Field guide for digital health founders
From first idea to clinical safety file.
The clinical questions a buyer, an investor or a regulator will ask, while they're still cheap to answer. Work through it on your own, in writing, before you pay anyone for help.
- Where products usually break, and the questions to answer for each one
- A pre-regulatory checklist you can hand to a consultant
- UK, EU, US and Australian rules side by side
Get the guide · €65
€49 with the codeuntil 30 November.
Two of the pages inside.
What's inside
The whole road
6 stages from first idea to your first meeting with a regulatory consultant, and what matters at each one.
Wellness or medical device?
The signs your product has quietly crossed the line.
Where products break
Every Lens dimension, with the questions to answer in writing before anyone asks.
Data, security, evidence
GDPR, cybersecurity and clinical evidence, planned before your pilot.
Your pre-regulatory pack
The checklist, plus the rules for the UK, EU, US and Australia side by side.
Half-price First Look
Own the guide and your first session with me is €175 instead of €350, within 30 days.
E
For founders and product teams building something that touches a patient's life, before or around their first funding round. Written by Emma Paraschiva, in clinical practice since 2013. Auditing digital health products is my work. About the Lens
Severity is fixed. Likelihood is designed.
Short on purpose. Every page is something to answer or check, not background reading.
Not sure yet? Start with the free self-assessment. It takes a few minutes and shows where your product stands. Take the self-assessment
Get the guide · €65
€49 with the codeuntil 30 November.
Educational content about clinical reasoning in product design. It doesn't give medical, legal or regulatory advice.