Five success factors for startups in medical device software
Do you have a software idea that could improve healthcare and social care? Here, we share some of our reflections after many years as consultants supporting innovation.
Success Factor 1: Build a clear business case
Many medical product ideas stem from a desire to improve healthcare, resolve a pain point, or address perceived inefficiencies. Often, someone envisions a healthcare application for a technology already thriving in another field.
For startups in healthcare and social care, it's relatively rare for an idea to be fundamentally commercial—born out of a desire to make money—and perhaps that's for the best. However, those driven by the will to improve the world sometimes forget to explore their idea's commercial potential. This often becomes evident when projects require funding from angel investors, venture capital firms, or public innovation programs.
Don’t let this hold you back! Before pouring your heart and soul into your idea, determine how it can generate cash flow. If this isn’t feasible, your idea might need a new angle. Without commercial potential, very few ideas make it to the finish line.
Where to start? Try the Business Model Canvas and seek input from experienced entrepreneurs.
Success Factor 2: Focus on your core technology
As an entrepreneur, you need to prioritize among your ideas. You likely have a core concept—the essence of your product. Around this, there may be a multitude of ideas and features that could add value for different customers. This is especially true for software, where additional functionality is easy to envision.
Unless you have unlimited resources, focus on building a Minimum Viable Product (MVP)—the simplest product that delivers value users are willing to pay for. If you don’t, and instead aim to solve every problem at once, your solution risks becoming unclear and mediocre.
Additionally, don’t reinvent the wheel! Use stable, existing components and frameworks to speed up development, such as for graphical interfaces, and base your technical choices on established platforms. This will help you stay focused.
Do you see a small but value-adding application for your core technology? Do you also envision a large potential market for an advanced product built on your core technology? Often, our advice is to start with the smaller application, build a strong business case, and expand only when you have resources and strong alliances. This approach pays off particularly well when your product requires verification, validation, and clinical data—challenges where a clear focus is invaluable.
Success Factor 3: Establish an effective management system
Few innovators are passionate about processes and routines. The focus is often on the product, customers, and a dream of success. That’s how it should be. However, a medical product—especially software—cannot be certified if developed solely through inspiration. It needs to be planned and documented according to detailed standards like ISO 13485, EN 62304, and EN 62366.
A prototype developed without structure can work well as proof of concept, to validate product ideas and attract interest. But your team must be prepared for a significant technical overhaul when transitioning to a development project aimed at creating a market-approved product.
We always recommend our customers adopt an electronic quality management system as early as possible. It’s neither expensive nor complicated—take a look at Focalcube.
Some of our customers start their regulatory journey with an ISO 13485 certification, which provides a solid foundation and ensures early adoption of proper management and tracking practices. This also helps establish a relationship with a certification body, easing the process for future MDR certification.
When developing your product, having someone in the team to establish systems for managing requirements and source code with traceability is critical. This enables good development practices and facilitates a smoother regulatory journey.
How far can you take your project before agreeing on clear processes and routines? What should the quality management system look like? Where do you start? Read more here: Success Factors for Quality Management in Small Businesses.
Success Factor 4: Prepare for collaboration
Should you go it alone or partner with someone powerful from the start? This is a common question for product companies. Often, focusing on your core technology and launching your Minimum Viable Product quickly is successful. However, public procurement systems make it difficult for small niche players to gain traction.
Our advice is to bring your product to a point where it stands on its own, offering a unique and focused value proposition. Think carefully before committing to a major partnership too early. Ideally, create conditions for a symbiotic relationship with multiple partners while developing your product and certification processes in parallel.
For software companies, it’s wise to prepare your architecture and operational environment for integrations. Eventually, exchanging information with other players will be necessary, and being ready for this will save you time and effort.
Success Factor 5: Build the larger team
It’s no secret that having the right people onboard is crucial for success. In medical technology, however, a team of brilliant innovators alone won’t suffice. Before your product reaches the market, your team must include expertise in quality management, regulatory affairs, and likely clinical competence. Achieving this with a limited budget and inconsistent funding can be challenging.
As consultants, we work with many small businesses, providing expert support as needed—on your terms. This allows our clients to focus on their ideas with peace of mind, knowing we’re with them every step of the way.
Often, you can obtain financial support from your regional innovation network to conduct a regulatory feasibility study in collaboration with a company like Medos. This can save you significant time and resources on your journey to market.
When you’re ready, we can assemble a complete team of project managers, architects, developers, testers, and QA/RA resources to help you succeed.
Feel free to contact us at Medos to learn more about our one-stop shop for medical software development!