Detect, Validate, Test, Register
Every project in the Hub follows the same four-phase route. It is not a network of contacts: it is a process that is repeated and measured, from the first need to the regulatory submission.
Detect
We identify real needs with healthcare institutions, companies and universities: clinical, technical or regulatory problems worth solving.
Validate
We assess the proposed solution against technical, clinical and regulatory criteria and define the route: which standard applies, which tests are needed and which regulator is involved.
Test
with Sigma ScientificThe device or technology undergoes safety and performance testing in a laboratory accredited under ISO/IEC 17025 and FDA ASCA, to FDA-recognized standards.
Register
with Sigma ScientificWe support the preparation of documentation for the applicable regulatory pathway (510(k), De Novo, PMA or the national regulator) and the route to market.
Detect
We start from a real need, not from a technology looking for a use. Healthcare institutions bring clinical problems, companies bring product and market challenges, and universities bring research questions and student talent.
- Healthcare partners share needs observed in daily practice.
- Companies propose product or market challenges.
- Universities contribute research lines and student teams.
Validate
Before anyone builds or tests, we check whether the proposed solution makes technical, clinical and regulatory sense, and we map the route it will have to follow.
- Technical and clinical review of the proposed solution.
- Identification of the applicable standards and the tests the device will need.
- Choice of the regulator involved: the FDA, a national regulator or both.
Test
with Sigma ScientificThe device or technology goes through safety and performance testing in a laboratory accredited under ISO/IEC 17025 and recognized by FDA ASCA, to FDA-recognized standards.
- Safety and performance testing.
- Design verification and validation.
- Testing areas include ultrasound, endoscopes, electrical safety and EMC, photobiological safety and human factors.
Register
with Sigma ScientificWe support the preparation of documentation for the regulatory pathway that applies, so the work done in the previous phases can reach patients and the market.
- 510(k), De Novo or PMA pathways with the FDA.
- National regulators in Latin America, such as Invima, Anvisa or Cofepris.
- A comparative strategy when the goal is to reach more than one market.
Training runs through every phase
Students and faculty from partner universities and Aleph University programs take part in real projects, so the method also becomes a way to learn regulatory practice.
Every project is measured
Each year the Hub will publish public metrics: projects supported, devices that advanced on their regulatory pathway, professionals trained and students connected with employers.
Clear terms from the start
The scope of each project, including laboratory hours and preferential rates, is agreed with each member and set out in its agreement. Testing services are provided by Sigma Scientific.
Have a need, a prototype or a device on the way to market?
Tell us where you are. We will tell you which phase you would start in.