5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)

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What should the medical device industry expect in 2018? Great question. From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals. This presentation covers: - Why you should expect it to be harder for devices to get to market and stay there in the EU - How to avoid the mad dash to update ISO 13485 certification before the deadline - Where the latest revision of ISO 14971 is and when to expect the next update - About Health Canada and their MDSAP deadline - Why companies are shifting from being compliance-focused to quality-focused Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions

Business

5 PREDICTIONS FOR THE
MEDICAL DEVICE INDUSTRY IN 2018
(AND HOW YOU CAN PREPARE)

Jon Speer is the Founder & VP QA/RA of Greenlight Guru.
• 20+ years in medical device industry
• Product development engineer, quality manager,
regulatory specialist
• 40+ products to market
• Expert at QMS implementations
• Dozens of ISO audits & FDA inspections
@greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280

#1 – IT’S GOING TO BE HARDER FOR
MEDICAL DEVICES TO GET TO MARKET
AND STAY IN THE MARKET IN EU

Image from MHRA (https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf)

Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market-
access/eu-medical-device-regulation/infographic-the-new-medical-device-regulation-mdr)

Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market-
access/in-vitro-diagnostic-medical-devices-directive-98-79-ec/infographic-the-new-in-vitro-diagnostic-medical-device-regulation)

http://ec.europa.eu/newsroom/just/item-detail.cfm?item_id=612136

#2 – MAD DASH TO UPDATE ISO 13485
CERTIFICATION BEFORE DEADLINE

#3 – ISO 14971 WILL BE REVISED FOR
INDUSTRY COMMENT

#4 - HEALTH CANADA WILL BACK OFF
ON MDSAP DEADLINE

#5 - MEDICAL DEVICE COMPANIES SHIFT
FROM COMPLIANCE-FOCUSED TO
QUALITY-FOCUSED

“NON-COMPLIANCE IS THE
SINGLE BIGGEST RISK FACING
MEDICAL DEVICE COMPANIES TODAY.”

Dr. Jeffrey Shuren, director of the FDA’s
Center for Devices and Radiological
Health, affirmed the Case for Quality’s
role in advancing solutions to ensure
patient access to high quality medical
devices and the FDA’s commitment to
their shared goal to improve patient
outcomes.

Case for Quality Initiative has one main goal: affording patient’s
access to high quality medical devices .
From Dr. Shuren:
“. . . compliance with FDA quality system regulations is not enough . . .”
“. . . FDA's purely regulatory approach that focuses on compliance with quality system
regulation may create disincentives for device makers to innovate device quality . . ."
“. . . shifting the focus from the minimum operational compliance requirements laid out in our
regulations to a higher sustained level of quality can provide end-users with a better product
and greater return on investment and quality for device companies through fewer recalls and
adverse events and greater consumer confidence in their products . . ."
https://www.youtube.com/watch?v=X4KAOCi1RuE

INCREASE VISIBILITY
AND CONTROL.
SHIFT FROM JUST
COMPLIANCE TO TRUE
QUALITY.
REDUCE THE UNKNOWNS
AND YOUR RISK.

The only Quality Management Software designed
specifically for the medical device industry.

https://www.greenlight.guru/quality-management-software-demo

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5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)

1. 5 PREDICTIONS FOR THE MEDICAL DEVICE INDUSTRY IN 2018 (AND HOW YOU CAN PREPARE)

2. Jon Speer is the Founder & VP QA/RA of Greenlight Guru. • 20+ years in medical device industry • Product development engineer, quality manager, regulatory specialist • 40+ products to market • Expert at QMS implementations • Dozens of ISO audits & FDA inspections @greenlightguru Jon.Speer@greenlight.guru +1 317 960 4280

3. THERE IS A SHIFT HAPPENING …

5. #1 – IT’S GOING TO BE HARDER FOR MEDICAL DEVICES TO GET TO MARKET AND STAY IN THE MARKET IN EU

6. MDR IVDR

7. Image from MHRA (https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf)

8. Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market- access/eu-medical-device-regulation/infographic-the-new-medical-device-regulation-mdr)

9. Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market- access/eu-medical-device-regulation/infographic-the-new-medical-device-regulation-mdr)

10. Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market- access/in-vitro-diagnostic-medical-devices-directive-98-79-ec/infographic-the-new-in-vitro-diagnostic-medical-device-regulation)

11. Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market- access/in-vitro-diagnostic-medical-devices-directive-98-79-ec/infographic-the-new-in-vitro-diagnostic-medical-device-regulation)

12. Image from TUV SUD (https://www.tuv-sud-america.com/us-en/industry/healthcare-medical-devices/market-approval-amp-certification/eu-market- access/in-vitro-diagnostic-medical-devices-directive-98-79-ec/infographic-the-new-in-vitro-diagnostic-medical-device-regulation)

13.

14. http://ec.europa.eu/newsroom/just/item-detail.cfm?item_id=612136

15. #2 – MAD DASH TO UPDATE ISO 13485 CERTIFICATION BEFORE DEADLINE

16.

17. #3 – ISO 14971 WILL BE REVISED FOR INDUSTRY COMMENT

18.

19. #4 - HEALTH CANADA WILL BACK OFF ON MDSAP DEADLINE

20.

21.

22. #5 - MEDICAL DEVICE COMPANIES SHIFT FROM COMPLIANCE-FOCUSED TO QUALITY-FOCUSED

23. “NON-COMPLIANCE IS THE SINGLE BIGGEST RISK FACING MEDICAL DEVICE COMPANIES TODAY.”

24.

25. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, affirmed the Case for Quality’s role in advancing solutions to ensure patient access to high quality medical devices and the FDA’s commitment to their shared goal to improve patient outcomes.

26. Case for Quality Initiative has one main goal: affording patient’s access to high quality medical devices . From Dr. Shuren: “. . . compliance with FDA quality system regulations is not enough . . .” “. . . FDA's purely regulatory approach that focuses on compliance with quality system regulation may create disincentives for device makers to innovate device quality . . ." “. . . shifting the focus from the minimum operational compliance requirements laid out in our regulations to a higher sustained level of quality can provide end-users with a better product and greater return on investment and quality for device companies through fewer recalls and adverse events and greater consumer confidence in their products . . ." https://www.youtube.com/watch?v=X4KAOCi1RuE

27. INCREASE VISIBILITY AND CONTROL. SHIFT FROM JUST COMPLIANCE TO TRUE QUALITY. REDUCE THE UNKNOWNS AND YOUR RISK.

28. The only Quality Management Software designed specifically for the medical device industry.

29. https://www.greenlight.guru/quality-management-software-demo

30. Jon Speer is the Founder & VP QA/RA of Greenlight Guru. • 20+ years in medical device industry • Product development engineer, quality manager, regulatory specialist • 40+ products to market • Expert at QMS implementations • Dozens of ISO audits & FDA inspections @greenlightguru Jon.Speer@greenlight.guru +1 317 960 4280

5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)

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