By Matt Gottschalk
Designing a medical device or combination product requires immense expertise in risk management to ensure compliance and control liability — and human factors engineering (HFE) is a critical (and increasingly scrutinized) input to this process. But, it can yield major benefits that extend far beyond increasing product safety and appeasing regulatory bodies. We sat down with Matt Gottschalk, Managing Director for Veranex’s European division to discuss.
What is human factors engineering (HFE) as it relates to medical device and drug delivery product design?
HFE is all about observing. It’s about studying how the users of your product react and interact with what you put in front of them. Most importantly, it’s about applying our observations and knowledge of human behavior — physical and cognitive abilities and limitations — to build healthcare experiences that are safe, effective, and don’t go against the grain of human intuition.
It’s important to note that an HFE team does a lot more than run studies and write reports. The real art of this activity is in how study observations are leveraged to influence and improve the design. The best HF engineers can turn their observations into actionable design solutions.
As it turns out, this is so important that the FDA and just about every other major regulatory body now require you to incorporate HFE as part of your design process. Why? There are pretty alarming statistics on how frequently use error actually happens. An estimated 250K Americans die every year due to preventable medical errors — making it the third leading cause of death behind heart disease and cancer.
So you’re telling me I have a new regulatory requirement to worry about now?
Technically, yes. For certain devices, (mainly Class II and III), the FDA requires you to incorporate human factors activities into your design process and oftentimes requests that data from your evaluations are included within your premarket submission. The FDA recently published a list 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 use-related risk, HFE data need to be included within your submission.
I say “technically” because HFE is a best practice of good design — I’ve never been a fan of calling it a regulatory requirement, although that’s still an important fact.
So how does one “do” human factors?
The FDA and a number of standards organizations (IEC/ANSI/AAMI) have released guidance on best practices for incorporating human factors engineering into the medical device and combination product design process. IEC 62366-1:2015 is the most commonly referenced in the industry (coincidentally also has the catchiest title).
These resources are great places to find education on what this process looks like. Today, many companies recognize HFE as a vital part of their organization, and they either have dedicated R&D resources on staff or they hire experienced organizations like Veranex to help them execute.
This sounds expensive and time consuming.
This is easily the top concern I hear from clients. “How long is it going to take and how much is it going to cost?” I tend to be annoying and answer this question with, “Do you know how much not doing this costs?”
The truth: You’re likely costing yourself by not effectively integrating human factors into your development process. Let me show you what I mean.
As you move through the various stages of product development, design changes and cost are inversely related. The same tends to be true in terms of the innovative impact these changes will have.
Unfortunately, it’s pretty common for companies to wait until they’ve reached what they believe is their final design to start evaluating it with users. Since changes become more difficult and costly at this point, instead of being able to leverage all of the feedback from your usability studies to make really valuable improvements, smaller compliance-driven changes like updated labeling and instructions are made instead. “Band-Aid” fixes like these may sometimes fulfill your risk management plan and regulatory duties, but rarely do they lead to a better, safer product.
So who loses in this scenario? The user certainly does — especially if they are injured. But who loses when they discontinue using your product, move to a competitor, file a lawsuit, or tell a friend or colleague about their negative experience? Unquestionably, your business loses too.
What’s really unfortunate about all of this is that, with simple planning, HF activities can often be done in parallel to other work. Rarely should they add significant time — unless they are done ad hoc.
So, “Do you understand how much not doing this costs?”
I understand its value, now how can I get my company to commit budget to HFE?
If you want to gain traction with your leadership team, you have to speak their language. The reality is that no matter where you are or what company you work for, every project has three major constraints: timeline, budget, and scope. Changes in any of these constraints means others must compensate, otherwise, quality suffers.
That means if you’re adding HFE to scope, in their mind, it is going to add cost and time. Your task is to prove that this is a fallacy and the upfront investment is worth the benefits in quality gained.
I tend to have the most success in gaining leadership buy-in when I use examples. So here are a couple of simple scenarios you can use:
Product Recall Cost Avoidance
A very tangible example of where an HFE investment is going to save you in the long run is avoiding product recall costs.
Let’s say last year you had a product recall due to use-related error of 10,000 units at $1,000 each (and we’re completely excluding the cost of potential lawsuits here). In total, just replacing the updated devices cost your organization $10M.
You’re confident that the root cause of this use error would have been identified if a stronger HF/usability program were incorporated into the development of the product. Unfortunately, your proposal of adding $500,000 in HF activities was denied.
Even though the upfront investment would have been large, the cost avoidance of performing HF would have proved to be much larger (1900% return on investment).
Hindsight is always 20/20 with these types of events, and, unfortunately, many companies get burned a few times before this lesson is learned.
Churn, or rate of attrition, is the percentage of customers who discontinue using your product or service in a given period of time. Now imagine each unit you sell produces $1,000 in annual revenue and you plan to invest roughly $250,000 in HF throughout development and postmarket activities. You end up with a better, more usable product — customers are happy and churn decreases.
This is a very simple example, but say the product has a 10-year life span and you avoid 250 returns per year ($250K).
Summing It Up
There are clear benefits to having a robust HFE program and a lot of tangible ways to prove its value beyond the ideas presented in this article. I like to think there is a lot of common sense involved — but to actually fund these activities, we often face an uphill battle on our own turf because of limited resources. Even if you are convincing, you must still ensure it is appropriately embedded in the DNA of your design process.
HFE becoming a regulatory requirement has, at the very least, catapulted it as a major topic of discussion for R&D teams and we are seeing a much wider spread adoption of it in some of the largest companies around the world. Sometimes the best way forward is a successful first project — and experienced healthcare product development firms like Veranex can support your R&D organization in whatever phase of development you’re in. Want to build something with us? We’d love to partner with you.
Managing Director, London
He is responsible for managing the success of the project portfolio as well as point person for all key pharmaceutical and medical clients in the region. He specializes in human factors consulting, is a master of usability study planning, and has a background in information technology innovation.