Proven Insights for Efficient Medical Device Design & Development

When navigating the medtech terrain, innovative concepts, eureka moments, and cutting-edge tech aren’t enough. You need sharper tools: strategy and optimization.

Years of experience leading FastWave Medical and engaging with Medsider's network of pioneering entrepreneurs have given me a front-row seat to the business side of medical advancements. In this article, I share some of those learnings with you.

Read on to learn how savvy startup leaders have conquered design and development hurdles, outsmarted potential roadblocks, and adapted on the fly to bring great ideas to market.

Design for manufacturing at scale

Dan Clark has spent more than eight years partnering with major medical OEMs to develop and market novel medical products. As the co-founder and CEO of Linear Health Sciences, his role spans marketing, business development, regulatory oversight, and steering the company’s growth strategy.

Linear’s flagship product, the Orchid SRV, is a tension-activated breakaway safety release valve that makes delivering fluids through an IV safer and more efficient. It prevents accidental dislodgement and can be used for any IV treatment, whether the patient needs the fluids given all at once or slowly over time.

The commercial success of Orchid is a result of thorough market research, an understanding of user needs, and a user-centric design that can be manufactured at scale.

Related:Navigating Your Way to Success in the Medical Device Industry

From the beginning, Dan emphasized the importance of collecting feedback from various stakeholders, not just physicians. For example, based on learnings from nurses who place IVs daily and need the valve to be visible against a white bedside, Dan’s team changed the Orchid device to a purple color.

Another key consideration was scalability. Orchid was designed to fit an array of medical tubing products used in different settings and scenarios.

To take a page from Dan’s book, interrogate everyone who is involved in the lifecycle of your product and make sure that your design allows for manufacturing at scale. A product might meet a market need, but if it’s difficult to produce, its commercial viability may be slim.

Convince payers early on

Steve Anderson’s engineering acumen and regulatory experience make him a golden asset to medtech startups. However, it was his son, Noah, who has special needs and has undergone numerous surgeries, that led Steve to his current startup, Preceptis Medical.

While serving as CEO of Acorn Cardiovascular, he and a neighbor came up with the idea of a device that could help doctors insert a tube in children’s ears in a less-invasive way. They ended up starting Preceptis in 2011, and in 2020, their flagship device — Hummingbird — received FDA clearance.

Related:Success Starts Early: Tips for Building a Thriving Medtech Startup

Steve advises understanding different value propositions for various stakeholders while you’re still in the development phase. A critical yet often overlooked stakeholder in this process is the payer. Their thumbs-up often dictates hospital purchases, so prove your device's worth, or it's a non-starter.

One of the most significant factors for payers relates to economics. Take Hummingbird, for example, which moves ear tube placement surgery from pricey operating rooms to the ENT surgeon’s office, reducing costs associated with surgery and inpatient recovery.

Yet, payers can also be swayed by other factors, particularly when it comes to life-saving devices. If your device has the potential to save lives, it might tip the scales in your favor, even though the economic aspect should not be entirely disregarded. Conversely, if your device falls outside this category, it’s essential to strategize early on in order to effectively convince payers of its value.

Harness first-hand experience and expertise

Inspired by personal experience and patient tragedy, Deanne McCarthy, an ex-ICU nurse, is revolutionizing oral care for immobilized patients. After losing a patient due to ventilator-associated pneumonia (VAP), a disease linked to poor oral hygiene, she envisioned a game-changing device capable of safely and effectively cleaning the oral cavity of patients on life support. Deanne’s startup, Swiftsure Innovations, has developed a disposable mouthpiece that enables nurses to reach all areas of the oral cavity, even those that are difficult to get to.

Related:Why Networking Is Crucial for Medical Device Startups

Deanne's secret weapon? Constant collaboration. Deanne knew she had a solid idea but needed the right expertise to bring it to life. So she partnered with an ISO-certified contract manufacturer, which significantly sped up the design and development phases, while also bringing technical precision to her vision. Although relying on external experts comes with risks, Deanne’s consultants were thoroughly invested. Their commitment was so strong that several joined her team as full-time members.

A critical component of Deanne’s strategy was keeping in constant communication with ICU nurses — those who would ultimately use the device. The journey from concept to final product was an iterative dialogue between nurses and her development team, refining every aspect along the way. Whether it was tweaking material specifications, aligning with user needs, or shaping the marketing approach, every step was based on the feedback Deanne and her team received.

Deanne’s story drives home the following point: when you're creating something new in medtech, continuous communication between domain experts and real users is crucial. Working with a development company that's not only technically savvy but gets deeply involved in the mission can get you there much faster.

Aim for resourceful prototyping

Tyler Melton and his team at Corveus Medical are developing a minimally invasive way to treat congestive heart failure. Their lean and efficient team has created a device that can deactivate the nerve known to aggravate the symptoms of this highly prevalent condition. This novel treatment opens up new possibilities for patients who previously had few or no options.

“One thing I didn't realize coming into the early prototyping stage is the utility of using off-the-shelf products.” Tyler shares.

To save resources, his team disassembled existing medical devices to reuse their components. This way, they were able to test ideas without significant financial investment, which was especially crucial in their first year of operation.

Tyler’s company is supported by the Center for Device Innovation and the Texas Medical Center, which has given his team access to a variety of expired medical parts. He recommends this approach to other startups for its efficiency in validating early-stage ideas. While custom-made products are eventually necessary, using readily available resources in the initial phases is a smart way to advance development while saving both time and money.

Inform, but don’t overload

With degrees in computer engineering and economics, an MBA, and a doctorate focused on transformative innovations, Waqaas Al-Siddiq knows a thing or two about making complex technology accessible.

His medtech startup, Biotricity, is taking great strides in opening up access to advanced cardiac health technology. Products from the company, like Bioflex, Biotress, and Bioheart have changed the game in cardiac monitoring, catering to the diverse needs of over 170,000 patients across the United States.

The adoption of new medical devices, Waqaas explains, requires a tightrope walk: informing patients without bombarding them. "You've got a wide range of consumers," he notes, "from the 'worried well' to those with little technical understanding, to a middle group who are tech-savvy and open to new solutions." Catering to such a diverse user base requires a delicate balance between providing enough information for patient empowerment and not overwhelming them simultaneously.

Case in point: Bioheart, Biotricity's continuous heart monitoring device. Despite focused marketing efforts on its unique continuous monitoring capability, some users still struggled to grasp this feature fully. In response, Waqaas tailored his communication in a way that informs the patient without causing undue alarm. The key lies in simplifying complicated concepts. Understand your user base, then adapt to their needs and refine your product messaging accordingly.

Develop With Confidence

Having a great idea in medtech is rarely enough. Making a dent in this space requires a holistic approach that encompasses everything from scalable design and stakeholder feedback to effective communication and efficient prototyping.

The strategies I shared with you aren’t just theoretical, they are practical, field-tested methods that have been instrumental in bringing groundbreaking medical technologies to market.

Here’s a summary of these valuable lessons distilled into bite-sized takeaways that can guide aspiring innovators and veterans alike to successfully ride the waves of the medtech ecosystem: