The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.

1. Clinical Validation &
Regulatory Approval
for health tech
DR HUGH HARVEY - MANAGING DIRECTOR - HARDIAN HEALTH

2. 2
Overview
Why and how do should I sell my product in the UK?
Why all this fuss about evidence for digital health tech?
How do I approach clinical evidence?
How do I approach regulations?

3. 3
Why and how should I sell
my product in the UK?
Gain access to the £27 billion spent on services in the NHS
annually.
What is the route to market for NHS?
Bureaucratically standardised procurement

4. 4
Why all this fuss about evidence?
Drugs don’t deliver safe and effective healthcare, people and systems do
The same goes for digital health tech!
“Algorithms are the new drugs”

5. 5
· Prove your product works!
· Demonstrated through studies
and publications
· Aim for academic credibility to
spread your reputation
· Fulfill technical and clinical
regulatory requirements as
part of your culture
· Bolster your product’s visibility
across regulatory networks
· Demonstrate long term cost
effectiveness of your product
suite
· Demonstrate business case
and value to purchasers
· Understand procurement
networks to accelerate clinical
adoption
· Procurement pathway
navigation
Overall strategy
Comprehensive top-down go-to-market approach
Clinical validity Regulation Health economics Procurement

6. 6
How do I approach
clinical evidence?
1. Ensure your product makes sense scientifically
2. Test it in the lab setting
3. Get some real world evidence
4. Publish

7. 7
Levels of evidence needed

8. 8
Clinical trial phases for AI

9. 9

10. 10
How do I approach
regulation?
1. Regulation is a culture, not a barrier - buy in to this!
2. Gather your clinical evidence
3. Write up & maintain all of the regulatory docs
4. Keep track of how it performs after release -
permanently

11. 11
Regulatory
pathway

12. Scientific validity Health economics Procurement
Network
The regulatory pathway
Agile Project Management methodology for software life cycle processes
● Define Intended Use
● Review guidelines
● Determine Device Class
● Establish a Quality
Management System
(QMS)
● Technical File (TF) planning
● Medical Device File (MDF)
● Design History File (DHF)
● Complete regulatory
development roadmap
● Train staff in QMS
● Select Notified Body
● Cyber Security readiness
● Supplier Relationships
● Conduct Literature Review
● Benefit-Risk Analysis (BRA)
● Build Clinical Evaluation
Plan
● Standard Operating
Procedure (SOP) design
● Risk Management Report
(RMR)
● General Safety &
Performance Requirements
(GSPR)
● Clinical Investigations
● Ethics Submissions
(IRAS/IRB)
● Clinical Evaluation Report
(CER)
● Prepare Post Market
Surveillance (PMS) plan
and report
● Prepare Post Market
Clinical Follow-up (PMCF)
plan and report
● Ongoing safety reporting
● Maintain Periodic Safety
Update Reports (PSUR)
Fundamentals Development Deployment Maintenance

13. 13
International Standards
27001
Information
Security
Management
14971
Risk
Management
13485
Quality
Management
Systems
62304
Software
lifecycle
process

14. 14
Use Specification
Establish a clear understanding and intention around what your device is supposed to achieve
Understand and clearly document:
∙ who your users are (n.b. your users may not be the patients),
∙ what disease process you’re intervening in
∙ what data you need for your models, and what your accuracy benchmarks
∙ what situations your product can and cannot perform in
This enables you to make specific marketing claims related to performance

15. Medical Device Software (MDSW)
Medical device software is software that is intended to be used, alone or in combination, for a
purpose as specified in the definition of a “medical device” in the medical devices regulation or
in vitro diagnostic medical devices regulation.

16. 16
Risk Class
Not all devices are in the
same risk class
Risk class defines which
route to take for CE
marking
Moderate Risk
2
High Risk
3
Low Risk
1
SaMD

17. 17
Clinical evaluation plan and report
Question answered Method used to
produce evidence
i. Valid clinical
association
Is there a plausible scientific
explanation for the device’s
use case?
Literature review
ii. Analytical validation Does the device behave
correctly in test conditions?
Verification testing of
software against technical
performance requirements
iii. Clinical validation Does the device behave
correctly in the clinical
setting?
Clinical investigation
Post market clinical follow up

18. • A description of the technical aspects of the device, including design and composition
• Review of intended therapeutic or application claims
• Clinical evaluation protocol and data inputs and parameters
• Summary of relevant clinical data and findings
• Description of the analyses used in the clinical evaluation assessment
• Strong conclusion regarding safety, performance and conformity, linking the results of the clinical
evaluation to specific, relevant ERs
• Data used in the analyses should be appended to the CER
• Content should be accurately referenced
• CVs of the authors should be included and it should be signed by the Author(s) and Reviewers
Clinical Evaluation Report (CER)

19. Clinical Evaluation Report
Claims & IUS
Clinical
Study dataLiterature
review
Clinical
Evaluation Plan
PMS &
PMCF data

20. 20
PMCF
Product Lifecycle
Documentation
Clinical
Evaluation
Report
Quality and
Safety
Documentation
UDI and
GSPR (ISO
82304)
PMS and
PSUR

21. 21
Sell in the NHS because it’s a large market and an incredible
stamp of approval!
Algorithms are the new drugs, and we need to evidence them
as such
You need robust evidence of clinical effectiveness in order to
sell to the NHS
Regulation is a culture (not a barrier) which opens more doors
Summary

22. Thanks
hugh@hardianhealth.com
@drhughharvey