Let’s talk about something exciting happening in medicine right now. Every year, brilliant minds enter the medical device market with ideas that could change patients’ lives—from personalized ankle implants to devices that naturally dissolve in the body. Innovation is booming, fueled by advances in technology, materials, and patient-centered design. Surgeons and engineers are collaborating like never before, pushing boundaries to develop more effective, less invasive solutions tailored to individual needs.

But here’s the thing: turning these brilliant ideas into real products that help actual patients isn’t as straightforward as we would hope. Start-ups, in particular, face a tough road as they work to turn innovative concepts into safe, effective devices that truly benefit patients. There are countless steps along the way, from developing the product, navigating strict regulations, and earning a place in the market, all of which can be overwhelming. But with the right tools, smart strategies, and strong partnerships, those challenges aren’t roadblocks; they are opportunities to push the industry forward and turn these big ideas into real-world solutions.

I’ve witnessed countless start-ups dive into this journey, and their early decisions about technology—including 3D technology—often make or break their success. Think of it like building a house—your foundation choices determine just how high you can eventually build.

Starting the Medical Device Design Journey

The journey always starts with an “Aha!” moment, usually when a clinician and an engineer put their heads together and spot a problem that needs to be resolved. It’s an exciting spark, full of potential and possibility. Then comes the tricky part—turning that spark into something tangible. This is where 3D technology emerges as a game-changer. Instead of spending weeks and hundreds (if not thousands of dollars) going through endless physical prototypes, you can explore and test designs digitally, spot potential issues early, and make improvements before anything is sent to a 3D printer. This digital-first approach not only accelerates the development timeline but also saves significant costs, crucial for start-ups working with tight budgets and schedules.

Next is what I like to call the “moment of truth”—treating your first patient. It’s similar to a first date; everything has to be just right. You need the right patient, the right conditions, and absolutely everything needs to align with your study protocols. Modern 3D technology makes this matchmaking process much more precise. For example, restor3d transformed from a university project into a successful orthopedic company by mastering this crucial stage of development. The organization’s success shows how the right technology, combined with careful planning, can turn an idea into a real-world solution that helps patients.

Engaging with Investors and Ensuring Success

First, you’ll need to win over quite a crowd: investors looking for proof the idea works, clinicians needing to trust the solution will improve patient outcomes, and regulatory bodies demanding solid evidence of safety and efficacy. This process can be similar to preparing for three different audiences who all speak different languages. This is where early-on detailed 3D models, simulations, and data visualization come into play. They help to tell a clear, compelling story that resonates with each group. 

In fact, we are seeing computational modeling and simulation as a value add when it comes to the U.S. Food and Drug Administration (FDA). In a recent presentation, “Modeling and Simulation in Personalized Care: An FDA Medical Devices View,” Pras Pathmanathan, senior research scientist at the agency, noted modeling and simulation can impact and demonstrate safety and efficacy in bench testing, animal testing, and clinical testing.¹ Truly, having reliable and predictable outcomes can position personalized devices for commercialization success, and regulatory submission is a linchpin.

Scaling the Start-up Solution 

As your start-up grows, success will introduce a new set of challenges—handling more cases without losing quality while keeping your team motivated and efficient. Scaling is about much more than handling larger volumes of cases; it’s about doing so without compromising on quality and patient outcomes. What might have worked for a handful of cases may no longer work for larger volumes. 

The level of coordination between engineers, clinicians, and regulatory teams becomes more complex, and manually handling basic and repetitive tasks can drain valuable time and energy. This is where having a robust 3D platform with smart features that automate repetitive tasks and keep everything organized becomes essential. It’s like having an efficient personal assistant who never sleeps.

I would even add that a well-integrated platform fosters collaboration. With cloud-based systems, teams across different locations—including customers and partners—can access real-time updates, share feedback instantly, and ensure everyone stays aligned, even as project complexity grows. 

If the financial investment in 3D technologies seems daunting at first, I would encourage you to think of it as planting seeds that yield returns throughout your growth journey. Digital testing saves you from expensive trial-and-error with physical prototypes. You can detect potential issues before they become problems and scale up smoothly when success hits. A strong 3D technology foundation allows you to ramp up production efficiently, adapt to increased demand, and meet tight deadlines without sacrificing quality. By addressing potential issues early in the development process, you also reduce the risk of costly setbacks later, saving both time and money.

Examples, such as the spine care market, show us how this investment pays off when innovation meets the right supporting tools. While the big players still dominate, smart start-ups are finding success by offering personalized solutions backed by advanced 3D technology. Companies like 3D Morphic and Carlsmed Spine have shown just how powerful this approach can be. They’re revolutionizing everything from surgical planning to implant design, and patients are benefiting. For example, in addition to treating non-emergency spinal surgery patients with its custom spine implants, 3D Morphic was able to work on emergency spinal procedures, which means the entire process—device design, manufacturing, hospital delivery, sterilization, and implantation—was completed within 24 to 48 hours of the surgeon having ordered the device. In special cases, the team reduced the process down to nine hours, a feat only made possible by integrating 3D modeling and simulation software into their workflow. 

What’s more, last year, Carlsmed announced favorable Medicare reimbursement for spinal fusions custom-made from anatomically designed interbody fusion devices, to the highest level of the new spinal fusion Medicare Severity-Diagnosis Related Groups, no less. Carlsmed’s achievement bodes well for future personalized device start-ups entering the space. Commercialization success in the crowded hospital environment often hinges on ease of reimbursement for clinicians and patients. 

3D Technology as a Strategic Ally

Throughout the last 30 years, there have been countless success stories of start-ups using a digital 3D platform to advance personalized care in innovative ways. The most successful instances treat 3D technology not just as a tool, but as a strategic ally throughout the journey. It’s fascinating to see how each company finds innovative ways to advance personalized care, often in ways never imagined previously.

For those dreaming of making a mark in medical devices, remember this: success isn’t just about having great technology, it’s about using it wisely at every stage. Focus on smart prototyping, thorough clinical validation, and technology tools that enable an organization to grow its operations. The medical device world is ready for fresh ideas and better solutions. The future belongs to those who can harness these tools to deliver what really matters—better outcomes for patients. 

The success stories highlighted here underline an important point—investing in the right technology isn’t just a business decision, it’s a patient care decision. As more start-ups adopt this model, the future of personalized medicine looks brighter than ever.

Reference
¹ tinyurl.com/odt250321

Nora Toure is a recognized leader in the additive manufacturing industry. She currently serves as the director of medical software sales for North America at Materialise, where she empowers healthcare providers and businesses to harness the potential of 3D planning and printing in medical applications. She is also the founder of Women in 3D Printing, a global organization committed to advancing diversity and inclusion within the 3D printing community.