About MedPhab

Who we are

MedPhab accelerates photonic device development for medical applications helping the customers to fast-track their “idea to product” pathway. As a group of partners from leading research centres and industrial players in medical devices and photonics, we work together to bring this into reality.

MedPhab is a sub-sequent of the MedPhab pilot-line EU project under Horizon 2020 research and innovation programme No. 871345.

Why we started

Developing medical devices needs matching different puzzle pieces of product development: from successful design, standardization, scale-up manufacturing mind-set as well as cutting edge technologies and expertise. MedPhab partners bring them all speaking the same language in photonics based medical device manufacturing.

Photonics is based on combining optics and electronics, and it enables various medical applications from diagnostic devices to instruments for treatment. However, both photonics in itself and its areas of application are fragmented, which poses challenges to equipment manufacturers. Furthermore, the strict regulations within the sector slow down the introduction of new solutions.

What we do

The purpose of MedPhab consortium is to accelerate the commercialisation of diagnostic devices and instruments for treatment based on photonics, and to reduce the R&D cost. MedPhab puts in place and offers systems, procedures and protocols suitable for all industry partners and RTOs to guide them through the device design, standardization and manufacturing.

MedPhab Benefits

Accelerate product development through world-class RTOs and industrial partners who speak ”the same language”.

You can be matched with the right R&D partners through a single entry point.

Get a comprehensive evaluation of technology readiness and guidance in development priorities.

MedPhab covers all project stages from prototyping to manufacturing development towards ISO13485.

MedPhab Way of Working

In MedPhab, a 1-5 maturity chart is designed to articulate the position in a typical medical device development process flow. MedPhab is strongly positioned in the stages of product development which focus on advancing manufacturing and integration level. Basic research as well as high-volume manufacturing is not in the scope of MedPhab

We apply the following approaches to assess technology and product maturity

• MedPhab 1-5 approach: we identify at which stage of the life cycle a product is.
• TRL (Technology Readiness Level): The maturity of a technology to provide its function.
• MRL (Manufacturing Readiness Level): The maturity of a technology to be produced.

ISO13485 is a standard that represents the requirements for a Quality Management System (QMS) for the design and manufacture of medical devices.

Production of a small to medium quantity of devices is done by MedPhab ISO13485 certified companies and RTOs, ensuring seamless transition from pilot line production to up-scaled production without the need for re-design.