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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.

Regulatory Support  Ÿ Ÿ•   Medical Competence   •   Value Creation  •   Health Technology Assessment   •   mHealth Compliance   •   Product ClaimManagerTM

 

Claus Schaffrath

picture claus w. title

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).

Luc Koch

picture luc w. titleI am a mechanical engineer with a specialization in software development and IT, and joined MD Squared with over 20 years of industry experience in Medical Imaging, Healthcare-IT, and Medical Devices. As product development professional I was responsible for project-, program- and R&D management in various clinical/medtech business lines, at multinational corporate level, and more recently in various start-ups.

I had senior roles in the development of products and platforms for Radiology and Cardiology, Healthcare-IT, Product Interoperability, Usability, Interventional Therapy in Oncology, and Cardiac Surgery. As R&D manager I learned how to turn business goals into inspiring yet realistic R&D programs and projects, and how to deliver results with high quality, on time and within budget. Having been responsible for Q&R, I know where to focus in the complex go-to-market of regulated medical devices, especially in today’s circumstances of fast moving (software) technologies and the many changes in the regulatory requirements.

I have a strong network of clinical, architectural, technological, regulatory and marketing experts, and have worked with many professional suppliers for both software and hardware. I am eager to help you to bring you innovation to patients and clinicians, in a predictable, professional and efficient way.

Miina Waratani

picture miina w. titleI am a trained medical doctor and an epidemiologist with over 16 years of research and consultancy experience in the Japan healthcare and pharmaceutical industry. My focus and field of expertise is in primary and secondary data research, including pipeline assessment of ethical drugs, early phase product assessment, clinical trial endpoint assessment, research to inform launch strategy, and post marketing follow-up research.

I am also experienced in observational epidemiology research having done researches such as:

  • Primary research studies to estimate prevalence of diseases/symptoms, to understand health related behavior among patients and healthy subjects. 
  • Patient reported treatment outcome studies in the areas of rheumatoid arthritis, opioid induced constipation, age related macular degeneration.
  • Real world evidence studies using secondary data (JMDC, MDV, chart review) to estimate disease prevalence, treatment pattern analysis (HAE, pediatric epilepsy, pediatric ADHD, HCV, RA)
  • Literature review to estimate disease prevalence across multiple countries (deep vein thrombosis, non-valvular atrial fibrillation)
Regulatory Support   •   Medical Competence   •   Value Creation  •   Health Technology Assessment   •   mHealth Compliance   •   Product ClaimManagerTM

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MD squared
Boerhaavelaan 33

5644BB Eindhoven

The Netherlands

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