How do you safeguard success in the Software as Medical Device industry? An expert’s guide to intellectual property
In the Software as a Medical Device industry, which includes AI products, the role of intellectual property (IP) cannot be overstated. Whether you're a founder of a software as a medical device company or a professional in the field, understanding and protecting your IP is critical for the growth and sustainability of your business.
What is IP?
IP can seem like a complex topic, but I’m here to break it down for you. I like to simplify it into two key categories:
1. IP Assets: Your Creations
Think of IP assets as the crown jewels of your company - they are what make your business unique. These assets encompass everything from the software code you painstakingly write, the sleek designs of your medical devices, or the user-friendly interfaces of your apps. These assets aren't just lines of code or blueprints; they represent the entire essence of your innovation.
2. IP Rights: The Legal Shield
This is what you wrap around your intellectual property assets to keep them safe from competitors. Protecting your creations isn't just about goodwill; it's about securing your innovation, making it attractive to investors, and ensuring your hard work pays off. These include patents, trademarks, and unregistered rights like copyright and database rights.
Why is IP so important for businesses?
In the early stages of a business, where revenue is often minimal, IP serves as the driving force behind investor interest. Investors are not just seeking immediate returns; they're betting on your innovative potential and the expertise behind your startup, encapsulated in your IP.
Failing to protect your SaMD or AIaMD intellectual property early on could make your business less appealing to investors and compromise your competitive advantage.
…and why is it particularly important in the software as a medical device world?
The software as a medical device industry comes with extensive regulatory requirements and a lengthy, costly path to market. IP acts as a safety net, providing investors with assurance that your solutions are shielded from imitators – reducing the risk associated with long-term investments. Given the intense competition, from both startups and industry giants, IP becomes your essential protection, ensuring your innovations remain exclusively yours.
What are the biggest challenges in IP?
One of the most overlooked challenges in IP is ownership. Many businesses stumble because they lack clear agreements with their collaborators. Whether you're working with external contractors for software development or designers for user interfaces, failing to establish clear ownership from the start can jeopardise the IP rights of assets critical to your business's value.
Competitor patents for software and AI systems can also pose a significant concern. It is important to consider whether there are patents that might impede your product's development and commercialisation.
These issues often lurk quietly and surface at a pivotal moment for your company - typically when seeking significant investment. Ensuring your agreements are solid from day one can spare you costly and potentially insurmountable issues down the road.
What can Hardian Health do for you?
As a qualified UK and European patent attorney, my expertise lies in helping Hardian’s clients protect their SaMD and AIaMD innovations. I’ll guide you through the essential steps, whether it's filing patent or trademark applications, protecting your brands or collaborating with other specialists in the field.
We’ll guide you through our step-by-step process, which includes…
1. Intended use
The first crucial step is defining your SaMD or AIaMD product's intended use. It's not just a regulatory requirement; it's the foundation of your product's development. An Intended Use Statement clearly outlines your device's purpose, medical indication, patient population, and more.
2. IP Healthcheck & IP Audit
Next, we perform an IP healthcheck or a more comprehensive IP audit. This involves assessing your current IP assets, ownership, agreements, and potential future assets. We also analyse the competitive landscape to understand any potential roadblocks.
3. IP Strategy
With the audit results in hand, we develop a tailored IP strategy. This strategy maps out protection plans, budgets, and roles within your organisation. It serves as a roadmap for both long-term and day-to-day actions, ensuring your innovation is captured, protected, and primed for negotiations with potential partners.
Executing the IP protection strategy involves filing patent or trademark applications, safeguarding your brand, and implementing trade secret protection strategies. We cover various aspects, from patents to copyrights, ensuring your intellectual property is shielded from competitors and potential threats.
5. IP Searches
We conduct patent searches, including novelty and freedom-to-operate searches, to assess the uniqueness of your ideas and identify potential patent obstacles. For trademarks, we perform searches to prevent brand clashes down the road, ensuring your marketing investments don't go to waste.
For ongoing support, we offer IP advisory services, sometimes on a retainer basis. This provides peace of mind, knowing that if IP issues arise, our expertise is readily available to assist you. We maintain a robust network of contacts and a continuous professional education program, ensuring that we can apply the law effectively to the latest technology developments.
It’s never too early to start thinking about protecting your SaMD innovation… and we can help.
Amid regulatory approvals, clinical validity, and myriad of other concerns, IP often takes a back seat. But don't underestimate the importance of IP - it's a cornerstone of your business strategy.
My advice? Start thinking about IP early, establish a robust plan, and build the necessary foundations. It's not always about heavy investments or immediate patent filings, but about protecting your innovation's value and ensuring a smoother journey to success.
At Hardian Health, we are here to support your SaMD innovation every step of the way. Get in touch with us today for expert assistance in protecting your intellectual property.
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
