Risk Management for Medical Device Manufacturers

Joe W. Simon

Description

As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability.
This book can help you build a bulletproof, risk process. You will learn how:
Designing product and manufacturing processes controls risks
Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency
Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans
Developing labels and instructions can help end-users and patients clearly understand the pertinent risks
Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary
Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.

Sujets

• Instruments
• Supplies
• Medical
• Médecine
• risk management

Informations

• Publié par: ASQ Quality Press
• Date de parution: 20 janvier 2022
• Nombre de lectures: 0
• EAN13: 9781636940144
• Langue: English

Extrait

Risk Management for Medical Device Manufacturers
● ● ●
Joe Simon

Quality Press Milwaukee, Wisconsin


American Society for Quality, Quality Press, Milwaukee, WI, 53203 All rights reserved. Published 2022.
© 2022 by Joe Simon
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher’s Cataloging-in-Publication data
Names: Simon, Joe W., author.Title: Risk management for medical device manufacturers / Joe Simon.Description: Includes bibliographical references and index. | Milwaukee, WI: ASQ Quality Press, 2022.Identifiers: LCCN: 2021951458 | ISBN: 978-1-63694-013-7 (paperback) | 978-1-63694-014-4 (epub)Subjects: LCSH Medical instruments and apparatus industry—Risk management. | Medical instruments and apparatus—Quality control. | Medical instruments and apparatus—Safety measures. | BISAC BUSINESS & ECONOMICS / Industries / Manufacturing | BUSINESS & ECONOMICS / Industries / Healthcare | MEDICAL / Instruments & Supplies Classification: LCC R856.6 S56 2022 | DDC 610.284—dc23
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Table of Contents
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Dedication
This book is dedicated to my parents, Bette and Orin Simon. Their continuous support and love made my life, education, work, and this book possible.


Acknowledgments
● ● ●
T o Ravi Bhullar (a genuine Indian Guru), without whom this book would not have happened.
To Steve Stegmeier, who provided the epiphany for the mustache curve (and, as I recall, had a pretty good mustache himself).
To an old supervisor, who said validation was too complicated for me—challenge accepted and obliterated.




Preface
● ● ●
Y ou may be asking, “Why do I need to read this book? What makes this different from all the risk books, articles, and presentations I’ve been exposed to in the past?” The short answer is…that there is no short answer. You’re reading this book because the ISO 14971 standard is not geared toward manufacturers. As a result, your risk documents have been collecting dust in a corner while your teams do the best they can to get product out the door and not hurt people in the process. Your systems are likely disconnected, and your people are aimlessly guessing how to design, validate, monitor, and update your products.
This book will help you fix all that. It will show you how to properly build and connect your risk documents, so you can have an efficient, effective, and compliant risk process that supports (rather than hinders) your people and your processes. The concepts in this book will help you make better products without all the guesswork and help you respond to issues faster and more effectively. As a bonus, when your people see how the work they do connects and helps improve the product (and, by extension, the lives of your users and patients), they will enjoy their jobs more and take better ownership of their work.
After finishing this book, you will understand that risk management really is simple and intuitive when done right. Yes, it’s broad in scope—but it doesn’t have to be so difficult, confusing, and convoluted. If you only take one thing from this book, I hope it’s that the occurrence rates in your risk documents need to be meaningful. They need to connect directly to your verification/validations and be the thresholds for your nonconformance (NC) and complaint processes (Chapters 3-4, 8, 12, and 16-17). If the only change you are able to make at your company is to implement the concepts in Chapters 3-4 (i.e., to capture your “NC” rates in your risk documents), much of the rest of the changes may happen organically.
The information presented in this book assumes the reader has at least a basic understanding of risk management—specifically, familiarity with the concepts in ISO 14971, hands-on experience with risk tools (for example, fault tree analysis and failure mode and effects analysis), and knowledge of the applicable regulations that apply to their products and to risk (for example, 21 CFR 809, 21 CFR 820, and the EU Medical Device Regulation [MDR] and/or the In Vitro Diagnostic Regulation [IVDR]). Hopefully, you are open to fixing some of the issues you have been struggling with for years. (If you are new to risk management, read through the regulations and standards, and consider taking an introductory-level course prior to reading further.)
As someone experienced with risk management, you already know that there are numerous inputs and outputs for each step in the risk process. Additionally, the process is very iterative. In other words, sometimes you need to begin the process before you’re able to clearly define your criteria. For example, if you are building a risk management process for your company’s first product, you won’t have similar products from which to define a “master harms list.” Because of this variety of inputs/outputs and the iterative nature of the process, it’s not very linear. This made it difficult to write a book and still address all the necessary background before digging into each topic. As a result, some topics may rely on information that is presented later in the book. I have made every effort to minimize this and present the information in as linear a fashion as possible, but the reader should be aware that this is a broad and interdependent process.
The information presented here is based on my knowledge and experience gained over many years of working and consulting in various areas of risk management. The information is also based on the regulations and standards that were available at the time this text was being written. As regulations and standards are updated, the infor­mation and references presented here will undoubtedly become outdated. Therefore, it is recommended that the reader not only assess how best to implement the concepts in this text, but also assess whether any changes have occurred to the referenced regulations and standards that would alter the implementation of the concepts.
Some of the concepts presented here were developed and honed while assisting a medical device company that was dealing with thousands of lawsuits for its trans-vaginal mesh products (you may remember the lawyers’ commercials). We were asked to help the company make its risk processes and labeling “bulletproof” (their words)—specifically, to ensure the benefits of its products objectively outweighed the risks (so the company could defend keeping its products on the market) and to properly disclose the risks to minimize the company’s future liability. While not all of these concepts were developed during that project, it emphasized for me the importance of the risk management process and started an effort to develop more meaningful and applicable risk documents. With the advent of the EU MDR and IVDR, there has been a focus to make sure risk management processes have the necessary procedural relationships to ensure the proper data are flowing in and the proper decisions are flowing out to drive necessary changes.
A man was so lazy he decided to exercise so he wouldn’t have to carry around those extra pounds all his life.
Do you want to carry around the extra weight of an inefficient risk process for your entire career, or are you lazy enough to make it efficient?
If you follow the steps laid out in this book:
✔ Your risk documents will have meaningful criteria and thresholds.
✔ Your products and manufacturing processes will be designed to control risks.
✔ You will have validated and verified your risks (initial and ongoing testing).
✔ Your verification/validation (V/V) sampling plans and sample sizes will be based on risk.
✔ Your V/V sampling plans will be adjusted based on where the variation is in your process.
✔ Your test method validations will be based on risk.
✔ Your NCs and complaints will use the risk thresholds to determine when a corrective action/preventive action (CAPA) is needed.
✔ Your NC process will work for “product, process, and quality system” nonconformances.
✔ Your risks will be properly communicated to the users and patients through labeling, instructions for use (IFU), training, etc.
✔ You will have an efficient “closed-loop” risk management system.
And,
•Your post-market surveillance (PMS) process can feed into the risk management system to determine if you need additional clinical/performance studies.
•Your risk documents will be audit ready.

These “bulletproof” strategies have been