How To Prevent Device Misuse Through Formative Studies

By Jim Kasic, Boulder iQ

The issue of misuse of medical devices is a major one. Whether it happens by patients using a device at home without proper training or by surgical staff looking for a faster way to operate a device, misuse has the potential to decrease a device’s effectiveness, expose people to serious hazards, and jeopardize a manufacturer's reputation.

Yet it is important to note that “misuse” does not always imply a safety risk. Sometimes, improperly using a device may result in reduced efficiency, less comfort, or more time to complete a task. Misuse could also refer to frequency of use, such as reusing single-use equipment multiple times. Regardless of the outcome, manufacturers want to prevent misuse and secure user acceptance in their efforts to increase market demand.

While it isn’t possible to eliminate all cases of misuse, device manufacturers can significantly reduce the instances — and chances — through formative studies.

These studies, also known as formative assessments, are assessments that the manufacturer conducts in the development process. Focusing on user interaction and experience, they carefully examine how people will use the device from ergonomic, comfort, and safety perspectives. Often, these perspectives overlap.

The QWERTY keyboard, while outside the medical device arena, is a good example. Studies looked at most-used keys and users’ most powerful fingers. Computer mouse design goes a step further. Formative studies look at ergonomics with efficiency as well as safety (e.g., carpal tunnel syndrome). Moving into the medical sector, childproof cap design must weigh safety with ease of use for adults and children of all ages and abilities.

Plan For An Iterative Process

Formative assessments are all about identifying potential use errors for any user of the device, whether provider and/or patient. They usually begin with a hazard analysis and then broaden to encompass form, function, and comfort.

The analysis is an iterative one, tied closely to the intended use statement and indications for use (IFU). “Intended use” is about what the device does. In contrast, the IFU is about how and when a user will use the device. So, the IFU would specify the disease, condition, injury, or illness the device will prevent, diagnose, or treat and the circumstances surrounding the device’s use. The IFU also looks at who will use the device, where, and for how long.

A developer would review the intended use statement and IFU, conduct assessments based on the information in those documents, design (or redesign) to mitigate findings, and then revise the statements as necessary. This process is conducted throughout the development process, but the key to preventing device misuse is to start as early in the design life cycle as possible. The later you go, the more expensive it is to make a change. Beginning in the prototype stage, plan for and conduct assessments multiple times through development. Where you can break the device down and test different parts of it, do so.

Draft The IFU Early To Save Time, Design Iterations

Utilizing the IFU as a guiding tool can be very helpful in conducting formative studies — if written at an optimal time. In most projects, developers write the IFU at the tail end of the development process, thinking that will be most efficient. But drafting the IFU in the initial phase of development as part of formative usability studies will help the development team better understand the end use of the product. In addition, if you start writing the IFU at the beginning of the project, it is much easier to challenge its assumptions and remain more objective. Later on, justifying the design can become the default position.

When users walk through how they will implement a device early on, with prototypes, developers can see if they are on track before expending substantial time in development. The result is usually a sizable reduction in the number and extent of iterations in design and testing, thanks to much greater accuracy in device requirements and specifications. Getting a keen understanding of how the design will be tested early in the process will streamline the design activities and get a device through development faster.

Incorporate End Users, Time, And Expense Into Project Plans

A formative study to identify how someone could use a device incorrectly is basically an intensive human factors analysis of potential misuses. Assessments typically include collection of both qualitative and quantitative data through user interviews, observation, and usability tests. Generally, the process starts with planned, formal internal discussions between experts from different disciplines to identify areas of foreseeable misuse. Typically, these discussions include representatives from design engineering, quality assurance, and/or regulatory affairs.

Next is involving end users to look at additional scenarios where they might misuse the device, whether because of design issues or unclear instructions. For example, if you are developing a surgical device, you’ll need to get input from a surgeon in the specialty that would use the device. You may also need input from a surgical nurse, technologist, assistant, or others. Beyond discussion, you’ll need end users to work with the device in the normal order of operation and observe their handling and operation of the device.

Formative studies with users are critical components of the development process – components on which it’s not worth cutting corners. Discussions and user tests are not ad hoc activities; project planning timelines must include realistic times for them. You also may need to pay users or other experts for their time and independent feedback and incorporate those costs into the development budget.

Putting Formative Studies Into Use

Developers, familiar with and invested in their devices, can struggle to envision potential misuse scenarios. As a result, they may reduce or even eliminate formative studies from their project plans. Since the point of a formative study is to identify potential areas for misuse you may not think of, working with experienced experts in medical device development can be a tremendous help. Familiarity with myriad types of misuse allows these experts to ask the questions and determine the scenarios that will pinpoint potential misuses for your specific device.

To illustrate, formative studies often involve electrical safety assessments. Consider a device that runs on battery power, which will need to be regularly charged through a wall outlet. Potential for misuse may include forgetting to unplug the device before patient use. Device development experts can craft the right studies to see how charging takes place, how often, where, and by whom – and then suggest an appropriate solution, such as a switch or cover that only allows operation when the electrical cord is disconnected from the device. Often, manufacturers of electrical medical devices design proprietary conductors, plugs, connectors, or other accessories to prevent misuse.

Studies also can involve nontechnical end-user issues. Development experts will know, for instance, when a nurse or other medical professional needs to be on-site when a user tests a device. They also can prepare cost estimates for budgeting purposes.

Formative studies need to take disposability into account, too, as mentioned earlier. Many manufacturers create disposable devices that are not designed to be re-sterilized, so they must develop ways to make sure items can only be used once. An endoscope might include a chip that allows the camera to work only for a set time once activated. Another device might have a single-use cover that allows a user to open it only once. Labeling and IFU may need to go through formative testing as well. Experts in getting medical devices through development and onto the market will be able to provide input needed into complete studies as quickly as possible.

Conclusion

To prevent medical device misuse through formative studies, developers can:

• Conduct assessments early and often.
• Incorporate realistic time for assessments in project plans.
• Include all potential testing costs in project budgets up front.
• Identify the right group of users and actively involve them in all testing phases.
• Iteratively make design changes and improvements based on input and feedback received.

Taking this approach will increase the chances of creating a user-friendly device that minimizes the risk of misuse, increases patient safety, and ultimately helps speed the device to market.

About The Author:

Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a B.S. in physics and an M.S. in chemical/biological engineering from the University of Colorado, and an MBA from the University of Phoenix. He can be reached at jim.kasic@boulderiq.com or on LinkedIn.