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Comate on the frontpage of DSP Valley

29 April 2015

Developed in Leuven, launched at the AAOS in Las Vegas

Comate & MedEnvision

Read more about the first succesful cooperation between MedEnvision and Comate and their medical device here:

It started two and a half years ago when a team of orthopedic surgeons went to MedEnvision asking for a medical solution. In a partnership with Comate, this triumvirate designed a patented medical device that has been launched at AAOS, the world’s largest orthopedic trade show, held in Las Vegas. A first batch of 20.000 pieces is being produced at press time.

MedEnvision starts from innovative ideas that increase efficiency in the operating theatre – thereby actively contribute to the reduction of the hospital’s Total Cost of Ownership – and turns them into sellable products. The best ideas to increase efficiency, enhance comfort or create savings, often come from Healthcare professionals who experience inefficiencies in their daily routine. Unfortunately, these ideas mostly remain just good intentions. Developing a marketable product for medical use requires a specific expertise. The uniqueness of the MedEnvision team is that it features the various disciplines that require this expertise. From product ideation and design over clinical validation to eventually commercialization. For the solutions where expertise in mechanical engineering and design is needed, MedEnvision can count on Comate, as it was the case for the GRIPPER.

The GRIPPER

MedEnvision’s first development, the GRIPPER, is a patented self-retracting device that was originated by an unmet need. The lack of nursing staff and/or assistants forced the surgeon to search for alternatives. The GRIPPER is fixed on a retractor (a surgical instrument used by a surgeon to open the surgical incision or wound) and therefore replaces the nurse or assistant who usually holds the retractor in place. Many advantages arise by using the GRIPPER: stable and reliable positioning of the retractor, soft tissue sparing and bone preserving, optimal visibility of the surgical field and reduction and reorientation of manpower.

The simplicity and ingenuity of the GRIPPER allows each surgeon, in a variety of circumstances, to perform surgery in the most comfortable way. Apart from the reliability, the GRIPPER ensures smooth and swift surgery. There are many healthcare practitioners with brilliant ideas that need to be explored and developed. MedEnvision and Comate will continue to rely on each other’s expertise and support to develop and market innovative products. Never change a winning team!

Medical design process

After planning the design and development steps and the individual responsibilities for each step, the design inputs are gathered. Product specifications are based on requirements from healthcare practitioners, risk management and regulatory requirements. These input requirements are translated by Comate’s team into design outputs (drawings, components, etc.). During the creation of the output documents, risks are identified and analyzed in a failure mode and effect analysis.

During the design verification, the team checks whether the device was correctly designed, i.e. make sure the outputs meet the inputs. The design validation successfully followed the design verification and confirmed that the product meets the intended use. By designing the GRIPPERTM according ISO13485, Comate and MedEnvision developed a reliable product that meets the applicable safety and regulatory requirements.

From DSP Valley – Nieuwsbrief April-Mei ’15 – 16″ – nr. 2