About us

Seasoned professionals in Medical Devices & In-Vitro Diagnostics

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We started in 2017 to work together with MedTech Start-Ups, Scale-Ups and Small- and Mid-sized Enterprises in assessing and realizing their Market Potential.

With our inter-disciplinary content matter expertise we provide the full circle of services for new and established companies in realizing meaningful innovations with a significant impact on the Standard of Care.

Our team of international seasoned MedTech professionals drives for better outcomes, lower cost and improved patient experience in clinical care.

Our successful clients come from a broad spectrum of the Medical Device and In-Vitro Diagnostic Industry in Europe, North America and Asia.

Circle with all segments
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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Dr. 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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Luc Koch

BSc | 

Lead Product Realisation

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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Will Ickenroth

BSc MM | 

Lead Business Development

As a mechanical engineer and master of marketing, supplemented with leadership development programs at leading institutes, I have built up a career with proven track records in Research and Development, Marketing, Sales, Business and General Management in large organizations and in a Start-Up. Nearly 20 years I have worked in leadership positions in the industry focused on healthcare, gaining extensive experience in developing, marketing and selling products in the field of medical imaging and medical devices. Activities varied, amongst others, from starting and leading innovations, selecting development and manufacturing partners, launching new products, setting up direct and indirect sales channels, building up relationships with Key Opinion Leaders, developing business plans for attracting funding, setting up strategic partnerships to integration of an acquisition. All of this in an international environment. Over the years I have built up an extensive network of experts in all kinds of areas. People that share my passion to support companies in developing products and solutions that contribute to the health and wellbeing of our society.
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Katarzyna Kolasa

PhD | 

Sr. Consultant Health Economics

Driven with the passion to health economics, I have more than 20 years of academic and industry experience in the field of healthcare. Holding various Regional and Global leadership positions, I have been working extensively within public health sector as well as pharma and medtech industry. After six years employment at the Kalmar County Council in Sweden, I held global and regional Health Economics & Outcomes Research (HEOR) positions at AstraZeneca and BiogenIdec respectively. At Bristol Myers Squibb and Lundbeck I lead Market Access teams in Central Eastern European (CEE) and Nordic Region. In the last five years, I gained experience with the pricing &reimbursement challenges in the field of medical devices. I supported Straub Medical as Global Market Access Lead. Before that, I was Senior Sales Director responsible for HEOR at GE Healthcare. Since 2018 I am a Professor at the Kozminski University heading Health Economics & Healthcare Management Division (HeM). I am the leader of the International Master Program Health Economics & Big Data (HEBDA) financed by the EU research grant. In October 2020, I was nominated to  the ISPOR’s Health Sciences Policy Council (HSPC). Since January 2020, I am chair elect of ISPOR Special Interest Group Digital Health as well. My biggest strength is the market access planning for a successful pricing & reimbursement strategy. Knowledgably of HTA guidelines, DRG financing and hospital procurement pathways across EU & US settings, I will be able to advice on the optimal market entry that ensures the best differentiation of a given technology against alternative treatment options.
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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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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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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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Erik van Dijk

Erik van Dijk

PhD | 

Quality and Product Development Consultant

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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