Medace offers a work-learning environment where clients set up and develop a technical dossier for clinical validation whilst producing a clinical grade product
Too many promising medical innovations never reach the market or the patient. One of the hurdles to take is finding your way through the ever more stringent and difficult landscape of medical devices and cell therapy (GMP) legislation and technical validation.
Medace offers a full service work-learning environment where customers (academics or entrepreneurs) are guided in how to set up and develop the technical dossier needed for clinical validation whilst producing their clinical grade product. The concept behind Medace was started within the Chemelot Institute for Science and Technology (InSciTe), which was set up to transform innovative biomedical ideas from an academic setting into medical devices.
Medace works with an EN ISO 13485:2016 certified quality and service package available for our customers on a use by need basis.
Medace provides:
• Specialized infrastructure (e.g. ISO7 and 8, and Class C and B cleanrooms)
• Validated and specialized equipment
• Quality Management System
• Trained professionals for hands-on guidance and support during development and validation
• Dedicated in-house training programs
The main stakeholders are early stage start-ups and academic groups who often lack the necessary skills and capabilities to successfully make it through this phase of innovation.
Resources needed
€7,4M of investment were raised to realize the development and clinical (cleanrooms) facility. In terms of human resources, the project is carried out by a dedicated team of technicians, quality specialists and other professionals to collaborate and work within the start-up and academic teams.
Evidence of success
Medace has so far won 11 clients (both ATMPs and medical devices), received 2 ISO certifications in 2018 and 1 GMP manufacturing license in 2018, run 2 clinical trials in 2018 and is expected to run a multi-centre trial in January 2020.
Potential for learning or transfer
Medace is a great example for regions which wish to increase and accelerate the valorisation of the research taking place in their regions. Indeed, Medace has already attracted the interest of other Dutch and European regions. The Medace approach holds great transfer potential as a way to overcome what people call “The Valley of Death”, i.e….. Too often this phase is considered to be insurmountable because of insufficient financial resource. However, the reason for not being able to attract the necessary funding and resources is often the lack of expert knowledge and the inaccessibility or unavailability of the necessary facilities. By applying an open innovation and co-working/sharing approach, Medace is able to overcome a number of these challenges in a scalable and affordable way.
Tags: Access to finance, Ecosystem, Entrepreneurship, Innovation, Manufacturing, Medical
