How humans factor (in medical device design)
Contents
1. Mary Brady FDA Often companies concentrate on the devices and BR Aun completely neglect the instructions packaging and ThermoScan 5 training Yet developing effective instructions for use and a training are a complex area in their own right For example if a device collects and manages data training should help users and their caregivers understand the are importance of gathering data for their health ier entre o How often is a great device supplied in an awful pack with incomprehensible instructions Photo device packaging and labelling are used just as an example no comment is intended about their suitability or effectiveness 30 IRT 4520 iLL i t Having recently purchased a thermometer Matthew was alarmed to find the thing was set up in Fahrenheit He read and re read the user manual and still couldn t find how to change the scale to Celsius It wasn t until inserting the battery that he found the smallest recessed button with tiny writing saying C F within the battery compartment Who ever wrote the user manual probably had no concept of the user needing to change the scale and so skipped over where the secret button was concealed A search on line revealed this must have been an issue as the most recent version of the manual had a very clear description of the steps to change the measurement scale with pictures showing the location What can you do to prevent this happening to your2. 2010 Usability Testing of Medical Devices Wiklund Kendler 36 Strochlic CRC Press 2011 Moderating Usability Tests Principles and Practice for Interacting Principles and Practices for Interacting Interactive Technologies Dumas Loring Morgan Kaufmann 2008 To Err is Human Building a Safer Health System Institute of Medicine National Academy of Sciences 2000 Handbook of Usability Testing How to Plan Design and Conduct Effective Tests Rubin Chisnell Wiley 2008 A development route map large Define _ gt Develop Industrialise Launch Project Project Management Closure Project Project Planning Design Supplier Manage Design Design Manage Transport Analysis Issue Review Selection Plan Review II Transfer Suppliers FMEA Resolution Quality rupees Planning Project Support Supplier Evaluation Mfg amp A i i ropear cacti Design Design Design Design FMEA CN Verification Validation Design Controls Gesion N Review III toraich Mfg Design Installation Release Test Design Data Evaluation Qualification Development Feasibility Operation Qualification Concept Usability Usability Design Planning Evaluation Process QMS Update Market Verification Research Usability FMEA Usability Performance kae User Verification anges Design SFE Supplier Development l Usability Quality Risk Validation Assessment I A identity apaia
3. How humans factor in medical device design by Fiona Theobald and Matthew Theobald How humans factor in medical device design By Fiona Theobald and Matthew Theobald Second Edition revised and updated after AAMI FDA Summit on Home Healthcare October 2013 three circles Copyright 2013 Fiona Theobald and Matthew Theobald All rights reserved Cover design by Three Circles Book design by Three Circles No part of this book can be reproduced in any form or by written electronic or mechanical including photocopying recording or by any information retrieval system without written permission in writing by the author Published by Three Circles Printed by Book Printing UK www bookprintinguk com Remus House Coltsfoot Drive Peterborough PE2 9BF Printed in Great Britain Although every precaution has been taken in the preparation of this book the publisher and author assume no responsibility for errors or omissions Neither is any liability assumed for damages resulting from the use of information contained herein Contents PMS WOLI Tiren E EES 4 Why Humans FACION ss erescoreorecuasaressnninersdcssorstenverdeetesstubeasazcane 5 When thingS gO WIrong s ssscccccceecssseesssseeeeeesseaseeensees 7 What is USI isch cestuiretncntietalertuetncstietbaeiivatateedanmeteneiemaas 10 Usability Strate gies ccccccccccsssssssssssseeeeeeeneesseeeseeeeeenees 11 Base JUMPING cccccccssssessssesse
4. verification validation and ultimately our product surveillance programme Tests can be selected from the armoury of Usability and Human Factor tests in order to challenge the design in an appropriate manner Device Testing Device tests can be split into two broad groups physical testing and usability testing Physical testing encompasses performance functions robustness and material tests on the device As with physical testing there is an array of Usability tests you can perform at various stages of a project The Usability plan should help to define what are the most appropriate types of test at the various stages within a project Both ISO 62366 and AAMIs HE75 list a wealth of different types of test so don t assume that Usability tests are only done with users in a normal use scenario Focus groups advisory boards and expert reviews can provide valuable information on the various safety aspects of your design As your design develops the scope of testing will broaden to include the instructions for use packaging and any training materials too uBisep Sd Aap JedIPSwW Ul 1037924 suewny MOH Usability Tests The FDA at present divide Usability testing into two types formative and summative Formative tests are evaluative They re the little acorns the small tests looking for design issues and testing various iterations of the design These tests enable you to explore potential scenarios to determine if t
5. Risk A Critical CE Marking Plan Risk Parameters Assessment Design Rak Banat Risk Qualification Requirements Assembly Assessment III Analysis Definition Process Process Surveillance amp Validation Validation Planning Clinical Design Clinical Programme Clinical Clinical Evaluation g ae Reporting Clinical Planning 2013 Three Circles Consulting Ltd all rights reserved 37 A Final Word It s no accident that you picked up this book At some point you must have asked yourself what can I do to make my device design work better for the users You took the time to explore the steps in this book that make the Three Circles Human Factors approach such a successful way to make this shift You may now think that this reflects a more pragmatic and effective way to get design right for the ultimate users You may have already begun to think about ways in which you can extract ideas from this book and apply them to your own business You may even have thought about how you can gain buy in from other leaders in your organisation You might have thought about instilling organisational guidelines or procedures that embody the steps we ve talked about Often we get inspired by the ideas or practices of others but we fail to put those ideas into operation As you read this book you may be feeling that you want to learn more about the steps that Fiona and Matthew have shared You may have already tried some of the ste
6. Severity what is likely impact of the use error is it an overdose under dose confusion e Probability how likely is the error to happen usually an informed estimate e Consequence what is the likely outcome of the error is it death minor injury or simply inconvenience This all feeds into a risk analysis to provide a risk score helping to identify what needs testing and where to concentrate the effort for example towards mitigating the higher risk items first before looking at lower risk items Bear in mind that regulators particularly the FDA apply a hierarchy to risk mitigations expecting that mitigations work at the highest practical level rather than simply defaulting to the instructions for use 26 The hierarchy applied is usually along these lines 1 Modify the device design to remove a hazard or reduce its consequences 2 Make the user interface including its operating logic error tolerant 3 Alert users to the hazard through inbuilt warning signals 4 Develop written procedures instructions for use and training for safe operation Planning Armed with all this information the planning stage should be relatively simple With our understanding of the Users Use Scenarios Designs and an identification of the potential problems we may encounter we can design our Usability tests to look for potential use errors This then spreads out into being our Usability strategy for design evaluation
7. can often lead to aha moments that would not have come to mind otherwise 18 Use Scenarios Now we know who our users are we can start thinking about where they will be when they use the device Examples of the places people may use the device right The likely Use Scenarios should be examined as part of any risk assessment or failure analysis as they can contribute significant risks to device use Users often make a trade off between comfort quality of life and safety We recently heard of a patient that stored and used their home dialysis machine on the balcony with a view whilst undergoing treatment So use scenarios should include how where the device will be really stored between uses Consider too that user capabilities e g alertness motivation attention will vary in different scenarios Another valuable consideration is scenarios that could result in device abuse Situations with for example bright lights low light level wet hands lack of privacy As more technology is used outside the clinical setting different challenges arise such as emergency planning for the patient what do they do when there s a power cut uBisep 914 p JedIPSW Ul 1037924 suewny MOH an excellent time for a brainstorm We now possess a list of usability problems to solve we know who is going to be using our device AM and where they are likely to use it We are starting to get Its a lot easier to be creative with a li
8. scrutiny Why Choose Three Circles Clients say they enjoy our friendly approachable manner They find it easy to talk with us about their concerns and issues with the knowledge that we can help find solutions We take a practical flexible approach to supporting the development of medical devices and combination device drug products We work with clients to provide just the right amount of support and guidance and only when it s needed Call or email us to discuss how we might work together on line www threecircles eu email hello threecircles eu phone 44 0 1270 61 86 93 three circles HUMAN FACTORS three circles QUALITY FACTORS three circles QUALIFICATION amp VALIDATION 41
9. FDA home healthcare summit in October 2013 As you read you will discover what should be taken care of at the outset and how this pays dividends later on We hope you enjoy your journey Fiona and Matthew October 2013 Why Humans Factor A few years back Fiona worked for a pharmaceutical company where they had installed a new manufacturing line The man responsible for designing the line a very clever man didn t believe in over mechanising a system so kept it simple by using gravity to help liquid flow through the line As part of the cleaning validation we had to identify hard to clean areas On her first visit to the line Fiona was a little taken aback to see the operators equipped with hard hats and a step ladder The pipe work under the vessels looked like a chemical plant maze To access the vessels the operators had to duck and weave around a network of metal pipes hence the hard hats To cap it all one of the water sample points was over six foot up in the air The design might make more sense if we told you the design engineer was over six foot tall and the pipe installation engineer was a very thin and wiry about 4 foot 9 inches Size was also an issue during a concept generation exercise for a new pen injector A few of the designers insisted on creating a pen which was very small and proceeded to generate a functioning small concept model They were following the same evolutionary idea as the miniaturisa
10. ame members through out the life of a project Trawling through design change history can be a challenge when rationales are not applied and the people involved in the change aren t part of the project any longer Usability FMEA A Usability FMEA considers failure modes and their effects from the users perspective The uFMEA is based upon the already created Task Analysis and Use Scenarios and flows through several steps User Requirements are mapped to Task Analysis for the device We find it useful to do this by considering three aspects of the user s interaction with the device e Perception what will they see hear feel e Cognition what are they likely to think about e Action what are they likely to do We consider all three aspects for both normal use i e what should be seen thought about and done for correct use of the device Then consider what would lead to a use error i e what the user does not hear from the device during use what they did not understand the actions they didn t take or did incorrectly This is examined from several perspectives e User how might the user do the wrong thing Environment how might the environment lead them to do the wrong thing Task Analysis User Requirements yp Use Errors Risk Analysis 25 e Device what conflicting features might lead them to do the wrong thing Then we move on to consider the outcome of the use error s e
11. came confused and didn t complete the dose However it was clear to the facilitator that the patient recognised what they had done wrong The facilitator could then probe to find out what they would have done if this failure had happened at home The patient may have said they d contact their healthcare practitioner as described in the instructions for use and training In this case the training and information provided would probably be assessed as appropriate as the user clearly knew what they d done wrong and the next step to take What you don t want to hear at this point is that there were 10 of patients in the study who didn t take a dose or only took a partial dose and none of them realised the error Human Factors Engineering file The culmination of all the usability activities is the compilation of a Human Factors Engineering file This tells the story of the device development from a Human Factors perspective The file provides traceability from User Needs through Usability evaluation to validation that the final design addresses those User Needs For the US the file forms part of the submission for the EU it must be available for inspection upon request 34 After launch Once your medical device is on the market there s a lot of useful information available to inform the next version of the device or even to spark a new device idea Information can be gleaned from customer support calls reported pr
12. device 1 Test your instructions and make sure they apply to your device and use scenarios 2 Test your packaging make sure it can be identified opened and stored safely Test your training materials make sure the users can understand them then know how to use your device safely and what to do if they have a problem 31 Validation The time has now arrived to sum up your Human Factors activities You know who your users are you know where they are likely to use the device you know the likely conditions the device and the user will experience You have mitigated your safety risks as far as practical You have frozen your product design The instructions for use packaging design and training materials are all working and so can be tested in what is hopefully your final validation studies In a validation study you evaluate routine and non routine use without placing patients at risk Hence Usability validation is usually not combined with any clinical trials when drug or therapy are not incorporated into the study Validation studies are designed to try and expose any potential use errors that may be encountered when using the device Therefore some validation studies purposefully omit training of users as they may not receive any if able to purchase the product directly 32 The key to designing a validation study is to examine the device s Task Analysis Look at the scenarios for routine and worst case use De
13. dle phobic and yet we persist in developing devices with a needle showing This is often countered by people who like to be able to see the needle to know how far to push it in Consumer devices like smart phones health gadgets PVRs bring new expectations and possibilities for medical devices setting precedents for patients wanting the same for their treatment On the other hand we may expect that users are able to use a smart phone app when they don t necessarily even have a mental model of how a smart phone works 4 uBisep 914 p je Ip w Ul 1037924 suewny MOH Many patients already experience a high burden from their disease physical cognitive financial and emotional Make sure your device doesn t increase this burden through a fear of the device embarrassment when using frustration or complexity when using On top of this users make inappropriate assumptions about how a device works or should be used leading to workarounds and non adherence both of which lead to vulnerabilities for the user These are exactly the types of Usability design challenges that should be accounted for early on when developing a new design This is usually the bit most designers live for meeting a new challenge and coming up with something novel Interesting solutions are often created from problem statements like an object that is seen when it needs to be and not seen when it doesn t Meeting with users
14. eeeeeeeessseseeasseeeenseaeeeesenes 12 Fell RUNNING cs ris scicans he be e es 13 Understanding the USEPS cccccceeeeeeeeeeeeeeeeeeeeeeeeaaeeeeeeaes 14 How to build your Usability programme 06 c0 14 People do Surprising thingS ccceeeeeeeeeeeeeeeseeeeeeeaes 15 A bit about different ways people think ceee 16 User RRESCAN CD iceicctnccasacsackaiaeaedtatavendieiantiateiactiatosaaaseeateais 17 Use SC CIN AINOS cscccsicis sivncciatersssta teseven aeeeeeer esate tees 19 Concept Generation cccccccceeeceeeceeeeeeeeeeeeeeeeeeeeeeeeeees 20 A development route Map ccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeaes 21 Considering FISK ccceeeseseeeeeeeeeeeeeeeeesssseeeeeeeseseeensaasess 22 Usability Specification cccsssssceeeeeeeessseseesssseeereeeseeees 23 Usability Pe WE sco cctso us SanGsadesioundauoiacsiextardinccetasieabics 25 Arela aO KAE N AE 26 Device TESUNG s acovesnicderasoestacacsiacceasstiutieaawyeiatianineacaceantutes 27 Usability TESIS seiciesienitereiaesneiieiet a P ERAS 28 Iterative SSN ops cedeacesapearns cubase tieraaceigaduouetiuieneiaacebiniads 29 What to LOS 2 cine ds soe ccda eens acqeeiale easets ioe e le Sb wiaiarates 30 A akc li q eee eee ene eens renee oyna ore ney Snereey rere nr 32 Human Factors Engineering fil ccecceeeeeeeeee eens 34 Aterian as ochre tose tcecoctiew A cock eaee 34 What S Next fscc sssysevssntvensctonss
15. elieving they were supposed to be used like catheters uBisep Sd Aep jedIPSwW Ul 1037924 suewny MOH A bit about different ways people think Let s take a moment Think of an elephant After all we all know what an elephant should look like right How would you describe your elephant Was it an African elephant a pink cartoon one a fluffy toy or a family group When we ask people to think of an item the image feelings or sounds that come to mind depend on their personal experiences 16 Before creating a slide for a conference presentation to illustrate this using injectors it hadn t even occurred to us that injectors belonged in engines too A similar lack of situational awareness in medical device use is a major factor in human error So assuming we know how people will think and behave when asked to perform a task can be very presumptive You may have overheard the comment that people are stupid when you see some of the surprising things that they do But given that we don t all think alike perhaps they were not adequately informed User Research User research is about profiling the people likely to use our device listing their characteristics their likely thought process es capabilities and limitations This research results in one or more User Profiles describing intended users of which there may be more than one distinct group vi such as children and adults Ss Many people are nee
16. elop your Usability strategy The standard also explains how a Usability strategy links with your Risk Management process The links reinforce the safety aspects that you are looking to address or incorporate in your product design As with many things in life the strategy you choose becomes a matter of how much risk you are prepared to live with e How comfortable are you with the risk of meeting a costly surprise if you choose to test late in development How much risk are you prepared to pass onto your customers your users Lets take a look at two strategies to incorporate usability into a medical device development project 11 uBisap SdIAep JedIPSW Ul 103924 suewny MOH Base Jumping The dare devil approach It s a high risk strategy that is often seen as the fast way of getting down the mountain For this strategy to succeed the device manufacturer has to be super confident in their design either because it is very similar either a design they have already done or it is very similar to what s already on the market In this scenario Usability testing is done at the last possible stage when the design is frozen and the company is ramping up for launch Sometimes testing is even done after launch when the regulators ask for the Human Factors Engineering file To take on this strategy you have to have a lot of confidence that your customers and ultimate users know how to work your device as well as you d
17. em later because the device didn t quite meet the limits imposed This often results in days of work justifying a change Being able to apply some level of rationale to all design features helps provide understanding as to why they are important and what it means to our users Just because you can do something technically doesn t mean you should clinically William Gregg Vanderbilt University Medical Center AAMI FDA summit Oct 2013 uBisep 914 p jedIPSW Ul 1037924 suewny MOH One of our favourite misplaced user needs was the device must be 163 2mm 0 2mm long The underlying rationale that unfortunately culminated in this item was that the device needs to be light and portable If the rationale had been stated earlier there would have been either a much looser dimension specified or more likely a freer scope given to the design solution Alongside the specification you will likely map out the normal user actions when they use the device The map is usually referred to as a Task Analysis and may include device responses indications to user actions This is also a good point to introduce traceability into the design process Traceability enables us to map design features and rationales within documents and throughout the design s development 24 Having these clear relationships is invaluable in enabling teams to keep track of design details and their relevance After all how many teams retain the s
18. erviceability The research is driven by statistical power requirements and test hundreds of people in multiple countries looking at peoples perceptions and preferences It isn t industrial design research either although sometimes people confuse the two Industrial design creates product designs that focus on form physical ergonomics marketing and brand development In Human Factors we are looking to see if a device is safe to use looking for use errors and user interface design problems When you get the response that was easy to use after having watched a participant struggle for 5 minutes to use your prototype device you have to question 10 what is really going on Usability studies have shown that after testing with just a handful of people the most severe use errors are likely to be revealed It s about good product design not just a regulatory hurdle to be overcome Joseph Cafazzo AAMI FDA summit Oct 2013 And because Usability is primarily looking at safety regulators throughout the world increasingly expect this type of testing and evaluation There is the added benefit that if you deliver a good product fit for purpose that pleases your customers it is likely to increases sales and reduce customer complaints Usability Strategies Now we re on the same page about what Usability is let s take a look at strategies for Usability The ISO 62366 standard has a very detailed process of how to dev
19. euesueseetetntdasantueeutssaseneninnuerads 35 Further reading erte aa iar EE ETET ETEEN 36 A development route map large cccccccccsseeseeeeeeeeeeeeees 37 A Final WV ORG ce serere areren EEE 38 POE ROM Ab ee at iocenios nese aeee nce setoiceeuaest eepcunseyresuteaneie 39 About WAG sesiec cers seen sinsuxanueecnssauaesasedusssmetenenieubiaseaudabicbis 39 About Three CCl Sof cis cis scien covsante senses vixexntacidesciiacditewsvanseds 40 A First Word Have you ever walked over to the kitchen hob pressed a button and lit the wrong ring Have you ever struggled with doors and pushed when you should have pulled Have you flashed your windscreen wipers in annoyance at another road user If like us you ve experienced any of these things you ll finish this book understanding why its important to get design right What we re going to do is help you see why its important to get design right for a medical device You may then think about how you re going to use this approach This book is about changing the way you look at design sharing the importance of understanding what your product s users need of it Its a consideration that s becoming increasingly visible as healthcare regulatory authorities around the world expect to see it s results in medical device and combination product approval submissions We ve revised the content to reflect the latest thinking from both industry and the FDA as discussed during the AAMI
20. g a typical user he didn t read the user manual and when finished tried to pull the cover off This proved to be nearly impossible He noticed a rather large button on the back side of the device pressed it and launched the cover into orbit much to the surprise of both him and a nearby colleague Sure enough there it was in the instructions a detailed section about the feature and the cover removal technique Conducting Usability testing during the formative stages of development means that use problems can be designed out or mitigated Consequently add ons won t become the designers worst nightmare Fiona had the experience of working on a project where minimal user needs had been defined at the outset As an early stage combination product the drug to be contained was often changing This meant that over time both the user and regulatory requirements kept evolving to the point that the device was starting to look something like Frankenstein s monster by the finish 29 uBisap BdIAep JedIPSW Ul 1037924 suewny MOH What to test According to regulations particularly in the EU and US the product should be tested This includes the device the instructions for use primary and secondary packaging and any training material that is provided Depending upon the nature of your device testing may also need to include maintenance and servicing of the device Most instructional materials out there are ineffective
21. hat their capabilities are 3 When will people be using your device Where will they be 5 How will they use it D Or are you assuming that as we are all human we all think alike so we must all want the same thing Usability is about checking that we have made the right assumptions It checks the assumptions with real users to make sure we are starting our design based on factual evidence not best guesses 14 After all what either of us need from a device may be completely difference to what our daughter may need or what the man down the street needs People do surprising things One thing you can expect when you place your device into the hands of representative users is that people will do the oddest things with it if they are not adequately informed You would hope that this person was stopped before they did any damage However we ve have witnessed a frail little old lady when asked to gently tap a device suddenly bang it hard onto a surface to knock the air out breaking the glass cartridge We have seen a man with big strong hands completely crumble an inhaler as he unknowingly twisted it the wrong way to activate it and then ask is that ok Confident happy people turn to gibbering wrecks when asked to follow a set of instructions that would have baffled Einstein Or the one that still makes us cringe a video of a lady who left several Type A insulin needles inserted in her stomach b
22. he instructions not clear Did we not give them the right equipment Human Factors Engineering of medical devices also described as Usability focusses on answering these questions by checking e Is the device fit for purpose e Is it safe to use e Does it give the user the right tool Sadly the answer to these questions is often NO uBisep Sd Aep jedIPSwW Ul 1037924 SUBLUNY MOH uBisep SdIAep JedIPSW Ul 103924 suewny MOH 20 of medical device errors are due to mechanical failure according to the Institute of Medicines IOM 2000 and Perrow 1984 We spend a lot of time during development testing our devices to ensure the build quality is robust and that the performance is acceptable But 80 of these failures are due to human error It is very easy to dismiss human error as stupid mistakes or to think that the users need more training However studies have found that contrary to blaming users many errors are caused partly by poor device design failing to account for the needs of users Susan Gardner from the FDA has said The problem usually isn t that the device broke rather it wasn t intuitively user friendly or the user didn t have instructions on hand or didn t know about a change in the way the device was to be used in a certain setting The bottom line is that 98 000 patients die annually in American hospitals as a result of medical errors Most of these errors can be associated w
23. hey do provide a worst case Alternatively you can test various combinations of design features to determine which combination is understood the best by users Summative testing is also described as Usability validation These are the fully grown oak trees the larger size tests with representative user groups They are performed on finalised product designs and with the final product associated documents and training Summative tests look to prove both that Usability goals are met and that residual risks do not produce any safety implications to the users 28 Iterative Testing During device development design starts out as an ugly duckling If Usability testing is carried out throughout the iterations your device should emerge as a beautiful swan Making changes to the design and specifications early on is much more cost effective than fixing a problem once the device is on the market if a spec change costs 1 changing a product in the market place costs 1m Denny Treu NxStage Medical AAMI FDA summit Oct 2013 However you can often spot where user testing has been carried out late in development Some peculiar little feature will be present If you read the instructions there will be great emphasis on this peculiar feature or it may even appear as a loose insert within the instructions For example Matthew came across a device that had to have a new protective cover fitted every time the device was used Bein
24. ith human error mishaps or at worst negligence In the USA the FDA and Health amp Human Services recognise Human Factors as a priority particularly for medical devices used outside of hospital environments Usability supports all five points of their strategy for home healthcare The message was clear at the October 2013 AAMI FDA summit on home healthcare Starting Human Factors activities early to understand users and caregivers real needs is fundamental to overcome most issues with using medical devices So it is clear that usability must start at the very beginning of design and consider all aspects of the device supplies training and other materials It boils down to developing a device that is simple to use just makes sense one that will work in a challenging environment with consistent and understandable user interfaces Over the course of this book we re going to take a look at what Usability is Usability strategies we ve witnessed and the ones we have seen work Then we need to think about who the device is intended for who are these users what makes them tick Lastly we ll look at how Usability fits with the device development process What is Usability Before we get into the detail let s clarify what usability is about Many people ask isn t usability something market research do Well no not in our experience Market research tends to examine device features pricing and s
25. l Plan Risk Parameters Assessment Design dae Qualification WET ETervur ynig Requirements Assembly Definition Process Process Qualification FMEA EDEUCELCUD Validation Planning Clinical Programme Industrialise Launch Project Closure Project Design Design Manage Transport Analysis issue Review II Transfer Suppliers FMEA Resolution Launch Preparation Mfg amp Assy Design Design a Processes Verification Validation Design N Review III Installation Release Test Qualification Development Operation Qualification Process M dat amp Verification QMS Update ili Performance Make Usability Changes Verification Supplier Usability Quality Validation Reporting CE Marking Risk Benefit Assessment III Analysis Surveillance Clinical Clinical Evaluation Reporting 2 1 2013 Three Circles Consulting Ltd all rights reserved For example there is the project manager who tracks the project helping to tackle conflicts and issues as they arise The designer who looks after the design and manufacturability of the device and also ensures that performance testing appropriately challenges the design Amongst these disciplines should be the Human Factors or Usability experts who work closely with the designer and risk manager to name but two Looking at the Human Factors track the journey is based on the ISO 62366 process and reflects the practicalities of working within a mul
26. n process so users needs are incorporated before designs are fixed Fiona has more than 20 years of development experience gained from a range of combination product and medical device projects across Europe and North America About Matthew Matthew s drive is helping people understand HF and quality increasing their effectiveness wherever they re used He ensures that quality and HF requirements support the development of products that meet users and regulators needs Matthew has over 20 years experience working at strategic and project levels with medical device and pharmaceutical organisations across Europe and the US He has presented at conferences throughout Europe delivered more than 50 training events co authored the book How to Build an Ark Project Management for the 21st Century and is a contributing author to several ISPE Guides 39 About Three Circles Successful device design doesn t happen by accident Getting the right balance of technical know how aesthetic design and understanding of your users needs leads to successful products that are safe to use and effective in their application By building your design process on a strong quality foundation your development programme progresses under control It progresses with the end in mind in this case your regulatory submission Behind every great device stands a strong manufacturing process Bridging the gap between development and launch involves go
27. o After all ts not the fall that kills you 12 Fell Running This approach is often perceived as slowing down a fast track project The strategy includes Usability activities throughout the various stages of product development It s the more conventional way of getting down a mountain Vicki R Lewis AAMI FDA summit 2013 In reality adding Usability activities to a project should not impact on time lines as activities can run in parallel with more conventional lab and physical testing Indeed these activities will greatly reduce the likelihood of expensive re designs or fire fighting as you get closer to scale up and launch preparation Of course Usability activities need to be budgeted for but e How much expensive is unfreezing a design to start developing new mould tools e How much more expensive is a product recall because of a foreseeable use error Taking this approach should not end messily as you descend your mountain Understanding the users Let s move to thinking about how to build your Usability programme to achieve the benefits we ve talked about already The key thing here is to understand the intended use of your device and a big part of this is understanding your users How to build your Usability programme There are five fundamental questions that your Usability programme should be designed to answer 1 Who are you making the device for 2 Do you really know what they need w
28. oblems from users and what s happening with similar products However bear in mind that users don t report all the problems they have with a device they may have devised workarounds for use issues Matthew recently learned that in many cases where a home use device is delivered to the patient or caregiver the instructions for use aren t left with the device Finding out how the user copes with this situation can be very revealing What s Next You may wish to talk with Fiona and Matthew about how to take care of Human Factors for your device They can both be reached at Three Circles by phone email or on line on line www threecircles eu email hello threecircles eu phone 44 0 1270 61 86 93 You can also reach out to us on social networks W evicevsability Ei Threecirclesltd in company three circles 35 Further reading These are some of the references that you might find useful for your medical device project ISO 62366 Medical devices Application of usability engineering to medical devices ANSI AAMI HE75 Human factors engineering Design of medical devices AAMI TIR 49 Design of training and instructional materials for medical devices used in non clinical environments Handbook of Human Factors in Medical Device Design Weinger Wiklund Gardner Bonneau CRC Press 2011 Design for patient safety User testing in the development of medical devices National Patient Safety Agency NHS
29. od process design and validation planning This results in a robust process supported by qualification and validation documentation Three Circles has the technical capabilities experience and a flexible approach to help you in these areas 40 Our approach to Human Factors is user centric e Researching your users intended uses and use scenarios e Helping you understand your users what s important to them what they need from your device e We help you plan create execute and report usability studies e We help you define and deliver a usability programme to produce a device that both meets users needs and provides use satisfaction Quality built in We help you put in place the right quality requirements and provide support throughout your project e Helping understand the requirements of international standards and regulations guiding development to achieve and maintain compliance e Helping you to put together packages processes and systems to build in quality from the start e Giving practical Quality support to your device project from initial quality planning through to validation Qualification amp Validation Our team can support your validation activities from the early stages starting from defining your strategy for process qualification and validation We can help create the plans to realise your strategy and support activities e g DQ IQ OQ PQ PV to deliver a validation package that stands up to
30. ps that we ve 38 discussed Perhaps you are thinking that you would like some reassurance support and guidance as you embark upon this journey What does the future hold for you and your organisation Where might focussing on Human Factors take you We enjoyed the discussions and challenges that led to us seeing this book come alive We hope you enjoyed reading it and will continue to enjoy using the steps in your projects The introduction of iPhones and smartphones was Fiona s saviour they enabled her to text whole sentences again The mini pen was redesigned and became the chunky pen to fit with the user needs And the manufacturing line water sample point was lowered so that the operators could reach it without using a step ladder although the network of pipes under the vessels remained the same Coincidently the smaller operators tend to be assigned to any work under the vessels Fiona and Matthew October 2013 About Fiona Fiona is passionate about helping people and their organisations develop medical devices and combination products that meet user needs Fiona ensures that HF tools and methods are utilised to understand how people interact with the device identifying the risks that can occur at each step She is skilled at translating these risks into requirements for Risk Management so that strong links are forged with Human Factors Of particular interest to Fiona is considering Human Factors early in the desig
31. st problems to solve than trying to start from a blank sheet of paper User profiles and scenarios help to create good design a picture of the problems we will need to solve with our solutions Concept Generation design At this point This is the fun stage How humans factor in medical device design One happy by product is usually the creation of lots of design Intellectual Property IP based on our problem seetess PPP tees an s o eeeceeeen statements and their potential solutions s c c e se A development route map When we have identified a design solution to take through development Usability activities should be formalised as part of the subsequent process We at Three Circles have mapped out a development route map to show the tracks and interactions that a typical development plan and team will take Define Develop Project Management Project Planning Design Supplier Manage Review Selection Plan Quality Controls Design Iteration Design Feasibility Concept Design Usability Usability Planning Evaluation Market Research Risk Clinical Design Clinical Planning Planning Project Support Supplier Evaluation Design Design FMEA Mfg Design Data Evaluation Research 2 Usability FMEA Design User Development Assessment II Identify Risk Critica
32. termine where the most critical safety risks or most frequently occurring risks may occur Test those scenarios with a representative set of users using a final product design Summative studies typically test at least 30 users although this may alter depending on the therapeutic area under examination and the size of potential user population Fiona was recently asked this question and was told in the same breath that there were only about twenty people in the country with the condition the device was intended for Hence it was impossible to test with such a large sample size you have to select your sample size accordingly But What acceptance criteria do you apply We believe this is an area where the current Usability standards can be a little confusing It is fine to apply a Usability goal such as 90 of users have to be able to inject a dose but as the FDA point out what happens to the 10 who failed By all means set a Usability goal but clarify that the failures will also be examined both to determine what happened to them and to ascertain whether safety was put at risk as a result of their actions What you are looking for is an assessment of the failures The conclusion may well be that you should re visit the design seeking to mitigate the observed failures And that s fine It s better than discovering a serious failure in the market A patient when asked to deliver a dose from a new device be
33. ti disciplinary team Let s look at each step on the journey in turn but first a bit about risk 22 Considering risk At some point you ll need to incorporate risk into the design process probably following ISO 14971 as you go As we know the likely problems and we now have some potential solutions concept designs now is a perfect time to marry the two together and perform an FMEA failure modes and effects analysis but from a User perspective We call this a Usability FMEA uFMEA more on the detail of this later on suffice to say the outputs of the UFMEA should inform and feed in to your risk assessments updated with design mitigations as you go Alongside drafting the uFMEA you ll usually be creating the first draft of Usability and product design specifications which underpin subsequent test programmes The uFMEA looks at the task analysis and potential risks the Usability Specification specifies the design and what it needs to be able to achieve Usability Specification In conjunction with the design specification this establishes the usability goals In other words what the user needs to be able to achieve when they come into contact with the device Providing clear Usability rationales for design and usability goals helps to support design decisions It is not unusual to encounter design specifications which had been set because they seemed like a good idea at the time only for someone to challenge th
34. tion of mobile phones An interested client liked the look of the pen but asked if they could make the design bigger as their customers were likely to find the device too small and fiddly Remember when all you could do with a mobile phone was text and make calls Then predictive text came to make our lives easier When Fiona got her first mobile with predictive text Matthew asked why she was only sending very short abrupt messages had he done something wrong No Fiona just couldn t override the predictive text and her messages were becoming garbled rubbish so she cut the content down to the absolute minimum We couldn t find the menu to disable the predictive text function So how do humans factor in medical device design and more widely in design It may seem obvious when you think about it but it s surprising how often we the users are forgotten in the rush to create a sexy device When things go wrong You may be wondering what happens when humans are not considered in the design process We d like to share a few examples that may help you see the harms that can arise According to the US Food and Drug Administration One third of medical device reports each year involve use error and human factors are inherent in virtually all device related incidents Only when things start to go wrong do people ask e What was missed during the design process e Why did they do that e Were t
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