10 Dos and Don'ts for Developing Medical Devices
Whether it involves focusing on ways to reduceheathcarewaste or trying to make your product “invisible,”Qmedhas come across plenty of helpful tips formedtechindustry experts.
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A panel of product design experts discuss the importance of front-end research and the reality that what people say they do often differs from how they really behave.
As an expert in integrating research, ergonomics, and design into new product development, Bryce Rutter knows all too well that what people say they do typically differs from how they really behave. That’s why relying on focus groups for medical device design doesn’t usually work, he said during a panel discussion he moderated Thursday at MD&M Westin Anaheim, CA.
Rutter, founder and CEO of St. Louis MO-based Metaphase Design Group Inc., asked the panelists how they parse out the real truth that shapes and informs product design, and to what extent they weave in people’s perceptions that, in many cases, influence their behavior and purchasing decisions.
The general agreement among the panelists and Rutter was that observational research on the front end is critical to product design. But the panelists each had a unique way of approaching the front-end research process.
Stephen Wilcox, founder of Philadelphia-based Design Science, shared a unique approach that his company takes in order to study how people use medical devices at home. It's not practical to just hang around a patient's home for days at a time, waiting to observe them using a device, he said. So what Design Science does is do an initial observational research session at someone's house, and then leave a teleconferencing system behind for follow-up observations.
“We just have them contact us via video and we do a video conference as they use their various devices, and that’s been pretty useful,” Wilcox said.
Front-end research can also be more of a strategic exercise when trying to determine what product to design next, as Ron Pierce explained. Pierce, the vice president and director of design strategy and research for Karten Design, of Marina Del Rey, CA is also a believer that the answers to all design problems lie with the people who interact with a product.
Pierce said he has learned that trying to observe nurses in the hospital setting is difficult because they know they are being observed so they are extra careful to do everything by the book. He said it’s more informative to get them away from the hospital by taking them to a restaurant or a coffee shop where they tend to be more open about what really happens versus what’s supposed to happen during a given procedure.
Likewise, Wilcox said surgeons will often say the most technically challenging parts of a procedure are the most stressful parts, but when he measures their biological stress indicators he finds that’s not usually the case.
The most technically challenging parts of surgery tend to be where the surgeon’s expertise is, so that part of a procedure isn’t actually that stressful for the surgeon, Wilcox said.
“They start freaking out when they’re near a structure that’s really outside their area of expertise,” he said.
In colorectal surgery, for example, when the surgeon is working close to the bladder, a structure they don’t know as much about, “that’s when you see these spikes in stress,” Wilcox said.
Going Beyond The Patient
Andrew Tochterman, leader of Philips Volcano’s coronary segment, echoed the importance of observational research in the design process. He also talked about ways to use that research to address economic and workflow inefficiencies in healthcare.
“It starts with understanding the problem you’re trying to solve and increasingly in today’s healthcare environment it’s not just about the patient,” Tochterman said. “Certainly the patient is a key component of that, but understanding ‘are you solving an economic inefficiency, are you solving a workflow inefficiency,’ and I think observation really allows you to hone in on where you see these gaps.”
Tochterman said he was impressed with the front-end research strategies that Wilcox and Pierce employ as consultants, but acknowledged that Philips Volcano isn’t quite at that level of sophistication. The one thing the company does make sure of, though, is that the product being designed has a strong enough value proposition to make it successful on the market, he said.
Giridhar Thiagarajan, an R&D researcher at Salt Lake City-based C.R. Bard Inc., said Bard has found value in engaging with key opinion leaders to learn the needs of a particular space. He said such leaders tend to be more articulate about problems and what their critical needs are in the operating room.
Rutter: 'Wow, everyone is getting it'
In an interview following the panel discussion, Rutter told Qmed he was pleasantly surprised by “how common the drum beat was on the importance of front-end research,” among the panelists.
That’s a relatively recent trend he said, adding that if he had posed the same question to a similar panel of experts two years ago there likely would have been just one panelist talking about front-end research.
“Now, it’s like, wow, everyone is getting it,” Rutter said.
The front-end research is the part of the design process that he said is most fascinating to him personally. “I want to figure out what’s broken,” he said. “I like the psychology of the game.”
The challenge, however, can be in convincing management at the C level of the potency of doing front-end research to examine the human factors that ultimately determine the success of a product. “It’s not just about understanding the needs that users articulate,” he said. “It’s about understanding the needs the user doesn’t articulate.”
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Remember this line? “Space: the final frontier.” But it is actuallymedtechthat is the final frontier these days for Star Trek-inspired technology, especially thanks to the $10 million QualcommTricorderXPrizeand its recently announced 10 finalists.
Human factors engineering is often required for medical devices, but it can be costly. Here are eight strategies to make it more affordable.
HFEis the study of how people use a device in its intended environment—correctly or incorrectly—and incorporating that data into the design of your product. The goal ofHFEis to ensure your device has been designed in a way that mitigates the risk of causing harm to its users to the furthest extent possible. You can find elements ofHFEin countless products you use every day—from a tool handle designed with a more substantial grip to prevent fatigue, to a safety guard shielding a sharpened blade, to the written instructions telling you what buttons to push and not to push.
For certain devices (mainly Class II and III), the FDA requires that you perform human factors testing on your device. The FDA recently published alist that further clarifies which devices are under the most scrutiny—however; it is not all encompassing. If a risk analysis of your device indicates potential misuse,HFEdata will need to be included within your submission.
There is no shortage of statistics backing the need forHFEconsiderations. For example, in 1998 the Institute of Medicine (IOM) reported between 44,000 and 98,000 preventable deaths due to medical error. More recent studies project that these numbers could be as high as 250,000 annually—which would make it the third leading cause of death on the CDC’s official list behind heart disease and cancer. Furthermore, these errors carry a tremendous price tag via the additional medical care that is needed to address them—an estimated $17 billion a year.
However, the benefits ofHFEextend far beyond increasing safety. WhenHFEis properly integrated into the product development process, products are often more effective, intuitive and inclusive of novel features that create competitive advantages, while improving the overall user experience. PerformingHFEtasks can also reduce the cost of development by uncovering and resolving serious usability issues early on in the design process.
The FDA and a number of standards organizations (IEC/ANSI/AAMI) have released guidance on how to properly perform your preliminaryanalysesand conduct formative and summative testing.
HFEdoes require an investment, though. Read on to discover eight powerful strategies recommended by industry experts to help avoid common pitfalls and get the most out of human factors engineering.
1. Save Money: Start Early
HFE/usability testing allows you to expose necessary design changes and uncover features that delight customers. The best way to maximize your investment inHFEis to start early on in the design process, when design modifications are relatively inexpensive.
According toTressaDaniels, manager of user experience for Becton Dickinson’s infusion division, “As soon as you have something to show your users, do it. The earlier they give feedback, the sooner you get the design right.”
One of the most useful tools to evaluate a device is a usability failure mode effects analysis (uFMEA). In short, auFMEAis a brainstorm of all possible use scenarios that could lead to a failure and a thought out analysis of what the potential consequences of that failure are. By using this analytical approach and assessing a device task-by-task, you can identify a great number of use-related risks giving you insight into the necessary design changes. All of this can be done without recruiting a single participant for a usability study.
Keep in mind that analytical processes do not represent actual users or realistic use, and since use-error is usually surprising to analysts, simulated use testing is necessary and should still be leveraged to identify use errors that can’t be predicted through analytical methods.
3. Tool: Heuristic Analysis
There is an enormous amount of knowledge in theHFEcommunity that you can and should be leveraging. Many consultanciesoffer heuristic/expert reviews at a fairly low cost. This is an especially helpful way to vet out multiple concepts at once.
“Heuristic evaluations are one of the most valuable but underutilized tools in Human Factors,” saysTressaDaniels, manager of user experience for Becton Dickinson’s infusion division. “Spending a few hours having a human factors engineer evaluate your product using industry standard heuristics can be one of the most effective and fastest ways to identify design flaws well before beginning usability testing.”
4. You Don't Always NeedIRBApproval
Many people get clinical trials and usability evaluations mixed up and assume that an Institutional Review Board (IRB) approval is needed. If the device is non-functional or functional but isn’t delivering therapy, you most likely do not need anIRBapproval. Work with your regulatory department to understand what’s best for your company.
5. Think Aloud Protocols With Breadboard Prototypes
Also known as a cognitive walkthrough, think aloud protocols are used to guide participants through the process of using a device while explaining their thought process after each task is complete.
The best part about this technique is that you don’t need a completely designed UI to perform one—in fact, you can obtain highly useful feedback from users just by building very simple paper or “breadboard” prototypes or even sketches that give a user an idea of what the final UI will be.
Depending on whether it’s software, mechanical, or electro-mechanical, you can even isolate certain features of the interface. This allows you to get very early feedback and will influence your design direction to be user-centric from the get-go.
6. Use Affinity Diagrams
Usability studies yield enormous amounts of data that can be difficult to sift through. Affinity diagrams can help you organize issues and uncover root causes of error patterns and problems that may have not have been uncovered earlier on.
It’s important to remember that we don’t know what we don’t know. Users may say they want a particular feature, but what they really need may be hidden behind a deeper problem.
7. Avoid Summative Testing Without a Formative
Prematurely moving into summative testing is one of the most common errors made when implementingHFEinto the product development process. By taking this “check the box” approach toHFEand only performing a summative test, you not only lose out on all the valuable design insights that formative testing yields, but you also risk discovering usability and safety issues too late in the development process.
A summative test must be performed with about twice the number of participants as a formative test—at least 15 participants per user group. A production level version of the full user interface must also be used. This means all training materials, theIFU, packaging, on-product labeling, etc. must all be the final version.
If during summative testing you discover patterns of error and design changes must be made to address them, then you not only spent more than you needed to on what will now be considered a formative test, but your design changes will be exponentially more costly than they would have been earlier in development.
8. Showing the ROI of Human Factors
ImplementingHFEearly on in the design process yields better products, increases sales and customer loyalty, and can reduce the total cost of development and product liability claims related to use-related errors. The ROI of human factors extends into a variety of areas.
To give a very common example, increased usability tends to yield lower support call volume. Let’s pretend you’ve completed a redesign of one of your products and implementedHFEactivities throughout the design process. Ultimately, you’ve found that the device has been well received by your customers due to its increased intuitiveness and there’s been a small reduction, about 10%, in support calls.
Assume your call center receives 2 million calls per year, with the average call lasting 4 minutes (.07 hours), and your staff is salaried at $30,000 per year, working an average of 8 hours per day, 230 days out of the year. Let’s also assume yourHFactivities cost roughly $50,000 to implement, and the product life is expected to last 3 years.
In this scenario:
Future Gain from Improvement = $395,560.46
[($2,000,000 x 10%) x .07hrs x ($30,000/1,840hrs)] x [(1+0.05)^3 - 1] / 0.05 - $50,000(1+0.05)^3 = $395,560.46
Total Gain from Improvement = $341,700
395,560.46 / (1+0.05)^3 = $341,700
Total ROI = 7:1
$341,700 / $50,000 = 7:1
In this example, an investment inHFEpaid off by about 7 to 1—a considerable return on investment.
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Designing an effective connected health device is no easy task, but here are a few lessons from companies whose solutions hit the mark.
Gone are the days when doctors' office visits were the only way to get patients and healthcare professionals together. Today, a plethora of connected health solutions give providers the ability to keep tabs on their patients 24/7 and enable patients unprecedented access to healthcare services.
But not all connected health solutions are created equal. Few doctors want a daily count of their patients' steps, and few patients want their healthcare providers replaced by a mobile app.
Here are lessons from five companies that are doing connected health right.
Target a Real Need
There are lots of connected devices that measure everything from steps to sleep—but to what end? With its automated patient engagement platform,HealthLooptook aim at a real problem in healthcare: costly hospital readmissions. The platform automates follow-up with patients who have been released from the hospital and provides digital check-ins, guidance, reminders, clinical questionnaires, and educational materials intended to make sure patients continue to improve and alert providers if there are signs of trouble.
Use Connectivity to Add Value
Connectivity is great, but in many cases, it’s not the whole solution; just another tool in the toolbox. Take, for example, Apollo Endosurgery’sOrbera Coach. This digital patient engagement platform is offered to patients who receive the company’s Orbera Intragastric Balloon System to help them lose weight. After the procedure, the app-based Orbera Coach program helps patients stay on track with their weight loss by integrating with activity trackers to keep tabs on progress, giving them access to group support sessions, and providing educational content and recipes to help increase their odds of success.
Know Your Users
While some people proudly wear their Fitbits to showcase their commitment to fitness, patients with a serious condition may not be so eager to flaunt their connected devices.iRhythmclearly had that in mind when it designed its ZIO XT patch for cardiac monitoring. The wearable device adheres to the chest and can unobtrusively monitor a patient outside of the hospital for up to 14 days. Users can even shower with it. “Nobody knew I was wearing the patch,” user Gregory Fisher is quoted as saying on the company’s website.
Do Data Right
Data can help inform patient treatment and ultimately improve care—or at least that’s the dream. In reality, many connected health solutions drown users in a deluge of data that their healthcare providers may or may not be able to trust.Abbott’s FreeStyle Libre Pro Systemfor continuous glucose monitoring, which recently won FDA approval, gets it right with a more strategic approach. A healthcare professional outfits patients with a small sensor, worn on the back of the arm, that measures glucose levels every 15 minutes for up to 14 days. After those two weeks, the patent returns to the doctor’s office, where their physician scans the sensor to download the data for review and discussion.
Don't Forget The Human Element
One of the main benefits of connected health solutions is the fact that such technologies can automate tasks that previously had to be performed by humans, such as recording patient data. That’s all well and good, but sometimes patients still need an actual human to help. Livongo took that into account when it built real-time coaching into its diabetes management platform. While a connected glucometer automatically uploads users’ readings to the cloud, provides data insights, and enables them to share information with others, users can also connect with Certified Diabetes Educators via phone, email, text, or mobile app when they need extra assistance.
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