insights
The Key to Creating Value from a Medical Device Idea? It’s YOU.
Most physician inventor entrepreneurs tend to be “idea people” and often their business experience is in practice management, while their intellectual property development experience is more limited. This often leads to a kind of paralysis as an “idea person” fears losing their idea by working with others with business development experience. By placing too high a priority on protecting and monetizing the idea too quickly, the entrepreneurs often stall out long before they can turn their idea into reality.
As Carol Roth wrote in Entrepreneur, ideas have little to no value in and of themselves. The value is all in the execution of that idea. And the key to execution is the team – you and the team that surrounds you.
So what differentiates your idea from all those similar ideas or devices? The answer is you. What you bring to the table, the passion you have for the idea, and the level of commitment you have for it is the primary distinguishing feature that divides ideas from ideas with value. You and the team you assemble, and how you frame a problem and its solution, the technology and other resources that you bring to the table and your willingness to do anything it takes to overcome the barriers is the crucial piece in creating value from nothing.
Knowing and recognizing some of the most common barriers to creating value from your ideas is a first step in overcoming them. Here are some of the most important barriers that must be overcome if you are to be successful in creating value from an idea.
- Confidence and Commitment
How confident you are that your idea will solve a problem or improve life for others may be the most important quality you need to have. Without an unshakable confidence in your idea, you are not likely to overcome the inevitable setbacks that you will face.
- Business Knowledge & Team
Knowing how to build a business with the necessary infrastructure is key to attracting financing for product development, protecting intellectual property, and establishing operations and sales. The key here is for the “idea” person to be able to identify and reach out to and be able to trust partners whose expertise complement their own strengths and compensate for areas of weakness. A strong business team with experience in developing medical devices is essential to being able to navigate the clinical advocacy vetting on the way to proving that your device is innovative, saves lives or improves health, or increases efficiencies in the healthcare system.
- Regulatory Knowledge and Endurance
Compared with other industries, the innovation pathway in the medical device sphere is long, arduous, and unique. Having an experienced pilot who knows the regulatory waters is key to successfully navigating the FDA’s safety and efficacy approval process.
Traditionally, medical device inventors followed a typical pathway to pursue product development, hiring a fee-for-service company paying by the hour for such things as defining the innovation, developing the device, analyzing the market, testing and marketing.
Unlike typical fee-for-service consulting firms, Kapstone partners works with physician inventors and manufacturers on a milestone basis with a focus on deliverables, not on hours. Unlike typical firms, we are positioned to share the risk and the reward of new product development, which better aligns our incentives with yours. We help you protect your intellectual property with IP Fit, which is a more efficient, cost-effective way to orchestrate your IP strategy to ensure protection of your idea, while helping you present the idea and identify the right partners.
Kapstone is able to look at projects from multiple angles due to our background in engineering, quality and regulatory affairs. We provide more than an engineering solution or a quality system, we partner with you to achieve a creatively balanced result that takes into account the various requirements of a medical device organization.
We partner with physician inventors and manufacturers of all sizes to rapidly develop and commercialize new medical devices. Contact us today at (704) 843-7852 or email us directly at info@kapstonemedical.com.
