The Top 5 Questions You Should Ask Before Developing a Medical Device

 In Design Strategy, Medical Product Design

Medical device companies must be future-oriented and innovative in order to remain competitive. They must constantly consider how to bring new devices to market that add value and meet users’ needs.

Of course, executives are especially attuned to goal-setting and new product development. From an executive’s perspective, the decision to develop a new device may seem abundantly obvious. But even when all the signs seem to be pointing in the same direction, it’s critical to stop and consider a few basic questions before pulling the trigger.

Here’s the thing: If executives pass down a vision for a new device “from the top,” without their team’s review, they don’t just miss a crucial opportunity to receive early input and feedback on their planned product. They also risk moving forward without the internal alignment needed to successfully develop it.

The following questions will meaningfully facilitate your decision-making process. They can guide your team in identifying big-picture goals, pinpointing risks, and developing a realistic project plan. In addition, because these questions spark internal collaboration and communication, they put your whole team on the same page with a shared perspective.

Taking the time to answer these questions can save your team weeks or months of catchup work down the line – and assist you in meeting your broader business objectives.

Planning for a New Medical Device: 5 Questions to Ask Your Team Before Getting Started

  1. What are the driving factors for developing this medical device?As an executive, you already have your finger on the pulse of your company’s big-picture business goals. These driving factors for a new medical device are your reasons for pursuing it  from the distinct vantage point of those business goals. Your leadership team must intentionally map those broader business goals to each new product you plan to develop. For example, a business goal might be to improve the lives of people who suffer from chronic pain.  That high level goal might be the driving factor for the creation of a spinal chord stimulation device. The driving factors are understood by the executive team, but it’s crucial that they be communicated broadly to the rest of your organization. When your entire team understands the driving factors for a planned medical device, it gives them a better idea of how to pursue and measure success.

  2. What are the project goals? The driving factors behind a new medical device relate to the broader business objectives. As such, they are distinctly executive in nature. The project goals, on the other hand, should be more collaborative and client-focused. They should include insight from the perspective of engineers and marketing as well as executive leadership. In addition, your project goals should reflect the reasons your internal stakeholders have agreed that it’s worthwhile to pursue a particular device. For example, your project goals might include launching an innovative product, system, and or service. Like the driving factors, you must communicate and prioritize your project goals clearly to the full team (including external agencies). Doing so doesn’t just give your team the necessary context to do their jobs well. It can also serve to energize your team by bringing them into alignment around a shared set of goals. The result is greater buy-in and an increased personal commitment to the project.

  3. What does the medical device development team think?Driving factors and project goals are all about engaging in broader visioning. Now it’s time to get some boots-on-the-ground feedback about your planned device. Your development team is in a position to tell you whether or not the goals you’ve set are realistic. They can also give you a sense of what will need to happen in order to ensure that quality benchmarks and project goals are met. Keep in mind that your development team is in the trenches making innovation happen. Their feedback is based in fact, expertise, and experience. You must hear them and take them seriously, even if their feedback means you have to adjust expectations or even go back to the drawing board. It’s not fun to hear your development team say a particular feature or functionality isn’t possible. But it’s better to take that message to heart in the early planning phases and adjust course than to admit defeat halfway through the development process. Listening to what your development team has to say at the outset allows you to more quickly identify and mitigate possible risks. It also enables you to hammer out a realistic budget and timeframe for your device.

  4. What are the anticipated risks and roadblocks — and how will you mitigate them? Any medical device development project carries with it certain risks. Those risks may stem from a number of places and include the following:

    • The market
    • Competition
    • Intellectual property
    • Technical feasibility issues
    • Scheduling concerns, and beyond

    It’s critical that you identify as many risks as possible before diving into the development process. Significant roadblocks require open communication between teams in order to plan appropriately. For example, your technical team might identify the existence of a patent owned by a competitor that would represent a major roadblock in the development of a particular device. Knowing this, the executive team can then decide whether to pivot or proceed with a more complete understanding of the risks and costs associated with the device.

  5. Where are you willing to compromise? In the abstract, it’s easy to envision an idealized version of a new product. One that is totally unencumbered by practical constraints. In the real world, though, product development almost always involves some degree of compromise. Time, money, and quality represent the three most common limiting factors. And, as any experienced product development professional can attest, it’s simply not possible to get all three variables to work in your favor at the same time. For example, you can build a device that’s both fast and cheap, but the quality is sure to suffer. Your best bet is to prioritize two of those three factors. It may help to model a handful of scenarios to find the best fit. For example, what would your budget look like if you launched your product in six months versus a year while maintaining a certain level of quality?

The questions you ask before you pull the trigger on a new medical device represent an extremely important investment of time. An investment that pays off in the form of an energized, aligned team and a smoother development process.

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