BIOE70028 Medical Device Certification

Lecture 1 - Introduction
Dr Warren Macdonald

w.macdonald@imperial.ac.uk
www3.imperial.ac.uk/people/w.macdonald
Department of Bioengineering
 Warren Macdonald
PhD, CEng, CSci, FIPEM, FHEA

• Working in Bioengineering since 1980

• Senior Teaching Fellow since 2012, at Imperial College since 2008
• worked in three 1000-bed teaching hospitals; Perth, Oxford (Nuffield Orthopaedic Centre), & KCH
• Senior Hip Bioengineer; Johnson & Johnson Orthopaedics for 2 years
• King’s College, London (Lecturer in Rehabilitation Engineering),
• 15 years as an independent consulting Bioengineer in orthopaedic
bioengineering.
• PhD on implant fixation in total hip replacement.
• Regulatory role and experience.
Email: w.macdonald@imperial.ac.uk
Phone: 020 7594 6372
Room: Bessemer 3.25
 Medical Device Certification
● Why bother?

● You’ve probably got inventions or innovations you want to progress

● How can you do that?

● What can go wrong?

 Medical Device Certification
Ex-Synthes Officials Get Prison Terms
in Bone Drug Case
Bloomberg, Nov 21, 2011

Three former Synthes Inc. (SYST) executives were sentenced to prison

terms ranging from five months to nine months each for their roles in the
unapproved trial of a bone-cement drug in which three patients died.

The cement, approved for elsewhere in the body, was used in the spines
of 200 patients with fractured vertebrae. Three patients died from a rapid
drop in blood pressure during spinal surgeries, prosecutors said.
 Medical Device Certification
Ex-Synthes Officials Get Prison Terms
in Bone Drug Case
Bloomberg, Nov 21, 2011

Three former Synthes Inc. executives were sentenced to prison terms

ranging from five months to nine months each for their roles in the
unapproved trial of a bone-cement drug in which three patients died.

The cement, approved for elsewhere in the body, was used in the spines
of 200 patients with fractured vertebrae. Three patients died from a rapid
drop in blood pressure during spinal surgeries, prosecutors said.

Pennsylvania-based Synthes agreed to plead guilty, sell the Norian unit

and pay a $23.5 million fine to settle the case. The agreement allowed the
company to keep operating in the U.S. without its products being banned
from Medicare reimbursement programs.
 Medical Device Certification
Ex-Synthes Officials Get Prison Terms
in Bone Drug Case

Bloomberg, Nov 21, 2011

Three former Synthes executives were sentenced to prison terms ranging

from five months to nine months each for their roles in the unapproved
trial of a bone- cement drug in which three patients died.
 Medical Device Certification
Poly Implant Prothèse pre-emptively
liquidated
CNN, January 27, 2012

The founder of a French company that made breast implants linked to a

major health scare has been charged by police investigating the scandal.

Implants made by PIP have been found to contain industrial-grade silicone,

instead of medical-grade ingredients.

Some 300,000 women in 65 countries received implants made by the

company
 Medical Device Certification
DePuy Hip Recall 2011

New York Times, 9th March, 2010

A unit of Johnson & Johnson, just months after saying it was phasing out
an artificial hip implant because of slowing sales, has warned doctors that
the device appears to have a high early failure rate in some patients.

The action by the company, DePuy Orthopaedics, follows more than two
years of reports that the hip implant, which is known as the ASR, was
failing in patients only a few years after implant, requiring costly and
painful replacement operations.

Medical Device Alert: DePuy ASR acetabular cups used in hip

resurfacing arthroplasty and total hip replacement
(MDA/2010/069)
 Overview
• I have a new device/system
• Will it Work
– Validation, Clinical trial
• Will it make money
– Business Plan
• Dare I put it in humans
– Safety and regulatory
 How do I get my device to market
• Meet regulatory requirements
• Principles are
– Process is planned
– Process is organised
– Process is reviewed
– Process is documented
• Met by
– A quality system
– A tested product
 How do I get my device to market
• Regulatory requirements
– Europe – Medical Devices Regulation (5 April 2017)
• CE mark
– US – FDA approval
– Japan – Ministry of Health and Welfare
– UK - UKCA mark (possibly) from 2022, plus CE mark
• Classification of Device in Europe (but FDA is similar)
– Class 1 – e.g. gloves - self certify
– Class IIa and IIb – most devices - need external audit
– Class III – cardiac devices
• external check of tests
• Clinical trial
• https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32017R0745
 Course Details
• Thursdays 9 – 11
• Group Work (groups allocated next week)
• Assessment by Coursework (one per group)
– Broken into three sub-pieces:
– Risk Management section due 3rd November
– System Specification section – 23rd Nov
– Technical File (complete) - 14th Dec.
• Peer Assessment of contribution to group
• Chemical Safety Lecture 12th Oct, 2.00 p.m. SAF
building G16 (attendance recorded)
• Project Choices on Blackboard
 Course Assessment
Assessment
The course is assessed by a group project (coursework only).
Each Group must prepare a Technical File as if for regulatory submission on their
chosen system. The technical file will typically be a collection of documents with an
overarching key or list, that could be called Technical File Contents or similar.
In addition there must be one set of rules for a working environment (eg chemical,
mechanical, electrical).
Submission : Submit one copy per group via Blackboard. Remember to put all the
names of your group on the assignment.
– Risk Management section - due 3rd November
– System Specification section – 23rd Nov
– Technical File (complete) - 14th Dec.

Deadlines : - 3rd Nov 16:00

– 23rdNov 20:00
– 14th Dec 17:00
 Technical File
• Specification – what the device is meant to do, its clinical use
• Description of device – technical specifications, drawings etc
• Annex 1 checklist – Including identifying standards
• Verification – tests to show that the proposed design solution fulfils
the Demand Specification
• Validation – tests to show compliance with annex1 including
meeting standards, including any special validation protocols
• Clinical evidence and evaluation – this can be of similar products
and why the results can be extrapolated to your device. Generally
you have not yet had any direct clinical experience.
• Risk analysis and management
• Ethical review and assessment
• Instructions for use (manual)
• Labelling
• PLEASE NOTE: CONFIDENTIALITY -
NO DISCLOSURE OUTSIDE IMPERIAL COLLEGE,
LONDON

• Note also: all work not your own should be

given attribution/credit to the originators
 Course Resources

• Course Description
• Projects List
• Marking Guidelines
• General Feedback (previous years)
• Project Resources Folder
• PEI presentations
• Standards, Guidelines and Regulations
• Example Files
 Course Details
• Thursdays 9 – 11 (1.31)
• Group Work (groups allocated next week)
• Assessment by Coursework – one per group
• Peer Assessment of contribution to group
• Chemical Safety Lecture 12th Oct, 2.00 p.m.
SAF Building – G16
• Project Choices on Blackboard
 Course Timetable
Wk Time Subject Lecturer

2 Oct 12 09 -11 09.00 Introduction 1 Dr W Macdonald

Group Working Dr W Macdonald

11:05 Risk Management 2 Dr W Macdonald

14 - 15 14.00 CoSHH and Chemical Safety 3 Dr D O’Hare

3 Oct 19 09 -11 09.00 Medical Electrical Safety 4 Mr P Egan

10:00 Group Allocation 56 Dr W Macdonald

4 Oct 26 09 -11 09.00 DeMystifying the MDR 6 R Hall

10.10 Design Control 7 R Hall

10.25 QMS & ISO13485 8

5 Nov 2 09 -11 09.00 End-user experience 9 Mr P Egan

10.00 Product Validation 10 Dr W Macdonald

NB Risk Analysis due 4th November

6 Nov 9 09 -11 09.00 Ethics 11 Mr P Egan

10.00 Clinical Trials 12 Dr W Macdonald

7 Nov 16 09 -11 09.00 Work on Assignment

Dr W Macdonald

10:00 Design in a Regulatory Context 13

8 Nov 23 10-11 10:00 Drop-in clinic Dr W Macdonald

NB System Specification due 25th

November

9 Dec 1 Work on Assignment

10 Dec 8 Work on Assignment

11 Dec 15 09-11 Work on Assignment

NB Full Technical File due 15th Dec.

 Dr Warren Macdonald

Email: w.macdonald@imperial.ac.uk
Phone: 020 7594 6372
Room: Bessemer 3.25
 GTAs
Maegan, Spiteri maegan.spiteri18@imperial.ac.uk
Groups 1 & 2
Xinyue Liu xinyue.liu18@imperial.ac.uk
Groups 3 & 4
Hussam El Nashar h.elnashar20@imperial.ac.uk
Groups 5 & 6
Halla Hakami h.hakami20@imperial.ac.uk
Groups 7 & 8
Natalia Torres Consul n.torres-consul21@imperial.ac.uk
Groups 9 & 10
Omer Katirci k.katirci22@imperial.ac.uk
Groups 11 & 12
20
 References
• PIP breast implants:
https://edition.cnn.com/2012/01/27/world/e
urope/pip-breast-implant-scandal-
explained/index.html