From Napkin Sketch to Patient Care: Understanding the Medical Device Development Process
- Sirena Meade
- Aug 3
- 7 min read
By Sirena Meade, The Biotech Beacon
When people think about bringing a medical device to market, they often imagine a brilliant invention followed by a long wait for FDA clearance. In reality, FDA review is only one milestone along a much longer journey.
Every successful medical device begins with a problem, not a product. From there, it moves through engineering, testing, regulatory planning, quality systems, manufacturing, commercialization, and finally into the hands of physicians and patients.
At every stage, decisions made early in development can dramatically affect the speed, cost, and ultimately impact to patients that the technology delivers.
To better understand this journey, The Biotech Beacon sat down with Danny Spond, President of JALEX Medical, a Northeast Ohio-based medical device development firm that has spent more than a decade helping companies navigate the path from concept to commercialization.
It Starts with the Problem
After working with organizations ranging from individual surgeon-founders to some of the world's largest medical device companies, Spond has noticed a consistent pattern. The companies that achieve the greatest success don't begin by asking, "How can we use this technology?" They begin by asking, "What problem are we trying to solve?"
"The companies that have been most successful," Spond explained, "have had the patient and surgeon problem as their core thesis. It’s not the inverse, building something innovative and then searching for the problem to solve."
Just as importantly, he believes those problems need to be understood where they actually occur. Not in a conference room or inside CAD software, but at the actual point of care, whether that’s an operating room, a clinic, a physical therapy office or at the patient’s home. Understanding the clinical workflow is only part of the equation. Developers must also consider reimbursement, hospital purchasing decisions, manufacturing requirements, and long-term economics before meaningful design work even begins. In other words, successful device development starts long before the first prototype is built.
One of Spond's recurring themes throughout our conversation was that successful medical device companies think beyond the end user. While physicians and patients are central to the design process, hospitals ultimately evaluate devices through multiple lenses, including reimbursement, purchasing decisions, workflow integration, and long-term economic value. Designing for clinical success alone is no longer enough; developers must also understand how their technology fits into the broader healthcare system.
The Medical Device Development Process
Although every medical device follows its own unique path, most successful technologies travel through a series of interconnected milestones.
1. Identify the Clinical Problem
A physician, researcher, engineer, or entrepreneur recognizes an unmet need affecting patient care.
2. Understand the Complete Use Environment
Who will use the device?
Who will purchase it?
How will it integrate into existing workflows?
What will it take to train end users?
How will it ultimately be reimbursed, if it will at all?
3. Design, Prototype, and Test
Engineering transforms an idea into a functional prototype through iterative design, bench testing, cadaver studies, animal studies, usability evaluations, and continual refinement.
4. Build the Quality Foundation
Quality management systems, design controls, documentation, and risk management become essential, not only for regulatory compliance but for developing a safe, reliable product to scale.
5. Develop the Regulatory Strategy
Depending on the device, companies determine the appropriate regulatory pathway, testing requirements, and submission strategy before engaging with the U.S. Food and Drug Administration.
6. Plan for Manufacturing
Manufacturing is not something that happens after engineering is complete. Material selection, production methods, sterilization, packaging, labeling, supply chain considerations, and cost of goods all influence design decisions throughout development.
7. Commercialize the Technology
FDA clearance or approval is an important milestone but it is not the finish line. The commercialization process includes demonstrating its value to end users, identifying hospitals willing to purchase the device, training physicians on how to use it, and showcasing its clinical and economic value to healthcare systems. Only then does the technology begin creating meaningful patient impact.
Although the pathway is often presented as a sequence of steps, real-world device development is rarely linear. New testing may require design changes. Manufacturing realities may alter engineering decisions. Clinical feedback may reshape the final product before commercialization.
As Spond put it, "Sometimes you have to go slow, to go fast."
Where JALEX Medical Fits
One of the more interesting aspects of JALEX Medical is that the company doesn't participate in just one stage of development. JALEX can contribute at nearly any stage of the journey. Sometimes a project begins with nothing more than a surgeon's sketch on a piece of napkin or the back of their clinical folders. Other times, JALEX joins an established manufacturer looking to expand an existing product portfolio.
The firm also supports regulatory planning, quality management systems, engineering development, and what Spond refers to as "project rescue." Contrary to popular belief, projects rarely stall because the underlying idea lacks promise. More often, companies encounter practical challenges such as shifting priorities, changes in funding, or internal teams being stretched. Some smaller organizations lack specialized regulatory or quality expertise, whereas large companies often develop communication silos between departments.
JALEX's role is to step into those gaps, acting less like an outside consultant and more like an extension of the client's development team. Because the firm's engineers, regulatory specialists, and quality professionals work together as full-time employees, each project benefits from multiple perspectives throughout development. Instead of viewing engineering, regulatory affairs, manufacturing, and quality as separate disciplines, JALEX approaches them as interconnected parts of the same development process. That systems-level perspective allows the company to support organizations ranging from early-stage startups to established global medical device manufacturers.
Why Even Large Medical Device Companies Need Outside Partners
It's easy to assume that large medical device companies have every resource they need internally. In reality, growth often introduces complexity. As organizations expand, departments become more specialized, communication becomes more difficult, and development timelines lengthen. Spond believes experienced development partners can help companies navigate these challenges. JALEX does not replace internal teams, but instead helps them focus on what they do best, expand their output abilities and provide an outside perspective on improvement opportunities.
"We're not here to compete with your engineers," he explained. "We're here to identify where we can support you and your team’s priorities and Mission.”
Because JALEX works across many organizations, the company also develops a unique perspective on what works and what doesn't. Lessons learned solving one company's development challenge can often inform solutions for another, creating opportunities to improve processes across the industry.
Northeast Ohio's Opportunity
When asked why Northeast Ohio continues to attract medical device innovation, Spond points first to the region's clinical strength. With organizations such as Cleveland Clinic, University Hospitals, MetroHealth, and Case Western Reserve University, the region offers exceptional clinical expertise, research infrastructure, and technical talent. Combined with the Midwest's manufacturing heritage and strategic geographic location, these assets create a strong foundation for medical technology development.
Despite these strengths, Spond sees several opportunities to further strengthen Northeast Ohio's medical device ecosystem. Like many leaders across Ohio's innovation ecosystem, he points to capital access as a continuing challenge for early-stage companies. He also sees room to simplify collaboration between industry and academic institutions.
While universities and health systems possess world-class expertise and testing capabilities, navigating those resources can be difficult for private companies. Breaking down those barriers, he believes, could accelerate innovation throughout the region. Perhaps even more importantly, Spond hopes to see stronger relationships develop between academia and industry. Too often, he says, the two sectors view one another as separate worlds when, in reality, they share the same ultimate goal: improving patient care.
More Than an Invention Story
Medical device innovation is often portrayed as the story of a brilliant idea that becomes a company. In reality, it's the story of integration. All the pieces to form a company including engineering, regulatory strategy, quality systems, manufacturing, commercialization, and clinical adoption depend on the others. Companies like JALEX Medical operate within those connections, helping organizations navigate a development pathway that is rarely simple but ultimately exists for one purpose: delivering better technologies to the patients who need them.
For Northeast Ohio, that perspective highlights something larger than any one company. The region doesn't lack ideas. It has world-class clinicians, researchers, engineers, manufacturers, and entrepreneurs. The opportunity lies in strengthening the pathways that connect them. When researchers, clinicians, engineers, manufacturers, investors, and development partners work together, promising ideas have a greater chance of becoming technologies that improve patient care. As Spond's perspective makes clear, innovation is rarely the work of a single breakthrough, it's the result of an ecosystem moving in the same direction.
Key Takeaways
Successful medical devices begin by solving a clearly defined clinical problem, not simply by introducing new technology.
Medical device development extends far beyond FDA review and includes engineering, quality systems, regulatory planning, manufacturing, and commercialization.
JALEX Medical supports companies throughout multiple stages of development, from early concepts to project rescue and portfolio expansion.
Large medical device companies often rely on specialized development partners to improve speed, coordination, and efficiency.
Northeast Ohio offers strong clinical, research, engineering, and manufacturing assets, but continued collaboration between academia and industry remains essential for growth.
Frequently Asked Questions
What is the medical device development process?
Medical device development typically begins with identifying a clinical problem, followed by engineering, testing, quality systems, regulatory planning, manufacturing, and commercialization before reaching patient care.
What does JALEX Medical do?
JALEX Medical provides engineering, regulatory, quality management, and development support for medical device companies, helping organizations move products from concept through commercialization. Read more on their website.
What is "project rescue" in medical device development?
Project rescue refers to stepping into stalled development programs, often due to changing priorities, funding, or resource constraints, and helping move them forward.
Why is FDA approval only one part of medical device development?
FDA clearance or approval is an important regulatory milestone, but successful commercialization also requires manufacturing readiness, reimbursement planning, physician training, and adoption by healthcare systems.
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