How insights-driven innovation can transform your medical device strategy

How insights-driven innovation can transform your medical device strategy

In a post-COVID world, more than ever medical device development teams face complex challenges: shrinking or uncertain budgets, regulatory and technology risk, and intense pressure to hit an ever-narrower time to market window, while achieving market success.

As these complexities multiply, Hydrix’s Insights-based innovation toolbox is proving to be a crucial element for market success in the MedTech industry. As demand grows, we’ve developed a repeatable process that has helped our clients design and launch with confidence. In this article, we explore some of the elements of this process, and how it can transform your product development planning, leading to better product outcomes, and increased likelihood of market-success.

At Hydrix, we blend market insights, best-of-breed product development practices, and medical device expertise seamlessly into an insights-based innovation process. This process incorporates best practices from design thinking, lean startup and business model canvas and adapts them specifically to the realities that medical device companies face.

The 3 pillars of an effective insight-based product development process:

1) Define what you know and what you don’t

2) Discover a problem worth solving and

3) Validate your solution early and often.

We include three key elements for a structured insight-based product development process: A definition phase, that allows teams to identify the highest risk assumption regarding their product or project and which will guide the insights process. A problem discovery phase – discovering or confirming the problem worth solving with the target customers. And thirdly, the solution phase, where we validate the concept or solution with customers, identify if there is a problem-solution fit and define the implications for the product and organization.

Transform your medical device strategy
Definition Phase:

Defining what you know and what you don’t, aka your critical assumptions.

This step is often overlooked or under-appreciated. However, how will you measure learning if you don’t document what you know right now? The main goal of the definition phase is to identify and analyze all the assumptions as they relate to the market and prioritize those that pose the highest risk to the business. By doing so, the team can focus on de-risking those assumptions from the start and increase the likelihood of success. The output of this phase is not only a shared understanding of the critical assumptions, but also a plan for how to test and refine them throughout the project in order to gather data and build confidence in making informed business decisions. Ultimately, the definition phase helps to set the foundation for the rest of the project and lays the groundwork for successful execution.

Problem Discovery Phase:

Understanding the true value-drivers for customers and uncovering “problems worth solving” through one-on-one, in-depth interviews.

“We know what our customers want” or “our customers don’t know what they want” is something we hear from teams that are skeptical about a Voice-of-Customer process and whether it can create any new understanding. True, the customer does not know the art of the possible. However, customers are experts at understanding their desired outcome and in describing the challenges they face day to day. They can tell us about the process that they use today and what they like or don’t like about it. They can tell us WHAT problem to solve, not HOW. The best way to map the customer journey, the ongoing frustrations with the process and their opinion of existing alternatives is through one-on-one, in-depth interviews. The discussion guide for these interviews is focused on getting stories, not speculation. It is very difficult for people to predict their future behavior. That is why we focus on learning about their current process, delights and frustrations.

But why not do a survey? We can get so much more data! Surveys can be useful for collecting large amounts of data and obtaining a broad understanding of customers’ opinions and preferences. However, they may not be the most effective tool for customer discovery, which requires a deeper understanding of customers’ needs, behaviors, and pain points. Most importantly, surveys don’t allow us to uncover the underlying motivations or emotions that drive customers’ behaviors. One-on-one interviews provide real insights into the desired outcomes and struggles of the customer.

Solution Testing:

The importance of problem-solution fit.

After identifying the problem, the next stage is solution testing. This involves generating ideas, developing, or testing concepts or prototypes, and then refining these to achieve the best problem-solution fit. At Hydrix we work closely with our clients to create stimulus material using low-fidelity and conceptual prototypes that are designed to understand the relative value of specific features. Our team of designers and developers can quickly visualize concepts that can be reviewed with healthcare professionals and patients.

Behavior plays a crucial role in solution testing, and it is vital to understand how customers behave versus what they say. Simply asking customers if they like a solution is not enough; it is important to test for actual behavior. Conducting experiments can be effective in testing behavior and understanding the reasons behind customers’ preferences. Our team has developed several experiments to test for behavior and gain insights into customer preferences.

So what? Once we gather customer data, this is the question we focus on as we debrief with clients. Our team goes beyond summarizing and reporting what the customer said. We map the responses back to the initial hypothesis, synthesize actionable insights, and provide guidance for product development decisions as well as positioning and messaging as the product nears commercialization. We leverage our in-house medical professionals to overlay the findings with decades of experience in the healthcare market and medical device development industry.

Bringing it all together: weaving market insights into every stage of development.

Insights-driven innovation begins with research during the exploration stage and continues until the release of the product (see graphic). The intensity and cadence of market input fluctuates across the development process, with most activity centered at the beginning – to get the requirements right, and the end – to get the go-to-market strategy, positioning, and messaging right. Market insights, along with feasibility studies and prototypes, reduce the risk of a project. The costs of change surge as development nears completions. The more market and feasibility uncertainty can be burned down at the beginning of the project, the better. Understanding and validating customer needs early reduces the risk of expensive late-stage changes, costly delays, and challenges of approval, among other risks.

A proven process for success: weaving insights-driven innovation into every stage of the development process.

Graphic: A proven process for success: weaving insights-driven innovation into every stage of the development process.

Stories from the trenches: Shaun Gregory, Co-Director of the Artificial Heart Frontiers Program (AHFP) shares his tips for getting the most out of an insights-driven innovation process

Shaun Gregory, Co-Director of the Artificial Heart Frontiers Program (AHFP) shares his tips for getting the most out of an insights-driven innovation process | Hydrix


Shaun Gregory

Co-Director of the Artificial Heart Frontiers Program (AHFP)

The Artificial Heart Frontiers Program (AHFP) is multidisciplinary consortium that applies cutting-edge technologies to transform the healthcare of people with heart failure. AHFP seeks to deliver urgently needed solutions, focused on the application of mechanical circulatory support (MCS) devices, for people suffering from untreatable forms of advanced heart failure. In late 2021, the team was at a critical decision point: Two different technologies targeting two different markets were on the table. Which way to go? Will clinicians accept the proposed novel technology? Will the next-generation technology offer enough differentiation and added value to make clinicians switch?

To answer these questions, Hydrix and the AHFP team collaborated on creating stimulus material that explained the benefits of the proposed technologies in a way that our respondents could quickly grasp and provide actionable feedback. We then recruited a diverse group of respondents, including cardiac surgeons and cardiologists from the United States, the United Kingdom, and Germany.

Here are some of the best practices we applied to maximize the learning

Tip #1: Start the insight process early.

Throughout the early development, the AHFP team consulted with world-class cardiac surgeons and subject matter experts. However, they knew that they needed input from a broad range of cardiac surgeons to understand the nuances of different markets. Regulatory changes, economic conditions, and emerging technologies will influence customer needs and preferences. As such, the team invested in market insights before moving to the next stage of development.

“We thought we had some good concepts and were moving in the right direction. We wanted to hear from a diverse set of customers to make sure and build conviction before moving to the next, more expensive stage of development.”

Tip #2: Talk to people you don’t normally talk to.

While understanding current customers is important, it’s essential to consider the needs and preferences of other customer segments. Over reliance on current customers is dangerous. Be clear on what other segments will be important to future growth and success of the product and make sure to include these segments in your in-depth voice of customer discussions.

“The big surprise came from a certain heart failure market. I am glad we didn’t just go for a group of tech savvy cardiologists – the audience was broad enough that we could capture the opinion of both the innovators and more conservative cardiologists. We often focus on the cutting-edge early adopters who are part of our known network and who we meet at conferences. We needed to hear from mainstream cardiologists who treat the majority of end-stage heart failure patients. Some of the biggest surprises came from this group of respondents and informed our go-to-market and marketing approach, which will have to start much earlier.”

Tip #3: Take full advantage of an iterative and collaborative approach

Taking an iterative and collaborative approach helps our clients achieve better results. For the AHFP project, we added a mid-project debrief after talking to half of the respondents in all of the geographies. We used this opportunity to pivot the recruiting criteria. As part of the first phase we realized that there is a very specific sub-segment of the market that had a high urgency and high problem intensity – making them ideal early customers. We also updated the stimulus material to make it more impactful and clear up some confusion.

“Without the iterative approach, we probably would’ve gotten 60% of the way there. However, with the frequent feedback loops and adjustments, we got all the way there. We got the answer that we really needed. This little bit of extra work and a couple more meetings yielded a big reward. By the end, I felt like we really nailed our device concept, our patient population and our customers and we got some really refined data because of that iterative process.”

Tip #4: Trust the process, follow the process.

Some customers want quick answers and would love to skip one or two steps in the process. From experience, we believe that the insights-driven framework and Voice of Customer process, combined with medical device development expertise sets our clients up for success. We believe in slowing down, in order to accelerate.

“We were one of those customers that wants something in a rush and wants a simple ‘set it and forget it’ process. We are all busy people, we love delegating and then walking away. Hydrix kept reminding us that this other process was much more beneficial. You’ve done Voice of Customer research a million times before, you know what you’re doing, you know what gets the best results. My top tip for other clients: follow the process, trust the process.”

Tip #5: The report at the end was the most helpful – it changed how we structured the program. It helped build conviction and create alignment for the hard decisions we had to make, especially in a large team!

We pride ourselves not only in collecting high-value data but also in presenting the insight in a way that is actionable and consumable at many organizational levels. Our clients use our reports to apply for grants, pass stage-gate milestones, align engineering teams, and brief communication and marketing agencies for updated messaging. Our reports synthesize, visualize, and cluster the data in a way that makes sense for the specific audience and questions you need to answer.

“The report at the end was the most helpful – it changed how we were structuring our program. It helped us to decide what to put in the grant application. If you don’t use the insights – what is the point? We might know 90% of what customers want but need to listen to the 10% on which we disagree. Hydrix was very thorough. All the interviews dived deep into the struggles and desired outcomes of the respondents. We not only got their functional requirements but the nuance within each market segment.”

Problem discovery and solution testing are crucial stages in the innovation process. By listening to customers and taking a beginner’s mindset, problems worth solving can be identified effectively. Behavior and problem-solution fit testing are essential for narrowing down the best solutions to the identified problems.

Hydrix has a team of experts that knows and has worked with clients to apply this process in order to get better product outcomes right from the start. Reach out to us so we can help you and your teams to get started with an insights-based product development process.

Further Reading

MCS device regulatory strategy planning Regulatory
Safety critical design for MCS developments Safety critical
Code generation accelerates MCS prototyping Code generation V1
LUDO platform supporting MCS programs LUDO platform
ISMCS Meet the team
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