MD squared - Medical Consultancy for Medical Devices
In a changing regulatory and commercial environment MD squared has a clear focus on driving Value Creation by a unique combination of marketing expertise, medical competence and regulatory support for Medical Devices.
It is MD squared’s mission helping to structurally enhance your product’s value and value communication with tangible evidence in a regulatory compliant way. For this MD squared has developed Product ClaimManager™, tailored tools and processes to generate critical insights, map relevant needs of your customer target group, and pinpoint how your product can contribute to solve them.
Product ClaimManager helps making informed and transparent choices throughout a product’s life cycle on building a differentiating claim portfolio and its validation costs. Also after market introduction MD squared helps monitoring and directing further value enhancing steps, be it with stronger product claims or broader indications of use.
MD squared commands over a global network of clinical specialists, marketing and regulatory experts to ensure profound and reliable insights even in complex cases.
I am a physician and electrical engineer and founded MD squared after working more than 20 years in Medical Devices and Image Guided Therapy, both in Hospital and Industry.
As healthcare marketing professional I was responsible in start-up, mid-sized and large international companies for Business Development and Product Portfolio Management over a broad spectrum of clinical areas. Over time I gained market experience and clinical networks in Neurology & Neurosurgery, Orthopedics, Spine & Trauma and Interventional Oncology & Radiology.
I got exposed first hand as marketer to an evolving regulatory environment and its challenges for communicating product value. Therefore over the past years I developped Product ClaimManager™, a practice driven approach of Value Creation for Medical Devices via a structural build up of product claims.
I am registered in the Netherlands as physician, certifed as Manager Regulatory Affairs Medical Devices EU & International by TUEV-SUED and as Lead Auditor for Quality Management Systems for Medical Devices (ISO 13485:2016) by BSI.
In my field of expertise I am an active contributor to the Deutsche Gesellschaft Biomedizinische Technik (DGBMT), member of the Deutsche Gesellschaft Interventionelle Radiologie (DeGIR) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE).