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Choosing Custom vs. OTS Medical Device Components

Posted by Greg Hurley on December 7, 2017

Choosing Custom vs. OTS Medical Device Components

Most engineers and product designers have run up against the same problem when designing a product. Your medical device design contains a number of parts and you come to a fork in the road: should you design a component from scratch, or go to the internet and your dusty stack of catalogs to see what is already available off the shelf (OTS)? Whether your design requires pumps, gears, or simple parts like shafts and gaskets, the decision to choose custom versus OTS components is usually based on the product into which it is going. You will consider design intent, time to market, and the overarching cost.

Off The Shelf (OTS)

You’ve decided to forgo the time and effort of CAD, drawings, tolerance analysis, and interfacing with potential contract manufacturers and chosen instead to buy preexisting components. Although there is a long list of benefits, the down sides could cause you to change direction. A part that is considered off-the-shelf (OTS) already exists and is usually readily available. A simple example is fluid pumps; there are thousands of pumps available from hundreds of companies from all over the world. While this may be a critical component to your product, your company may not be in the business of designing pumps. Timing and personnel constraints may cause management to direct you to shop around for a pump that suits your needs. In the hypothetical case of our pump, we would need to narrow our search by type, usually based on the application. At this point, it may be wise to consult with a component supplier to help narrow things down. A gear pump, diaphragm pump, and peristaltic pump all move fluids, but they do so at very different pressures and accuracies. You still need to decide which is more important to the final product. In many cases, a component supplier will be able to recommend a size and direction.

Factors to Consider: OTS VS Custom

Often, one of the biggest benefits of buying OTS is that the component supplier will be able to give you all of the performance and test data that an engineer would have had to find through theory, simulation, and empirical testing. Life test data is one of the hardest data sets to obtain yet one of the most useful. Many suppliers will stand by their product, help to remedy or address warranty issues with their products, or help with best practices in implementation and assembly.

With so many benefits, it is easy to think that buying OTS components is the way to go. However, there are a few substantial drawbacks. The odds are pretty good that you will not be able to find exactly what you need. In almost every case, such limitations will cause the OTS component to drive the design, rather than the opposite. This could be anything from physical dimensions and mounting points to performance or life expectancy, which means that you are forced into a part or an assembly that is either overkill or subpar.

Obsolescence is also a real problem. Things may be going great with production and sales, until the component supplier informs you that they will be discontinuing the product that you buy from them. This puts you right back at the starting line. A scaled-back version of this issue occurs when the supplier makes changes to their component. This sometimes requires extensive supplier audits and requalification of the component. Your supplier may do this as a cost savings measure or to appease a larger, more lucrative customer. Either way, it is not something over which you have control. Similarly, you are at the mercy of this supplier for timely delivery or other contractual issues, such as minimum order quantities (MOQ) or unscheduled price increases.

Custom Designed Components

Many engineers and product development companies design products for highly specialized industries and may lean towards designing custom components. This may be because the product must perform very specific functions with precise accuracy. In these cases, budget is less of a concern. On the other hand, fast-turn consumer products are more likely to have these generalized OTS components. Because the specifications of the overall product are known, the component can be designed to have the exact fit, form, and function required. With a custom designed component, you can also have control over the quality and tolerances as well. If your company has internal manufacturing, you will not be reliant on any other company for delivery, and you will also be able to iterate your design more quickly. Even if you are reliant on a contract manufacturer to manufacture your in-house designed part, you may still have a more reliable supply chain compared to OTS suppliers. Moreover, any components that are designed in-house will be able to be patent-protected by the company. This means that competitors will have a more difficult time duplicating your design, and it could be an added revenue stream for the company in the future.

The perceived cost-benefit depends on a lot of criteria. The upfront cost of tooling, setting up an assembly line, or other capital expenses could negate the per-part cost savings of designing in house. Building your components in large quantities over many years may make this method worthwhile. Ultimately, quantity is going to be one of the biggest drivers in ROI realization.

The predominant downside of designing in-house is the time and level of expertise required to design the component. Let’s consider the fluid pump again: You are an engineer working for a medical device company, and a new product will make use of an infusion pump. Your company has not made or used infusion pumps in the past. In the conversation of whether or not to make this in-house, you must now consider the time and effort to become experts in this area of design, the nuances of manufacturing, navigating the intellectual property in the area, and regulatory compliance. Along with building the component to your specifications, it is now up to you to test it in a statistically significant quantity under various use case scenarios. Depending on the product, this could mean highly accelerated life testing (HALT), environmental, or regulatory testing. If this is going to be a major product for your company, or if there is nothing on the market that suits your needs, then taking this path may be justified.

Like many other decisions in engineering and manufacturing, deciding to use OTS or custom parts is not a simple choice, and one way or the other, it should probably not be a companywide blanket policy. The advantages and disadvantages must be determined and understood. Thus, supply chain, marketing, upper management, and other groups outside of engineering need to be involved. Any company that has developed a product has likely been faced with this decision, and the majority would probably reconsider some of their decisions in hindsight. This is all a large part of the engineering business and a valuable learning experience for engineers to undergo.

Topics: medical device design, engineering, product development

Human Factors Engineering: Caring for Caregivers

Posted by Kristyn Berry on October 20, 2017

Human Factors Engineering: Caring for Caregivers

The Psychological, Emotional, and Logistical Challenges Involved in Caring for Loved Ones and How to Reduce Burden Through Design

Today, medical research and innovations are allowing people to live much longer lives. Early diagnosis and the ability to manage chronic medical conditions from home are increasing the demand for effective, intuitive home health devices.

When applying human factors engineering to medical devices, all users who may come into contact with and/or use a device must be considered in the design process. An increase in home health devices can mean an increase in types of users, such as caregivers, who will be interacting with the device. With the growing population of non-professional caregivers in the United States (i.e., family or lay person), it is becoming important to engage this population in the early stages of the design process.

For example, a family caregiver who is responsible for administering medication to an adult dependent can be recruited to interact with the device and provide early feedback. This inclusion is critical to ensuring a device is safe, intuitive, and easy to use. It is also important to consider the psychological, emotional, and logistical challenges that caregivers encounter as part of the healthcare delivery process, and use those insights to develop better medical devices.

The Caregiving Population in the United States

Family caregivers are unpaid, non-medical professionals who care for a loved one or a dependent, as opposed to a professional caregiver, such as a licensed practical nurse hired to take care of a loved one’s primary medical needs in the home. The population of family caregivers is growing in the United States. An increasing number of individuals are providing full-time unpaid medical care to a loved one on a weekly basis, and these caregivers do not fall into a specific age-range. Some are younger and have their own commitments of going to school and raising a family, while others are entering retirement age and spending time with family or taking on their own endeavors. As of 2015, approximately 43.5 million adults had provided unpaid medical care to an adult or child over a year. Approximately 15.7 million caregivers of adults cared for someone who had Alzheimer’s disease or another form of dementia. (1) The average caregiver is 49 years old; 48% of caregivers are between the ages of 18 and 49, and 34% of caregivers are over 65 years of age. The average age of the person receiving this care is 69 years of age. Family caregivers spend an average of 24 hours per week providing care for their loved ones, while 1 in 4 caregivers spend 41 hours or more per week providing care. Family caregivers who live with their dependents provide care approximately 40 hours per week. It is worth noting that there is also an ever-growing financial burden to these caregivers along with the unpaid hours supporting their dependent. For example, as more people are able to treat their chronic conditions at home, there is a cost associated with purchasing medications and medical supplies and in some instances caregivers are covering these costs. Costs of services provided by family caregivers have slowly increased over the last decade.

The Psychological, Emotional, and Logistical Stresses Involved

While family caregiving can be a rewarding experience by allowing a person to spend more time with a loved one, it also presents many challenges. A study done by the Department of Informatics and the Institute for Clinical and Translational Science at the University of California (Irvine) found that “other than the obvious medically-driven tasks, such as attending a patient’s doctor appointment and dispersing a patient’s medication, being a caregiver also implies many non-medical tasks: from the small chores of cleaning the house, cooking meals, and picking up groceries; to providing financial assistance, emotional comfort, and even IT help.”

Along with the emotional burdens of caring for a loved one comes the emotional distress and doubt of potentially not caring for a loved one appropriately or safely. In hopes of gaining a support network and medical information, caregivers may refer to Facebook groups and other online chats for medical information, but caregivers as well as medical professionals have concerns about these resources. One caregiver has explained “Being a caregiver is a job.’ Participating in online support groups raises the question: Is the information exchanged accurate and safe? (2)

The many burdens that come with family caregiving raise the question: How can designers and researchers create devices and other technologies that help mitigate existing challenges?

How to Reduce Burdens Through Design

According to the HE75 AAMI Guidance Document on Human factors engineering - Design of medical devices, there are multiple factors to consider when designing medical devices not only for patients and professional caregivers, but for family caregivers as well. (3)

Learnability and intuitiveness: With an increased amount and range of home care medical devices, devices “should be easily learnable by lay caregivers and patients.” If the design of the device has a similar appearance, feel, and operation to devices users interact with on a daily basis, intuitiveness will increasingly be based on the design of the device and less reliant on the training (which could vary) provided by healthcare professionals before the patient or family caregiver brings their device home.

User guidance and training: Both lay caregivers and patients have a diverse background of literacy, language, and education levels, which could impact their use of home care medical devices. “Documentation, user guidance, and training materials should be provided that can be easily understood by lay caregivers and patients.” These resources should also incorporate multimedia elements to make the documentation easy to digest and accommodate people with different learning styles and capabilities.

According to HE75, “Lay caregivers and patients cannot be expected to master new technology at any cost and do not have the resources available to perform excessive maintenance and calibration or to obtain replacement units easily if a medical device malfunctions…they are not necessarily comfortable with technology and might have little health care knowledge to bring to bear when learning to use medical devices.” In order to account for patients and lay caregivers with a diverse range of backgrounds who have not necessarily been thoroughly trained on instructional materials, HE75 recommends the following design guidelines for device training materials and documentation:

  • Write training materials and documentation at the 8th grade level or lower: If a device is so complex that this guideline cannot be met, it is probably not suitable for home use.
  • Use large font size and high contrast: With respect to the design of text, 12- to 16-point fonts should be used, and the text-to-background contrast should be high (Hogstel, 2001; Adams and Hoffman, 1994).
  • Include illustrations: Documentation should include illustrations that are appropriate to the age range of the target user population (Hogstel, 2001; Weinrich and Boyd, 1992).

According to the FDA’s 2016 Guidance “Applying Human Factors and Usability Engineering to Medical Devices,” an individual’s characteristics should also be considered when designing a medical device. For the family caregiver, these considerations may include the following:

  • Mental and emotional state,
  • General knowledge of similar types of devices,
  • Knowledge of and experience with the particular device,
  • Ability to learn and adapt to a new device, and
  • Willingness and motivation to learn to use a new device.

In addition to considering the usability of a device, the overall design such as the look and feel must be considered as well. During in-field observations and testing of home healthcare devices with patients and caregivers, it is evident that users often want a device that is differentiated from medical devices found in clinical environments in terms of the size, weight, aesthetics, and ergonomics. For example, many users at home want a portable device that can easily be carried around with them as they go through their normal everyday tasks at home.

Families, professional caregivers, and patients may all be interacting with a device and/or medical equipment in the home and may interact with these products differently. In order to accommodate different styles of use in a home environment, differences between a healthcare facility environment and a home environment should be considered to appropriately design for users. For example, in a home environment that is not designed with regulatory constraints in mind, lighting may vary and could affect how users can interact with their device. Along with lighting, temperature and space can vary as well. For example, cord management should be considered to account for potentially cluttered or messy spaces at home. Conducting home-based research studies can help device manufacturers understand the home use environment and all the different scenarios that a user can encounter on a daily basis in the home. Considering home use environments in this way can help to mitigate the risk of use errors occurring when users interact with medical devices and can help manufacturers design devices that can be used by family caregivers and patients. (4)

When using a device in the home, the resources and expertise provided by healthcare professionals at a medical facility are not present. Colleagues in the field assist healthcare professionals with training, troubleshooting, and new perspectives as needed. While patients and caregivers may receive some formal training before leaving a medical facility, “most home users lack formal training, beyond an hour or two with their doctor or pharmacist.” (5)

According to the article Modern Healthcare: Family caregivers feel unprepared for medical responsibilities, many caregivers struggle when taking on medical and nursing responsibilities. In 2012, an earlier report by the United Hospital Fund and AARP found that nearly half of family caregivers across the U.S. were taking on medical and nursing responsibilities, like changing catheters, often without help. Having an easy pathway to communicate with doctors and other healthcare professionals can reduce anxiety that family caregivers suffer and reduce the possibility of medical errors. (6)

Resources like the AARP Family Caregivers Division often hear the experiences of family caregivers firsthand and suggest the use of telehealth and digital technologies to assist them, such as:

  • Mobile applications
  • Medication reminders
  • Online chats with doctors, pharmacists, or other healthcare professionals
  • Mobile family communication hubs
  • Task calendars

Research done by the Department of Informatics and the Institute for Clinical and Translational Science at the University of California (Irvine) particularly suggests the creation and use of a digital integrated platform that enables caregivers to have their personal schedules and information as well as their caregiving responsibilities inclusively stored. “The integrated care system may allow a caregiver to set up his/her comfort task zone for a day. It could link with calendars from work, life and caregiving activities, and automatically calculate the daily workload of a caregiver. When the calculation exceeds the threshold set by the caregiver, the system could send warning signals to remind the caregiver that there are more tasks that he/she can do on a particular day, and also send messages asking for help to the caregiver’s friends, family members, and other non-primary caregivers.”


Although not officially healthcare professionals themselves, family caregivers often play a role similar to that of a healthcare professional. As researchers and manufacturers for medical and healthcare devices, we must keep these individuals in mind by considering how their challenges and backgrounds guide their approach to using medical devices and designing to accommodate these approaches.


  1. Alzheimer's Association. (2015). 2015 Alzheimer's Disease Facts and Figures.
  2. 2001 Family Caregiver Alliance (Reviewed and updated 2017). National Center on Caregiving. “Hiring In-Home Help.”
  3. ANSI/AAMI HE75:2009(R)2013. Human factors engineering- Design of medical devices.
  4. R.J. Branaghan, “Human Factors for Home Use Medical Devices- the Home Is Not the Same as the Hospital,” July 2017. Russell J.
  5. A. Sutherland and M. Cavanagh (Design Science), “Coming Home: Designing for Medical Device Use Environments,” July 2016.
  6. E. Whitman, “Family caregivers feel unprepared for medical responsibilities,” Modern Healthcare, Sept. 2016.

Topics: medical device design, human factors engineering, home healthcare

Balancing Branding and Usability in Medical Device UI

Posted by Heather Gass on August 29, 2017

Balancing Branding and Usability in Medical Device UI

Branding versus usability… the responsibility falls on the designer to determine the balance in medical device user interface design. Designers struggle to uphold the spirit of the brand when pursing usability and often fear that the use of branding can reduce successful task completion. We tend to overlook that it’s both branding and usability that shape the user’s opinion and feelings of success when using a product. To help achieve this harmony in a UI design, here are some tips and suggestions to keep in mind.

What is branding?

Let’s define what we mean by brand and branding. The brand is not the logo or the color palette; it’s the promise of what a company stands for or the value it offers its customers. For example, a brand could represent the promise that its products are accurate, durable, and safe. Branding is an expression of the brand’s identity through the application of the brand’s guidelines to the user interface. Branding is not simply adding the logo to the interface, but rather considering how the brand’s identity can be reflected in all aspects of the interface, including informational components, input controls, and navigation.

In UI design, we’re aiming to deliver on the brand through the application of branding to the user interface.

How is brand expressed through the user interface?

UI design patterns have become a popular tool for solving common design problems because they add an element of familiarity to an interface. Users feel comfortable using patterns they recognize; they identify a text box with a magnifying glass icon as a mechanism for performing a search, and they know that pressing a button-shaped element will initiate an action. Though UI design patterns tend to be familiar to users, they may limit options for the designer and could lead to an interface that feels generic and lacks identity.

This is where branding comes in. The judicious application of branding to an interface can elevate the experience to a unique and memorable level far beyond that of standard design patterns. Here are a few areas to consider when incorporating branding into an interface.


Microinteractions are contained single tasks that result in some form of feedback, such as changing a setting, picking a password, or refreshing a screen. They are everywhere in interface design, and while small and subtle, they can make the difference between a product that is used and a product that is loved. A clever and well-designed animation in a microinteraction gives users a moment to dynamically experience your brand and leaves them with an emotional impression. Think about how brand can be incorporated into microinteractions that give immediate user feedback, help users navigate, or encourage interaction.

Gmail’s pull-to-refresh microinteraction

Gmail’s pull-to-refresh microinteraction uses Google colors and subtle animation to add a bit of playfulness to an otherwise mundane task.


Color plays dual roles in user interface design. It can serve a functional role, such as calling out important information. It can also serve an aesthetic role in expressing the brand’s identity and boosting appeal, such as in a page background color. The challenge is to find ways to use branding colors to serve both purposes without competing.

When considering color in a UI design, examine the brand’s color palettes, and think about the significance of the colors to the brand and how the colors might be applied to improve flow and hierarchy or indicate status. Color can be used in its aesthetic role on the outer wrapper, or chrome, of the user interface to express the brand’s identity. For the data-dominant inner areas of the user interface, color can be used in its functional role to facilitate task completion and draw attention to important data, such as status or alarm states. In both cases, colors from branding guidelines can be used, but their purposes are distinctly different.

In some cases, the primary brand palette may not have enough color variety to lead the user through task completion. This is especially true if the brand guidelines have previously been applied only to informational materials or web sites (versus task-oriented user interfaces).

For example, a palette of dark blues, light grays, and soft greens may need complementary shades of red or orange to stand out and communicate critical information. In cases like this, you might need to extend the brand guidelines to include meaningful colors for status.

Also keep in mind that color alone should not convey meaningful information. Vision impairments, like color blindness, can make it hard to distinguish certain color combinations. Use this opportunity to combine color with other graphical elements that convey both meaning and brand.


Branding color applied to the chrome and data elements of the UI (front) gives a cohesive and fully branded feel to the UI, while branding color applied only to the chrome of the UI (back) feels more generic and lacks identity.

Tone of voice

The style of communication in an interface can greatly affect perception. For the brand traits you are trying to embody, ensure that the tone of voice used throughout the content in the interface comes off as an authentic embodiment of your brand’s promise. Authenticity helps to build trust with users. Also ensure that the tone used is conducive to the user’s task at hand. For instance, a friendly, approachable tone should still be clear and succinct in communicating instructions. The use of tone is not limited to larger chunks of text; it should carry through to short blocks of text and labels like success messages, status indicators, navigation, and even alternative text descriptions that may be hidden from the visual interface but used by screen readers for vision impaired users.

For error messages or alarms that appear when users are feeling stressed or frustrated, ensure that the tone of voice does not distract from the message. Provide solutions or next steps for resolving errors when possible, and avoid using language that will cause the user more stress or frustration.

Example of tone of voice guidelines for user prompts

This example of tone of voice guidelines for user prompts defines the tone to use and provides examples.

Here are a few more suggestions to keep in mind while incorporating branding into the UI:

  • Understand the branding guidelines, and bend or break when needed. If you are unfamiliar with the brand guidelines at the start of a project, do some research. How did the authors account for the color palette’s use on screen? Are there separate guidelines for task-based applications versus informational guides? Sometimes you may find that these things haven’t been accounted for, and you may need to create new guidelines or defy existing ones to ensure that your interface provides a good experience for users.
  • Defer to content over branding. Elements that only display brand assets like a logo or a color swath may be fine for marketing materials, but it is best to prioritize task functional elements over branding elements and incorporate branding more subtly, such as through typography, layout, and color scheme.
  • Consider platform UI patterns. Ensure that branding and layout patterns don’t conflict with standard UI patterns for the platform on which they will be built. Take advantage of user’s familiarity with certain platform patterns, and don’t let branding make them unrecognizable. For example, if you are developing an iPhone app, stick to the iOS human interface guidelines so that users will automatically have some familiarity with the elements in your app.
  • Perform usability testing with your designs. In the medical realm, usability evaluations are required to ensure safe use, but they should also be used to identify areas of improvement in the overall experience. In testing, pick up on cues that your brand is coming across in the experience; look for patterns in facial expressions, body language, and verbal comments made by users throughout the test.

For your next UI design, keep these points in mind when the internal battle between branding and usability arises, and remember that both elements influence the user’s opinion of the product. Considering both of these aspects throughout the UI design and development of your medical device will create more unique, creative, and usable product experiences.


Topics: Medical Device Development, UI, Branding, usability

Cybersecurity 101: Making Medical Devices Secure AND Usable

Posted by Chris Thurrott on May 11, 2017

Cybersecurity 101: Making Medical Devices Secure AND Usable

Medical devices are becoming increasingly pervasive and interconnected, with hospitals averaging 10 to 15 network-connected devices per bed. 90% of hospitals were victims of cyber-attacks in 2014 and 2015, and it cost the healthcare industry $6 billion to address these attacks. Healthcare (unfortunately) is becoming the most victimized across all industries, accounting for 27% of all breaches in the first half of 2016.

H1 2016 data breaches by industry

It’s important now more than ever to control access to medical devices so only the right people can do the right things with them. Also known as access control, authentication, or identity management, getting cybersecurity wrong can lead to security problems, poor usability, or both.

What kinds of security problems?

  • Multiple parties have demonstrated that it is possible to gain control of certain insulin pumps and remotely perform actions such as wake up the insulin pump, start and stop the insulin injection, or immediately inject a bolus dose of insulin into the human body.
  • A pacemaker manufacturer recently had to issue patches for a security hole that could allow an attacker access to implants remotely. The attacker was able to issue catastrophic commands like generating shocks or disabling the implant over a wireless network. Unfortunately, the manufacturer sustained a costly hit to its stock price.
  • Hackers can exploit insecure medical devices to attack a health facility’s entire network. Separate attacks on two U.S. hospitals took one facility’s computers offline for a week, while another had to notify over 30,000 patients that their records had been deleted and potentially disclosed to the attackers. In addition to higher operating costs, impaired patient care, and having to pay for credit monitoring for affected patients, these facilities also had to pay ransom to the attackers to get their systems back online.

“Just lock it down” doesn’t work.

After reading the examples above a medical device developer might be inclined to enforce rigid security requirements, like 20-character complex passwords that must be changed every 7 days. Don’t do this.

XKCD comic on password strength misconceptions

An overly complex password can provide a false sense of security and can lead to problems like the following:

  • One system timed out every five minutes, requiring the user to log back in. That translated into the clinician spending 1.5 hours of each shift logging in.
  • Another system prevented users from logging in if they were already logged in somewhere else. So if a clinician going into surgery discovered she was still logged-in outside the operating room, she’d either have to un-gown or yell for a colleague in the non-sterile area to go log her out.

When users, especially in health care, are faced with obstacles to getting their job done, they get creative in working around those obstacles, making the systems less secure. Researchers looking at this topic found the following workarounds:

  • Putting Styrofoam cups over proximity sensors or having a junior team member repeatedly press the spacebar on everyone’s keyboard to prevent timeouts during a procedure.
  • Sharing passwords to a medical device among entire hospital units by taping the password onto the device.
  • Sometimes well-intentioned medical system manufacturers encourage workarounds, like distributing this sticker (branding altered to protect the guilty).

Password reminder sticker and instructions

Workarounds like these can cause problems with inadvertent or unintentional exposure of protected health information as well as accidents, such as entering a medication order for the wrong patient, because the previous clinician did not log out properly.

Make it usable AND secure.

Logging in is never a primary user goal; users log in so they can accomplish some other task. It’s essential to make authentication as easy as possible for authorized users while preventing those without permission from using the system. Medical device developers should minimize these distractions so users can focus on necessary tasks.

One place to start is to carefully develop a threat model, analyzing which interactions with a device are higher risk and need securing. For example, knowing that the infusion pump is running or infusion time remaining might be lower risk and not require login, while changing the dose is probably higher risk and needs to be password-protected. This way, the user can still get needed information from the system without having to expend time and effort logging in. Once a user is logged in, they should be able to take “protected” actions for the duration of their login session. Forcing authentication for each individual feature leads to choppy workflows and potentially insecure workarounds.

If your system requires users to log in, consider ways to reduce or eliminate the need for them to memorize and enter information. They have enough stuff to remember for their “day job.” Consider the following:

  • Authenticating with a badge or fingerprint.
  • Show a list of users so people only have to remember their password.
  • Simplify the password to a number or shape.
  • Minimize or eliminate complex password “recipes”

Simple password examples

It’s important to consider everything that could go wrong, and give the user a clear path to resolving problems. As medical device developers, one way we can do this is by providing clear messages for authentication errors, a means of resetting a forgotten password directly on the device, and a way to get help if the user cannot resolve the problem independently.

We also need to consider carefully how and when to end a user’s login session. If the session ends too soon, it could interfere with the user’s work, but waiting too long could leave the session open to misuse by unauthorized and authorized users alike.

Creating usable and secure systems starts with understanding the user’s workflow and adapting the system to it. This is much easier than changing human behavior. We should observe users performing their work in context to answer questions like:

  • What information do they need? What actions are they taking?
  • How often do they need to interact with the device? For how long?
  • What else are they doing? How often are they interrupted?


In the U.S., the Food and Drug Administration is applying increasing scrutiny to cybersecurity, issuing guidance on cybersecurity documentation needs for premarket submissions and maintaining a repository of additional resources. Medical device developers need to consider security throughout the product development process.

In the end, medical products need to address both usability and security concerns to minimize risk, be effective, and achieve market success. Considering them together, rather than separately, will result in a more balanced approach.

Sources and further reading


Topics: Medical Device Development, cybersecurity, user needs research

Human Factors in Design: 3 Cognitive Patterns to Keep in Mind When Designing a Product

Posted by Kate MacNamee on March 2, 2017

3 Cognitive Patterns to Keep in Mind When Designing a Product

Human factors research is often described with a focus on human behavior: what is the user doing, what did they press, click, or move, and how? This doesn’t always get at the heart of an issue though. Just as important as what the user did, is why they did it. The most effective human factors research, especially when assessing risk, doesn’t focus solely on user actions. Instead, it recognizes that the user is part of a larger system. Yes, it exposes how device design and interface structure affect user behavior, but it also considers the fact that behavior may stem from the cognitive patterns and mental models that users themselves bring to the system.

Although usability testing is an important step in evaluating the design of a device or system, designers and engineers can use already-known patterns of human cognition to get a head start designing products that are less prone to use error and that work with the way our brains work, rather than against. This article is meant to provide product development teams with a brief introduction to a few psychological principles that can allow us to do just that.

1. Recognition beats recall (and working memory)

The Fact: Our brains are already working hard to get us through the day, especially in healthcare settings where there may be a large amount of activity in a small space, both physically and temporally. However, the brain’s resources are finite; the more the brain is required to pay attention to a task, the fewer resources it has left to allocate to other tasks. Such a task could include noticing an alarm or holding information in short term memory. This means that complicated products with a large number of steps and options may be more prone to use error. The average working memory capacity is 7 items +/- 2 items, so asking users to remember even up to five pieces of information could prove too taxing.

The Solution: When complexity is unavoidable, products that ask users to remember as little as possible often work best. Memory is one of the more effortful processes at our brains’ disposal. Incorporating features into an interface that prevent the user from having to recall a step or an item location freely will make for better products. Cueing participants with meaningful icons, effective drop-down menu headings, and transparent or shallow interfaces in which the organization of information is conveyed, can absolve users from having to remember the path they last took to find a certain piece of information or complete a critical step. The ways a designer chooses to require recognition (or not) by the user as he or she uses an interface can vary, and they often depend on user expertise, automaticity, workflow, etc. Still, it’s valuable to consider, and to minimize where possible, the amount of cognitive resources we ask users to employ.

2. Primacy and recency effects

The Fact: When people hear or read a list of steps or items, they tend remember the items near the beginning and end of the list better than the items closer to the middle of the list. These patterns are known as the primacy and recency effects, respectively.

The Solution: In scenarios where multiple steps or items need to be remembered to use a device correctly (e.g., a list of warnings in an IFU), consider positioning the items that are most important to be remembered near the beginning of the list. Before placing important items near the end of a list, however, consider whether users are likely to read the entire list.

3. Affordances are everywhere

The Fact: People attempt to use objects in ways that are based on affordances (the perceived ways in which a user may interact with an object, device, or system). Affordances may be communicated to a user through an object or device’s shape, texture, or other characteristics. When a product provides affordances that are consistent with the way it is intended to be manipulated by its user, we call the product intuitive or user-friendly, because we understand how to use it without having to learn. Affordances can be rooted in the way our bodies naturally interact with the physical environment, or in the way our cultures and experiences have shaped our perceptions over time. Don Norman, author of The Design of Everyday Things, one of the seminal books on usability, famously discusses the affordances of doors. Most people have tried to pull a door they should have pushed, or vice versa, and then felt a little embarrassed for doing so. Luckily for all of us, psychology suggests these mistakes aren’t ours, but are the fault of doors that convey the wrong affordances. Vertical door handles that are easy to wrap your fingers around afford a pulling motion, while flat plates or horizontal bars affixed to the face of a door afford a pushing motion. Doors that appear to afford one motion but that require a different motion from the user to work (e.g., a door with a vertical handle that must be pushed to open) are called “Norman Doors.” By understanding affordances, we are less likely to design “Norman Products.”

The Solution: Think about how you can communicate your product’s intended use through design affordances. If a heavy monitor should be lifted using two hands, provide two obvious handles on either side of its body that can be gripped while the user’s wrists are in a neutral position. If a needle cap should be pulled straight off and not twisted off, place ridges on the cap that are aligned perpendicular to the pulling motion required. The ridges are visual and tactile clues for the user who can perceive that they would only provide useful friction while pulling and not twisting. These are just two simple examples; the list of example affordances that can be used in product design goes on and on.

We’ll never be able to fully predict user behavior, so usability evaluations and validation testing to ensure safe and effective use will always be important. However, we can use our understanding of psychology and cognition to inform our designs and get a head start when it comes to designing products or medical devices that are intuitive and less prone to use error.

Topics: human factors, product design, product development

The Case for Words in Medical Device UI

Posted by Chris Thurrott on January 5, 2017

Medical Device UI

“A word is worth a thousand pictures” – Bruce Tognazzini

While it is possible to communicate using only pictures (just ask the ancient Egyptians) it is almost always better to use words as well. You might have been able to parse the picture above, but it was undoubtedly easier to read the words in the title of this article.

A request we often hear when beginning a graphical user interface (UI) project is to minimize (or even eliminate) on-screen text. Project teams think that icons will make the medical device easier to use, and/or that text is too difficult to translate. While including properly tested icons and other graphics can aid usability and make a UI more appealing, relying on them exclusively can actually make medical products harder to learn and use.

Here’s why you should use words in your medical device UI, and some tips on how to make internationalization (I18N) easier for your team:

Enhanced Usability

As the Nielsen-Norman group writes, there are only a few icons that users will instantly recognize, and these are for simple concepts like “home” and “search”. Trying to represent more complex concepts such as those found in the medical world will lead to confusion unless the icon is accompanied by text. What’s a good icon for “analyze”? For “therapy”? A good rule to follow is that if it takes you more than 5 seconds to think of an icon to represent something, it’s unlikely to be understood by a majority of your users.

Even if it’s easy to determine what an icon is (a heart) it might be difficult to figure out what the icon means in the context of use (is it related to “favorites”?  “cardiac function”?)

Compliance with Regulations and Guidelines

In the United States, one of the factors the Food and Drug Administration considers when evaluating applications to market medical devices is adherence to design guidelines such as AAMI HE:75 Human factors engineering – Design of medical devices. This document’s advice for medical product designers includes:

  • Use symbols only if 85% of intended users recognize its meaning in a specific clinical setting (section 10.4.3).
  • Never use illustrations and graphics instead of text for instructions. Only use graphics to help users understand the text (section
  • Include text labels with icons wherever they are used (section
  • Use graphics and white space to enhance understanding and make the device look less intimidating (section 21.4.7).

All of that being said, the inclusion of graphics and icons can have benefits, including:

  • Faster control recognition
  • Larger and more uniform targets make it easier to tap or click
  • Lower information density provides a less intimidating appearance
  • Illustrate concepts that are hard to describe in words
  • Users can more quickly interpret proportions and trends communicated with graphics than with numbers
  • Visual appeal

The takeaway is that you can and should use icons and graphics where it makes sense but you have to back them up with text to assure usability.

Using Your Words

A user interface is a conversation between your product and users about what users want to accomplish and how the product will help the user make that happen. It’s vital that both parties are clearly understood. The words you choose for your interface matter, so always be thinking of the person who will be reading those words. What do they need to know at each step? How can you explain it briefly and clearly?

Once you have the right words, you will need to translate them for use in different countries. For many types of medical products, you will be required to translate the instructions for use and other training materials for each locale. If you set things up properly in your software you can leverage this work for the UI text as well.

It starts with the user interface design and layout. Different languages will require different amounts of room to express the same thought. Here’s an example from AAMI HE:75 (table 21.4):

AAMI HE75 Example

Languages can also vary in other ways, including:

  • Sentence structure – adjectives come first in English, second in Spanish and other languages (see “pure oxygen” above).
  • Use of gender – English is neutral, while Spanish and other languages use masculine/feminine nouns and articles.
  • Reading direction – English and other Western languages read left to right, while Hebrew, Arabic, and others read right to left. Happily, languages like Chinese that were historically written vertically have evolved toward horizontal orientation, especially in the computer age.

All of this impacts developing your software code, but don’t despair. Following the tips below will help you smoothly internationalize your product and also benefit your English versions (cleaner designs, easier to update labels, etc.)

  • Choose frameworks and fonts that support string extraction and international character sets.
  • Extract text like button labels and error messages from your code base. This makes it easier for your software to switch languages on the fly and provides a ready-made work list for your translation provider. Don’t include text in your graphics either.
  • Keep text brief and clear to start with. Watch out for idioms that won’t translate.
  • Leave room for text expansion. Languages like German and French might need 25% or more additional space, but it’s best to look at the specific words and languages in your product. Methods like flexible layouts and placing labels on top of data fields (instead of beside them) can help.
  • Do a test run on your mockups with a machine translation service like Google Translate so you can find design issues before coding. Always have a native-speaking subject matter expert check the final text.
  • Start early and do your homework. Careful planning and early testing will help avoid problems when you’re ready to launch. Articles from Intel, PhraseApp, and product engineering blog Zühlke are a good start for more in-depth tips.

Topics: medical device, user interface, user centered design

Prototyping Your Medical Device User Interface to Reduce Cost + Risk

Posted by Chris Thurrott on November 16, 2016

Medical and life sciences devices are packing greater functionality into sophisticated workflows involving screens and hardware controls. Regulators and an increasingly sophisticated user population demand that these devices be safe, effective, efficient, and appealing. Following a user-centered design process that includes human factors usability testing is essential to achieving that result.

It’s vital to gather user feedback early so that changes make it to the final product. Good user experiences don’t happen by accident, or on the first try. And the rework involved if you discover usability problems in a production-ready product can be incredibly expensive. So, how do you get the input you need without breaking the bank?

In the software world you develop iteratively. You release version 1.0, then react to market feedback, because developers can make and deploy changes quickly. But this is harder with medical and life sciences devices whose hardware and embedded graphic user interface (GUI) software is tightly intertwined.

The answer is to use a prototype, “something that makes your ideas ‘real enough to feel’ so you can get feedback from users.” Just as the physical aspects of a product are modeled with increasing levels of fidelity, user interface prototyping progresses through several stages according to where you are in the development process and the kinds of questions you need users to answer. Here’s how to use prototypes appropriately for where you are in your development process.

“I’ve got an idea…” – Low Fidelity Prototypes

When you’re in the early stages of a project, it pays to explore many different approaches. Low-fidelity prototyping gives you time to generate more ideas instead of sweating the details on only a few, and keeping the investment low allows you to throw away ideas that don’t work.

For example, on a recent food tracker project, we wanted to explore some of the following questions:

  • When people look at the device, is it to check status or take an action?
  • What actions are most important? Most urgent?
  • What’s the most important data? What data can we get rid of?

We began by sketching on paper so we could concentrate on ideas vs. design details. We came up with concepts that represented a range for each of those questions. Once we had a good variety of approaches, we sketched them in PowerPoint to share with the rest of the team.

Keeping things simple helps you, your users, and your stakeholders focus on what’s most important at this stage:

  • Overall organization of functions (conceptual model)
  • Information hierarchy
  • Navigation

Here are some examples of the many low-fidelity prototyping tools available:


Prototyping on paper is easy to understand, fast, and inexpensive. Grab a notepad and some markers and have at it. It doesn’t have to be fancy; it just has to communicate your design.

Once you have a set of screens, run a quick usability test by simply stacking up your screens and asking users to point to what they would tap or click on. Then make quick changes by overlaying sticky notes.

If you want to automate things a bit more, snap pictures with your smartphone or use a tool like POP (Prototyping On Paper) for even more interactivity.

Microsoft PowerPoint

Almost everyone has access to PowerPoint and its simple drawing tools. By using these tools and PowerPoints ability to import icons and other images, you can quickly build concepts to show users, and share files with other members of the team so they can add their own tweaks. You can even add animations and hyperlinks to make your prototype interactive and get a better idea of where the design can be improved.

Balsamiq Mockups

Balsamiq is a powerful tool for quickly building user interfaces. It has a huge number of built-in controls that you can drag, drop, and rearrange. Its goal is to be as fast as paper sketching while still providing the advantages of drawing digitally. It lets you make changes without starting over, reuse elements over multiple screens, and has the ability to resize and rearrange graphics.

Another great Balsamiq feature is its “sketchy” appearance. Having things look a little rough reminds the team that the design isn’t final, and prevents people from getting hung up on appearance when giving feedback.


“How will this really work?” – Medium-Fidelity Prototypes

Once you’ve decided on an overall approach, you’ll want to design more of the key workflows and conditions users will encounter in the real world, such as initial startup, normal use, and error conditions. Making sure you think about every conceivable state of design will prevent surprises when you get to development and help ensure a seamless user experience.

Prototyping at medium fidelity helps you evaluate questions like:

  • What’s the right amount of information density on a screen?
  • What terms make the most sense to users?
  • How can we use color, icons, and graphic design to communicate information simply?
  • How well does my screen interact with physical buttons and other interface elements?

On slide 1 - Here’s an sample from our food tracker, showing the hardware buttons drawn on-screen so users can click them.

As you can see, we’ve added colors, icons, and a schematic of the hardware buttons. Adding these details and testing them with users helped us change course and gave us more confidence that we had addressed the riskiest areas of the design.

At this stage you’ll be sharing the designs in progress with an increasing number of stakeholders on your team. Showing them prototypes helps you gather input, build support, and uncover design issues more effectively than written specs or static wireframes.

A helpful tool at this stage of the process is InVision.

InVision is an online prototyping and collaboration tool that’s quick to learn. You create screens in your drawing tool of choice and import them to your InVision project. You then link the screens using “hotspots” to simulate workflows. Users click the hotspots to simulate tapping the hardware or software controls, and the app even simulates gestures like swiping and double-tapping.

When change the design (which should be happening often as you iterate), all screens are updated, with InVision maintaining hotspot locations and a version history of each screen.

The prototype can then be shared on the web or loaded onto a tablet or phone for testing offline. The LiveShare feature lets multiple remote collaborators work on the design together, allowing them to point and sketch on the screen so everyone sees what part of the design is being discussed.


“Let’s build this thing” – High-Fidelity Prototypes

After several iterations of designing, testing, and refinement your team will be converging on the final design. Now is the time to make sure you get the nuances right, and can clearly describe every detail to the people who will be implementing the design. High-fidelity prototyping tools can help you experiment with more complex interactions, communicate the design to the development team, and begin testing the design on real hardware.

If you are blessed with a development team that is close by and can rapidly implement the user interface, you might be able to skip a high-fidelity prototype in favor of coding the real thing. If not, prototyping can help reduce your risk.

For example, our food tracker relies on a slide-up keyboard that animates into position. Trying to describe the slide-up gesture, the animation, and the appearance of keys being pushed with nothing but static screen images or text left a lot to (mis)interpretation. With a high-fidelity prototype we were able to clearly show the developers our intended product behavior.

Here are a couple of high-fidelity prototyping tools:

Axure RP

Axure RP has vast libraries of pre-built controls (buttons, text fields) and behaviors that let you simulate data entry, conditional logic, and animations. For example, you can allow a user to enter data by tapping on the keyboard, animate the keys pushing in and out, and then take different actions based on what value was entered.

You can build your screens with Axure’s built-in drawing tools or import from other drawing software. One of Axure’s more powerful features are “Masters,” which let you create reusable components so that visual or behavior changes can be made in one place but applied throughout your prototype.

Crank Software Storyboard Suite

Crank Software’s Storyboard Suite bridges the gap between prototyping and production-level implementation for embedded devices like medical products. Using the suite’s Storyboard Designer component, you import Photoshop files and link them into a prototype. Developers then import the prototype into your target hardware where the Storyboard Engine component translates your screens into real code for production deployment. This bidirectional workflow lets your designers and developers collaborate closely to fine-tune the design as you go through formative and summative testing.



User interface prototypes can help you lower project and usage risks while shortening the development cycle and reducing costs. They can help you understand what your users need and ensure that your whole team has a shared understanding of the product design.

And remember these tips:

  • Start small – prototype the user’s main workflow(s) and areas where use errors or safety issues could occur.
  • Test your design with users early and often. The earlier you find issues the less costly they will be to fix.
  • Don’t overinvest – you need to be willing to throw away what you’ve done.
  • Start with low fidelity prototypes to get the right organization and navigation scheme.
  • Progress to medium fidelity prototypes to work through design details.
  • Finish with high fidelity prototypes to test nuances and communicate to your team.

Topics: medical device, user interface, user centered design, prototyping

Overview of Latest FDA Guidance Documents for Medical Device Development

Posted by Kate MacNamee on August 31, 2016

The FDA recently released the latest version of three guidance documents addressing unique device identifiers, adaptive study designs, and real world evidence in regulatory research. In addition, two guidance documents related to whether a 510(k) is needed when making changes to an existing or pre-amendment device were released. To get a better sense of what these guidance documents will mean for medical device product development, we took a closer look at each, and have provided our insights below.

FDA Guidance’s

Adaptive Design for Medical Device Clinical Studies

Adaptive studies involve a prospective (i.e., a priori) alteration to the clinical study protocol, and often require careful planning in the design phase. This guidance relates most strongly to feasibility studies or pivotal clinical trials, and provides important suggestions and parameters for the conduct of such studies to maintain proper empirical and ethical boundaries during the course of research.

At the core of adaptive design are two principles: plan ahead, and be transparent. All plans to change the study protocol, whether the change pertains to sample size, longevity, or analysis, need to be justifiable for the benefit of the study and, most importantly, the benefit of the patients and end users of the device being tested.

Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

In September of 2013, The FDA came out with the Unique Device Identifier (UDI) rule, which states that any medical device used and marketed in the United States must have a UDI, which an FDA-accredited facility would provide.

The UDI must be present in two forms: plain text as well as automatic identification and data capture (AIDC) technology (i.e. barcode or similar technologies). The plain text is present so that health care providers, patients, FDA members, and other device users accurately record and enter the UDI as data when needed. AIDC technology, on the other hand, allows for fast and accurate data communication and record keeping within and across facilities.

The guidance itself is short and to-the-point. It totals ten pages, and provides instructions as to acceptable sources and technologies needed to obtain a UDI for your product.

Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices

This draft guidance is meant to supplement and support the regulations already in place for evidentiary support in medical device approval applications. It details the types of real-world data (RWD) that have the potential to inform the FDA of device use patterns and efficacy. Examples of RWD might include administrative and claims data, quality improvement registries, and electronic health records (EHRs), and it can be helpful when sponsors are looking to conduct postmarket surveillance, expand indications for use, carry out post-approval surveillance commitments, identify a control group, etc.

Still, the guidance emphasizes that the consideration of this type of data is varied, and its acceptance depends heavily on the extent and quality of data that sponsors are able to obtain. Some sources of RWD might be appropriate for postmarket surveillance only, whereas others might also be able to inform premarket decisions regarding product safety.

The inclusion of high quality (reliable across collection sites and/or over time) RWD as evidence in both pre- and postmarket development can be a cost savings and might prove useful for those products which significantly benefit patients, therefore, it should be distributed as soon as possible. It is important to keep in mind, however, that RWD could still fall under investigational device exemption (IDE) regulations, and whether or not IDE regulations apply would be determined on a case-by-case basis.

510(k) Submission for Existing and Pre-amendment Devices

The FDA also recently released two guidance documents to help sponsors and manufacturers determine whether a new premarket notification or 510(k) is needed when making changes to an existing or pre-amendments device. One is for devices, generally, and the other is for software products. There are a series of very helpful flow charts within the guidance documents that help manufacturers determine the need for a new 501(k). Ultimately, however, the FDA asserts that they will make decisions on a case-by-case basis. The dynamic nature of the medical device field makes it difficult to create hard and fast rules that can apply to a diverse set of devices. These guidance documents do their best to convey the types of changes that will require a 510(k) by emphasizing that, at its core, a 510(k) is required when changes to the device significantly affect the safety and risk associated with proper use of the device. This might seem somewhat vague, but it can be applied to everything from labeling to material changes. When making the decision as to whether or not your device will require a new 510(k), it’s best to refer to the flow charts provided or communicate directly with the FDA.


Topics: medical device, Medical Device Development, product development

Medical Device Materials: Turn Up the Steam with Polypropylene

Posted by Bob Ketelhohn on January 29, 2016

It was not that long ago that when a client mentioned the words “plastic part” with “steam sterilization,” the only medical device material options that came to mind were high-end plastics like PPSU (Radel®) and PEEK. Yes, those materials are expensive in the plastics world, but they work and are known quantities. As my college statics professor always said, “When in doubt, build it stout, out of things you know about.” Good advice, unless cost suddenly becomes priority number one. Increasingly today, polypropylene (PP) is successfully going toe-to-toe with far more costly materials in the steam-sterilized medical device market.

I’m one of those odd engineers who actually enjoy going to plastic compounder conferences for material technology updates. Over the past few years, PP has shown up more often in the high-performance technical offerings in which durability and steam sterilization are combined requirements. What’s not to like? PP offers strong resistance to steam sterilization, very low cost, a wide array of mechanical performance characteristics achieved through different additives, and even recyclability for increasingly landfill-averse European markets. PP also has one major advantage that the others are still trying to figure out: soft elastomer overmolding that is chemically bonded. More on that later.

I was curious, so I went to and looked up the overview of mechanical properties for a few of the more popular steam-resistant plastics used in structural components.

Medical Device Materials Table






As you can see from the general numbers listed above, PP is not that far off from the other materials in terms of strength, particularly when you start adding glass. There are also more exotic ways to strengthen PP, like adding long glass fiber or carbon fiber, but then you lose the cost benefits and molding tool life. Now, would I go out and replace every laparoscopic scissor/grasper handle with PP? Probably not, considering the high loads and precision feel required in those tools. However, there are plenty of other, less functionally critical medical device parts that should be considered. As I wrote in a previous blog, Intelligent Engineering: Utilizing Data to Impact Tomorrow’s Design, finite element analysis is a helpful tool for making material decisions by providing preliminary feasibility simulations.

Recently, I worked on a grip component that was a legacy part made from injection-molded PPSU. While surgeons do grip this particular part, there are no major bending loads translated through it. The designers refined the ergonomic shape while I worked with material suppliers to come up with the ideal steam-capable plastic and overmolding. In the end, we reduced the cost of goods by many orders of magnitude by using 20 percent glass-filled PP combined with a soft durometer thermoplastic elastomer (TPE) overmold to eliminate a couple of O-rings. The product requirements called for the part to function after 10 steam sterilization cycles, and this particular part passed without any issues (it probably could have tolerated more). It will be packaged and sold as a disposable, but many European hospitals tend to sterilize anything that still looks usable, so we determined that surviving 10 cycles would be appropriate.

In terms of overmolding, PP is the Holy Grail of materials. Most of the higher-performance and lower-durometer-range TPEs are polypropylene based, which makes it much easier to bond hard materials to soft. For overmolded seals in particular, TPEs unlock design freedom that was thought impossible just a few years ago. Granted, overmolding requires another tool, but with low material costs and the highest-quality design it affords, overmolding pays for itself quickly. I understand that great strides have been made with bonding silicone to PEEK and PPSU, but again, those are more costly materials whose high level of functionality is not always required.

I’ll admit that PP is not all unicorns and rainbows. While it flows like water during molding, sink marks, swirls in the surface finish from glass reinforcement, and shrinkage can be significant challenges. Also, the inherent flexibility of PP needs to be considered when the user’s feel is a high priority, but 20 percent glass-filled is a good compromise between tool life and product rigidity. Heavy walls are another limitation of PP. I worked on ConMed Corporation’s DetachaTip Laparoscopic Instrument not too long ago, and specific sections of that handle were over 0.25 inch thick. We could have “faked” thickness with ribs, but a ribbed part doesn’t always feel or look the same as a solid part. Consequently, we made that handle from injection-molded PPSU.

ConMed DetachaTip Laparoscopic InstrumentIn closing, this is why I love polypropylene:

  • Let’s be honest. It’s cheap!
  • It withstands repeated steam sterilization cycles like many highly engineered plastics.
  • With the right combination of additives, polypropylene can be made strong, and more importantly, stiff.
  • You can overmold directly to it with PP-based TPEs that will also survive steam.
  • Creative designers can work around many of the molding and mechanical performance shortcomings.
  • It’s one of the most widely recycled materials, so it can be used to accommodate sustainability goals. .

Topics: medical device, engineering, Medical Device Development

Health IT +Telehealth Developers: These Users Need Your Help!

Posted by Kristyn Berry on October 30, 2015

The telehealth/health IT industry is in an endless state of innovative disruption, spurred by start-ups, innovators, and technologists rethinking how best to address today’s healthcare needs and improve the patient/doctor experience. In an age when the term “design thinking” has seeped into so many different industries, there is ample opportunity to rethink culture, space, and connectivity and center this on the user experience.

Rethinking telehealth connectivity relates to the redesign of other medical-related technologies as well, such as mHealth and Wearable Health devices. The required connectivity between these products will likely redefine the overarching communication system used to distribute and process the data and resulting insights related to a patient’s health.

This rethinking of culture and space has led to technological advancements in remote patient monitoring, virtual doctor visits, and the increased use of electronic medical records (EMRs). Virtual doctor visits give people living in rural areas access to a wide variety of medical professionals, even though they might be located hundreds of miles from a patient’s residence. And EMRs follow patients throughout their lives — even if they change from one primary care physician to another — making it easy for a physician to access a patient’s medical history.

The growing trend in telehealth has companies introducing products like Salesforce’s Health Cloud, which seeks to make the patient/doctor experience more about “patient relationships, not records,” says Dr. Joshua Newman, chief medical officer and general manager of Salesforce Healthcare and Life Sciences. But when thinking about patient/doctor relationships, it’s important to consider the different types of users who stand to benefit from telehealth technologies, and the important things to consider when developing technologies for these users.

Image source: and veteran populations could greatly benefit from telehealth technologies, considering that they’re located all over the world, in critical situations that place them in physical and psychological danger, and are often put into emergency situations that require immediate point-of-care solutions. A recent article in mHealth News details mHealth and telehealth initiatives that are outlined in the 2016 budget proposal for the Department of Veterans Affairs (VA). More than $1 billion is being put toward these initiatives, many of which focus specifically on mental health treatment, as it is hoped that telehealth systems can help to maintain and improve the treatment of veterans with PTSD and other stress-related conditions. About $30 million is going to interoperability initiatives and $230 million to upgrades to the VA’s EMR system. These upgrades would assist in streamlining the MyVA portal that gives veterans access to VA services from various locations and devices, allowing veterans more involvement in their care and giving medical professionals a better understanding of their needs.

Image source: patients represent another group that can benefit from telehealth technologies, considering that this population often has special healthcare needs that require consultation from specialists who may not be local to where their families live. A report from the American Academy of Pediatrics pointed out that “there is a significant disparity in the geographic distribution of pediatric physicians across the country, resulting in many underserved regions…most commonly found in rural regions, but can include suburban and urban settings.” Telemedicine can offer pediatric physicians the ability to treat and consult with a greater number of patients, resulting in decreased wait times and reducing the need for pediatric patients to travel long distances for treatment.

Image source: patients can benefit from telehealth, especially in the context of home healthcare. An increasing number of seniors are living with chronic diseases and rely on health monitoring devices that are easy and safe to use in the comfort of their own homes. Physicians rely on these devices to collect information that they can view in real time or refer to during an appointment with the patient. Additionally, telehealth technologies like videoconferencing offer physicians the ability to conduct remote-access virtual consultations, creating a huge benefit for older populations with significant mobility challenges. They now have the option of speaking with a doctor from home instead of having to travel to a doctor’s office. The increasing adoption of telehealth systems and home healthcare devices is also driving the need for training in the use of these products, which leads to greater awareness by patients as to the state of their own health.

Image source: wsj.comPhysicians also benefit from technologies like remote patient monitoring and EMRs, and from interactions like virtual patient visits. EMRs enhance the ability of physicians to quickly access patient information from virtually any location. They also promote consistent care compliance by creating a single location from which to retrieve a new patient’s past medical history as the patient is treated among various facilities and by different doctors. This is especially important for patients suffering from chronic conditions. Telehealth technologies also help to reduce the frequency of ER visits, and can free up physicians to devote more time to patients. However, physicians continue to be concerned about the usability aspects of these technologies and the ability of EMRs to achieve interoperability between software platforms. Recent government figures mentioned in an article by CIO show that “48 percent of physicians have adopted EMRs, while electronic records are in place at 59 percent of hospitals.” EMRs should be capable of getting the most meaningful patient information/data to the right people at the right time, and in a perfect world would be able to function seamlessly across hundreds of different organizations.

How can users’ concerns be resolved and their needs incorporated into future telehealth technologies? Here are some suggestions for how developers could address usability concerns:

  • Consider the physical needs and limitations of an aging population and develop technologies that account for their potential auditory/visual/memory/motor impairments and technical experience levels.
  • If technologies are being developed for in-home use, consider the space that a product will require, available power sources, the need for wireless connectivity, etc.
  • Consider the amount of data and information that is presented to the user. For example, a large amount of information may be overwhelming or unnecessary to an elderly user, but may be informative and appreciated by their caretaker.
  • Develop training plans as necessary, keeping your user in mind.
  • Include options that incorporate a multidisciplinary approach for healthcare professionals (HCPs), allowing them to consult other HCPs as they see fit before offering treatment options or making a potential diagnosis.
  • Realize that technologies developed will be accessed by patients with chronic conditions who may require extra assistance utilizing and interacting with the technologies.
  • Physicians naturally seek out technologies that reduce workflow and increase efficiency while giving them confidence that they’re delivering their patients safe, high-quality care. In a TEDMED talk entitled “The Human Factor,” UK physician Pritpal Tamber discusses physicians’ general resistance to change and their feelings of doubt and cautiousness when encountering new technologies. Physicians will be resistant to technologies that are unreliable, increase the steps involved in working with patients, or interfere with their ability to make decisions related to patient treatment.

Topics: mHealth, healthtech, telehealth, health it