Biomed 01 | One-stop-shop
This project focuses on aligning the value chain for biomedical production by addressing three main requirements: the creation of produceable and integrable biomedical building blocks, the development of suitable production machines, and the establishment of appropriate common production processes. Additionally, it is necessary to standardize and qualify these processes according to the latest guidelines from regulatory bodies.
In Biomedical Production Technology, the necessary common machines and processes have been identified and are being brought together in an ecosystem known as the One-Stop-Shop. This is a term for the 'counter' behind which the chain is aligned: end-users thus have access to all multidisciplinary knowledge and aligned technology in one (virtual) place.
Vision
The vision of the One-Stop-Shop is to organize generic themes within the Biomed projects, such as ecosystem, generic equipment and infrastructure, standardization, and qualification of biomedical innovations developed within the projects.
This central hub will expedite the market entry of the developed biomed products, fostering knowledge generation and the development of a reliable production pipeline within the Netherlands and beyond.
Mission
The One-Stop-Shop aims to create a dynamic ecosystem that brings together developers, suppliers, and end-users of biomedical innovations, enabling the seamless introduction and fabrication of cutting-edge biomedical products to the market. Regulatory compliance is promoted through the establishment and application of dedicated standardization and qualification frameworks.
This ecosystem ensures an organized innovation pipeline by utilizing both existing and newly established specialized facilities, enabling the continuous and scalable production of biomedical products and devices.
Services
To accomplish our mission of creating an innovation pipeline for manufacturing biomedical products, the One-Stop-Shop is organized into five distinct topics:
Ecosystem
In/external connections, value proposition, ​dissemination, communication
The goal for Biomed is to collaboratively build sustainable connections and foster synergetic partnerships that bridge gaps in product development, accelerating progress toward successful market entry and sustainable growth. To build a Biomed ecosystem, we are fostering both internal and external connections. Companies are encouraged to generate a clear value proposition, enabling them to grow into control points within the value chain. Additionally, we organize the dissemination of knowledge and communicate results effectively.
Standardization
Development of (inter)national standards
Standardization of biomedical innovations is organized by NEN. In recently launched European initiatives, Dutch knowledge institutes play a leading role in developing standards (norms) for biomedical production technology. NEN will develop a standardization platform for Biomedical Production Technologies, following a similar approach to the ISO Technical Committees.
Qualification & Regulation
Setting up a qualification framework to ensure regulatory acceptance
Before biomedical innovations can enter the market, they must be qualified to facilitate their regulatory acceptance.
The One-Stop-Shop is building a general qualification framework to expedite this process. We have established a structured, step-wise strategy that aligns with existing regulatory standards and guidelines.
In many biomedical research projects, animal testing remains a common practice. This approach has historically been essential for understanding complex biological systems and developing new treatments. However, there is a growing recognition of the ethical and scientific limitations of animal testing.
The National Institute for Public Health and the Environment (RIVM) is at the forefront of guiding the transition towards New Approach Methodologies (NAMs). These innovative methods aim to reduce, refine, and ultimately replace animal testing by leveraging advanced technologies and scientific techniques.
To learn more about the landscape of NAMs and how they are shaping the future of biomedical research, please visit this link.
Generic Equipment
Production process blueprint
We will facilitate the use of generic equipment for the production and qualification of biomedical innovations. Based on the developed equipment, we are investing in private equipment developers to automate these tools and processes.
Infrastructure
Building the manufacturing pipeline
Because the production technology is still in its infancy, it is not yet clear how the many competencies within the consortium fit together. This includes questions such as: What does it take to integrate a functionalized biosensor into a microfluidic chip?
To facilitate the partners in the biomedical ecosystem, equipment is made available for the production and characterization of initial prototypes. Companies and research institutes can carry out key steps in developing and characterizing their products, including manufacturing of components and early prototypes, all while collaborating with partners on-site in an open facility. To support the manufacturing of our biomedical products, a virtual production line will be used. In this setup, all suppliers produce components in their own environments, and the products are assembled later.
For more information on the facilities please follow this link.
Contact
For more information regarding this project, please contact Sabine Middendorp, Project Leader, One-Stop-Shop, at s.middendorp@hdmt.technology