Finding Bite-Sized Solutions to Product Development Problems

A medical device should work like a clock: simple on the surface while built on a complex collection of interdependent moving parts, from sensors to software, all working together in harmony. Getting from an initial idea to a finished product isn’t straightforward. Complex challenges inevitably arise.

Sometimes those challenges look like a tangled ball of yarn, where unraveling the threads of the problem can seem like an intimidating and arduous process. It can be human nature in these circumstances to regain confidence by turning your team’s attention to other problems that are more straightforward. And, indeed, there are always other problems to solve.

Yet it’s preferable to meet the convoluted challenges head-on and succeed. We don’t waste time and budget on easily solved problems before we know if the uncomfortable ones can be solved. Separating the toughest challenges into digestible, “bite-sized pieces” makes the process less intimidating and helps push the project forward.

We find this approach works.

  1. Inventory the risks associated with the functions of each piece of the device. Inventory all device functions and identify which ones inspire fear; i.e. the probability of the risk is not negligible and its impact is frightening. A simple example: What if the valves don’t seal properly? That could cause leakage, which can contaminate a sample, or over-deliver a medication. Or, what if you need a custom pump in order to deliver within the required flow rate tolerance? Is the time you’ll spend developing a custom option going to blow the project schedule?
  1. Rate the risks and tackle the biggest ones first. We estimate and assign a numerical value to each risk to help plan our work. If we’re rating on a scale of 1-25, a 25 would be a showstopper. Our list will include intricate as well as straightforward challenges. We then attack the highest-rated risks first, whether they are tough or easy to solve, but with a focus on the tougher ones. Those tangled balls of yarn that make us wonder not how to solve the problem, but if it can be solved.

  1. Break down the complex challenges into digestible bits. For example, how do you control the temperature of a liquid in a cartridge when you can’t directly measure that temperature because the liquid is fully enclosed in plastic or foil? Break this down into discrete ideation challenge questions: How well do you need to control the temperature? How close to that liquid can you measure temperature? Is there an analog to that temperature elsewhere in the product that thermally mimics that temperature? Did you know the temperature of that liquid recently and can you devise a way to measure the heat transferred to or from that liquid? Can you temporarily benchmark that liquid temperature by instrumenting something nearby and then develop a calibrated surrogate temperature to use for your control? Is there a technology that will allow you to noninvasively measure that liquid temperature from nearby? Each of these challenge questions is individually more accessible than the original complex question, and each can be tackled independently, preventing “getting stuck” and increasing the odds of a good solution.

  1. Keep going, tracking risk reduction along the way. Team members can divide and conquer these risks. We track them individually as we de-risk by working through solutions, and use a combination as an overall risk rating for the device, which becomes a tracked metric as the development progresses. We’ve found it’s critical for the project manager to be technical in order to understand the high-risk challenges and why they’re high-risk.

    Here’s an example of what risk reduction actually looks like on a development project over time:

Product Development Chart

  1. Collaborate and listen. The entire design process is collaborative. Our typical project involves four or five different teams, each working on some aspect of the product that has to function correctly and interface with others. Our teams may need to work with a dozen different vendors to find the right sensors, circuits, and motors. As solutions evolve, it’s necessary to frequently ensure one team’s solution plays well at the interfaces.

The best way to stay focused on solutions is to break down every challenge into pieces. And solving those challenges, one at a time, is the best way to gain confidence in your finished product. Ask the right questions. Figure out what matters.

We’ve used this approach to solve problems that our clients had been struggling with for years, and over time, it’s made us fearless. We get excited when a client asks, “Do you think this can be solved?” because we welcome the challenge. Confidence is critical in our industry, and we’re so confident in our skills and ability to solve challenges that we’re not afraid to bring them up. Got a problem that you haven’t been able to solve? Reach out, and let’s have a conversation about it.

Jenny Regan

Jenny is a co-founder and CEO of Key Tech, spending her time guiding corporate strategy, managing client relationships, and overseeing company performance. Over the course of her 30+ year career, she has consulted to clients in the medical, industrial, and energy industries and her work has contributed to the advancement of precision diagnostic instruments, flow measurement, and control systems. Jenny holds degrees in Mechanical Engineering and Physics and is a registered professional engineer. Beyond Key Tech, Jenny is an avid supporter of STEM education and of women in engineering, is a technology career mentor, and a member of the Board of the Engineering School at the University of Maryland. She is also a wife, parent and yogi. Namaste.
Jenny Regan


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