Interview GuideParticipants.Heidi Mehrzad, HFUX Research Helene Quie, Qmed Consulting A/S

Technology.Simon Sunde, SundeMedia ApSHelene Human factors and usability, often used interchangeably. Yes, it can be a tricky topic,

and by one that can create some confusion, and that's why on this episode of the Qmed podcast, Heidi Mehrzad from HFUX Research and I will work our way through the process of Human Factors Engineering and touch on some important nuances of human factors and usability and the benefit of applying the human factors engineering process when developing a product/medical device/combination product.

Today, we will talk a lot about topics that are important and relevant and timely. This topic human factors normally creates a lot of confusion, and often raise a lot of questions, and many more discussions. Therefore, today I am here with Heidi Mehrzad from HFUX Research, and we're going to deep dive into human factors engineering.

Heidi’s background and experience working within Human Factors Engineering and Usability aspects.

Heidi Mehrzad is a Human Factors Consultant and the founder of HFUX Research, with over 15 years of experience in human factors and usability engineering, testing, and field research.With an extensive background in the medical field as an EMT, as well as working within the medical device and combination product development industry for the past 15 years, her passion has been directed at identifying best methods and techniques for optimizing human and product performance, in order to develop the safest and most effective product possible in order to improve usability, user experience, and ultimately user safety patient safety and quality of life.Conducting international field studies in professional medical environments, as well as home health environments, her focus has been on medical imagining and surgical navigation in endoscopic surgery, cardiology, electrophysiology, pulmonology, as well as home healthcare devices, such as combination products, such as drug delivery devices, and home health applications. She holds patents in GUI design for medical imaging and navigation software systems. She’s worked and conducted research in the U.S., as well as Luxembourg, Italy, Spain, Denmark, France, and Switzerland. She holds a BS in Aeronautics and a MS in Human Factors and Systems, both from Embry-Riddle Aeronautical University.

So Heidi, welcome.Heidi Introduces herself……(see above)

Hi ;-) Thank you for having me. It’s a honor to be part of your podcast series.Helene Topic for today is Human Factors Engineering and Usability for Medical Devices and

impact of the MDR.

Heidi, You and I have talked quite a few times about design controls, risk management, clinicals, and the role of human factors in it all. When to apply which activity and how much of it is enough? Regarding Human Factors Engineering and Usability, can you try and walk us through what the specific terms stand for and where does the requirement come from? Are there differences between the requirements to apply in EU and US?

Heidi Answer could touch on: Definitions; Human Factors and Usability Engineering

Sure, well, as far as terms and what they stand for…

Human factors is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, taking into account their capabilities, limitations, and tendencies; and the profession that applies theory, principles, data, and other methods to design in order to optimize human well-being and overall system performance. It falls underneath the field of applied psychology.

Ok, so what does that mean?

Human factors is the practice of designing products, systems, or processes to take proper account of the interaction between them and the people who use them.

Ultimate goal of human factors is to understand user interactions with products and systems to optimize the user experience and overall system performance and minimize the risk of use errors.From an FDA perspective it’s goals in general are to achieve: Safety (patients and users) Ease of use (transparency) Ease of learning Efficiency of use Subjective appealAnd from a practical point of view, applying human factors is to: To avoid mishaps Establish advantage by designing and engineering a better product in respect to the user and

their workflow and user needs To sell devices, particularly in mature markets Reduce production, development and training costs, as well as maintenance costs by

addressing more concerns upfront during the definition phase, opposed to later in the development, or even during maintenance and training

Now, usability… Is an element of human factors; It is the goal when designing a product; Refers to the ease of use and learnability of a human-made object and the understanding of

how users interact with these objects; It is the measure to apply when evaluating a product;

Usability is a component of human factors that is directly focused on effectiveness, efficiency and satisfaction. It is also focused on creating qualities of UIs that result in rapid learning, user satisfaction, and efficient interaction. The term ‘usability’ is a multi-dimensional quality that refers to the ability of a human to interact easily and relatively error-free with a system or product. There are 3 major components to understanding the usability of an object. Ultimately it comes down to knowing your: Device users Device environment Device user interfaces and their tasks Terms such as ‘user-friendly’ and ‘intuitive’ have emerged as descriptors of usability which translate to subjective attributes regarding whether a system or device works and acts in the way the user expects, therefore avoiding frustration and annoyance in carrying out an intention. It can be measured and scored in usability tests conducted on products.

So how is Usability measured? You can use the 5Es to understand users and their needs…Is it Effective: How completely and accurately the work or experience is completed, or goals reached.Is it Efficient: How quickly this work can be completed. (Efficiency of use)

Is it Engaging: How well the interface draws the user into the interaction and how pleasant and satisfying it is to use. (Subjective satisfaction)Is it Error Tolerant: How well the product prevents errors and can help the user recover from mistakes that do occur. (Also, known as Error frequency and severity.)Is it Easy to Learn: How well the product supports both the initial orientation and continued learning throughout the complete lifetime of use. (Also, known as Memorability, Ease of learning.)

So…

Human Factors is the science we apply to research, design and engineer a product with respect to the end user.

Usability is the goal and measure used when evaluating these efforts with respect to the end user.

Human factors is a method to achieve usability.

Where FDA and EU requirement are coming from (special incidents or case)?

Human factors as a science and the study of it actually goes way back and found its beginnings in the aviation and transportation industry, often concentrating on high stress human-machine environments, like the cockpit in an airplane, or the train driver in railroad engineering, with making its greatest strides and advancements during WWI and II, while engineering, technology, and innovation was soaring – and then makings its way through all complex engineering industries, such as nuclear, automotive, surgical theaters, all the way to medical device development. Key always being on the focus of improving the human-machine/system/device interaction and avoiding quote on quote “human error” with them, in order to achieve optimal and safe human and product performance.

With respect to the FDA and EU requirements and their origin, they also have been present for quite some time. For example, the need for human factors has been implied for a very long time under the FDA Quality System regulation, 21 CFR 820.30, under Design controls.

But it wasn’t until 2007 where one of the biggest official standard concerning “usability” and the application of human factors to achieve it, came out, the IEC 62366, replacing the up until then very loosely followed guidance IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability – which was first published in the 70s or 80s (don’t quote me), where medical device companies started understanding that it wasn’t just an “added” bonus to your device development process, or a fancy luxury to have your device be “safe, effective, AND usable”, it now was an official requirement. And then the usability movement in the medical device development industry started taking off. Manufacturers started to understand more and more that usability wasn’t just implied anymore, instead required. So with that the need for more guidances and standards started growing, with ANSI/AAMI publishing HE75 in 2009/(R)2013, Human Factors Engineering – Design of Medical Devices (Section 9, Usability testing), and the FDA publishing its first draft of Applying Human Factors and Usability Engineering to Medical Device in 2011, finalizing it in 2016.

Guidance documents in both regions.

The human factors engineering process, usability testing, and risk management guidance is provided in documents, standards, and guidances, such as: IEC 62366-1: 2015, Medical devices – Part 1: Application of Usability Engineering to Medical

Devices, adopted in the United States as ANSI/AAMI/IEC 62366-1:2015. IEC/TR 62366-2: 2016, Medical devices – Part 2: Guidance on the Application of Usability

Engineering to Medical Devices, adopted in the United States as AAMI/IEC TIR62366-2:2016.

FDA Final Guidance (2016), Applying Human Factors and Usability Engineering to Medical Device.

ANSI/AAMI HE75:2009/(R)2013, Human Factors Engineering – Design of Medical Devices (Section 9, Usability testing).

ISO 14971: 2007, Medical Devices – Application of Risk Management to Medical Devices. ISO 14971: 2012, Medical Devices – Application of Risk Management to Medical Devices. FDA’s Quality System Regulation.

Recently the FDA has been making a great effort at putting out more detailed and topic specific guidances, such as ANDA specific, HF comparative analyses, and combination and biologics guidances. All great to read and dive into to seek more comprehensive understanding on the topics and the overall HF world, but also great for tips and guidance on what to do and how to do it. While they are all applicable, the FDA guidances, while doing a wonderful job at explaining the human factors and usability engineering process applied to medical devices and combination products, they naturally concentrate on FDA’s preferences in documentation, activities, and order of all.

Now, how much and what activities to apply is actually completely dependent on the product to be developed. Obviously, there are general steps every product development process should follow, ensuring an HFE plan is in place, formative and summative testing is being conducted when needed, applicable, and required, use-risk analysis is performed alongside, identification of critical and essential tasks is performed, as well as ensuring actual user needs are addressed. An optimal HFE process will also include initial exploratory research to ensure the correct user needs are uncovered, addressing usability issues in similar products on the market, or if new, the actual users are observed in their actual use environments to establish what gaps are to be filled with this device to be developed.

As far as “how much”, I am a human factors professional, so I will always advocate for more, as I am very aware of how the benefits of human factors are directly correlated to the quality, safety, effectiveness, and success of a product. But in all honesty, you know you have achieved the optimal amount of human factors when you have exhausted all design use-related risk mitigations, you have evaluated and validated your product with actual users, and you have found it to be safe and effective for the intended use by the intended users in their use environments, and that without them harming themselves; and the users are actually experiencing a pleasant and uncomplicated use of your product, because it is addressing a formerly unmet need, or improves their quality of life in patient’s cases. And that is only achieved by actually implementing the human factors engineering process fully into your product development process and then carrying out its activities when needed and required.

Helene So now being a small start-up company with good funding. What would be the process that this company ideally would go through in respect to Human Factor Engineering?

Heidi Answer could touch on: When in the Design Control process initiate your usability activities. Goal is to

define the parameters that would make the medical device safe and effective for real patients under real conditions of use.

Ideally, no matter the size, should implement the HFE process fully into their product development process in a manner that integrates human factors from the very beginning or every product development project, whether it is a brand new product with no similar products on the market, one with a history of predicates, or even a follow-up version of an already previously developed product, like a 2.0 version. This means that when you first sit together around a table and discuss the “idea” of a new product, a human factors should have a seat at the table as well, as his or her perspective will always represent one of the most critical ones, and that is the one of the actual user who will eventually be the one using your product. The users are the ones you are creating the product for, so they should be represented at the table at all times. This means, that when you are proposing a new project and are writing a project outline, human factors should be involved.

When you write your product development plan, a human factors engineering plan should be written alongside. When you gather and define your product requirements, it should be done alongside its user and usability requirements. When your product is tested for functionality, it should be tested for usability. When it goes through design verification, it should go through usability verification, when design validation takes place, usability validation should be included. I am sure you are noticing a trend here… human factors and usability is there from beginning to end.

Establishing a Competitive Advantage by;o Understand how users feel about the deviceo Understand how the device performs in relation to its competitors

The reason why you should integrate human factors from the beginning to end, is honestly one of the most basic ones and that is, in order to address users needs through design, you need to establish an understanding of how users think how they operate with current solutions, where the gap is between those and the users need, and finally how the users end up using your device and with that also feel about it. This is what will set your device apart from others. This is how you create a competitive advantage to other manufacturers and device makers – simply by developing a product design to meet users needs optimally. Not overloading it with useless and unnecessary functions, not to overwhelm a user, but also not keeping it so basic that the user experience is completely ruined. It’s that fine optimum you should strive for, and honestly that is only achieved by considering the user, performing human factors research, considering user experience, safety and effectiveness in your design, testing it with actual users (usability testing), in order to ensure you have addressed the users needs from all angles.

How to establish the research aspect of the identified problem company is trying to solve.

And this starts in the beginning with performing human factors research. From my experience this is best achieved when you perform initial exploratory research, or even observational field research, in which you study how actual users perform in their environment with current solutions on the market. Or if you don’t know yet what you are trying to create, but you know there is a problem, study the problem. Again, get into the field and observe people’s habits, workflows, tasks included to achieve a goal, use steps inbetween, how many, how cumbersome something is, how many gaps the current solutions on the market have to meet users needs, and so on. Take the time in the beginning of a project, invest time, resources and money to uncover unmet needs in the market, and then identify the human factors needs to address such. It will save so much time, money, resources, and headaches later in the product development process, I can guarantee it. Because it is always easier to change a list of requirements, make changes to a design in your drawings, or even tweak a prototype, then to try to figure out in the end stages how to address usability challenges, when your molds have been made, or worse when your already in validation stages or are even worse than that when your product is already relases to market.

What are the primary usability questions to address?

Well, for that think of the bigger picture.You want to first identify the problem, then identify the system or device by asking: Who? What? Where? When? Why? How?And then conduct research addressing some core values of system or device performance, such as:

Usability Effectiveness Flexibility Safety And efficiency

What methods to use?

This is done with all sorts of methods. Human factors and usability research comes with a plethora of tools and methods in all stages of the development process, from exploratory, to directional, to evaluative, all the way to validation.There is for example: ethnography, focus groups, interviews, workflow analysis and all many more in the exploratory beginning stages. Or for example: expert reviews, error analysis, heuristic reviews, preference testing, and our favorite – usability testing, for the directional and evaluative stages.

Which document to developo User Specificationso User Interface specificationo uFMEA o Usability Engineering Plan

As for documentation, from an FDA and 62366 (which is used as the general guidance also applying to the European markets and worldwide for that matter) perspective, its become a very unified thinking as of these last years, which is that you should: Establish your HF/UE plan Identify your user needs Prepare your use specification Identify user interface characteristics related to safety and potential use errors Identify unknown or foreseeable hazards and hazardous situations Identify and describe hazard-related use scenarios Which all falls under your Use-related Risk Analysis (URRA) Establish your User Interface Specification Conduct your formative testing: usability testing and record such in your formative test

reports, addressing your URRA, in order to identify and evaluate optimal design mitigations for such, in order to mitigate risk

Then select the hazard-related use scenarios for summative evaluation Establish user interface evaluation plan, which means develop your Human Factors/Usability

Validation Plan/Protocol Conduct summative/validation testing and write your Human Factors/Usability Validation

Report And then finally for the FDA, summarize this entire human factors engineering process from

A to Z in the human factors engineering report

I often meet that a product should be easy to use. How to define and measure the product requirement “easy to use”.

Well, there is no general definition, but when you think about on a rudimentary level, the more you involve the actual users in your design and development process, the more unmet needs you will uncover, the more safety and usability issues you will identify, allowing you to address more potential use errors, the “easier” your product will become. But remember, usability isn’t just about something being “easy to use”, you should always think about whether your product is:

• Effective• Efficient• Engaging

• Error Tolerant• AND Easy to Learn/Use

Helene Can we briefly touch on what the difference is between Formative and Summative testing and the difference in set up and timing during the development phase.

Heidi Answer could touch on: Nature of Formative testing

Formative testing is for directional purposes, or to evaluate an element gain insight and know in which direction to head, and for verification purposes… and is conducted while the product is still “forming” or being developed…

It was formerly known as “Verification Testing” Conducted while product is in development, early and often

o Are part of the human factors engineering processo Conducted iteratively o Inform product design and use-related risk analysis o Uncover additional user requirementso Identify additional use hazardso Make design refinements

While FDA does not review results, a summary of formative testing is included in your human factors engineering summary report that is required at submission, and the FDA can also

o Typically requests summary of formative results Key findings changing product design (including materials) Updates to user interface and risk analysis

Formative Testing is:Conducted while the product is still “forming” or being developed Testing can involve simple product mock-ups, early prototypes, or even partial designs (e.g.,

components) operating in simulated-use modes Test participants should be representative of the intended user population(s) The Sponsor to determine how these evaluations should be conducted. The decision to perform formative evaluations is left to the Sponsor. However, note that: Formative evaluations are part of the human factors engineering (HFE) process to optimize

the product user interface o Conducted iteratively o Used to inform the product user interface as well as to update the use-related risk

analysis (URRA) At early stages, use-related problems can be addressed more easily and less

expensively Agency Review of Formative Studies FDA does not review the results of formative studies in its entirety because the product

tested in such evaluations may not represent the final finished product However, FDA typically requests for a summary of formative study results, which discusses:

o key findings and any changes made to the product and/or labeling o how the findings were used to update the user interface and risk analysis

Determining the Number of Formative Studies to Perform How many formative studies to conduct is ultimately determined by the Sponsor However, note that the following can be assessed through formative evaluations:

o Specific aspects of the product user interface o Design options and modifications o Product labels, labeling, and packaging o Instructions for Use

Iterative modifications of user interface based on formative results

Nature of Summative testing

Summative Testing is: Previously called “Validation Testing”

Required for FDA and CE approval Based on risk analysis (URRA) Must be in actual or simulated environment Minimum 15 users from each profile Must use the final to-be-marketed product design Very specific protocol and report IRB submission and approval (required)

The steps needed to create a human factors/usability study.

Study design Intended users, use, use environment, training, etc. Recruitment of actual representative users in the demographics and geographies where

product will be distributed and used. Production equivalent device 15 users per distinct group Study protocol (use-risk analysis, critical and essential tasks) IRB submission and approval FDA protocol review Conducting study Data analysis and reporting Consulting an HF expert, not just winging it

Helene Can we touch on the understanding of what is clinical investigation compared to a usability study? In general, there are a misunderstand and some companies also try and combine these two activities. Are these the same thing? Are these different things? Maybe share a bit of thoughts about where they’re the same and where they’re different.

Heidi Answer could touch on: Users versus patients What happens when users are also patients?

Fundamentally the only difference most likely is in availability for testing, due to a factor of how prevalent or uncommon a disease or medical condition is in patients.

However, form a process and testing standpoint they are very much alike. You still look at the “user”, whether patient or common user, the same. You look at their capabilities, habits, limitations, skills, background, environments, etc. and then design to address such.

The only thing where things become tricky is when you are looking at orphan disease patients, where you have to consider surrogates for testing. But the design process should remain the same.

Helene What are overall the benefits of Human Factors Engineering?Heidi Answer could touch on:

Besides allowing you to develop a superior product to others, because it is developed in line with actual users needs, addressing usability, user experience, safety, effectiveness, and improved product experience, it also: Reduces errors Increases productivity Reduces support costs Reduces training time and cost And it can Increase job satisfaction for people having to interact with the devices, such as

healthcare professionals for example, in reducing their stress, challenges, and anxieties around complex devices.

Helene I’ve heard stories of a lot of companies when they do usability and human factor studies, one of the steps in that study is for the operator or the user to read the DFU as part of

human factor studies. Other give the user the products and then observe. They do nothing except from writing down what the users are doing while using the product.What to do if consider if they don’t read the instructions? What risk mitigation to do? Relationship between design controls? Putting something in a DFU as a risk control as a risk mitigation. That’s not an effective mitigation. This is one of the reasons why the ISO says that labelling should not be your primary means of mitigating risk.

Heidi Answer could touch on:

This is a rather tricky subject. While I can completely relate to being on the side of the manufacturer and understanding the challenge of users not reading the instructions, at the end of the day as a human factors professional I am a user/patient advocate. And companies must learn to optimize their labeling and IFU design in order to ensure users are using their materials without issue and difficulties. This means, optimizing the packaging design and labeling to ensure the user understands the MOST critical use steps, warnings, and precautions.

As for users not reading the instructions, or not using them during testing, this is all dependent on what your goal is for the usability test. If it is to test the design of the IFU, then naturally you would prompt the user to read it and then conduct an interview to understand the comprehension level of the user afterwards. However, if you are testing the entire system in the users natural environments and habits, then you cannot prompt them to read the instructions, especially not in a summative test for example, where the goal is to establish of a product is safe and effective as design, exhausting the risk mitigation process entirely with respect to design, hard and software, as well as labeling and packaging design.

Which brings me to your last point, companies falling into the bad habit of “risk mitigating” everything with instructions and labels. The reason why this cannot and should not be your primary risk control and mitigation is very simple and brings this topic full circle – the best labeling and instruction risk mitigation is worth nothing when the user doesn’t understand the text or pictures and goes at it without, or worse, never finds them in the first place and doesn’t read them at all. Then what? Leave the user exposed to an unsafe product because its safety mitigations are in the text that was never read? I mean, we could speculate on and on about great IFU, packaging, and labeling design, but what good are they when the product is poorly designed? And yes, of course there are always instances where the instructions and training for example is mandatory prior to product usage, but again this is part of a comprehensive and well design risk management and design control process, in which human factors is fully integrated, in order to address such situations successfully.

Helene How does our human factor testing differ for these devices that may be used by trained professionals versus the layperson and the common everyday human being?

Heidi Answer could touch on:

From a requirements perspective it is rather simple, when testing the product, formative and summative, you naturally have to apply and “test” the training approach and its materials as well. In addition, you have to consider the individual environments they will be using the product in, which you will have to simulate during testing, especially during summative testing. Therefore, in some cases you will be testing in a simulated living room, while in others you will be simulating a fully equipped operating room. Also, you have to consider the user when they are patients with orphan diseases, as these are not as easily recruited as others, and you might have to swing the demographic net of testing locations wider, in order to conduct formative and summative testing successfully. And finally, in either case, never underestimate how much planning and preparation goes into usability testing. While some can be quick and dirty, as summative test is typically never conducted in under 6-12 weeks, depending on the device, when considering planning, preparation, recruitment, testing, data analysis, and final reporting.

From a product design perspective, you are simply designing for two different demographics and

have to look at their individual needs and backgrounds in order to optimally address the capabilities they bring, such as previous knowledge and skills, and how those could help in designing the optimal human-device interaction.

Helene Heidi, there's a thing that always confuses people and it's around sample size. How many products do I need to do for this? And how many samples do I need for this test and that test? And the human factors areas is certainly one of those areas as well. Human factors guidance talks about an N of 15, so where in the world did this come from? Whatever your sample size that you're proposing, you need to have a rational, a justification, an explanation to corroborate that that total number in your human factors testing, that that's appropriate.

Heidi Answer could touch on:Requirements?

Well, thanks to the FDA it has become a very simply equation, you should always have 15 users per distinct user group and/or condition. This means for a very simple product only having one user group, where training is not a factor, it becomes a total of 15. But when you have for example, which is very common: patients, healthcare professionals, and lay caregivers, and there is a potential for training being or not being provided, now you are looking at 15 trained and 15 untrained patients, 15 trained and untrained lay caregivers and 15 healthcare professionals, as from a knowledge experience, most often they are considered as “already trained”, BUT not for everything, I am just talking for devices that are common to their everyday usage, as for example an injection kit would be. Not complex devices for example surgical theater devices, requiring official training. Anyway, back to our equation, that now has become a sub total of 30 patients, 30 lay caregivers, and 15 healthcare professionals, which makes 75.

I will say, often the required 15 users are split 7 to 8 in trained and untrained, but I have also seen this as not acceptable by the FDA in some cases. Therefore, 15 is the rule of thumb per distinct user group, and then any variation of that should captured in your summative protocol and submitted to the FDA for their review and input to be on the safe side. And honestly, that’s something you should always consider. Early FDA input. Don’t wait until the last minute or go into summative testing without any kind of prior discussion or review with the FDA. It’s just good sense to get their input if you are seeking their approval.

Helene So, Heidi, continuing on, summative / validation human factors testing. What does that mean? And does it have to be done on the final version of the device?

Heidi Answer could touch on:Requirements?

Well, summative testing is a part of your design validation testing/process. You are looking to validate your product from a usability / human factors perspective. This means you are validating that all your use-related risks and identified hazards with respect to use of your devices have been sufficiently mitigated, and your device is safe and effective. And in order to do that it has to be the device you are looking to validate and release on to the market. So, yes, it has to be on the final version, or as FDA puts it “production equivalent”, device. No ifs whens or buts, as we like to say.

Helene What are the human factor requirements for post market surveillance? Any differences between EU and US?

Heidi Answer could touch on:Requirements?

Helene Could you maybe talk about a few of the challenges from a human factor's perspective for people who are developing a manufacturing combination products?

Heidi Answer could touch on:Requirements?

Of course. Like I said earlier, drug companies have only just started their journey into human

factors, as some combination products have been previously considered simply drugs, they are now combination products and therefore require the medical device input from a human factors perspective.

With that being said, there are some key factors that have to be looked at with respect to combination products. First and foremost, is it a biological or a drug that is combined with a device to create the combination product, because that will determine not only submission pathway, but also applicable human factors guidance.

And with respect to product design, identify the primary mode of action and then the key components of such that influence device/medication use: Labeling Packaging ProductAnd then Identify risk(s) of use, which with a combination product you have the added factor of misuse or use errors that can lead to medication errors.

So that means you should be thinking about: That labeling, packaging, product design and nomenclature are key system elements that

influence medication use And to identify how a medication error might occur, a complete understanding of how the

drug will be used is necessary, including: o who will handle or use the product o the chronicity of use o the environments of use o how the end users will interact with the drug product (e.g., the product, container

closure, container label, and accompanying labeling)

Guidance: Safety Considerations for Product Design to Minimize Medication Errors FDA expects manufacturers to develop drug products using analytical methods to

investigate, understand, and correct identified risks These methods should be applied early in drug development to build safety into the product

design and throughout a drug product’s life cycle Goal is to design a drug product that enables safe and correct use and eliminates or reduces

design elements which could cause use related hazardsAs far as testing goes, participant recruitment and availability can become tricky when rare conditions and diseases are involved. Surrogates for such are acceptable, but should always be discussed with FDA prior, to ensure comorbidities and are aligned with FDA expectations.

Helene How to work with FDA in regard to the Human Factor engineering activities? Be proactive and come up with a plan for how you plan to address your human factors before the authorities tell you how to do it. A great opportunity to take it to FDA in advance maybe via a pre-sub.

Heidi Answer could touch on:Personal experience in when and with what to interact with the FDA and what the outcome has been.

Well, actually, like I said earlier, the more you involve the FDA in your early stages, the less headaches you will have later. Seek their input by discussing your human factors approach, a pre-sub could be good. But also, have them review your validation test plan, your summative study protocol. With this you usually submit your URRA, your protocol, your IFU and or any training materials, and a “production equivalent” prototype, or better the product you will be performing this test on. They will provide you with feedback within 90 days and trust me it’s very much worth it. Their insights or questions often will allow you to prevent major challengers during your testing or even worse during submission.

Helene Are you aware if there changes to come with the MDR in respect to Human Factors Engineering?Reviewing the MDR there are only two direct references to Usability where almost the complete ISO 14155 about clinical investigations on medical devices are incorporated into the regulation. Do you see any changes to come with the MDR?

Heidi Answer could touch on:

I am not fully aware of all implications of the MDR changes, but I do know that with the category of “combination products” now, the pharmaceutical companies have been exposed to human factors for the first time and are now starting their journey into the human factors engineering process.

I am also aware of the “usability” items or activities that have been built into clinical investigations, such as “usability related questions” to be completed by the patients in the trial, addressing fundamental questions, like “was it difficult to perform the injection?”… and while these are a great addition to your clinical investigation during a trial, helping to add nuances to the use and effectiveness of a product in your trial, they DO NOT replace usability testing or the entire human factors engineering process. Nor is it acceptable by most regulatory bodies, especially not the FDA. But I most definitely can understand the confusion around it when its incorporated or “added” to the clinical investigation part, so as long as it is understood it is not a replacement and simply an “addition” to increase the quality of data from your clinical trial.

As far as changes, I am very certain that all bodies, standards, guidances, etc. will continue to more and more incorporate human factors. Because after all you are designing devices for humans to interact with, so it is only natural to consider the “human” factor in it.

Helene Heidi, we previously touched on the benefits conducting a proper Human Factor Engineering process and that this would result in safer and better-quality products. Listening at conferences and listening to companies it is like the usability aspects has not really established itself as a valid process within Medical Device development. Wrapping up on the last question I know this is a topic that you have given deep thoughts so can you try and walk us through some of the barriers that you see out there for proper implementation?

Heidi Answer could touch on:

This is always a tricky one for me, as there is no set path forward that will guarantee the optimal integration and application of human factors engineering. However, I will say that it is not uncommon to see companies thinking of “human factors and usability engineering” as an afterthought and as something they can add quickly at the end in order to ensure they performed the required summative test. Sadly, its most often too late at this stage. Because now you are heading into a validation test

without any prior input or verification from a human factors perspective or even the user. You are just asking for it now in my opinion. What I also commonly see if the cherry pick behavior, where companies do the HF activities that are convenient or low cost or effort. Now, I won’t say they can’t get lucky and it works out, but again, you are just asking for headaches later in the process. What I also see is companies having entire human factors engineering teams, yet, they aren’t fully included or incorporated in the development process, or worse don’t have any authority in project decisions or input and can be overruled by the project manager or senior management team for trivial reasons, because none understand the implications of bad human factors.

Honestly, I could go on and on. But it all comes down to the same thig and that is that companies till don’t understand the value of human factors – as it is still seen as a “requirement” or a “checkmark” to complete without them truly understanding of how human factors can be a game changer to the success of your product, how user experience design can be transformative from a mediocre product to being the market leader in that category.

Therefore, I think it all starts at educating companies not just on the human factors engineering process and its regulatory requirements, but actually provide insights into the true value of human factors engineering, usability testing, and user experience design. And not have project team members and staff exclusively deal with these subjects, and attend these educational sessions, instead start at the top. The head of the company, the senior management teams, the decision makers. They need to understand the true value of HF. Because once they do, they will want to implement the human factors engineering process into the development process, and fully integrate it, cross-train teams, start the human factors activities at the beginning of a project and not just at verification, or worse validation stages, and most definitely, they will want to ensure all of this is done at the proper stages of development, as they understand the consequences of an improper HFE process and design, and comprehend that bad design can’t be fixed with an IFU or manual.

Helene Thank you Heidi for walking us through the Usability aspects of Device development. Really appreciate you sharing your insight and experience.Remember questions to Heidi can be sent to the email qmedpodcast@qmed.com and we will on the Qmed homepage upload a link to the email. We will answer live on a weekly basis the next 8 weeks the questions and upload these on LinkedIn. Thank you to all of you for listening in.