Current project example: TROCHANTER BRACE


Problem:


A bony muscle insertion (trochanter major) on the hip must be detached in various hip prosthetic surgical procedures, or breaks off unintentionally during the operation and must be reattached. Tension forces are high on the trochanter major, which often delays or prevents the onset of healing. Existing implants have a high rate of failure (the bone does not heal, and is painful) or greatly hinder patients.


Idea:


The conventional plates currently used do not meet the basic requirements. Patients experience pain and cannot move flexibly. A new flat-profile implant combined with flexible multifilament wires addresses this need by achieving greater stability than normal plates, with less local irritation.

Development stage 1 - The first generation:


An initial model was produced manually, and the first CAD drafts (3 dimensional computer models) are created by a development company. All activities with outside partners are protected by non-disclosure agreements.

The plate was further developed on the basis of the first draft. Biomechanical testing with a simple prototype showed that the new implant is superior to existing products.


Patenting, market analysis, partner search:


A professional patent search was done, and the results analyzed to determine whether an invention or inventions of the same or similar nature already existed. The existing patent application for the invention was updated and improved in many regards. Drawings were made that also included all relevant variants in the patent protection.


A market analysis was then done, focusing on the market potential and the competing products already on the market.

Although every year there are over 200,000 operations worldwide in which a trochanter plate could be implanted, the existing products sell only about 15,000 per year. The other operations involve “homemade” solutions by the individual physicians. This clearly shows that there is no accepted solution that gives patients and physicians real value or benefit.

Together with the Institute for Rapid Prototyping in St. Gallen , Switzerland , we made further prototypes and optimized the design of the implant.

Parallel to this, we looked for a partner who was already active in the market category. Their job would be to manufacture the product in series, and to distribute the product worldwide, ideally with an own distribution network or distribution partners.


Development stage 2 - the second through fourth (current) generation


Finite-element analysis was done at a German university. After this test series, the design was adapted for the serial production of the prototypes.

In the final test phase, biomechanical tests were performed at a third-party institute in Germany . The properties of the plate were subjected to ongoing load-testing and carefully recorded. For comparison, one or more competing implants were tested, the results of which explicitly confirmed the benefits and added value of our implant.