MII x sync2brain – From business model development to a certified legal manufacturer

Project management by Ingo Hämmerle

Ingo is a managing director, founder and investor. Together with his team, he developed the 4C Concept and is a pioneer of Regulatory Thinking®. He is an active member of important networks in the healthcare industry.

23 Oct, 2023

Case Study | Project with sync2brain GmbH

Medical innovations often emerge from research and are driven by a scientific perspective. However, in order for such product ideas to actually reach patients, a market-oriented view must be developed. This was the challenge faced by the startup sync2brain GmbH. As part of a service project, the experts at the MII turned the original scientific idea into a solid business model that takes into account the challenges of the healthcare industry. With respect to the requirements of the 4Cs, an implementation strategy was developed and, under the guidance of the MII, the first major milestone was successfully mastered: the certification of the quality management system (QMS) according to ISO 13485. Thanks to the focused approach of the MII, a research-focused project was transformed into a market-oriented company in a very short time.

The challenge

The product of the startup sync2brain – a combination of software and hardware solution for the personalization of transcranial magnetic stimulation – is based on many years of scientific research. Besides the existing scientific and medical expertise, however, a market-oriented view still had to be developed to bring the innovation into application. The challenge was not only to develop a business model, but also to implement it. The topic of regulatory affairs seemed like a “huge, unconquerable mountain” to the young company, and it lacked a meaningful prioritization and implementation strategy. Financial resources were limited and should only be used as needed. In addition, the team did not have the necessary expertise in C2 and C3 at the beginning.

“With the MII’s jump-start, we have successfully mastered the first important milestone on the way to becoming a medical technology company in the shortest possible time. The support took away the fear of the big mountain and enabled us to simply take it into our own hands. In this way, we have shown that a research-focused project can become a market-oriented company.”

Dr. Ramona Samba

CEO, sync2brain GmbH

Our solution

These challenges were addressed by the MII experts and startup coaches together with the sync2brain team. In doing so, a reasonable and demand-oriented balance between the development of internal know-how and the involvement of external support was always maintained.

The following aspects were systematically worked out by the MII within the scope of the service project:

Development of a three-stage business model
  • Analysis of the existing scientific foundation from an entrepreneurial point of view
  • Research on the target market and patient group
  • Evaluation of the C-topic areas for the development of an initial business model: from sales in the research market, to market access as a medical product, to scaling up by expanding the indications
  • Preparation of a corresponding business plan
Alignment of C2 and C3 to the target market
  • Formulation of the intended use of the product and determination of its risk class according to the MDR
  • Clarification of the resulting requirements for a QMS
  • Assessment of the expertise and resources already available and identification of the competencies still required to achieve the goal
  • Systematic team building in the areas C2 and C3
Guidance on QMS according to ISO 13485
  • Provision of templates to the required extent, i.e. selected according to already running company processes
  • Low-threshold assistance with questions arising during QMS development
  • Integration of Regulatory Thinking® in the sync2brain team, i.e. establishment of a common understanding for the necessity and advantages of regulations and standards
Ensure successful audit through pre-assessment with MII partner
  • Extensive pre-assessment of the QMS documentation prior to the audit
  • Preparation of a report including optimization proposals based on the assessment

The MII also supports the startup in negotiating and concluding supplier contracts and applying for public funding.

Our formats and methods

The development of the business model and the identification of the needs and resources for its implementation were carried out by MII’s internal experts – through market research, HR measures, consulting sessions and joint workshops. In addition, the qualified network of the MII came into play when setting up the team.

sync2brain was able to build up the QMS independently with the help of a few templates and guidance from the MII. This was made possible primarily by Regulatory Thinking® as a central method. In this way, regulations and standards, as in this case MDR and ISO 13485, are used as an orientation aid and thus to one’s own advantage.

Finally, the MII, together with one of its selected partners, conducted a pre-assessment of the QMS and created a reporting. Based on this, sync2brain was able to make final adjustments to their QMS before the audit by the Notified Body took place.

The result

As part of the multi-part service project for sync2brain, the MII developed an entrepreneurially promising and regulatory plausible business model. Since then, this model has already been convincing in several applications for public funding as well as in conversations with investors.

By “helping others to help themselves” in setting up the QMS, the startup succeeded in creating a first version of the documentation within six months. After a total of one year with about one full-time position, the QMS was successfully certified by the Notified Body according to ISO 13485 in the first attempt. With the help of the MII, sync2brain was able to tackle this first milestone in the implementation of their business model in a resource-efficient and independent manner.

As a certified legal manufacturer, the startup can now dedicate itself to the milestones of technical documentation and clinical studies for CE marking of their product “bossdevice MEDICAL“. Also in this respect, the team draws on the pragmatic approach around the 4Cs and Regulatory Thinking® provided by the MII.

sync2brain GmbH commercializes a novel technology that for the first time enables effective, personalized therapy for patients with stroke or depression – with much less side-effects compared to conventional therapy. Their bossdevice combines devices for electroencephalography (EEG) with devices for transcranial magnetic stimulation (TMS) of the brain. It synchronizes the stimulation to the individual brain state making TMS most effective. The bossdevice is already available for researchers and will be certified as a medical device in the coming months. The long-term goal is to establish bossTMS therapy as a standard procedure for the treatment of stroke, depression and other neuropsychiatric disorders.

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