1. Quick Investors Reference Guide
to Regulated Medical Device &
Digital Health Space
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Braingels 2016

2. This presentation is the sole property of Physio-logic Ltd and is protected by Copyright ©. Any
use of this presentation without the prior written approval of Physio-Logic Ltd is prohibited.
This presentation does not constitute regulatory advice and should not be regarded as
replacing professional consultation. We recommend that you receive specific professional
advice in relation to any regulatory matter.
 What does regulation stands for?
 How does it impact me?
 Tips & pearls
 Digital vs. non digital MD regulation in a nutshell
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3.  Barrier to Market
It Comes with the Territory…
 Typically attributed to product approval by regulatory agencies
(FDA, CE, AMAR etc.)
 Extends to the entire lifecycle of medical device from inception
to end of life
 A collective name for three disciplines:
 Regulatory Affairs (RA)
 Quality Affairs (QA & QC)
 Clinical Affairs (CA)
What Does Regulation
Stands for? 3

4.  Is my product regulated as Medical device?
 What is its classification?
 Which regulatory requirements apply to my product?
 What is my time to market?
 How much will it cost me?
 Start up wisdom, innovation, leverage good regulatory science
and medicine
QRC Strategy & Work-plan
What Does Regulation
Stands for? 4

5. It Impacts Your ROI

6. The Impact –Early Stage
How Does it Impact Me? 6
 Betting on the “wrong horse”
 Time to market
 Do it right the first time:
 Q: Are we developing the right product?
 A: Due-dilligence; QA & CA feed the answer
 Q: Are we developing the right product right?
 A: Design control practice, Quality by design
 Wrong doing, under doing, over doing
 burn rate, dilution…diminsh ROI

7. Increase Your ROI
How Does it Impact Me? 7
 Valid Regulatory strategy
 Clinical strategy
 Quality plan
 Gates
 Control

8. Bottom Up QRC Work-plan & Budget
How Does it Impact Me?
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 Harmonized with R&D WP
 Manage your risk
 Time to market
 Burn rate
 ROI

9. Compliance (Late Stage)
How Does it Impact Me?
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10. Tips & Pearls
How Does it Impact Me?
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 Due diligence: screen strategy – is QRC project risk
aligned with your investment strategy, are project
plan and budget valid?
 Control your investment – do it right the first time
 Understand that ensuring your project is handled by
competent QRC expert is in your best interest as
investor

11.  Three risk classes
 Risk vs. benefit
 Intended use
 General controls, special controls and PMA
Medical Device Regulation
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Digital Health Regulation
 Four classes driven by risk and classification rules
 Loosely tied to intended use
 Conformity assessment
Paradigm more established but struggling with
innovation

12. Digital Health Regulation is Challenging
• Regulation is (always) behind technology
• Booming health apps. Nd Health IT products
• Multiple stake holders (HIPPA, FD&C Act, FTC Act,
CMS)
• Multiple types (mHealth, CDS, Health IT, Personalized
Medicine, Telemedicine, wearable device (IOT))
• The demarcation between FDA regulated product vs.
nonregulated is complex and tricky at times.
• The ramifications of this demarcation are extensive!
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13.  Risk (privacy, hacking, injury, miss-diagnosis, delay
of treatment, misuse, error)
 Functionality focused (administrative, medical
device etc.)
 Narrowly tailored
Risk Based Approach for Regulating Digital Health
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14. Regulation Goes Beyond FDA
 FCC, RTTE
 FTC
 HIPPA (Privacy, Security)
 EC Privacy directive (95/46/EC)
 ISO/IEC Health IT Standards
 Liability for defective products (1985/374/EC &1999/34/EC)
 General product safety (2001/95/EC)
 Sale of consumer goods (1999/44/EC)
and much more…..

15. Our Mission Statement
Successfully Navigating the Regulatory
Maze

16. Founded & Managed by Gadi Ginot
• Over 20 years industry experience in managing
Medical Device & Combination product regulation,
quality and clinical development
 Pharma (Teva)
 Medical Device
 International experience (scores of relocation to
the EU, US)
• Internationally renown
• Unprecedented accomplishment in navigating precut
certification thru FDA and Notified Body

17. Full Service Solution for Medical Device
Manufacturer
• Largest vendor in Israel (over 30 experts on board)
• We cover all bases of Medical Device
• Designated Digital Health Team
 Usability
 FDA 513(g), 510(k), PMA
 CE Mark
 ISO13485, ISO9001, CMDCAS
 CLIA
 International registration
including AMAR, Russia, CFDA
 Compliance
 HW & SwQA
 Design Control
 Risk Management
 Performance
evaluation
 Clinical evaluation
 Clinical Trials
 HIPPA
 Cybersecurity

18. Gadi Ginot: gadi@physio-logic.co.il
050-8317449
www.physio-logic.co.il
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