Strategies for Product Design and Development
When navigating the medtech terrain, innovative concepts, eureka moments, and cutting-edge tech aren’t enough. You need sharper tools: strategy and optimization. Here are some lessons from ambitious entrepreneurs in the field.
Design for manufacturing at scale: Design products that not only meet user needs but can be manufactured at scale. Collect feedback from all stakeholders—like nurses and technicians—to make your product more user-friendly. Scalability is key; ensure the design can handle mass production.
Speak the payer’s language: Focus on proving your product’s cost-effectiveness early in the development phase. Payers, who often determine hospital purchases, need to see how your product saves money or improves efficiency. Tailor your pitch to meet the interests of all stakeholders.
Harness first-hand experience and expertise: Collaboration is crucial. Engage with experts and real users to fine-tune your product. Continual feedback helps ensure you’re meeting actual needs, and it’s essential to partner with the right people who share your vision.
Prototype prudently: Use existing products and components to save time and money during the early stages of development. Surround yourself with experts and use available resources to avoid mistakes and move faster.
Adapt the way you educate: Understand that different healthcare professionals have different workflows and tailor your product to fit seamlessly. When communicating with patients, simplify complex information without overwhelming them, adapting your message for different levels of understanding.
Design for Manufacturing at Scale
Throughout his career, Dan Clark has been instrumental in bringing next-generation medical devices to market in different companies. “I can't stand the idea of not having a new innovative way to do things or a different perspective,” he says. 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.
“Medical tubing dislodgement has been fundamentally accepted as status quo when it doesn't have to be and, quite honestly, it shouldn't be,” says Dan. 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 boils down to a few key aspects: thorough market research, an understanding of user needs, and a user-centric design that can be manufactured at scale.
From the get-go, Dan knew the importance of collecting feedback from various stakeholders, and that goes beyond just physicians. For example, the Orchid safety valve is purple because the nurses reported that they need the valve to be visible against a white bedside—a simple design tweak that makes the nurses’ job a whole lot easier.
Another key consideration was scalability. You can't just design an innovative product; it also has to be practical to produce regularly. Before commercialization, Dan ensured Orchid was designed to fit an array of medical tubing products used in different settings and scenarios, so that the company can ramp up production to meet the demand, without compromising quality.
Meeting a market need is step one. Successful commercialization at scale requires user-centric design and scalability too. To take a page from Dan’s book, pick the brains of everyone involved in the lifecycle of your product. These can be nurses, technicians, and whoever else uses your product. Make sure to design your product simply and smartly, so it lends itself to manufacturing at scale. A complex design that’s difficult to manufacture hinders scalability and market penetration.
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 an idea to help doctors insert ear tubes in children right in the doctor's office instead of the operating room. They ended up starting Preceptis in 2011. By 2020, their Hummingbird device received FDA clearance to make the procedure simpler and more accessible for both doctors and young patients.
Medical device companies often need to win over multiple parties. Steve advises understanding different value propositions and incentives for various stakeholders while you’re still in the development phase—healthcare networks, providers, regulators, payers, and investors. Changes in the healthcare system create both winners and losers. “What it gets down to is having a very clear idea of what your value proposition is, and how your device is going to provide value to the stakeholders,” says Steve. By understanding who will benefit from your device and who might not, you can tailor your messaging accordingly.
One critical stakeholder that’s often overlooked in the early product development phase is the payer. Their thumbs-up often dictates hospital purchases. So it’s important to prove your device's worth to them, or it's a non-starter.
Payers are typically most interested in the economic advantages of a medical device. 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. Demonstrate how your device can save costs or improve efficiencies within the healthcare system to gain their approval.
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.
Steve’s advice is to understand the value propositions and incentives for various stakeholders—healthcare networks, providers, regulators, payers, and investors—early in the development phase. Tailor your messaging based on who benefits from the device and especially ensure the payers see its economic advantages.
Harness First-Hand Experience and Expertise
Frustrated by the challenges of providing oral care to ICU patients on life support, Deanne McCarthy, an ex-ICU nurse, founded Swiftsure Innovations to tackle a very serious issue. Poor oral hygiene in these patients can lead to ventilator-associated pneumonia (VAP), a condition that’s often fatal. To address this, Deanne and her team developed a single-use mouthpiece that enables nurses to safely and effectively clean all areas of the oral cavity, even around obstructive tubes.
With support from the Creative Destruction Lab accelerator, Deanne has led Swiftsure Innovations to achieve significant milestones in a short time. Within 18 months and on a budget of less than $1 million, the company reached design freeze, transferred manufacturing, completed a positive clinical use validation study at the Cleveland Clinic, and registered with the FDA. Currently, their product is available through a limited commercial release.
“You don't have to know everything. You can be a technician with a really good idea, and the limited experience in the industry can be an asset, it gets you curious about all the options and you can unlock the best path forward by just literally talking to as many experts as possible,“ shares Deanne. One effective way to connect with experts and access valuable resources is by participating in accelerator programs. They provide access to a wealth of expertise and resources. In Deanne’s case, the Creative Destruction Lab (CDL) played a pivotal role by offering the support and connections she needed to propel her idea forward.
Deanne's secret weapon is 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. However, it’s important to interview multiple candidates and check references thoroughly when selecting product development partners or consultants, since relying on external experts comes with risks. By doing her research, Deanne was able to find consultants who 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 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. So, iterate based on user feedback and carefully select your external partners.
Aim for Resourceful Prototyping
Tyler Melton is the co-founder and CEO of Corveus Medical. He previously consulted for top pharmaceutical companies at Accenture and honed his strategic planning and financial modeling skills at the J&J Center for Device Innovation.
At Corveus Medical, he and his team are developing a catheter-based device designed to deactivate the nerve that aggravates heart failure symptoms. This novel treatment opens up new possibilities for patients who previously had few or no options. The company has made significant strides with successful preclinical studies and are now gearing up for first-in-human trials, a critical step toward FDA approval.
“One thing I didn't realize coming into the early prototyping stage is the utility of using off-the-shelf products.” Tyler shares. His team disassembled existing medical devices and reused their components. This was a great way to test ideas without significant financial investment, which was especially crucial in their first year of operation.
Tyler advises making full use of the resources at your disposal. For example, 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 advises embracing a similar mindset to validate early-stage ideas. Although you’ll eventually need custom-made products, using readily available resources in the initial phases is a smart way to advance development while saving both time and money.
Tyler’s existing resources reach beyond readily available bits and pieces. He advises tapping into existing expertise and networks that can validate your design assumptions and provide guidance. For example, Tyler attributes part of his success to the advisory network at the Texas Medical Center and the expertise of his head of engineering. This support network can be other entrepreneurs, too. “You can’t know everything. Even if you could, your community, your support in the startup world is really, really important to making sure that you're making the right decisions, because one mistake can cost everything. Surrounding yourself with people is a really solid way to make sure that you're on the right path,” shares Tyler.
To follow in Tyler’s footsteps, try to use existing product parts for prototyping and make full use of the resources at your disposal. Don't try to solve everything on your own. Surround yourself with experts who can validate your assumptions to avoid costly mistakes, and be intentionally active in your community.
Avoid Clinical Myopia and Information Overload
Waqaas Al-Siddiq brings over 15 years of experience in technology and healthcare to the table. He is the founder and CEO of Biotricity, a company working to bring a change in remote patient monitoring, particularly in cardiac care.
Before founding Biotricity in 2014, Waqaas worked at IBM, AMD, and Intel, and later ventured into investment banking. His work with wireless sensors and cloud technology, especially at Higi—a healthcare platform that sold for $50 million—sparked his interest in connected health.
At Biotricity, Waqaas is focused on developing a range of products for continuous cardiac monitoring. Their products have already tracked over 170,000 patients across the U.S., providing comprehensive tools for both patients and healthcare providers in managing heart conditions.
The adoption of new medical devices, Waqaas explains, requires a tightrope walk. In his case, he recognized that their device was going to be used by a variety of professionals—cardiologists, general practitioners (GPs), electrophysiologists (EPs), nurses, and medical assistants (MAs)—each with their own workflows. What he did was to analyze and address the specific needs and routines of each user group early in the development process, to ensure seamless integration into their daily practices.
The second piece of advice Waqaas stresses is the importance of 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.
In sum, Waqaas’ advice is, first, to understand the diverse workflows of medical professionals when developing devices to address their specific needs. This ensures smoother adoption. Second, he advises looking out for a balance in patient communication. You need to offer enough information to empower users without overwhelming them. Tailoring messaging to different consumer groups—from the "worried well" to tech-savvy individuals—helps with getting your message across. Remember: simplifying complex concepts is key to effective communication.