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Quick Investors Reference Guide
to Regulated Medical Device &
Digital Health Space
1
Braingels 2016
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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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
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
It Impacts Your ROI
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
Increase Your ROI
How Does it Impact Me?7
Valid Regulatory strategy Clinical strategy Quality plan Gates Control
Bottom Up QRC Work-plan & Budget
How Does it Impact Me?8
Harmonized with R&D WP
Manage your risk
Time to market
Burn rate
ROI
Compliance (Late Stage)
How Does it Impact Me?9
Tips & Pearls
How Does it Impact Me?10
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
Three risk classes Risk vs. benefit Intended use General controls, special controls and PMA
Medical Device Regulation
11Digital Health Regulation
Four classes driven by risk and classification rules Loosely tied to intended use Conformity assessment
Paradigm more established but struggling with innovation
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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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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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…..
Our Mission Statement
Successfully Navigating the Regulatory
Maze
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
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
