Partner with the UCSF Hypoxia Lab

The UCSF Hypoxia Lab is one of the world’s most experienced centers for human physiologic testing. As a nonprofit, university-based laboratory, we prioritize scientific rigor, participant safety, and leverage UCSF’s unique medical and data science resources, while maintaining a strong commitment to cost-effective and efficient research practices.

Our lab brings more than 60 years of experience conducting controlled physiologic studies and has safely enrolled more than ten thousand participants. We are able to conduct not only controlled laboratory studies in healthy volunteers but also real-world studies in adult and pediatric patients at the UCSF Medical Center, enabling comparisons across the full spectrum of physiologic conditions.

The UCSF Hypoxia Lab has developed many of the protocols that have become industry standards for evaluating physiologic monitoring technologies, and we continue to innovate new methods to improve the accuracy and equity of devices. Our expanding collaboration with the Uganda Hypoxia Lab also enables faster study timelines and larger, more diverse participant populations than most testing centers can provide.

In addition to conducting regulatory-grade verification studies, we conduct regulatory science research that enables us to offer methods that we anticipate will become industry and regulatory standards. We also maintain an advanced data science and analytics team that can generate insights beyond what is required for regulatory clearance—helping teams understand device performance and improve their technologies. We create custom, secure interactive workflows and data visualization tools to make study data accessible and actionable for R&D team (beyond the reporting used for regulatory clearance). Our studies also leverage adaptable, custom-built hardware and software systems designed specifically for the unique needs of each study.

Together, these capabilities make the UCSF Hypoxia Lab a unique partner for companies seeking rigorous, innovative, and globally relevant evaluation of physiologic monitoring technologies.

For each participant, we record the Monk Skin Tone Scale for the inner upper arm, finger, forehead and occasionally other sites where the pulse oximeter may be placed. Additionally, we collect objective skin pigment data from the same sites with a Konica Minolta Spectrophotometer CM-700d.

The sponsor is responsible for providing their pulse oximeters and placing them on the research subjects. They also must collect their device’s data and provide that to the lab after study completion (if requesting a report for FDA). If a sponsor would like other secondary data (eg. arm circumference, a different skin pigment scale), they should collect this data themselves with permission from the participants. Sponsor staff must be present during the study.

This depends on the study sponsor’s preference. Since 2013 the FDA requires that a validation study should have participants with a range of skin pigmentations, including at least 2 darkly pigmented participants or 15% of the subject pool depending on the study size. Based on anticipated changes to FDA and ISO regulatory frameworks, we currently aim to schedule at least 24 participants per device evaluation with at least 25% of the participants in the light, medium and dark groups from the Monk Skin Tone Scale and the individual typology angle.

Up to six participants can be studied in a single day, with 20-30 arterial blood samples from each subject.  This number may vary if the device under test requires additional setup time (e.g., signal stabilization and optimization) or if the sponsor requires additional metrics (e.g., surface temperature and arm circumference).

For a verification study for regulatory purposes, you should consider a minimum of 10-12 participants in order to have enough data to submit an FDA 510k report in accordance with 2013 guidance. Of note, as of 2026 both ISO and FDA are updating their guidance and standards, and a minimum of 24 participants if not more is likely to be needed.

Clinical research is the way doctors and scientists learn about new ways to prevent and treat illness in people. Clinical research is the fastest way to find answers to the many questions about health and disease. It is sometimes called “human research” or a “clinical trial.”

At UCSF most research that needs human volunteers happens in hospitals and clinics. Other types of research studies take place in a doctor’s office, a treatment center, a nursing home, or a community clinic. Some studies involve asking questions in an office, by telephone, or even on the street or in a home.

There are different ways volunteers participate in clinical research. For example:

• Volunteers participate by filling out questionnaires about their health, or they may answer questions about their health in an interview with researchers.
• Volunteers may be asked to donate specimens such as a tube of blood or a tissue sample for a clinical research study.
• Volunteers may participate in clinical research to find out if new treatments, or new ways of using known treatments, are safe and effective to use in people.

The faculty, staff and doctors at UCSF are dedicated to research and are deeply committed to finding new ways to prevent and treat illness and improve the health of patients who come to the University Medical Center for healthcare.

A typical study session lasts around 1 to 2 hours.

30-40 minutes of this time includes blood sample data collection and breathing on the circuit, while the remainder of the time is allocated to pre- and post-study tasks (i.e., signing the consent and skin color data collection beforehand, waiting ~10 minutes after study to apply pressure to wrist and ensure subject experiences no adverse effects).

There will be no out-of-pocket expenses for participants to complete the study. The Hypoxia Lab receives funding from sponsors to study the sponsors’ devices, as well as several grants in order to cover independent research-associated costs.

According to the UCSF Institutional Review Board (IRB) website, an IRB is “a committee — operating under federal regulations, state laws and institutional policy — that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects.”

All human subject research must be reviewed and approved by the IRB at UCSF or the Uganda Heart Institute REC in Uganda in order to be carried out. All of the Hypoxia Lab studies have received IRB or REC approval prior to being conducted.

According to the World Health Organization’s (WHO) website, clinical trials are “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.” This may include the testing of medical interventions such as “drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments and preventive care.

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.”