How to Find (and Fill) Market Gaps
The medical device industry has lots of opportunities—but success requires more than a good idea. This will help you find and validate market gaps in the medical device space. It’s not a roadmap, but by following these steps, you’ll increase your chances of getting a medical device to market.
Understanding the Medical Device Landscape
The medical device industry is changing fast—and one of the biggest transformations is a move from traditional Operating Rooms (ORs) to ambulatory surgical centers (ASCs). This shift affects not only where procedures are done but also how they are billed and reimbursed. For example, ASCs have different equipment needs and space constraints than hospital ORs, so we’re seeing an opportunity for more compact, portable, or multi-functional devices.
Value-based care is also becoming more important in healthcare. For medical device innovators, an approach that prioritizes patient outcomes and cost over volume of services means focusing on solutions that improve clinical outcomes and have clear economic benefits. Devices that reduce hospital readmissions, shorten recovery time, or enable more efficient use of healthcare resources will succeed here.
Finally, device classification and regulatory requirements are key for any medical device entrepreneur—so early knowledge of your classification can save you a lot of time and resources. For example, if you know your device will be a Class II, you can plan ahead for the resources and time needed for a 510(k) submission.
Finding Market Gaps
Finding unmet needs in the medical device market is a multi-faceted process.
Observe procedures
Spend time in clinical settings to identify inefficiencies and pain points. This might mean shadowing healthcare professionals, watching surgeries, or observing patient care in different departments. Look for moments of frustration, workarounds, or time-consuming tasks that could be solved with new technology.
Talk to clinicians
Have in-depth conversations with healthcare professionals, surgeons, nurses, technicians, and other specialists about their challenges and what they would like to see in better tools. Ask about their daily struggles, the limitations of current devices, and what features they wish existed. For example, a conversation with an orthopedic surgeon might reveal a need for better surgical planning tools or more ergonomic instruments.
Examine underserved areas
Look for areas of limited innovation, specific medical specialties, or patient populations. Pediatrics, geriatrics, and rare diseases are often overlooked—so these may be big opportunities. Don’t forget to think about geographic regions or healthcare settings that are underserved by current medical device solutions.
What to Look For
When looking at potential innovations, seek out solutions that can make a big impact—and preferably a global one.
Focus on accessibility and usability. Healthcare professionals work under time pressure and in stressful conditions, so devices that are intuitive and easy to use will be adopted more. Consider training requirements, compatibility with existing systems, and the potential for user error.
Commercial viability is also important. What’s the size of the market for your innovation? How many procedures could use your device annually? What’s the reimbursement potential? A great idea still needs a big market to be commercially successful.
Regulatory considerations should also be part of your market gap analysis. Some areas of medicine have fewer regulatory hurdles, which allows for faster market entry. Others have more regulatory hurdles but may be more rewarding for successful innovations.
Finally, consider technological trends and how they can create new opportunities. Advances in areas like AI, 3D printing, or miniaturization can solve long-standing healthcare problems.
Validating (in the Market) Your Idea
Even if you think you’ve found a market gap, you’ll still need to thoroughly validate before investing big.
Start by evaluating market appeal. Quantify the number of patients or healthcare providers affected by the problem. Use official sources like government health statistics, medical society reports, or published epidemiological studies. Then, put a number on the economic benefit of your solution. This could be cost savings for healthcare providers, improved patient outcomes, reduced long-term care costs, or increased efficiency in medical procedures.
Next, do deep research to make sure your idea is truly unique. This should include:
Patent searches: Use patent databases to search for existing or pending patents that are similar to your idea. This will help you avoid potential infringement and identify where your innovation differs from existing solutions.
Literature review: Read medical journals, conference proceedings, and industry publications to understand the current state of technology in your area of interest. This will help you identify gaps in existing solutions and position your innovation.
Competitor analysis: Look at existing products or companies in similar areas. Understand their strengths and weaknesses to see how your innovation can add value.
You’ll also want to start thinking about the regulatory requirements your device will need to meet. This might mean reading FDA guidance documents for your device type or looking at similar devices that have been approved.
You could also talk to potential users during the validation process, including healthcare providers, patients, or hospital administrators. Their feedback will be invaluable when you’re refining your concept and making sure it meets real-world needs. If appropriate for your device, you might even consider doing a small pilot or clinical trial. This can be resource-intensive but will validate your concept and generate data for regulatory approval and market adoption.
Finally, consider the long-term potential of your idea. Will it be relevant as healthcare practices change? Can it adapt to future technology? Thinking about these factors will help ensure your innovation has legs in the market. For example, a device that can be updated with software updates will have a longer life than one with fixed functionality.
The Takeaway
Medical device innovation is worth the effort, but it can be tough. By finding a real market gap, you’ll have a better chance of success.
At Concise Engineering, we help innovators do exactly that—then get their impactful medical devices to market. Our team will guide you through every stage of the development process, from concept to launch. We know the challenges of medical device innovation and have the expertise and knowledge to help you overcome them.
Do you have an idea to discuss or need help on your journey? We’re here for you. Our services include market analysis, product development support, regulatory strategy, and more. We can help you refine your concept, navigate regulatory pathways, and develop a strategy for market entry. Get in touch to turn your idea into a reality that improves patient care and changes lives.
For more insights and strategies on successful product development in MedTech, read Justin Bushko’s book Medical Device Fireside Chats, available to read instantly on Amazon.