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I clearly remember standing in the operating room (OR). I was there with our sales representative to observe a case as part of our normal Voice of Customer (VOC) process. I had seen well over 50 procedures by this point. We gowned up and when the surgical team was ready, we quickly entered the OR and disappeared against the wall. It was supposed to be a routine case using a competitive device. The procedure would take maybe an hour to have part of the patient’s intestine removed. Our device concept was a new electrosurgical vessel sealer — basically a fancy pair of scissors that can seal blood vessels prior to cutting them. Electrosurgical tools like this have been around for decades, but our product concept was new. The market was new to us, and we needed some customer insight.

The surgical team progressed quickly and professionally through the case. Unfortunately, things got interesting. The case began to slow dramatically. The competitive device was acting abnormally. We stepped away from the wall to take a closer look. The surgeon clamped on a vessel and paused. That is when I noticed that the device was coming apart in his hand. The plastic housing was splitting along the ultrasonic weld, and in the middle of a case. This could be dangerous, leading to parts falling into the patient, or worse yet, sealed vessels that failed after the surgery. I turned to our sales rep and let him know what I saw.  He very politely leaned forward and whispered to the surgeon. The surgeon unclamped the device, looked at it, and then exchanged it for a new device from the scrub nurse. The case continued and all was well with the world. 

I later found out that the device had been reprocessed over 10 times. It was a single-use disposable even though we had been assured prior to the case that reuse did not occur. Without being physically there to see the device used, our team may never have even thought about that failure mode.

VOC is step one for a reason. Here are a few ideas to quickly and cheaply incorporate VOC into your product development process so that you don’t miss key requirements or break the bank.

Step one

I have heard more times than I can count that ‘VOC takes too long. Let’s just skip it. We know what our customers want.’  First, realize that VOC is not a box to check off. It is a methodology and a mindset. It is critical to business operations and product development. The team needs to live and breathe VOC. VOC is iterative and should be done throughout all of development, regardless of the class of medical device you are producing or the size of your company. Properly conducted VOC can provide invaluable insights at any phase of development, from in-depth knowledge into how your market thinks and how your product is used to expectations for product improvements, and more. Plan on at least one customer touch point at each phase of the development process.

Skip it at your peril.

Costs can scale

VOC does not have to be a highly expensive or formal process. Small-scale, informal activities, known as formative studies, are extremely useful. Observing a minimal number of cases or speaking with a handful of customers can be eye-opening. While it may not be as comprehensive as a formal summative study, formative studies can easily identify trends very quickly. Feeding that information back into your product development can steer an MVP into something that customers not only want but cannot live without. 

Furthermore, VOC does not have to be, nor should be, a large focus group or an over-the-top endeavor. In addition to groupthink, focus groups can be costly and it takes your customer out of their use environment. There are many different types of VOC research activities that can quickly and accurately gather key information, all for different price points. Set a budget and then ensure you can interact or observe customers in the use environment. Whether that is in the OR, using a simulator, or otherwise, being able to see how a product is actually used, versus how a customer says they use it, can be a game-changer. 

Learn who your customers actually are

When you start VOC, you should have a clear idea of who your target market is, but it may not stay that way. Put a line in the sand to establish a starting point and then keep an open mind. Look for other areas where your product may be more suitable or sales avenues you haven’t considered. Are there different customers in the same space you might not have thought about?

Approaching VOC with a problem-solving mindset, rather than pushing a solution, inevitably leads to better outcomes. This mentality has steered many a company from a solution that is simply adequate to a solution that is far more profitable. 

It’s good

How many times have you heard the dreaded phrase, ‘it’s good,’ or ‘it’s fine.’ A more neutral sentence has never been uttered. Get around these types of lackluster responses by asking open-ended questions and do not be afraid to ask follow-up questions to get a deeper answer.  Sometimes customers are so used to using a workaround that they may not have considered there might be a better way. Asking why five times can help get to the real root cause, allowing you the opportunity to solve a genuine customer pain point. Be sure to capture these user needs and refine as VOC progresses. Do other customers share those pain points?

Ask questions and then validate, validate, validate. 

Enough is enough

It seems like VOC can go on forever. How do you know when to stop? Don’t get stuck in analysis paralysis by using two simple techniques: the 50% rule and prioritize your risks. The 50% rule isn’t really a rule, so much as a guideline. It simply says that when a concept activity or design is roughly 50% complete, it is time to start prototyping. Less than 50% and you might not have enough fidelity in the design to be useful. More than that and you start risking costly rework. We use the 50% rule to help us determine when to stop an early-stage activity and go make a prototype or run a test. You can learn a lot from sketches and CAD, but until you build it and show it to a customer or stakeholder, it has little value. Using the 50% rule, you spend less time on the computer and more time with the people buying your product.

In addition, once you have collected your user needs, it is time to dive deeply into your product and development risks. List them all.  Then, prioritize the risks by impact to your business, your product safety, and your sanity — no need to make multiple lists, one will do.  Next, focus on the highest risk and address it. Use the 50% rule as necessary to test your idea. Once adequately addressed, move on to the next lowest risk, and then the one after that, on and on until you have addressed each item to an acceptable level. Some minor residual risks are ok. Once the risks have been sufficiently addressed, then and only then is it time to begin moving to production. If you move too soon, you risk incorporating expensive fixes later. If you move too late, you risk losing time to market. By using a prioritized list, you can ride the fine line in between.

This methodology ensures that you are developing a safe and efficacious device with the customer in mind. 

Conclusion

Learning about device reuse, how a customer would view reuse, and how reuse is handled in the field was vitally important to our development process. Those insights directed our efforts from requirements development through product launch. VOC is more than a check box at the end of the concept phase. VOC is a scalable weapon that should be wielded throughout the entirety of a product’s lifecycle. It can save you time and money by avoiding costly rework. VOC gets you off top dead center and moving toward a product with deep value.

About the author:

Keir Hart has been in product development for 20 years, with all but five of those in the medical device industry. During that time, he has worked on a variety of devices from electrosurgical tools and semi-autonomous robots to wearable monitoring products. He has worked for large companies like Covidien and BD, as well as small companies. He has been using Lean Product Development in his design company, Flying Pig Designs for more than nine years.

Article source: MDDI