Running a successful medical device company requires deep knowledge of complex and specialized technologies, how to navigate regulatory requirements, and a thoughtful intellectual property (IP) protection strategy. ZetrOZ Systems’ Dr. George Lewis, inventor of the sam® soft tissue healing pain relief ultrasound device, shares insights on how effective IP portfolio management can improve organizational efficiency that creates a competitive edge in today’s health technology industry.
“In health technology, success requires effective management of your intellectual property and internal processes,” said Dr. Lewis. “ZetrOZ Systems has a portfolio of 48 patents protecting our proprietary innovations in long-duration ultrasonic therapy. Our open innovation and partnership strategy is synonymous with our mission to improve healthcare across the globe by sharing knowledge, expertise, resources, and experience with the broad healthcare community and frontline healthcare providers.”
According to Dr. Lewis, the following five steps will help guide companies in the development of an effective strategy:
- Consider company size – The company’s size and current stage of development should help guide its strategy. A smaller company in earlier stages of development may not see the same benefit of dedicating resources toward a formal IP strategy as a more established company with several intellectual properties in its portfolio.
- Create an outline – Outlines organize thoughts and lead to more cogent ideas. Keep a list of team members involved and the type of IP protection being sought. Remember to conduct comprehensive market research to ensure the company’s goals aren’t interfering with existing copyrights.
- Assess demand and barriers to entry – It’s essential to consider if the IP solves a problem in a way that’s unique and innovative. ZetrOZ differentiates itself and meets market demand by developing the premier high dosimetry non-invasive technology for soft tissue healing and pain management; it maintains processes to safeguard the integrity and confidentiality of its research and to ensure compliance with federal regulations.
- Consider third parties – Hardware companies often rely on third-party suppliers and partners to scale the production of a new product. These relationships can sometimes expose IPs to risk. For example, if a third-party manufacturer of components is subject to a hack or cyber attack, the sensitive data of all the companies they are working with has also been compromised. When developing a strategy, think about any third parties that could be involved in the creation of core services or products.
- Perform an IP audit – Perform a thorough audit of the IP to identify potential risks and gaps in protection. Prepare contingencies for any pitfalls throughout the process.
Connect with the state bar association if you do not have an attorney on your team. They can provide recommendations for experienced lawyers to help file appropriate protections. Patent examiners review applications and determine if applicants meet all requirements. Once approved, companies receive a notice of allowance, which establishes the date by which applicants must pay issue fees, and can be accompanied by a statement of the examiner’s reasons for allowance.
Proper management of IP involves a well-developed strategy to secure sensitive information on proprietary technology, including the internal processes and methods that went into developing it. A sound strategy should also detail how to properly allocate resources, and help organizations identify and capitalize on new opportunities for research and development.
