MII x Fysor – How an idea became the product “Apelvo”

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.

27 Oct, 2023

Case Study | Project with Fysor GmbH

An innovative product idea with a pure training approach can be launched on the market as a lifestyle product. But such a business model must also take into account the requirements and opportunities of the 4Cs in order to be successful. At the beginning of this journey, Mark Kässer, idea giver and founder of the startup Fysor, faced this challenge alone. Within several service projects with the MII, the key fundamentals for market entry were created – from company and team building, to the evaluation of market access opportunities and a regulatory mapping of the product requirements, to the development of a user-centric business model.

The challenge

The idea for “Apelvo” – a playful, motivating smartphone application for pelvic floor training – came from the daily work of physiotherapist Mark Kässer at Tübingen University Clinic. Initially, it was a one-man team with no previous entrepreneurial, regulatory or relevant technical knowledge. At this point, the product idea itself was expected to benefit various users, but it was unclear which market segments would actually be central to the success of the product. It was also unclear what requirements of the 4Cs were to be met by a lifestyle product and what degree of implementation would be required.

“What do you need on the journey from the idea to the first protected product sold profitably? So many things! One’s own expertise and perseverance, are just as important as travel companionship and a willingness to learn. In the meantime, I’m on a good course with a tailwind, meeting people and opportunities I never would have expected. Without the support and guidance of the MII, I would never have embarked on this journey.”

Mark Kässer

Founder, Idea Giver, & CEO, Fysor GmbH

Our solution

Founder and idea giver Mark Kässer initially took part in the MII’s accelerator program to acquire basic knowledge of the 4Cs and their interconnections. The central element of the subsequent service project was then to develop a market access strategy for the product idea. In doing so, the following topics were systematically addressed by the MII:

Evaluation of market access opportunities
  • Research on the market and the target groups, including conducting interviews
  • Development of personas and derivation of requirements for the product
  • Execution of user tests
  • Analysis of direct and indirect competition
  • As a result: Confirmation of the need for an IP strategy

Regulatory mapping

  • Formulation of the Intended Use of the lifestyle product “Apelvo”
  • Identification of the applicable regulatory framework for a product that is not covered by the MDR
  • Derivation of general product requirements according to EU regulations (“Blue Guide“)
  • Identification of necessary testings (e.g. EMC test) and preparation of a corresponding plan
Preparation of market access
  • Implementation of the IP strategy, e.g. through patent and trademark registration
  • Test of the product-market fit
  • Acquisition of key-opinion-leaders (KOL)
  • Development of a sales structure in differentiation to the competition

The MII startup coaches also assisted Fysor in building a team with the necessary know-how, establishing the company in 2021, and seeking financing.

Our formats and methods

Over an extended period of time and depending on the issue at hand, the startup Fysor was accompanied by different experts and startup coaches from the MII and benefited significantly from the MII network. Extensive research on regulatory issues as well as on the different market segments, joint workshops and regular consultations with the team were an integral part of the service project. The requirements and opportunities arising from the 4Cs were continually reflected on the business model which was then continuously sharpened.

Regulatory Thinking®” served as the central method for strategy development. In addition to knowledge of the market, competitors and customers, the regulations relevant to the “Apelvo” product were taken as the starting point for strategic decisions. This also included methodological approaches from ISO 13485, e.g. in the area of design and development, which are useful for lifestyle products in a selected way.

The result

Thanks to the industry-specific know-how of the MII, the potential of the “Apelvo” idea was recognized and the startup was supported in user- and market-centric product development. The focus was always on balancing the requirements of each of the 4Cs and identifying their interactions. The developed business model has already convinced in various applications for public funding such as investBW or in innovation competitions such as the Science2Start Award. Likewise, the MII experts – with the involvement of the MII network – were able to contribute significantly to the development of the team and the company.

Fysor was my first project, which I supervised as a MII Startup Coach. Mark and his idea convinced me so much that I decided to join as a Co-Founder in 2021. The startups at MII also benefit from the experiences I make on this journey.

Ingo Hämmerle

CEO MII & Co-Founder Fysor GmbH

The original idea of founder Mark Kässer became the finished product “Apelvo Trainer” with a sharpened market access strategy and consolidated IP protection. Essential prerequisites have been created so that the startup Fysor can now aim for market entry in 2024.

Fysor GmbH develops training systems with a high motivational factor, which bring back the joy of life and well-being to those affected. The first product “Apelvo Trainer” is the only pelvic floor training system that can be used unnoticed (non-invasively) in daily life. The combination of pelvic floor training with the playful use of smartphone or tablet promotes motivation and contributes to sustainable success.

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