Aleph News · October 2026 · By the Aleph University Team · 4 min read
Aleph University introduces the Aleph Innovation Hub, an innovation ecosystem for medical devices, regulatory science and health technology. It brings graduate education, accredited laboratory testing and regulatory strategy together in one place.
Anyone who wants to take a medical device from the lab to the market usually has to knock on three different doors: a university to develop talent, a laboratory to run the tests and a consultant to map out the regulatory pathway. Each door works on its own, and along the way time, money and good ideas get lost.
The Aleph Innovation Hub was created to bring those three doors together. It is a new strategic unit of Aleph University, built so that universities, healthcare companies and accredited laboratories work together from the start of each project instead of joining at the end.
Why the Aleph Innovation Hub
Innovation in medical devices moves faster than institutions can support it in a coordinated way. Some universities develop talent with no direct link to industry. Testing laboratories work apart from academia. Companies innovate without the regulatory support they need to reach the market on time.
The idea behind the Hub is simple: no advance in health technology should stay on paper because the bridges are missing. Innovation has real impact when academic training, scientific evidence and regulatory strategy move forward together from day one.
Sigma Scientific, anchor founding partner
The Hub starts with Sigma Scientific as its anchor founding partner. Sigma Scientific is a medical device testing laboratory accredited under ISO/IEC 17025 and recognized by the FDA ASCA program (Accreditation Scheme for Conformity Assessment).
Sigma Scientific supports manufacturers with safety and performance testing, design verification and validation, and regulatory submissions to the FDA, including the 510(k), De Novo and PMA pathways. Its areas of expertise include:
- Diagnostic and therapeutic ultrasound
- Medical endoscopes
- Electrical safety and electromagnetic compatibility (EMC)
- Photobiological safety and human factors validation
- Testing to FDA-recognized standards such as IEC 60601, IEC 62127, IEC 62359, ISO 8600, IEC 62471, ISO 13485 and ISO 14971
With this partnership, a project that starts in the classroom can move straight into an accredited testing and regulatory validation environment, which shortens the path from idea to market.
One origin: Dr. Jorge Millán
The Hub grows out of the career of its creator, Dr. Jorge Millán, a biomedical scientist with more than 25 years of experience in medical device testing, regulatory compliance and FDA submissions.
Dr. Millán is the founder of Aleph University and the founder and Biomedical Director of Sigma Scientific. He holds a Ph.D. in Biomedical Engineering from the University of Miami and has authored more than 25 scientific publications. Because the same person founded the university and the accredited laboratory, academic training and the regulatory validation of medical devices share one origin. That is what makes the Hub possible.
What the Hub does
The Hub works in six areas:
- Applied research and innovation in medical devices and digital health
- Regulatory science, testing and certification
- Joint training and academic mobility
- University and industry collaboration, and employability
- Entrepreneurship and project incubation
- Internationalization and strategic alliances
Every project follows the same four-phase method: Detect, Validate, Test and Register. In the last two phases Sigma Scientific provides laboratory testing and regulatory validation. The result is a process that is repeated and measured, rather than a list of contacts.
A regulatory bridge between Latin America and the United States
The Hub has a binational focus. Aleph University wants to be the entry point for Latin American universities and companies that need to work within the FDA regulatory system, with support in Spanish and technical backing in the United States.
Aleph University is also a member of BioFlorida, Florida’s life sciences industry association. That places the Hub inside an established statewide network of MedTech, BioPharma and digital health companies, universities and investors.
What each partner gains
- Partner universities: access to real device testing for theses and capstone projects, co-created programs and mobility to an accredited laboratory in the United States.
- Healthcare and technology companies: a more direct path to the FDA, with accredited testing, regulatory strategy and prepared talent.
- Clusters and industry associations: academic training and laboratory testing for their member companies, adding to their network rather than competing with it.
- Students and graduates: real projects and direct contact with medtech employers.
Join as a founding member
The Aleph Innovation Hub is open to universities, companies and institutions that want to take part in its founding stage. Membership is formalized through a Memorandum of Understanding (MOU), with a designated institutional coordinator and participation in at least one project or initiative per year.
Would your institution like to join? Write to us at info@alephuniversity.us or visit the Hub website to learn about membership.