From Clinical Innovation to the Market

Choices of a StartUp to Navigate the current Regulations

Fitting a promising innovative technology into solving a relevant clinical problem requires many critical choices to consider early on.

Based on a real-world example in measuring cardiac output in heart patients, Arthur Bouwman, cardio-anaesthesiologist and co-founder of a medical device start-up, and Claus Schaffrath, partner at a medical device consultancy, describe clinical and regulatory choices, and their consequences for bringing a medical device to the market.

A duo-presentation by Claus Schaffrath, partner at MD squared B.V. and professor Arthur Bouwman, cardiac anesthesiologist, Catharina Hospital / co-founder, Amazec Photonics.

Claus is driven by Bringing clinical needs and technical innovation together. He sees clearly one strong trend in Health Care namely personalized healthcare, such as 3D printed implants/organs or targeted cancer therapy. To make those work you need the right diagnostic devices first.

About Claus Schaffrath
I am a physician and electrical engineer, and founder and partner at MD squared.
My professional life over the past 25 years has always been where the clinical and technical world come together in MedTech, and I have held business & marketing, clinical and regulatory roles across a broad spectrum of clinical areas and medical devices.
I am registered in the Netherlands as physician and certified in Regulatory Affairs for Medical Devices in the EU & International, and as Lead Auditor for Quality Management Systems for Medical Devices. In my field of expertise I am also an active contributor to the German Society of Biomedical Engineering (DGBMT), member of the German Society of Interventional Radiology (DeGIR) and the Cardiovascular & Interventional Radiological Society of Europe (CIRSE).

About MD squared B.V.
MD squared – Growing MedTech Together
MD squared is a MedTech consultancy located in the Netherlands, which provides the full circle of Start-Ups, Scale-Ups, and Small & Mid-sized Enterprises with inter-disciplinary content matter experts across all areas of concern in MedTech. In a volatile environment, our insights enable our clients to make informed choices, and our hands-on support helps to achieve their critical goals and timelines. We are committed to supporting meaningful innovations that will shape the future of Healthcare and help our clients in accomplishing superior results: better outcomes, lower costs, and improved patient experience in clinical care.

Claus Schaffrath is speaker at the 2022 edition of the Health Tech Event, innovation meets regulation.

Leave a Reply

Your email address will not be published. Required fields are marked *