Manufacturing for

In Vitro Diagnostics


Industry and Research Alliance M4IVD

The Manufacturing for In Vitro Diagnostics (M4IVD) was founded in 2019 to form an industry and research alliance that is focused on the development and pilot manufacturing for In-Vitro Diagnostics (IVD) products, including Point-of-Care (POC) devices, under a GMP quality management system and ISO 13485.

With many small to medium sized Swiss life science companies that are active in the research and development of biomarkers, M4IVD addresses an important gap in the technology transfer infrastructure in Switzerland. Integrating expertise and technologies from various partners, M4IVD offers a platform that helps companies to successfully accelerate the development and pilot production of IVD tests for companion diagnostics or personal health.

Why do we need M4IVD?

Ideas are generated by startups, which may fail to deliver or take a long time to develop their product due to lack of funding and / or development experience.

A platform like M4IVD can play a role in developing these ideas to completion.

What are the most common challenges that POC-IVD startups face?
  • Access to funds.
  • Product development: Expertise to design, build and launch the product.
  • Transition from lab development to small scale production to initiate clinical trials.
  • Manage cost and quality.
What are main objectives of M4IVD?

Will address an important gap in the technology transfer infrastructure.

No centre for pilot manufacturing of IVD tests. 

Many small and medium sized companies are developing biomarkers. M4IVD will support such companies by acceleration of development and pilot production. 

Bigger companies focus on central lab technologies. POC segment is open for M4IVD and its customers.

Members of the Association

M4IVD has generated great momentum in the exchange and integration of knowledge and experiences from various partners. Founded in 2019 by 5 industrial, 6 research, and 2 public partners, the alliance is growing as work progresses. As such, the whole chain from research to commercialization is covered.

A significant part of the M4IVD overall budget is provided by our industrial partners.

M4IVD Partners Contribution Scope

Asecud is a swiss medical device development company with a mission to ensure the availability of invitro – diagnostics products for wider population around the globe through a decentralized manufacturing business model with local partners.

Basel Area Business & Innovation is a non-profit agency dedicated to helping startups, institutions and companies find business success in the Basel Area.

BioInitials develops non-invasive medical devices to monitor the health-state of the oral cavity. Their goal is to increase the degree of oral health among the general population, to prevent periodontitis, diabetes and cardiovascular diseases.

The Swiss Center for Electronics and Microtechnology (CSEM) is a private applied research and development center specializing in micro- and nanotechnology, photovoltaics, system engineering, microelectronics and communications technologies.

Effectum Medical is a company builder for the Medtech industry. Their objective is to support innovators in establishing sustainable businesses and to reach a successful exit.

ETH Zurich is one of the world’s leading universities in science and technology and is known for its cutting-edge research and innovation.

HEMEX AG is a Swiss investment and consulting company headquartered close to the Basel global life sciences hub, with its main focus to bring innovative drugs, medical devices and in vitro diagnostics to the market.

HSR Hochschule für Technik Rapperswil is all about practical teaching, innovative research, constant knowledge transfer with the industry – and bringing these fields together for the benefit of all.

Inofea developed a patented platform technology that shields sensitive enzymes, which positively demonstrated substantial benefits to customers in numerous applications.

Mulier Health develops personalized innovative health-tracking platforms that give every woman the option to track her individual health.

FHNW is one of Switzerland’s leading universities of applied sciences and arts, actively involved in teaching, research, continuing education and service provision – both innovative and practice-oriented.

Predemtec is focused on the research, development and manufacture of innovative diagnostic tests for use in the detection of dementia-related risk factors.

The Swiss Tropical and Public Health Institute (Swiss TPH) is a world-leading institute in global health with a particular focus on low- and middle-income countries.

Switzerland Innovation forms an ecosystem for domestic and international companies allowing them to further their research activities in partnership with universities and higher-education institutions.

The University of Basel, founded in 1460, is the oldest university in Switzerland and has an international reputation of outstanding achievements in research and teaching.

Volpi is the optoelectronics innovator that enables leaps in measurement accuracy through its proven performance, individualized approach, and enabling solutions.

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M4IVD supports Swiss TPH in obtaining a grant from BRCCH for combating COVID-19

One of the 11 research projects that got selected and received funding through Fast Track Call for Acute Global Health Challenges (FTC) initiative by the Botnar Research Centre for Child Health (BRCCH), was submitted by Swiss TPH with the support from M4IVD.

The FTC is an Emergency Response to COVID-19 and the unprecedented global health challenges stemming from the pandemic, for which Fondation Botnar commited CHF 20 million to international research efforts. Within the Diagnostics area the project of Swiss TPH received funding to develop a simple, low-cost device that can detect antibodies against SARS-CoV-2 by using saliva. The project seeks to identify individuals who have been previously infected with SARS-CoV-2 and to provide valuable insights into the variations in the immune response to COVID-19.

During pandemic isolations Covid-19 immunity testing is critical to allow people who have immunity to return to social life and work, in particular for critical positions, such as health workers. In contrast to other immunity tests, which are all blood based, the Consortium proposed to develop an easy-to-handle saliva sampling test to be used at home (self-testing). In pandemic situations, home testing is critical to prevent the spreading of infections when attending pharmacies and physician offices.

Link to project

Get in touch with us

Chairman of the board

Sören Fricke


Pascal Winnen

For all enquiries, please email us using the form below.