About us

Our Core Values

We share with our clients the excitement to bring novel technology to patients and they can rely on our commitment to diligently analyze the context in which they want to bring their invention to the market. They can count on our support as part of their team to find pragmatic solutions within our assignment to bring them closer to the agreed goal.

In doing this we are guided by three values, Competence, Curiosity and Care, which stand for our philosophy how we approach the work with our clients and amongst ourselves

MD-squared-about-us
Here we provide regulatory and market support and take the role as liaison to find the right partners

North America

Our homebase where we provide the full service for Medical Devices and In-Vitro Medical Devices

Europe

Here we provide regulatory and market support and take the role as liaison to find the right partners

Asia

Our team

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Claus Schaffrath

MD MSc | 

Managing Director

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 developed 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, certified 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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Erik van Dijk

PhD | 

Lead Product Realisation

With a solid background in Applied Physics, I’ve held various leadership roles in medical device companies. After starting my career at a large corporate, over the past years I’ve worked with a number of start-ups and scale-ups in various roles. I’ve fulfilled both operational roles, with a focus on product development and setting up supply chains prepared for growth. Next to that, I’ve also had strategic roles with a focus general business operations, fundraising and (financial) restructuring. In all my roles my key strength is to convert the strategic direction of the company in concrete actions that take into consideration the company’s constraints such as cash flow, regulatory requirements and other resources. In a start-up and scale up phase, it is critical to quickly make decisions and implement them to move the company forward.
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Jeroen Kortsmit

PhD | 

Clinical & Marketing Consultant

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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Nancy Zhang

MBA MIS | 

Regulatory Affairs Consultant

With over 15 years of experience working as regulatory affairs professional in medical device industry my experience covers a wide range of products: Medical imaging system, physiology monitoring devices, minimally invasive surgical devices, and software as medical devices. My role includes defining global regulatory strategies, ensuring product compliance during the development phase, and obtaining product approvals globally, specifically in EU (CE marking) and USA (510(K). As a native Chinese speaker I bring with me also has an in-depth understanding of NMPA regulatory, guidelines, standards and clinical requirements with strong communication and negotiation skills. During my career as regulatory affairs professional, I also gained experiences in the advanced development phase, which includes preparing clinical strategies from a regulatory perspective, obtaining CA, EC or IRB approvals. As strong advovate of lean and agile methods I am particularly interested in the early stages of developing a device and assisting companies who are struggling with regulatory dynamics. I hold two master’s degrees in Biomedical Engineering and Innovation Science and am Regulatory Affairs Certified (RAC Devices).
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Abel Swaan

PhD | 

Clinical Consultant

As a licensed (BIG registered) Technical Physician, I have been among the first one hundred of this novel discipline in the Netherlands. Before I joined MD squared in 2023, I had various roles in the medical technology sector. For spine surgery, I designed and tested 3D-printed drill guides for pedicle screws for the treatment of scoliosis with UMC Utrecht. With laser light (OCT), I analyzed the prostate tissue l during my PhD at Amsterdam UMC. For this, I performed laboratory, animal, and in-vivo studies. Also, I designed a new dual-modality probe and modified an OCT system to combine OCT with spectroscopy. At the Health and Youth Care Inspectorate (IGJ), I monitored product market introduction & training efficacy, supervised post-market surveillance reporting, and conducted external regulatory and compliance audits. To work at the forefront of medical technology, I joined Bilihome, a startup in neonatal care, as CTO and led a multi-disciplinary product team. I was responsible for product verification, validation & manufacturability, and defining and executing regulatory and intellectual property strategy. Next to my daily activities, I joined the Future and Innovation committee of “De Jonge Specialist.” Also, I’m active in the Dutch Association for Technical Medicine (NVvTG), of which I was a board member.
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Lars Ottevanger

MSc | 

Marketing & Business Development

I have a background as medical biologist with a master’s degree in Science Based Business. I have 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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Wouter Jeninga

BEng | 

Technical Consultant

I am a physics engineer with experience in the development and production of medical devices. Before MD-squared I worked at two medical device start-ups and at a high-tech manufacturing company with various medical and high-tech devices in my portfolio. In these companies, I have developed myself into a technical lead and product manager, responsible for product development and manufacturing. As such, I understand the challenges that come with developing, producing, and maintaining compliant medical devices. I excel at understanding the technical background of a product and collaborating with the team to bring their idea to fruition, all while building compliant documentation without overhead. I joined MD-squared to enable medical device innovation and support start-ups with my practical and sustainable approach.
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Sherry-Lee Soledad

Office Management & Business Support

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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Lucas van Doorne

BSc | 

Clinical team assistant

I’m a student of Clinical Technology, a study that combines both medicine and engineering to tackle the problems the innovative world of medicine.  During my bachelors study, I was the commissioner of external affairs on the board of my study association and got in touch with various MedTech companies and entrepreneurs. Within MD-Squared, I implement knowledge from both a technical- as well as the medical side to support MD squared. I focus on improving data and efficiency for the clinical team, standardizing processes and assisting where possible in clinical strategies for clients.
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Don’t hesitate to ask us your questions.

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