competitors in the field,
2. The reimbursement rate for its intended use is relatively low, and
3. the intended use is not very well thought through.
From the external perspective, the Medical Device/Diagnostics-IVD industry is full of challenges, such as limited healthcare spending, high operational complexity, increased competition with ever-increasing new players in the market, disrupting innovative technologies, and, of course, increased regulatory scrutiny.
As such, to guarantee successful entry into the market, it is important to implement a joint market access and regulatory strategy from early on (Figure 1).
Figure 1. Various challenges call for a joint Market Access and Regulatory strategy.
© CENTIVIS AG
We are grateful to the FHNW and Medidee for providing us this opportunity to present to the CAS CARAQA program participants. To the participants we would like to wish the best of luck with the rest of the program!
Are you interested in upskilling your team in diagnostics access capabilities?
Learn more about customizable training sessions from the Diagnostics Reimbursement Compass —A 90-Minute Guide to Define, Demonstrate, and Capture Diagnostics Value Confidently here.
*Medidee is a regulatory consulting agency (RA, CA/CRO, QA) with sites in Switzerland, Germany, Denmark, Belgium, USA, India and APAC, serving companies of all sizes ranging from academic startups to majors. Its core focus is on regulatory affairs, quality insurance, clinical affairs and digital health for medical devices and in vitro diagnostics.
Want to know more about diagnostics? Contact us at info@centivis.com