Clinical Evidence Requirement of Software as a Medical Device (SaMD) - PowerPoint PPT Presentation

Clinical Evidence Requirement of “Software as a Medical Device” (SaMD) Dr David Hau Senior Medical Officer, Clinical Section, Medical Devices Branch Innovate Health Conference 27 June 2019

Essential Principle 14 Clinical evidence Every medical device requires clinical evidence, appropriate for the use and classification of the device , demonstrating that the device complies with the applicable provisions of the Essential Principles . From the Therapeutic Goods (Medical Devices) Regulations 2002 – Schedule 1, Part 2 1 Innovate Health 2019

The essential principles Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1 General principles Principles about design and construction 1. Use of medical devices not to 7. Chemical, physical and biological properties compromise health and safety 8. Infection and microbial contamination 2. Design and construction of medical 9. Construction and environment properties devices to conform to safety 10. Medical devices with a measuring function principles 11. Protection against radiation 3. Medical devices to be suitable for 12. Medical devices connected to or equipped intended purpose with an energy source 4. Long-term safety 13. Information to be provided with medical 5. Medical devices not to be adversely devices affected by transport or storage 14. Clinical evidence 6. Benefits of medical devices to 15. Principles applying to IVD medical devices outweigh any side effects only www.legislation.gov.au 2 Innovate Health 2019

Level of clinical evidence should be commensurate with intended use • Significance of the information provided by the SaMD to the healthcare decision • Seriousness of the healthcare situation or condition • Do the target population include any vulnerable group (e.g. children, at-risk adults)? • If intended for use by lay users, what level of support from healthcare professionals is intended? 3 Innovate Health 2019

What is clinical evidence for a medical device? Clinical evidence guidelines: Medical devices 4 Innovate Health 2019

What is clinical evidence for a software medical device? www.imdrf.org 5 Innovate Health 2019

Clinical Evidence Clinical Evaluation ① Valid Clinical Association ② Analytical Validation ③ Clinical Validation Does use of your SaMD’s Is there a valid clinical Does your SaMD correctly accurate, reliable, and precise association between your process input data to generate output data achieve your intended SaMD output and your accurate, reliable, and precise purpose in your target population SaMD’s targeted clinical output data? in the context of clinical care? condition? 6 Innovate Health 2019

Clinical Evidence • Alignment of clinical content with current clinical guidance and best practices for the target population • Accurate and reliable output • Accuracy, reproducibility with test data representative of intended use • Performance for clinical use in indicated patient population • Useability study • Real-world / ongoing data showing clinical outcomes • Clinical study data demonstrating effectiveness for intended use • Observational study or Intervention study, preferably with control group 7 Innovate Health 2019

Equivalence • Equivalence for conventional medical devices is based on: • Clinical characteristics • Technical characteristics • Biological characteristics • Equivalence for SaMDs should include at least the following considerations: • Intended use • Algorithm • Useability 8 Innovate Health 2019

Further considerations • Initial setup – oversight by healthcare professional, with continued review • Healthcare or technology literacy required of the user • User training 9 Innovate Health 2019