Our Team

Marco Kalms offers profound expertise in operational management, strategic approach, market access and reimbursement. In 2012, he founded Kalms Consulting, focusing on European market access for international medical device, diagnostic and bioscience companies.

Marco has more than 30 years of experience in operational, strategic and market access leadership positions in the healthcare industry. As a long-time Sales Manager, Country Manager Germany and Managing Director Europe, he contributed significantly to the growth of American Medical Systems, Inc.

In his role as Managing Director Europe, Marco developed market access strategies to open up new markets in the EMEA regions.
It is this mixture of operational business and market access experience that is an essential part of the expertise the Kalms Consulting team offers to support healthcare companies. Many international clients have been benefiting from the services of Kalms Consulting for more than 6 years.

As the Co-Founder and COO of Kalms Consulting, Dr. Stephan Binder is responsible for business development; as well as Kalms Consulting’s networks and strategic partnerships.

He has almost 20 years of strategic and operational consulting experience: such as in the fields of medical devices, diagnostics, healthcare IT and bioscience; as well as in hospital workflows and efficiency. Along with strategic market access and reimbursement, key opinion leader networking and product launches, his experience includes technology transfer and applications for public grants (German and European).

Due to his work in project groups at various Hamburg hospitals (now Asklepios Group), the University of Hamburg, the CFEL (Center for Free-Electron Laser Science) and the constant global expansion of Kalms Consulting’s international network, Stephan has profound international working experience with interdisciplinary teams.

Stephan has a Ph.D. degree in physics, in the fields of optics and bio-organic systems and a certificate in Medical Physics and Technology.

Dr. Katja Schroeder is our expert for bio-medicine, market analysis, market access and medical marketing.

She has worked for medical devices and pharmaceutical companies in Germany and internationally. Her responsibilities included strategic upstream marketing, planning and implementing product launches and KOL relationships. She also has experience in sales and sales management, and indirect leadership in matrix organizations. In addition, she has strong experience in the communication of clinical evidence, investigator initiated trials and developing concepts for physician training.

Dr. Katja Schroeder holds a Ph.D. degree in biology in the field of molecular cell biology. During her studies and working experience she became fluent in English. In addition, Katja holds a degree as a Market Access Manager from the European Business School.

As a result of her highly diverse scientific and working experience, she is experienced in the communication of medical topics to various target groups.

Gerald Schröder is Head of the KALMS OPERATIONS business unit and Senior Consultant at Kalms Consulting GmbH.

He established this department strategically for the Kalms Group and set up an ISO 13485-certified quality management system. His experience in finance, logistics and device distribution is an important asset for the Kalms Operations Business Unit. He oversees an experienced team of customer care experts, quality specialists and technicians.

In addition to this activity, as Manager Regulatory Affairs Medical Devices International, he is an experienced consultant in both Regulatory Affairs / Quality Affairs and in the areas of Medical Aids and Enteral Nutrition.

He is a native speaker in German, fluent in English and has considerable knowledge of Russian.

Madeleine Künz holds a Bachelor and Master of Science in Molecular Life Science from the University of Lübeck and a PhD (Dr. rer. nat.) in Chemistry. Before joining Kalms Consulting, she has worked for over 10 years in international research facilities and the pharmaceutical industry. Her research work mainly focused on rational drug development in national and international interdisciplinary work based on structural biology, biophysics and chemistry. Her understanding of medical technologies is further supported by her additional education and work experience as a paramedic for 7 years as well as advanced education in health technology assessment.

Due to her state of the art interdisciplinary and profound life science and technology knowledge she assesses innovative technologies fast and can translate them into strategic options. Furthermore, differentiation as well as compatibility assessments allow her to draw an accurate picture of the innovation´s value.

She is in charge for systematic method assessments especially for diagnostic but also therapeutic procedures, preparation of value dossiers, straightforward evaluation of scientific publications, as well as market research with subsequent preparation of reimbursement dossiers for medical device technologies.

Her work focuses on the DACH region but deep knowledge of the European key markets in the UK and France allows to coordinate and well align also pan-European projects.

Dr. Benjamin Schulz is our expert for bio-physics, medical technology, market analysis and strategic business development.

He has been working for companies from the renewable sector as well as medical technology companies as a Strategy and Technology consultant, being responsible for evaluation of new products and technologies as well as market analysis. Moreover, he had the responsibility for selecting new, innovative hardware and software.

Being a manager for a team of 50 people, for whom he developed new processes and best practice solutions, he gained leadership experience.

As an independent consultant, he has many years of experience in strategic business development.

He holds his Ph.D. degree in physics, in the fields of optics and bio-organic systems. During his studies, he acquired fluent English language skills.

Since he was working in an interdisciplinary field of science, he is highly skilled in explanation complex topics to different target groups.

Dr. Julia Knorr focuses on market access and reimbursement projects in bioscience and innovative interdisciplinary medicine.

She has worked for several years as a Project Manager in the pharmaceutical industry and has profound experience in the study lead of post-marketing studies from the early set-up phase to study start within Europe.

She has additional expertise in the study set-up in bioscience and pharmaceutical development including regulatory duties as well as in the study management of Investigator Initiated Trials throughout Europe and North America.

Julia has a degree in Biochemistry and holds a PhD in Drug Discovery and Biophysics. Besides her mother tongue German she speaks English and Spanish fluently and has considerable knowledge of French.

Jennifer George is a Senior Consultant for Quality & Regulatory Affairs with over a decade of experience in the medical device industry. She specializes in regulatory-compliant product development and has extensive expertise in implementing and monitoring quality and risk management systems in accordance with ISO 13485 and ISO 14971. Jennifer is well-versed in European regulatory frameworks, including IVDD/IVDR and MDD/MDR, and serves as a Qualified Person Responsible for Regulatory Compliance (PRRC). Prior to joining Kalms Consulting, she worked in international research institutions and the biotechnology and MedTech sector. She holds a diploma in Biotechnology and brings more than 15 years of project management experience. A native German speaker, Jennifer is fluent in English and possesses solid knowledge of French.

Dr. Benjamin Dose holds a Bachelor and Master of Science in Molecular Life Sciences from the University of Hamburg and Friedrich-Schiller University in Jena, respectively. Funding by the German Academic Scholarship Foundation allowed him to join different labs and to acquire expertise in diverse scientific fields like structural biology at the DESY (Deutsches Elektronen-Synchrotron), protein evolution at the University of Cambridge (UK) and natural product research at the Leibniz Institute for Natural Product Research and Infection Biology.

In 2021 he finished his Ph.D. (Dr. rer. nat.) in biochemistry with distinction in the field of natural product research. Furthermore, he is also an author ofseveral publications in high-impact scientific journals. He accumulated several years of scientific experience in various multidisciplinary, international research groups and has proven the ability to work effectively in innovative areas of bioscience.

In 2021 he joined Kalms Consulting as a consultant to facilitate regulatory conform translations of innovative diagnostic and treatment ideas to medical devices in the German healthcare market

Dr. Luise Fuhr joined Kalms Consulting as a Consultant in 2023. She holds a Bachelor of Science in Biology and a Master of Science in Molecular Life Sciences from the Free University Berlin and Humboldt University Berlin, respectively. In 2019 she finished her Ph.D. (Dr. rer. nat.) in Molecular Biology with focus on the circadian clock and molecular cancer research and continued her work in the field as a Post Doc. She gained scientific experience in various multidisciplinary research projects and proved her ability to work effectively and independently. During her Post Doc she had the possibility to change perspectives and was involved in the setup of a QMS according to ISO 13485 for an IVD developed at the Charité. With her knowledge she supports medical device manufacturers to gain regulatory compliance from development to product-specific technical documentation at Kalms Consulting. Furthermore, she is author of several publications in high-impact scientific journals preparing her for the assessment and analysis of scientific literature for regulatory compliance and market access activities. Her background in molecular biology furthermore enables her to assess medical technology especially in the diagnostic field.

Dr. Sandra Mühmel owns profound knowledge in the sector of medical devices as well as in organic chemistry. As former international product manager at a Germany medical device company she has profound experience in planning and implementing product launches as well as medical marketing. Moreover she was involved in several reimbursement and market access projects.

During her chemistry studies she focused on hydrogen storage and usage of sunlight as energy source for generating medical drugs. Her PhD thesis was in organic chemistry. As a founder and CEO of her own startup company she knows about the challenges to face in a sensitive sector concerning market access, market analysis and marketing. Sandra is fluent in English language.

Dr. rer. nat. Josée Naegelen has over 30 years of experience in marketing and scientific support in laboratory diagnostic companies, with a focus in hematology. Prior to joining Kalms she worked in various senior positions for global IVD companies, based in Europe and the US, in Global Product Management and Strategic Marketing Hematology as well as Vice President Business Development and Customer Relationship. As Senior Consultant, she provides a profound knowledge of diagnostic device industry and laboratory hematology market and end user needs. She worked in France, Germany, and globally in EMEA positions as well as in US headquarters.

Josée holds a doctorate degree in Pharmacy with a specialization in Clinical Pathology from the University of Besançon (France) and she also worked as assistant in a university hospital laboratory before joining the IVD industry.

Barbara Senger is our expert for medical marketing, market access & development and patient related PR. After over 10 year experience in commercial marketing & communication positions she started to work in 2006 in leading positions for medical devices companies in Germany and DACH region.

Her responsibilities included operative downstream marketing as well as strategic upstream marketing, planning and implementing product launches and KOL relationships. She is well experienced in change & integration management of medical brands and companies. She also has experience in indirect leadership in matrix organizations.

Barbara Senger holds a degree in marketing (IHK) and communication management equivalent to the bachelor of arts media & communication. During her working experience she became fluent in English and has considerable knowledge of French.

Hannah Kleitke joined Kalms Consulting in 2020 and is mainly active in the areas of Quality & Regulatory Affairs, Market Access and Event Coordination.
She holds a Bachelor and Master of Science in Biotechnology from the Technical University in Berlin as well as a Master of Science in Medical Sciences – Cardiovascular Research from the University of Freiburg. Additionally she is currently doing her PhD in the field of translational immuno-cardiology.
Hannah is a native German speaker and fluent in English.

Martin J. Emerson has served as the President and Chief Executive Officer of Monteris Medical since joining Monteris in July 2016. Mr. Emerson has over 30 years of medical device industry experience, including CEO positions with both private and public companies.

Prior to joining Monteris, Marty spent eight years as the President and CEO of Galil Medical, a private company and leader in the cryoablation market. During his tenure, Galil’s interventional oncology sales increased eightfold, and the company was acquired by BTG plc in June, 2016. During the eight years leading up to Galil, he was President and CEO of American Medical Systems (AMS), a public urology and gynecology device company with sales of over $500 million.

Prior to both Galil and AMS, he held various management positions, both domestic and international, with Boston Scientific Corporation and Baxter International. He currently serves on the Board of Directors at Tepha Medical, SubioMed and Contraline. Previously, Marty served as a board member of Vascular Solutions, Wright Medical, Lifecore Biomedical, Incisive Surgical and AdvaMed. Marty holds a B.S. degree in accounting from Marquette University.

Ms. Volkart is chief financial officer of Natureworks LLC, an advanced materials company offering a portfolio of renewably-sourced polymers, since October 2018. From October 2012 to July 2018, she served as chief financial officer and, for a portion of that time, as senior vice president of commercialization for NxThera, Inc., a medical device company pioneering the application of convective radiofrequency thermotherapy to treat urological conditions. Ms. Volkart served as global chief financial officer of Tornier N.V. from 2010 to 2012 including the period of its initial public offering, and was chief operating and financial officer, corporate secretary, compliance officer and treasurer of Spine Wave, Inc. from 2006 to 2010. Prior to 2006, she held various executive and financial positions at American Medical Systems, Inc., Medtronic, Inc. and Honeywell, Inc. Ms. Volkart holds a B.S. in accounting from the University of North Dakota and an MBA with a concentration in strategic management from the University of Minnesota.

Ms. Volkart has served as a member of the board of directors of Memry Corporation (December 2004-September 2008), SonoSite, Inc. (October 2005-March 2012), Antares Pharma, Inc. (October 2021-May 2022), Modular Medical, Inc. (December 2019-present), and Tactile Medical Systems (January 2023-present). She has also served on the Board of the Minneapolis Heart Institute Foundation and as a community member on the Audit and Finance Committees of Hennepin Health Systems.

Gary Goetzke has over 35 years of global experience in public and commercial coverage and reimbursement policy, health economics, market development, strategic planning, mergers and acquisitions, and launch implementation. Gary has also served on the Board of Directors of Impedimed, Ltd., an Australian headquartered global medical device company with operations in the United States and Europe.

Gary has deep experience and contacts in the healthcare industry, having worked for 15 years with Medtronic in a variety of leadership experiences in key markets in the United States, Europe, and Japan, before focusing his passion and energy on the medical device start-up industry. For the past 10 years Gary has held senior global leadership positions at Inspire Medical Systems, a once fledgling start-up with a current market valuation of approximately 9.14B dollars.

Gary holds a Juris Doctor Degree from Hamline University and a Bachelor of Sciences Degree in Political Analysis with an emphasis on macroeconomics.

Mirjana Popadic has more than 15 years of Executive Assistant experience. She has a sound understanding of project coordination and management along with a profound knowledge of all necessary tools and software. Mirjana also serves as the office manager for Kalms Consulting and Kalms Operations. With her excellent interpersonal skills and ability to express complex and highly confidential business information, she diligently prepares and coordinates communication between all business parties.

She reports directly to the President/CEO and senior management team and deals with daily and long-term administrative tasks: such as managing appointments for all team members, preparing correspondence and arranging travel plans for the executive staff. She serves as the primary point of contact for internal and external constituencies on all matters pertaining to the President. Additionally, she is responsible for contract management. Mirjana is a native German and Serbo-Croatian speaker and is fluent in the English language.