Creating medical technology products brings with it high risks and cost but can also generate huge rewards. Medical product development combines the challenges of creating systems with high-reliability, needs for a strong focus on human factors, and a complex regulatory landscape — including both traditional certification agencies and the FDA.

Reliability is a critical factor for medical devices. Lives and health outcomes may depend on consistent accurate results and durability for medical technology devices. Even for the lowest risk Class I devices, reliability is imperative. With Class III devices, the risk profile is extremely high requiring the highest standards of a rigorous design, verification and validation regimen are required.

Here are the top four mistakes to avoid when developing medical technology devices:

Underestimating the importance of human factors

Failure to properly consider and address human factors can miss the criticality of risk reduction in medical devices. Mistakes from sub-optimal attention to human factors present the possibility of safety issues impacting treatment, data acquisition, and treatment delays.

Because processes in medical practices deal with people under stress, user interfaces must consider the patient and the practitioner. Practitioners are busy people and not necessarily looking for the latest and greatest new technology, so critical functions need to be obvious. A medical device that does not include human factors studies and implementation practices risks overloading practitioners working hard in “the heat of battle.” To avoid undue stress and the chance for errors, medical practitioners need to be able to work with the technology in a way that is not cumbersome or confusing.

Many products in the medical technology space fail because the practitioners simply do not want to use them or find that the products interfere with their treatment or surgical processes. For devices that interact or are in direct contact with a patient, product designers need to pay attention to the comfort of the patient. Ease-of-use and ease-of-learning considerations are also important. Instructions need to be clear and concise for patients, with little room for interpretive error. Failure to implement sound human factors input may result in the patient not wanting to use the required medical technology.

Testing for human factors early and often is needed to ensure performance goals are being achieved. And this testing cannot always be performed with digital simulations. Designers and engineers can always learn from observing prototypes put into action. Invariably, the unexpected will be found and it is easier to take corrective actions early instead of having to redesign flaws late in the process.  

Unrealistic schedules, underestimation of challenges, and under-funding

As with any technology product company, those in the medical space are living in a highly competitive environment. There are never enough resources — time, staffing, or budgeting. Project plans must have reserves for unexpected developments or challenges. Pushing too hard on schedules can result in short cuts being taken that drive the team to make compromises that affect risk and reliability. With that approach, things will inevitably go wrong, and the certification processes (medical and others) will invariably take more time than expected.

In early-stage companies, money is often in short supply. Before starting development, work to have sufficient funding to complete the full development process. Having a development process that does not have sufficient financial reserves for the unexpected can result in compromising the relevant processes needed to achieve goals with efficacy and safety — along with the regular tradeoffs related to cost, size, weight, etc. Worst case, it is not uncommon for startup companies to run out of funding needed to get through the full development process, or not to achieve milestones required by investors for staged funding.

Failure to follow the right classification path

Risk classification is one of the most crucial decisions early in the project. Particularly when working with early-stage companies, there is not always a clear understanding of the risk classification levels or the implications of avoiding this entirely by developing a product that is “health and wellness” oriented without realizing the risks being taken.

Often in startup companies, when the management team realizes the impact of a higher-risk product definition, they will sometimes flip to skipping an FDA certification process by veering towards a product in the “health and wellness” category instead. There is a fine line when it comes to the claims that can be made for a product from a medical perspective. However, just because a product is not getting an FDA certification does not absolve the company from liability if a product causes injury or other harm.

In a drive to generating revenue with a device without medical claims, the ultimate full cost of development will be higher. Certainly, a product can initially be created less expensively and more quickly by bypassing medical certification. Often this is done with the mindset to first release a direct-to-consumer product and then go back and get certification for medical performance claims. However, the incremental costs to pivot a consumer product to an FDA certified product can be significant. It will likely be necessary to go back over the design from an early stage to ensure that process documentation and test results are there to back any medical claims. Going back means having to define and document explicit requirements, produce documentation (risk analysis and mitigation plans), and perform the verification and validation testing along with reports to prove efficacy, usage profiles, and safety.

Failure to clearly define requirements

It is crucial to start medical technology product development with a clear definition of requirements. The team must explicitly delineate the intended product claims, identify the target practitioners for the use of the product, define the environmental constraints, and of course, assess the appropriate risk profile to drive the class designation. Even more critical than in commercial or consumer products, failure to define requirements early and clearly results in burning capital and lost time. Failure to identify or needing to modify requirements downstream on projects can also impact the architecture, risk profile, and validation/verification plans. It may require going far back into the design to assess and document the impact to claims and how they will be verified and validated.

Making mistakes such as those outlined here can result in problematic product development. Correcting mistakes in the process is costly in terms of both finances and schedule. The rigor that is required for development of medical technology solutions is on par, and sometimes exceeds, that required classically in developing aerospace and Department of Defense projects — other industries subject to high regulatory and stringent test and validation requirements. Proper planning and discipline can help avoid costly and painful errors. In some cases, to ensure the highest standards are followed, it may be helpful to engage a product development partner with relevant expertise in navigating such a complex environment.