Most of us would love to continuously “be innovative” and create lots of intellectual property to create exponential value for our companies. But saying that is a whole lot easier than doing it. As with anything, having a basic framework and process for creating an intellectual property (IP) pipeline is vital to getting where you want to go with your company. Much like the way Google Maps works, an Intellectual Property Development Process provides a sort of roadmap for generating value.
What we outline below is one such roadmap Kapstone Medical has developed and utilized many times over. It is essentially a 5-step process to Intellectual Property Development that guides you, and lays the foundation you need to develop your pipeline with flexibility, minimal cash outlay and maximum value creation.
To be honest, there is no mystery here. No magic pill. In fact, every step is something that engineers and marketers have used for a long time. The trick is in the diligent follow-through; the adherence to continuing to chip away and make progress toward your goals even when it feels like things have stagnated and other priorities barge in.
The 5 steps to Intellectual Property Development are:
- Key Requirements
- Competitive Review
- IP Landscape Review
- Concept Generation
Let’s break down each of the steps into their concrete components.
Key Requirements – These include the design requirements and overall business requirements; the unmet needs of the company, providers and the end users that your experience and expertise will allow you to better address. What technical features and benefits will be needed to separate your product from competitors’ devices? Keep the list simple and clear. What are the financial considerations, potential revenue and costs and when would those occur? You may want to start a simple spreadsheet with the first tab used for keeping the list of requirements. Don’t worry that your list may be incomplete at this point. Just start the list and you can always add to it later.
Competitive Review – Conduct and establish a process for ongoing competitive review (see blog post on competitive research). Build on your spreadsheet with tab #2 that identifies key attributes of your idea compared to key competitors. Key attributes include overall design and rationale, features, benefits, and how your device will be differentiated. Find as many competitors as you can, and as much information on each competitor as possible. List the key regulatory clearances issued for all of the products. And if you can find it, list the average sales price (ASP) of these competitive devices. Identify the similarities and areas of differentiation. Words help, but pictures are even better.
Review Intellectual Property Landscape – Use online searches to start compiling similar concepts and group major concepts into Intellectual Property buckets. This becomes tab #3 of your spreadsheet. Identify the areas where there is “white space” between claims or patents. Add images to provide a quick reference overview. You can also copy and paste the first independent claim of patents that cover the competitor devices you have already listed in tab #2 alongside the other competitive information in this tab. In this way, all relevant information on the competition is readily accessible.
Concept Generation – Alongside the disciplined activity outlined above, take some time to brainstorm a variety of concepts and approaches for intended product. Use simple hand sketches or rough CAD models to aid the discussion and help generate multiple concepts and variations. Don’t narrow them down too quickly. Inventors often make the mistake of sacrificing the best idea for the first idea. Many times, ideas take time and discussion in order to really develop. As a simple mechanism to test your various ideas, lay them up against the competitive matrix that has already been developed to quickly assess the market, financial and Intellectual Property potential. Then, alongside your design team, begin the process of feasibility assessment (see earlier article on the benefits of a formal feasibility process) followed by careful down-selection to a single idea (or two) to take into a development phase.
Documentation – Begin a quality documentation file early to lay the foundation for necessary forms, records and instructions to ensure adherence to U.S. and international regulatory requirements down the road. Often this documentation includes a formal design inputs list, hazards analysis, and a design plan. Documentation of design features early on also greatly helps the patent process.
Adherence to an Intellectual Property development process like the one outlined above will allow you and your team to generate value for your company in a way that is efficient, flexible and cost effective. This is one of several processes that the Kapstone Medical team uses every day. Kapstone Medical’s knowledge and depth of experience provides inventors and medical devices companies with invaluable resources and insights into Intellectual Property development. We partner with our customers to develop the business model and strategy that will make them competitive and successful not just as a startup but also as the company grows and matures.