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How do you merge digital and physical design to create seamless, user-friendly medical devices? At MD&M Minneapolis, Delve's Senior Director of Digital Product Design, <a href="https://www.linkedin.com/in/kensoliva/" target="_blank">Ken Soliva</a>,&nbsp;led a thought-provoking panel discussion on <a href="https://www.delve.com/news/delves-curt-irwin-and-ken-soliva-to-speak-at-medical-design-manufacturing-conference" target="_blank">"Bridging the Digital-Physical Divide in Medical Device Development</a>."&nbsp;
The session brought together industry leaders to share their insights on integrating these design methodologies to build innovative and human-centered healthcare solutions.

We've been developing medical devices to meet rigorous standards for 55 years.

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Panelists included: 
<ul><li><a href="https://www.linkedin.com/in/katkoehler/" target="_blank">Kat Koehler</a>, Principal User Experience Researcher and Designer at <a href="stryker" target="_blank">Stryker</a>, with prior roles at&nbsp;<a href="https://us.pg.com/" target="_blank">Proctor & Gamble</a>, <a href="https://www.hp.com/us-en/hp-information.html" target="_blank">Hewlett-Packard</a>, <a href="https://www.dexcom.com/" target="_blank">Dexcom</a>, and <a href="https://www.bd.com/en-us" target="_blank">Becton Dickinson</a>. </li></ul>
<ul><li><a href="https://www.linkedin.com/in/paula-b-573988a/" target="_blank">Paula Bernard,</a> UX/UI & Human-Centered Design Manager at <a href="https://www.inspiresleep.com/en-us/" target="_blank">Inspire Medical Systems</a>, with previous roles at <a href="https://www.medtronic.com/ph-en/healthcare-professionals/services/innovation-lab.html" target="_blank">Medtronic</a>, <a href="https://www.uhcglobal.com/" target="_blank">UnitedHealthcare Global</a>, and <a href="https://www.optum.com/en/business/health-plans/advisory-healthcare-consulting/strategy-growth/applied-innovation.html" target="_blank">Optum Innovation & Research</a>. </li></ul>
<ul><li><a href="https://www.linkedin.com/in/jeremy-van-hill/" target="_blank">Jeremy Van Hill</a>, UX Systems Design Integration at <a href="https://www.jnj.com/" target="_blank">Johnson & Johnson</a>, with&nbsp;previous roles at Radius Innovation & Development (now <a href="https://www.jabil.com/" target="_blank">Jabil</a>), <a href="https://www.cambridgeconsultants.com/" target="_blank">Cambridge Consultants</a>, and <a href="https://www.electrolux.com/" target="_blank">Electrolux</a>.</li></ul>
The panelists addressed the challenges and rewards of merging hardware and software design, highlighting strategies that improve patient outcomes and adapt to the evolving demands of modern healthcare.
 
(Note: The transcript has been edited for length and clarity.) 
<h2>Traditional product development approaches vs a workflow that enables cohesion </h2>

Jeremy van hill

Jeremy Van Hill: Ten years ago, when you looked at a typical medical device development process, you’d see a clear, linear path with all the traditional stage gates and phases mapped out at the top. Then there would often be just a simple line across the bottom labeled 'software'. It was a visual reminder that hardware and software development were treated as separate, disconnected entities. 
It’s better now, there has been some progress toward a more integrated approach, but we still have a long way to go in healthcare. I think fundamentally this relates to a company’s organizational structure. It’s very difficult to integrate hardware experience and digital experience if each is developed by siloed teams that rarely interact. 
Paula Bernard: One challenge I've seen is navigating the intersection between waterfall and agile approaches when developing the separate but connected components of physical and digital. The medical device industry is typically very waterfall-driven due to the many constraints it must operate within. But as more companies undergo agile transformation, you often end up with a blend of agile and waterfall, which can create its own set of challenges.

Paula Bernard edited

Paula Bernard:&nbsp;Typically, especially in larger companies, user research doesn’t happen much at the early stages of development. At Inspire, we’ve found success by bringing a human-centered design framework upstream, integrating it much earlier in the product development process.
A human-centered framework is simple but powerful. It starts with empathy. We encourage the people building our products to talk to customers and immerse themselves in their world. Often, customers can’t articulate what needs fixing, but through observation, we can identify pain points they might not even realize. That’s why I bring engineers into the field with me. Nothing replaces observing users in their natural environments and using all our senses to understand their experiences.
To ensure we’re solving the right problem, we test assumptions and hypotheses directly with users during the critical “define” phase. Sometimes business stakeholders have an idea they're particularly confident about, so we frame it as a hypothesis to validate.
Once we’ve defined the problem, we ideate. This is more than brainstorming; it’s about bringing together a cross-functional team to develop solutions that are feasible, viable, and desirable. After ideation, we move into rapid prototyping and testing. We put prototypes into users' hands, observe how they interact, and refine based on their feedback. We keep refining, prototyping, and testing through multiple cycles until we identify the best solution.
In medtech, clinical efficacy is often prioritized. But in a competitive landscape, successful products need more than effectiveness—they must be what customers want. Today’s healthcare consumers have choices. That’s where human-centered design shines. It brings desirability on par with viability and feasibility, helping ensure we’re developing the right product that truly meets users' needs.

Ken Soliva THUMB

Ken Soliva: I’ve taken part in contextual inquiry, and it’s always eye-opening and rewarding as a designer to see how people use products in their real environments. You get to watch users navigate workarounds and experience frustrations firsthand. Once you move past the initial ego hit of seeing someone struggle with something you designed, it opens up so many opportunities to improve the design. Whether you're a designer, engineer, or strategist, you gain new perspective through those observations. That’s why it’s so important for a cross-disciplinary team to be involved in empathy-building from the start and to collaborate closely throughout. It’s an exciting process.

<h2>Enabling collaboration across disciplines</h2>
Ken Soliva: Creating cohesive experiences across hardware, software, and services is challenging. Inside or outside of medtech, companies that succeed put in a lot of effort. To bring a large team along on that journey, you need to get their buy-in and help them see how their contributions will not only make the process smoother but also lead to the desired business outcome. 
Kat Koehler: I&nbsp;encourage teams to connect with coworkers—even those halfway across the world—not just to discuss projects, but to get to know one another. Building these relationships is critical. I have seen a project where the team skipped this kind of meet-and-greet, and as a result, interactions have become very transactional and the team is facing challenges. We’re now working on helping the team get to know each other better, and I’m confident this will get things back on track.

Jeremy Van Hill: When it comes to enhancing collaboration across teams, I’m really big on user needs and requirements. Often, you’ll see separate documents for software requirements, marketing requirements, and other areas. To me, that separation just doesn’t make sense. I think product development teams should spend more time working together on a central requirements document. I believe more truly impactful design happens in that requirements spreadsheet, than in Figma, SolidWorks, or any other design tool. Ken Soliva: Right. It all boils down to aligning on a shared vision for what you’re going to create together.&nbsp;So Kat, you've been a strategist, a designer, a researcher, an engineer. You've worn these different hats. From your perspective, what are some ways to enable collaboration across disciplines? Kat Koehler: First, be crystal clear on the problem. Does the entire team agree on what problem we’re trying to solve? Understand what a typical day looks like for your users and create journey maps for all relevant personas. Keep refining the problem statement until you’ve fully defined it, identifying when and where issues arise. Next, align teams on a shared vision. What’s been effective for me is establishing a 'North Star' vision of the overall user experience. Avoid dividing tasks by saying, 'software is doing this' and 'hardware is doing that.' Instead, walk through the experience from the user’s perspective. Finally, clarify team dynamics, roles, and responsibilities. There will be overlap between software development and hardware design. When those areas interact, establish who’s responsible for what—and do it as early as possible.

Kat koehler

Ken Soliva: Right. Clarity on collaboration, communication, and teamwork—both technically and interpersonally—lays the foundation for team members to thrive. Kat Koehler:&nbsp;To Jeremy's earlier point about siloed teams, a communication plan for the project has to be in place. We had a plan once where one day every week,&nbsp;the software engineer and UX designer physically sat together at a desk. They worked together at one desk, one screen, because that's how things get done. They need to be together as much as possible.

<h2>Building a culture of collaboration</h2>
Paula Bernard: Building psychological safety is essential for fostering a culture of collaboration. It means creating an environment where people feel safe to challenge ideas and approaches with courage and kindness, while remaining open and respectful—especially when engaging with diverse or neurodivergent perspectives. 
High-performing teams aren’t necessarily the smartest; they’re the ones that trust each other the most. Strengthening those interpersonal connections sets your team on the right path, empowering employees, boosting morale, and increasing engagement. 
Psychological safety also promotes healthy debate. With so many perspectives, especially in global organizations with diverse cultures, it’s not about deciding who’s right or wrong—it’s about bringing those ideas together effectively.

Ken Soliva: Yes, psychological safety is so important because innovation can be intimidating at first. When someone introduces a new concept, the initial reaction is often negative because change can be hard to embrace.
But if you nurture those ideas when they’re still in a fragile state and give people a chance to see their potential, they can grow into something truly amazing. The goal should always be for the best ideas to win, not just the ones that come from someone in a specific role due to their responsibilities or background.
You want the team to bring forward their best ideas and then work together to decide which ones will ultimately make it into the product.

<h2>Can more cohesive digital-physical design really improve patient outcomes? </h2>
Jeremy Van Hill: This is such a challenging and important question. It’s almost impossible to claim that a particular patient outcome was directly related to more cohesive digital-physical design. With this caveat, I have definitely worked on projects where patients have seen significant improvement in benefit and the biggest delta between the previous gen and the next gen was some sort of design unification change. 
Do you know what's easier than changing the behavior of a patient or surgeon? Almost anything. It’s often simpler to change the product or adjust the business model than to alter the behavior of end users. 
So, when we talk about collaborative digital-physical development, the question we’re really asking is: how can we minimize the behavior change required from our users? Can we support their existing workflow through hardware design adjustments or by enhancing the device with software?

Kat Koehler: I always aim to ease the burden on the healthcare provider or the patient through my products. I once&nbsp;worked on a continuous glucose monitoring system. The device includes an applicator that inserts a sensor onto your abdomen, which then communicates with an app via Bluetooth.

During our user testing, we realized that some users didn't understand that when they put their phone on airplane mode, they wouldn’t receive glucose readings because the Bluetooth connection would be disabled. So we worked hard to make the help text so usable and easy to understand that users could figure this out without needing to consult their healthcare team and ask, "Can you please work on my phone?" Our goal is always to&nbsp;keep things simple for users and free up healthcare providers to focus on more critical tasks. Ken Soliva: Improving healthcare through thoughtful, integrated design is hard work, but it's incredibly rewarding when it leads to positive outcomes. I’m grateful to be in this field alongside dedicated professionals like you, all working to make healthcare and medical devices better for everyone.

Learn more about&nbsp;<a href="https://www.delve.com/medical-devices" target="_blank">Delve Product Development Services for Medical Devices.</a>

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Insights from our MD&M Minneapolis panel highlighted the challenges and benefits of merging hardware and software design, emphasizing how an integrated approach can improve patient outcomes and meet the evolving demands of modern healthcare.

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