QUARTERLY OF THE INDUSTRIAL DESIGNERS SOCIETY OF AMERICA SUMMER Medical Evolution. FATHER OF ID n SMART TO WISE n NEW DIRECTIVES

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1 QUARTERLY OF THE INDUSTRIAL DESIGNERS SOCIETY OF AMERICA SUMMER 2014 Medical Evolutio FATHER OF ID SMART TO WISE NEW DIRECTIVES

By Michael Wiklud ad Stephe Wilcox, FIDSA michael.wiklud@ul.com sbw@dsciece.com THE BENEFITS OF APPLYING HUMAN FACTORS ENGINEERING Is the awakeig over?

Let s give the medical idustry the beefit of the doubt ad say yes.

2 By Michael Wiklud ad Stephe Wilcox, FIDSA THE BENEFITS OF APPLYING HUMAN FACTORS ENGINEERING Is the awakeig over? Has the medical idustry fially come to embrace the beefits of huma factors egieerig, arguably decades after the aviatio, military ad cosumer product idustries did so? Let s give the medical idustry the beefit of the doubt ad say yes. Although for may years ow idustrial desigers have bee icluded i the product developmet team for medical devices, as recetly as the early 2000s oly a small proportio of medical compaies had really embraced huma factors egieerig. Those that had did so primarily to give them a competitive advatage i the market, as opposed to meetig safety goals, per se. Today, however, medical device maufacturers are doig a reasoable job of itegratig huma factors egieerig ito their desig processes. A key motivatig force has bee FDA regulatios callig for devices to meet users eeds, as well as a slowly icreasig level of agecy oversight ad eforcemet. Regulatory agecies ad surrogates (for example, otified bodies i the Europea Uio) i may other atios have followed suit. However, a uiteded cosequece of this situatio is that a large proportio of medical compaies ow seem to view huma factors egieerig primarily as a regulatory imperative tightly liked to risk maagemet rather tha to product developmet. They perform huma factors egieerig with the goal of cotrollig risk so that they have a safer device ad ca obtai regulatory clearace to put it o the market. This meas that regulatory affairs ad quality maagemet, rather tha product developmet professioals, ofte cotrol the plas ad budgets for huma factors egieerig, resultig i a disruptio of what we take to be the atural state of affairs: the itegratio of huma factors egieerig with idustrial desig. Oddly, there appears to be little discussio about how huma factors egieers ca work with idustrial desigers to improve a device s usability ad competitiveess i the market, as well as to meet safety ad regulatory goals. We propose that medical device maufacturers should ow cosider a retur (or, we could call it a progressive step) toward a middle groud where huma factors egieerig i cojuctio with idustrial desig is applied to address both regulatory ad commercial imperatives. This is likely to be the place where compaies ca make strides toward icreased user satisfactio ad profit while maitaiig protectio agaist what ca feel like a disaster: a regulator rejectig their product. The readers of INNOVATION are likely to be well iformed about what costitutes good huma factors egieerig. If ot, tutorial resources iclude the FDA s ow Huma Factors Guidace to medical device maufacturers, stadards published by the Associatio for the Advacemet of Medical Istrumetatio ad the Iteratioal Electrotechical Commissio (IEC), ad multiple textbooks o the subject. So this article dispeses with further tutorial cotet except to summarize that good huma factors egieerig ivolves three imperatives: learig about users; establishig proper user-iterface requiremets ad applyig huma factors egieerig desig priciples to produce good user iterfaces; ad coductig iterative studies of users iteractig with prelimiary, refied ad fial desigs to cofirm their safety, effectiveess ad usability. Oh, ad may we add 44

Michael Wiklud is geeral maager of huma factors egieerig at UL Wiklud. He is co-author of Usability Testig of Medical Devices ad Desigig Usability ito Medical Devices.

3 Michael Wiklud is geeral maager of huma factors egieerig at UL Wiklud. He is co-author of Usability Testig of Medical Devices ad Desigig Usability ito Medical Devices. He teaches courses o huma factors i medical techology ad software user iterface desig at Tufts Uiversity. Stephe Wilcox, FIDSA is a pricipal ad the fouder of Desig Sciece, a 30-perso firm i Philadelphia that specializes i optimizig the huma iterface of products, particularly medical devices. He was chair of the IDSA Huma Factors Professioal Iterest Sectio for a umber of years ad is the other co-author of Desigig Usability ito Medical Devices. a fourth: cofirmig that users ca iteract with a device i a satisfyig maer. The fourth objective is the key to movig back toward a middle groud where commercial imperatives receive their due. Accordigly, the balace of this article discusses how maufacturers ca fie-tue their huma factors egieerig processes so that they are ot just about fulfillig the requiremets of FDA s guidace, Applyig Huma Factors ad Usability Egieerig to Optimize Medical Device Desig, 2011, or IEC s broadly-applied huma factors egieerig stadard ISO/IEC 62366:2007, Medical Devices Applicatio of Usability Egieerig to Medical Devices. I our view, achievig desig excellece for a medical device s user iterface requires gatherig accurate iformatio about users ad how they might ideally iteract with the give device. It also requires brigig users ad evolvig desig solutios together o a sufficietly frequet basis to keep a device s desig movig i the right directio. Thus, for the remaider of this article we will discuss a couple of our pet topics ethographic research ad usability testig providig a update o how these well-established techiques are still havig a impact o desig. Compaies that master these techiques ad egage competet desigers are sure to produce medical devices that rise above others, deliverig o the promise of safety, effectiveess, usability ad user satisfactio. Ethographic Research The figure above provides a fairly abstract summary of where ethographic research ad usability testig (as well as the applicatio of techical huma factors iformatio) fit ito medical product developmet. We take the term cotextual iquiry to be equivalet to ethographic research ad have used the former i the figure because it is what teds to be used i the relevat stadards ad guidelies. The poit of the figure is that the regulatory imperatives icrease as the product developmet process advaces toward completio. Movig from left to right, ethographic research is ot required, strictly speakig, but is ecouraged by both the IEC stadard 62366:2007 ad by the FDA Guidace metioed previously. Also, iterative formative testig is ot strictly required. However, speakig from experiece, a Desig History File (documetatio required by the FDA) that does ot show evidece of formative testig raises a red flag amog regulators. It suggests that the maufacturer has ot applied huma factors egieerig i a appropriately comprehesive maer. Summative testig, o the other had, is a hard requiremet. The Role of Huma Factors i Medical Device Developmet Oe cosequece of placig disproportioate emphasis o the regulatory aspects of huma factors egieerig is a cocomitat reductio of resources applied to ethographic research i favor of more resources applied, particularly, to summative testig. We thik this is a mistake. The purpose of ethographic research (ad its methodological cousis) is to create a foudatio of iformatio about the real world of product use. Without this foudatio, the desig team is at risk of doig a brilliat job of solvig the wrog problems because of miscoceptios regardig what ethographic INNOVATION SUMMER

MEDICAL DESIGN Iformatio graphic applied to the use of a surgical kit research is desiged to illumiate: who the users are, what the eviromet of use is ad what procedures a give device will be

4 MEDICAL DESIGN Iformatio graphic applied to the use of a surgical kit research is desiged to illumiate: who the users are, what the eviromet of use is ad what procedures a give device will be subjected to. I fact, this plays out later, vis-à-vis regulatio, because the summative testig that is ultimately doe will have to be defeded to the otified bodies, icludig the FDA, as realistic realistic i the choice of participats, realistic i the use eviromets that are simulated ad realistic i the tasks that participats are give to perform. Without direct evidece of what goes o i the real world, it ca be difficult to defed these choices. Aother, sometimes overlooked, role of ethographic research is to establish accord amog the desig team. Without a body of valid evidece to refer to, the team is vulerable to the expert who has veto power over its ideas by virtue of the expert beig the oly oe with kowledge of actual use. The team is also vulerable to the gridlock that ca result from stayig i the realm of opiio rather tha the realm of evidece. Without solid evidece about users, use eviromets ad actual procedures to drive desig decisios, the desig process ca be slowed by edless debates resultig from the fact that everyoe, ievitably, has a opiio. Thus, good evidece ca speed product developmet by providig a way out of this opiio-based gridlock. We do ot have space here to go ito great detail regardig the coduct of ethographic research, but let us provide some advice regardig what we have foud useful i the cotext of medical device developmet: Documet the research usig high-resolutio multichael video. The complexity typically associated with the use of medical devices ad the eed to capture the 46

5 details puts a particular premium o high-quality video. O the oe had, close-ups of cliical details are ofte importat; o the other had, it is usually ecessary to uderstad what each member of a multiperso team is doig. It follows that the video system must be able to accurately capture fie details as well as multiple actors the case for both high-resolutio ad multiple cameras. Aalyze the video to achieve rigor for the research. The results of ethographic research are typically reported i a aecdotal fashio. This approach may ot be adequate for the life-ad-death ature of medical device developmet. Video aalysis ca yield quatitative data crucial for a full uderstadig of the key issues, for example detailed timig of key evets ad frequecy couts of errors or problems. Such data do ot replace the user-cetered isights that are the hallmark of ethographic research, but ca serve as a importat supplemet to them. Use iformatio graphics to report the research. Give the complexity of the pheomea captured, graphic approaches to summarizig the iformatio ca be ecessary to make that iformatio accessible. Creatig tools for visualizig iformatio is aother role that the desiger ca play i medical device developmet. The image o the left provides a example. Each row represets a actual use of a multipart surgical kit, with each item of the kit represeted by a differet color ad the trasitio through the raibow from yellow to purple (summarized at the top) represetig correct use. Time is represeted o the horizotal axis. Thus, at a glace, oe ca see that there is a good deal of variatio i the timig of kit use ad that there are several departures from the expected procedure items of the kit are used i a variety or orders. periodic evets of iterest to occur. Settig up videocoferecig for idirect observatio ca, thus, be a reasoable compromise betwee relyig solely o iterviews ad direct observatio. I sum, ethographic research is importat for medical device developmet, ad it requires tools ad methods that may ot typically be used for such research outside of the medical area. Usability Testig Is there aythig ew to be said about usability testig that is ot covered ad the covered agai ad agai by the literature? We believe so. It is about coductig usability tests i a maer that covers the regulatory bases without forsakig product commercializatio beefits, maitaiig them as a tool for the desig team, ot just the regulatory professioals. We advise medical device maufacturers to desig their formative usability tests those coducted while a device is i the flexible developmet stage to geerate the maximum amout of isight possible about the user experiece. We recommed strogly agaist makig such tests just about safety issues ad the basic ability of users to complete tasks. We offer the above advice because a safe ad effective device might still be rejected by the market. After all, plety of safe ad effective devices are sellig poorly; they would ot be o the market if regulators had ot deemed them so. They are probably sellig poorly for may reasos (such as high price, poor service, missig features), but a crucial oe might be poor usability compared to competitive offerigs. Notig that usability is a high priority for medical device users, devices with poor usability certaily ca laguish. A properly desiged formative usability test may be a compay s salvatio. Here is a checklist to be sure that a formative test serves the multiple goals it ca ad should serve: Use videocoferecig for home-healthcare projects. For example, for chroic diseases such as diabetes or real failure (of icreasig importace for medical device developers), it is ot ecessarily efficiet to sped all day at a patiet s home waitig for the Focus o frequet ad critical user iteractios with the device. Call upo users to perform tasks that will have a disproportioately large ifluece o their ability to use the device for its iteded purpose, certaily i a safe ad effective maer, but also with satisfactio. It INNOVATION SUMMER

6 MEDICAL DESIGN A scee from a test coducted i UL,-Wiklud s medical usability test lab. is OK to ask users to perform tasks that are ot safetyrelated. You are testig for your ow compay s sake, ot just to satisfy the regulators. Call upo test participats to state what they like most ad least about the device ad ask for detailed suggestios o how to improve the device. This is ot biasig the test participat, ad it fits right i with the goal of idetifyig opportuities for product improvemet while there is still time. Remember that formative usability testig is ot early as costraied as summative usability testig, which maufacturers perform to validate a desig ad support a regulatory submissio. Go so far as to ask participats to compare the tested device to their visio of the ideal device, which might be quite similar or differet from that preseted. Also step back ad ask them to compare the device to its cotemporaries already o the market. You might lear that your device represets a great leap forward i usability, or that it is ot much of a step forward ad eeds work. Cosider coductig larger tha usual formative usability tests if the user populatio is particularly heterogeeous such that you expect a wide rage of user characteristics ad maers of device use. Covetioal wisdom ad commo practice suggests that eight to 12 test participats might be sufficiet to gai deep isight ito a device s iteractive performace. But a larger test might be the solutio to gaiig more uaced ad beeficial isights ito how to optimize the device s user iterface. Ad, i what might seem atithetical to commo practice, the greatest beefit from usability testig might occur at a earlier stage of desig, whe thigs ca be chaged for a reasoable cost. Alteratively, thik about coductig may perhaps a half doze or more small formative usability tests e route to the best possible user iterface desig ad resultig user experiece. To be sure, we are ot advocatig a departure from usig formative usability tests to achieve safe ad effective desig solutios, which is the most importat amog huma factors egieerig imperatives. However, there is every reaso to derive broader beefit by also focusig o o-safety-related desig matters. A Fuller Visio Our mai poit is that if you must do a rigorous job of huma factors egieerig to satisfy safety ad regulatory requiremets ayway, why ot also apply huma factors egieerig i a maer that will lead to products that people love? We fear that the last few years have led to the partial or full displacemet of huma factors egieerig from product developmet i favor of regulatory affairs ad quality cotrol. We certaily do ot object to the ew focus o medical device risk. But let s get back to applyig huma factors egieerig to ehace the user experiece as well as make medical devices safer. This will afford greater opportuity for idustrial desigers ad huma factors egieers to work collaboratively to create great products that deliver great user experieces. 48

APPLICATION NOTE UNDERSTANDING EFFECTIVE BITS

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