NextGenMicrofluidics Concept for the quality label “MIH certified”

NextGenMicrofluidics Concept for the quality label “MIH certified”

Project Deliverable by BNN
Project: NextGenMicrofluidics (Grant Agreement No. 862092) Topic: DT-NMBP-03-2019 – Open Innovation Test Beds for nano-enabled surfaces and membranes (IA)
Date of publication: October 2021
Area: DfTD
BNN team involvement: Clemens Wolf, Andreas Falk, Johanna K. Scheper

As part of the H2020 project NextGenMicrofluidics, BNN was in charge of developing the basic concept for the quality label “MIH certified”. This confidential project internal deliverable report explains the concept of the “MIH certified” quality label, and how it can be implemented within the NextGenMicrofluidics Open Innovation Test Bed (OITB).

To summarize, the clear benefits of the “MIH certified” quality label concept are:

• Common understanding of requirements for a Quality Management System (QMS)
• Mapping of services for reliable offer identification
• Building trust among customers and stakeholders
• Potential time savings in the go-to-market process

As an OITB project, NextGenMicrofluidics set up the Microfluidics Innovation Hub (MIH) to function as a convenient hub, enabling customers to access the facilities necessary for developing and manufacturing components for their products via the MIH partners. Customer satisfaction is paramount to MIH, ensuring that the services it offers comply with relevant quality standards and are provided in a secure and dependable manner.

Conversely, MIH must carefully select the most suitable partners to meet customer expectations. The “MIH certified” label and its certification process aids in categorizing each service available through the Hub. It also provides guidance to service providers regarding the requirements for offering their services, be it for research and development or production, adhering to market-specific regulations.

The awarding process was designed to help the MIH gain insights into which OITB partners can offer services at specific Technical Readiness Levels (TRL) and quality standards, instilling a high level of confidence in meeting customer needs. A comprehensive collection of information further assists MIH in facilitating a smooth transition of services from the development stage to higher TRL levels or even manufacturing standards.

The primary purpose of the MIH certified label is to enable a modular approach to the services offered within the OITB facilities. Through the labeling process, valuable knowledge should be gained, allowing for the assembly of a suitable supply chain from the predefined and established services listed based on each customer’s specific needs. This modular approach was designed to accelerate, simplify, and reduce the cost-to-market for OITB customers. Notably, for the development and production of in-vitro diagnostic systems, compliance with the In Vitro Diagnostic Regulation (IVDR) serves as a facilitator for potential clients in streamlining their products’ go-to-market process.

The requirements for obtaining the MIH certified label, and thus the ability to offer services in the OITB, must vary depending on the specific sector. Beyond the sectoral distinction, it is essential to differentiate whether a service is intended for production or solely offered for research and development (R&D). Additionally, the potential for transferring a development service to a production environment was also considered in the concept development.

BNN was able to lay the foundation for the development of the label and set a strategic direction for MIH to become a reliable partner with a jointly administered quality concept. Lessons learnt during the implementation of the “MIH certified” quality label concept are used for future finalization considerations of the final label. Customer specifications will be used to re-sharpen the concept concerning manufacturing under European law.

The original deliverable is confidential and can only be viewed by project beneficiaries.