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MD squared expands its Clinical Services to Japan

Per July 1st Miina Waratani joins the company as Clinical Consultant for the Japanese Market.

2.5 years after getting started to provide Medical Consultancy for Medical Devices, MD squared broadens its profile in clinical evaluations and clinical data research and prepares its first steps towards the Asian Market.

 “I am very pleased that we were able to convince Miina to join MD squared”, says Claus Schaffrath, Managing Director of MD squared. “She is a trained medical doctor and epidemiologist based in the Tokyo region, and brings with her over 16 years of research and consultancy experience in the Japan healthcare and pharmaceutical industry. Miina will strengthen our Medical team and be able to provide direct support to our Japanese clients who are now planning their Clinical Evaluations and Product Claims in compliance with the new European Medical Device Regulation.”

Miina Waratani added “I am excited to be a member of a company focused on supporting the medical device industry deliver quality healthcare to patients. I believe that my knowledge and experience can provide solid support to medical device companies, especially in regard to clinical evaluation and trial endpoint prioritization for medical devices”

You can find more information about Miina and her background HERE

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Claus Schaffrath

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).

 

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Luc Koch

I 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. 

 

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Jeroen Kortsmit

I am a Biomedical Engineer with over 10 years of experience in Medical Devices and Image Guided Therapy in business and research roles. I'm well versed with clinical and regulatory challenges in start-up environments. I know how to set a (pre)clinical strategy to demonstrate safety and effectiveness for regulatory approval.

My expertise is in developing and substantiating customer-centric value propositions and designing Minimal Viable Product (MVP) on their base. I create product claims and supporting evidence which make the difference.

 

 

 

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Lars Ottevanger

I have a background as medical biologist with a master’s degree in Science Based Business. I has worked as business development manager for Medical Device companies and I'm founder and COO of a MedTech start-up in the Netherlands, that develops hard- & software for intraoperative assessment of tumor margins.

I am responsible for developing and executing the strategy for this company and mainly responsible for commercialization, finance and business development, with the focus on Europe. I have a network and experience in the start-up & scale-up MedTech ecosystem, and have a passion for bringing medical devices to the market.

 

 

 

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Sherry-Lee Soledad

As an Office Manager I am running MD squared’s Project Backoffice and I always like to say that I love doing the work backstage in order for a company to shine on stage.

After my studies in Culture, Organization & Management I entered the corporate world in an international trust office, a place where a variety of businesses seek fiduciary or financial services or asset management. I quickly got intrigued by the variety of my supportive work and discovered that I’m a real all-rounder and love the versatility of having a supporting role across different areas. It is this breadth of assignments, the variety of projects and  the multidisciplinary approach, which I also like in my work for MD squared. 

I help organizations with administration, legal, compliance, social media marketing and management support tasks. In combining my various interests and talents I can help to achieve the best results. This way I can unburden busy, passionate entrepreneurs so that they can fully focus on their core business.

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Boerhaavelaan 33

5644BB Eindhoven

The Netherlands

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