Create Valuable Medical Products with Human Factors Integrated Design
Medical devices are complex to develop. The process can take months for a relatively simple product to years for something more sophisticated.
As a company bringing medical devices to market, your priority is to develop a successful, safe, and effective product as quickly as possible. But before your medical device can hit the market, it’s subject to many rounds of evaluations and testing, not to mention the all-important regulatory approval process.
Human Factors Engineering (HFE) is a pivotal part of the development process that sets your product up for success. That’s because HFE has two main purposes: managing risk and optimizing usability. Incorporating HFE into your medical device design process not only maps perfectly to the FDA’s goals of safety and effectiveness but also guarantees your product will be designed for an excellent user experience.
Though including HFE provides tangible development benefits and a higher caliber product with increased likelihood of market adoption, many teams struggle to incorporate it fully.
HFE should be a core component of the design process. Here’s why uninformed teams get it wrong and how your team can get it right.
3 Common Mistakes Design Teams Make
There are plenty of understandable reasons why teams might not treat human factors as the integral part of the process that it should be. Frequently, it’s because adding more time for research activities and increasing costs with additional personnel is an unattractive proposal to any team. At the onset of a project, schedule and budget tend to be the top priorities. Thus, the importance of HFE is often minimized.
When this happens, it creates obstacles for the design teams. Ones that can easily be avoided.
And even if HFE activities have made it onto the schedule, product developers have a high risk of misapplying the discipline because:
1. Companies lacking HFE experts shift the burden to the designers.
When HFE is not fully incorporated — or worse, completely excluded — from the design process, the design team is forced to fill that role. Meaning they have to make assumptions about the product, whether that’s based on past experiences, information provided directly from the client, or their own research. And while designers have their own areas of expertise, it’s not human factors engineering. Those assumptions will likely require rectifying in later stages of your device development.
2. Ambiguous or rigid development structures can discourage collaborative work.
When done well, teams integrate HFE continuously and throughout the whole design process. In the absence of a collaborative development structure, teams stay segmented by their discipline, throwing chunks of work back and forth. These cycles of work can span months, often without informing the other side of any significant developments, diminishing the opportunity for valuable collaboration.
Ideally, it should be a full team effort in parallel. HFE is a critical part of your larger team, where everyone plays a role together and works toward a common goal.
3. Companies and teams assume markets don’t shift and insights don’t change.
When you’re in new product development mode it’s easy to reflect on the success of a previous champion, especially when you’re planning the development of its successor. It is also easy to assume that the specific knowledge you utilized to meet user needs, market trends, and regulatory requirements will work again. Unfortunately, without reconfirming and updating those insights, you could be shooting at an old target. Human factors plays a critical role in the uptake and synthesis of new user insights, covering anything of substance that may affect previous knowledge of the use of the device. These new insights are then utilized by the team at large to define actionable success targets.
Without HFE expertise, you restrict your ability to discover effectively, evaluate objectively, and make design decisions off data-driven evidence.
How MPE (Formerly Mindflow Design) Integrates Human Factors Throughout Development
To create the most valuable device — not only for your business but for end users as well, each phase of the design process should include HFE.
MPE (Formerly Mindflow Design) adheres to a Guideway Design and Development process for product development to achieve that.
The Guideway Design & Development Process Focuses on the User
In Phase 1 (Strategy), we define our success targets and create a strategy to achieve them. Research and information gathering takes place to inform requirements. Early formative activities are conducted to identify usability concerns and opportunities, and user needs are defined. At this point, a use specification document is formed, guiding early concepting and formative research activity. Frequently, members of the design team are included in HF activities to experience the raw data as a visceral corollary to HF insight. Reciprocally, the HF team is included in design activities to explore and give nuance to compelling concepts.
In Phase 2 (Design & Development), we evolve rough concepts into prototypes that look and work like real products. A human factors engineering/usability engineering (HFE/UE) plan is created, use-related risk assessments are conducted, and the requirements started in phase one for usability and user interface (UI) are finalized. As product development continues, the HFE/UE plan is further defined, the use specification is completed, and mid- to late-formative evaluations take place. HF and design teams continue to work collaboratively.
In Phase 3 (Manufacturing), a human factors validation study is conducted to ensure the advanced concept meets its requirements and a testing report is created. A formal HFE/UE report is delivered for inclusion in your submission to the FDA.
Tests Are Conducted in Accurate Conditions
To achieve the best outcomes, it’s vital that evaluations reflect real use cases of your device. Testing a device in a boardroom and talking through its possible risks and use errors is too far removed from the actual situations where the device will be used. It’s an entirely different experience to conduct those tests in a simulated scenario that replicates environmental factors.
To create optimal conditions for human factors testing and evaluation, MPE (Formerly Mindflow Design) developed an adaptable space called the Living Lab. This lab contains two suites that can each create different immersive situations for testing, such as doctors offices, operating rooms and home care settings. Each suite consists of a testing room whose activities may be observed from a separate room through a one-way viewing window.
The purpose of this space is to capture how the device functions in as close to its true environment as possible. Doing so leads to more accurate data that can be applied to device development, allowing a focus on lowering risk and creating an optimized user experience.
Benefits of an Integrated HFE Process
Taking the time throughout the design process to properly incorporate HFE means you’ll come away with a well-researched and thoughtfully designed product. That’s obviously a massive benefit in itself.
But HFE impacts the design process and ultimately your device’s success by:
Streamlining your timeline and preventing costly re-work
When HFE is incorporated into the design process, it may seem like it adds time to the project schedule. But taking the time to integrate research activities up front actually speeds up the entire process and provides a level of predictability to the schedule.
By integrating HFE into the design process, the tests, evaluations and reports conducted throughout our Guideway process will have uncovered both risks and use-related errors and optimized your product to be safe and effective. When it’s time for final reports and FDA submission, you’re unlikely to hit last-minute roadblocks that require your design team to go back to the drawing board.
Achieving better product-market fit
Finally, with HFE, you strengthen your business outcomes. Getting the market to adopt the product you’ve developed requires a deep knowledge of the people — purchasers, users and patients — who will actually use it.
Because HFE embeds deep research and testing into the design process, the data and insights found will provide the foundation for strategic design decisions, thus guiding the formation of a desirable product. Products that are safe, easy and enjoyable to use achieve better sales, more customer satisfaction and improved patient outcomes.
For instance, BBI created a device to detect pressure ulcers in patients before they happen. Employing human factors engineering as an integrated part of the design process led to a product that’s remarkably easy to use and highly-effective. Plus, it has drastically improved the patient experience, helping at-risk patients get out of the hospital faster.
“Good design is good business.” And good design includes Human Factors.
HFE elevates your product — but it’s not meant to improve upon a completed design. To be effective, HFE needs to be a key part of the full development process. A core belief at MPE (Formerly Mindflow Design) is that human factors and design teams need to work together to create well considered products that achieve targeted and impactful results.
Design brings one perspective, and HFE brings another. Together, they form a holistic solution, one that connects technology and devices to the people who are using them.
Without both areas of expertise, you risk creating a product in a silo. No matter how much time and effort you spend, you’ll still be missing a piece. For the most effective, safest and successful products, your process should fuse design and HFE together.
