Programs for Health Startups Programs for Health Startups
How to design a program and its mentoring for digital health and medtech startups.
What this presentation covers
What this presentation covers
What this presentation covers
When software is a device
Health software can be a medical device
Under EU law, software meant to diagnose, monitor, predict or treat disease is a device.
- Diagnosis
- Prevention
- Monitoring
- Prediction and prognosis
- Treatment
Risk class under Rule 11
Rule 11 sorts software by harm
Software that informs diagnosis or therapy starts at class IIa and rises with possible harm.
- Class I all other software
- Class IIa informs diagnosis or therapy
- Class IIb serious deterioration or surgery
- Class III death or irreversible harm
Clinical evidence
Plan the clinical evaluation early
The MDR requires a planned, documented clinical evaluation with evidence suited to the device.
- Set and justify the level of evidence
- Plan the evaluation
- Run it
- Document every step
The FDA’s approach
The FDA focuses on risky software
The FDA oversees software functions that could harm patients if they fail.
- Not a device not regulated as one
- Low-risk device enforcement discretion
- Risky device FDA oversight
Evidence that fits the risk
Match the evidence to the risk
NICE asks for more evidence as risk rises; most medical devices fall in tier C.
- Tier A system services
- Tier B communicating about health and care
- Tier C informs, diagnoses or treats
The evidence gap
Funding is not evidence
Top-funded US digital health firms had not yet shown impact on disease burden or cost.
- Healthy volunteers studied most
- Few studies in high-burden patients
- Few measured outcomes, cost or access
Getting reimbursed
Germany reimburses apps while evidence grows
Low-risk health apps can be listed for up to 12 months while proving benefit.
- Apply to BfArM safety, data protection, evaluation plan
- Decision within 3 months
- Trial listing up to 12 months
- Final listing once benefit is shown
Hospital pilots
Give every pilot a clinical owner
Agree an endpoint, a data plan and a decision date before any pilot starts.
The mentor pool
Clinicians and regulators in the pool
Pair clinicians with experts in regulation, reimbursement, hospital buying and data protection.
- Clinicians workflow and endpoints
- Regulatory affairs risk class, MDR, FDA
- Health economics reimbursement and price
- Hospital buyers how purchases are decided
Measure progress
Track evidence, not only users
Follow each startup from risk class to clinical proof and a paying buyer.
- Risk class decided and documented
- Evaluation plan endpoints agreed
- Pilot sites signed hospitals
- Payer route reimbursement filed
Sources
The research behind this presentation
- European Parliament & Council of the European Union (2017) Regulation (EU) 2017/745 on medical devices (MDR), Article 2, Article 61 and Annex VIII Rule 11 Official Journal of the European Union, L 117, 5 May 2017
- U.S. Food and Drug Administration (2022) Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff FDA, Center for Devices and Radiological Health, 28 September 2022
- National Institute for Health and Care Excellence (2022) Evidence standards framework for digital health technologies (ECD7) NICE, published 2018, updated 9 August 2022
- Federal Republic of Germany (2019) Sozialgesetzbuch (SGB) Fünftes Buch, § 139e Verzeichnis für digitale Gesundheitsanwendungen Federal Ministry of Justice, gesetze-im-internet.de
- Safavi, K., Mathews, S. C., Bates, D. W., Dorsey, E. R. & Cohen, A. B. (2019) Top-funded digital health companies and their impact on high-burden, high-cost conditions Health Affairs, 38(1), 115-123
Design for clinical proof
Settle the risk class early, plan the evidence and line up the payers.