Population Health

Tech transfer, commercialization and FDA regulations

Image of a wearable device on someone's foot

CoMotion

The University of Washington’s office for support in IP protection, business development and commercialization of technology is called CoMotion.

Some of the resources that CoMotion offers to researchers seeking to commercialize digital and mobile innovations from the UW are:

  • IP advising, protection and licensing – Consultations, invention disclosures and resources for starting up companies.
  • Funding – The CoMotion Innovation Gap fund offers researchers a bridge between research grants and seed-stage investment. Funding of $50,000 is available for one year, out of which $10,000 is reserved for business development activities. In order to apply, researchers must go through a customer discovery and marketing training process.
  • Innovation Training – Weekly seminars, workshops and other training activities to build tools and skills for entrepreneurship and innovation. Speakers include entrepreneurs from the Seattle area.
  • Express Licensing Program – Created to make software, digital products, databases, and tools created at the University of Washington easily available for external use. These licenses have standard terms and conditions that allow for rapid licensing by companies, organizations or individuals.

U.S. Food & Drug Administration

The FDA is increasingly involved in regulating the use of mobile technologies in health care. A full guidance document on how the FDA intends to regulate mobile apps is here.

The FDA has also developed an interactive tool for investigators to understand which federal laws apply for health apps.

Examples of what the FDA intends/does not intend to regulate

Regulated

  • Apps that are extensions of medical devices or control medical devices.
  • Apps that transform the mobile platform into a regulated device (blood glucose monitoring, mobile ECG, mobile stethoscope).
  • Apps that perform patient-specific analysis or provide patient-specific diagnosis. Examples are apps that calculate dosage of medication, radiation therapy treatment planning software and so forth.

Discretion will be used in the following cases

  • Apps that provide supplemental clinical care (coaching, prompting for management of cardiovascular disease, obesity, diabetes, etc.)
  • Tools for patients with specific conditions or diseases to track health information and share information with their provider who will use it in a disease management plan.
  • Apps that use patient diagnosis to provide clinician with best practice guidelines.
  • Apps that are drug-drug interaction or drug-allergy look-up tools.
  • Videoconferencing portals specifically intended for medical use to enhance communication between patient and provider.
  • Apps that transmit photos that may be used by providers (e.g., skin lesions or wounds).
  • Apps that perform calculations used in clinical practice (BMI, mean arterial pressure, APGAR score, etc.)
  • Apps that enable individuals to interact with EHR systems

The FDA’s position on how to regulate mobile technology is constantly evolving. A summary of what they did in 2016 is here. General information on digital health from the FDA is here.

Examples of FDA-approved apps from 2016-17

  • MoMe Kardia – Detect cardiac arrhythmias in patients by sensing ECG, respiration and motion. Worn as belt or necklace.
  • Quell – Wearable pain relief using nerve stimulation.
  • Dario – Blood glucose management system.
  • Qbtech – Clinical decision making support for diagnosing and treating ADHD.
  • Johnson & Johnson – Integrated blood glucose monitoring and diabetes management platform
  • Clarius Mobile Health – Wireless, handheld ultrasound scanners.
  • Propeller Health – Digital asthma and COPD management.
  • Pear Therapeutics – Digital treatment of Opioid Use Disorder, schizophrenia and PTSD.

A full list of FDA approved mobile devices or apps is here.

A comprehensive 2017 report on the use of apps and wearable sensors is here.

UW resources for FDA regulations