Sports Medicine Innovations AG

Skills

Competences

Sports Medicine Innovations AG is a one-stop supplier of all topics concerning the development and commercialisation of medical devices. Depending on the developmental stage of your idea/ product, SMI plans and coordinates the necessary steps for placing the innovation in the market. Whether licensing or trade sale would be the model of choice- SMI supplies you with costum-tailored services covering all activities from idea to the marketed product. SMI is part of the Sports Medicine Excellence group, a multinational network of outstanding orthopaedic surgeons. With this cooperation, SMI keeps pace with the ever changing clinical environment and employs this network to benchmark the development of ideas and products. By using its clinical and business network and employing a lean hierarchy, SMI speeds up time to clinical application and finally time to market.

Idea/ Assessment of economic viability

Unlike other players in the field, SMI uses a parallel approach in creating and developing ideas from innovators. While some players strictly segregate IP from feasibility issues, SMI is aware, that economic efficiency plays a central role in developing ideas and that economic viability of a product is essential for successful market implementation. SMI addresses economic viability of a product in a very early stage by analysing and estimating market needs and opportunities.

Development of business model

Depending on the market analysis and on the developmental phase of the project, a viable business model is developed, which allows reliable budgeting of the project. Business models range from licensing to establishing start up companies with defined exit scenarios. SMI assists you in finding the right business approach for your innovation.

IP assessment and protection strategies

Like in any other knowledge- based industry, the assessment and protection of intellectual property plays a central role in the medical device market. SMI assists to evaluate the intellectual property of the innovator by searching patent databases or performing searches for work of prior art. SMI assists in patenting or by addressing other strategies for securing the intellectual property of the innovator.

Realisation phase

In this phase the project is checked for technical and medical feasibility. Employing a network of surgeons, MedTech suppliers and engineers, SMI coordinates the design and construction of functional models and prototypes, which reflect the intended clinical function of the device. Depending on type of the device Finite Element Analysis (FEA) is performed to be able to simulate device behaviour and stability. SMI coordinates these activities and assists in finding the device of your choice.

Clinical Development and Regulatory Services

Depending on the type of the device and its regulatory requirements, SMI plans and coordinates clinical activities to introduce the device to the healthcare market. These activities range from establishing first user groups in the orthopaedic field with concomitant CE marking using the clinical network, or- in more complicated settings- the coordination of conducting clinical trials on basis of contract research. This comprises establishing clinical trial protocols with accompanying documentation (Case report forms, Investigator’s Brochure, etc.) as well as medical and regulatory writing activities. SMI addresses clinical issues and pitfalls and assists you in finding your route to clinics.

Commercialisation

The possibilities to commercialise medical devices are as diverse as medical devices are. SMI has experience in licensing as well as establishing start- ups for trade sales. SMI employs the experience and network established over years in the MedTech Industry to assist you in finding the right business model and partner for the commercialisation of your product.