[Guest Piece] Synthesis-Net in MedTech: Our Journey and Vision for the Future

Presenting at the Med-Tech World Summit

This October at the Med-Tech World Summit, our Head of Business Development, Dr. Bela Venesz, PhD will be speaking about THE PERSONAL PROFILE OF APPROPRIATE LEAD USERS IN SUCCESSFUL MEDICAL DEVICE INNOVATIONS, while our Project Manager, Bence Török will be part of a panel discussion talking about SOFTWARE AS A MEDICAL DEVICE and THE CHALLENGES THAT LIE AHEAD.

Mission and Vision

We aim to make an impact on regulated industries through the use of technology, all driven by our commitment to improve lives. The motivation behind our mission is simple: we pursue success by delivering added value and fostering collaborative partnerships.

Two Decades of Evolution and Growth

Synthesis-Net launched in 2003 with three owners consisting of two internal managers and the parent company – an established Hungarian IT company. The motivation behind the venture was to help the parent company rewrite their desktop solutions for the Web. That initial focus did not pan out. After a couple of pivots, the company began offering software development services to clients in Hungary, Austria, and Germany. 

In 2005, it secured its first North American partner – a young California-based company focused on developing solutions for the blood-banking industry. This collaboration was the company’s first exposure to Software as a Medical Device (SaMD) or regulated software. After finding its niche in regulated software, the company experienced a period of rapid growth. The team was young, and their lives revolved around supporting their clients and growing the company. 

Transitioning to Majority Ownership

Although the parent company retained a two-thirds stake in the company, beyond their initial investment, they treated it with indifference. By 2016, the company with around 100 employees had outgrown its parent and was at a crossroads, the departure of one of its co-founders and a redistribution of his and some of the parent’s shares to the remaining co-founder and three of his key managers improved motivation and allowed the organization to continue scaling. However, the parent company still held the controlling stake. In the next few years, team size and revenue continued to increase rapidly, and the goal of the internal owners was to finally secure a controlling stake in the company they had built.

New Brand, New Direction

The company ushered in 2023 with a management buyout that gave the internal owners control of their company. In order to provide a foundation for the future, the new majority owners are defining a new vision and mission to guide the company and its team in the coming years. Since this process coincides with the company’s 20^th anniversary, the company will let go of its parent’s name and rebrand. The new majority owners are also building a foundation for the future by diversifying their client base. Although 80 percent of current revenue comes from the U.S. market, the company sees great potential in Europe as well and the DACH region in particular. It is this potential that led Synthesis-Net to join the Bavarian Medical Valley Association.  

Our goal in this market will be to build trust among potential clients regarding our technical abilities and domain knowledge. We need to explore the appropriate channels and content in order to achieve this trust. In addition, we feel a US presence will also be indispensable and are contemplating establishing an affiliate in that country. 

Our Expertise in Regulated Software Development

Today, we cover all aspect of the Software Development Lifecycle (SDLC) including quality assurance, regulatory consulting, and support (Tier 1-3) activities. We have considerable domain knowledge in SaMD and can assist clients in setting up the appropriate Quality Management System (QMS), drafting Standard Operating Procedures (SOPs) and in the approval process for both the US FDA and the EU MDR. We strive towards long-term collaborations and have good team retention which allows us to ensure domain knowledge stays in-house. 

For MedTech solutions a suitable QMS and developing appropriate development and testing protocols is extremely important. Extensive documentation is required to develop and secure approval for solutions. Documentation is not often something developers like to spend time on but is required for securing approval of solutions from the relevant authorities. Our analysts and testing engineers play an important role in this process. We also work with our clients to ensure their SOPs are appropriate.

The Company’s Future: Strategic Growth and Innovation

Our future plans involve expansion into the DACH region for which the first step was joining the Bavarian Medical Valley. Another way we would like to support expansion into the German speaking market is to explore establishing an affiliate in Austria to help grow our sales team responsible for the DACH region. Parallel to this, a plan for a US affiliate with a dedicated US sales team to support our US activities is also in the works. Along with these short-term expansion plans, one of our long-term goals is building a community of experts in the medical field, who can support us with their knowledge. Combining their medical expertise with our technical know-how would yield us, as a company, MedTech knowledge that could unlock great potential for innovation where it is needed.

Exploring the Med-Tech Horizon: Join Us at the Med-Tech World Summit!

Mark your calendar for an unparalleled experience this October at the Med-Tech World Summit in Malta. Set sail into the future of Medical Technology, Digital Health, and the revolutionary impact of AI on healthcare. This prestigious event brings together eminent researchers and trailblazing minds for a transformative journey. Dive into a series of anticipated networking sessions, enlightening conferences, and an expansive expo floor showcasing leading exhibitors and groundbreaking start-ups.

While awaiting the event, stay updated on the latest trends in medical technology. Stay at the forefront with instant updates and dive into engaging feature articles nestled within the pages of the newest edition of BLOCK Magazine.