Class 1 Devices

Case Studies in Medical Devices Design

Peter J. Ogrodnik

• Publisher: Academic Press
• Year: 2014
• Print ISBN: 9780128000281
• eBook ISBN: 9780128007969
• Topic: Technology & Engineering
• Subtopic: Biomedical Science
• Index: Technology & Engineering

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library.Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA). This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS.- These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes.- Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products.- Joins up theory and practice in an accessible style.

Chapter 1

Introduction

Abstract

This chapter introduces the book and provides information on the individual case studies.

Keywords

design rigour

class I

510(k) exempt

wire cutter

orthopaedic braces

over the counter items

This book complements the original text in Medical Devices Design: Innovation from Concept to Market¹ (from now on I am going to call this the reference text). The intention of this book, and its sister books in the series, is to support the concepts presented in the reference text through case studies. In the context of this book, the case studies consider Class I (EU) and 510(k) exempt (FDA).²

1.1. Reminder concerning classification

Before we go any further with our discussions, we should remind ourselves about classification systems. In the European Union, there are four levels of classification, classes I, IIa, IIb and III. We are only considering those in Class I.³ In the USA, the FDA system is different but similar; the classification we are considering is 510(k) exempt. We will be examining the classification of a device within one of the case studies in this text. We will be looking at making a classification in the next chapter.

What does a Class I or 510(k) exempt classification mean for a medical devices company? It does not mean that the design rigour is any less; it simply means the application process for clearance to market in the EU or in the USA is easier than for the others.

Note: This textbook, nor any textbook, is a classification bible. One should always refer to the current information to perform classification of a medical device. The only sources one should ever use are the EU and FDA website. Never use an out-of-date guideline, book or pamphlet; that way, madness lies!

1.2. A reminder concerning the importance of design rigour (or design control)

Quite often, I have to talk to students concerning design rigour and the question comes back – why? It is very simple. One day, and I hope never, you may be in a criminal court because your device has hurt someone, potentially seriously. If you have not followed a rigorous design process, you should be prepared for a long holiday in a not-so-nice government funded resort. If you want to avoid a stay in prison, then why not simply do things properly from the start? As we say in England, this is a no brainer!

This text represents neither design theory nor design analysis. This subject matter is covered in the main text that this book refers to (the reference text). You should read the main book before attempting to go any further. Do not rely on this text alone.

1.3. A reminder concerning understanding the problem

One of the biggest frustrations I have when talking to some ‘medical devices designers’ is their lack of any clinical experience. Indeed, I have heard it said that they do not want to understand clinical practice as it ‘limits their ability to design’. That is complete and utter rubbish. To design anything, one must understand, fully, the issues: the environment, the political, the social and the economic. If you do not appreciate what the problem is, and where the boundaries are, then you cannot design a commercially viable device. You may well have a device, but it will not be one you can ever be proud of; it will become a millstone around your neck⁴ and you will live to regret it.

1.4. A reminder concerning a team/holistic approach

When you start your design process, you have to define the design team. As stated in the reference text, include as many of your subcontractors as possible, at the earliest stage possible. This includes manufacturers, packaging suppliers and shippers. Include end users and their support staff. Get as much input into your designs as possible, as soon as possible. Do not sit yourself in an ivory tower pretending to be the ‘design guru’ that all bow down to. No man is an island, no matter what Simon and Garfunkel say.⁵

Teamwork is an essential part of design. A good designer needs to be able to bounce ideas off others and accept their critical feedback when it is given. No one is the sole expert on anything: opinions differ, attitudes differ and skills differ. You need to be able to Design for All, and not just design for one. You will only succeed in achieving this outcome if you operate with a team philosophy.

Remember to look at your project with a ‘wide-angled lens’. Focusing on minutiae will not help you in the end. Be holistic in your approach; adopting a team philosophy is a start. However, you need to consider the project as a whole. If you do not, something will come back and ‘bite you’ at the very end, and design changes late in a project drive up costs astronomically.

1.5. A reminder concerning costs

Research and development can be a very expensive business. Not only can you be stripped of cash by overuse of consultants but also the very cost of essentials can be daunting. Prototypes can be very costly, simply because they are prototypes. You will, undoubtedly, underestimate the time you will spend on the project, but you must try to avoid to. Design projects can get a life of their own and can act as a cash ‘black hole’, sucking in funds for little or no return. Work out a project budget and stick to it: do not be tempted to say to yourself ‘only need to spend a little more’; ‘just a little further’; ‘not quite right yet…a little more’.

One of the biggest issues is to know when to stop. Design teams can go on ad infinitum making ever more small changes, but only for changes sake. Determine the value of design modifications before going ahead. If a small change increases t...

Table of contents

• Cover
• Title page
• Table of Contents
• Copyright
• Dedication
• Acknowledgements
• Chapter 1: Introduction
• Chapter 2: Classification
• Chapter 3: Taking the Design from Idea to PDS
• Chapter 4: Conceptual Phase
• Chapter 5: Embodiment Phase
• Chapter 6: The Home Run
• References
• Annexure I: Essential Requirements