The journey from scattered notes on a cocktail napkin to a licensed medical technology can be daunting—a quest packed with high attrition rates and the risks that come from the dynamic nature of science and the marketplace.
For Jason Kralic, PhD, assistant vice president of technology innovation at the Center for Technology Innovation & Commercialization at Wake Forest Innovations, the path to a licensable product is a familiar journey. A neuroscientist and seasoned business development professional, Kralic has developed a keen eye for what works, and what doesn’t, when it comes to developing therapeutics, medical devices, diagnostics and other medical technologies.
Jason Kralic, assistant vice president of technology innovation at the Center for Technology Innovation & Commercialization, describes the characteristics of a good innovation.
After years in industry at the likes of GlaxoSmithKline, Innervate BD Solutions and Opexa Therapeutics, Kralic now uses his expertise to facilitate and accelerate the development and commercialization of medical technologies developed by faculty and staff at Wake Forest Baptist Medical Center.
He shares the top five characteristics he notices in any successful technology opportunity.
1. It identifies a ‘real’ problem
A successful technology addresses a problem in need of a solution. According to Kralic, the best solutions stem from ‘real‘ unmet needs. “If someone brings you a solution where there is already a tolerable and effective treatment, then the technology is not likely to be successful, especially given the time and risk associated with bringing an early stage technology to the marketplace,” says Kralic. “Ideally the solution targets a problem in which there is no acceptable standard of care or at least differentiates in a clinically meaningful way from existing treatments.”
2. It provides a reason to believe
The risk of failure is exceptionally high when developing healthcare-related technologies. A drug in late preclinical development faces just an eight percent probability of receiving FDA approval. Successful technologies are able to withstand the demands of thorough clinical testing, regulatory requirements and the marketplace. “You need a reason to believe your technology will beat the odds,” says Kralic. “A strong scientific rationale is the foundation on which a successful technology is developed.” Drug discovery, prototyping and clinical testing prove the technology is effective and has characteristics that differentiate it from similar products.
3. It exposes and addresses the risks
When planning the development of a technology, Kralic and his team identify questions that will expose, address and reduce the risk of failure. “If the technology is going to fail, we want it to fail as quickly and cheaply as possible” says Kralic. “For a technology to be successful, you must be able to recognize the most critical information gaps and development risks. Address them as early as possible.” Failing to recognize or ignoring gaps and risks—like unknown information about specificity, selectivity or potential side effects—will likely be identified by investors, partners or regulators and lead to more significant development costs or setbacks later in the process. Inventors and developers of successful technologies are open and honest about potential weaknesses and use this information to guide the technology’s path for development.
4. It has a known market
“The potential value of a technology is determined by the benefit to the patient,” says Kralic. Effectively defining the patient population and unmet need your technology will serve can often determine success or failure, and according to Kralic, bigger populations aren’t always better. “Don’t go after the biggest market, go after the right market.” Kralic gives sodium channel blockers as an example. In studies, sodium channel blockers were not amenable to treating neuropathic pain generally; however, they were shown to have an effective use in a sub-population of neuropathic pain patients with trigeminal neuralgia. Matching the therapeutic with the right population—patients who suffer from a specific neuropathic pain condition—was key to the technology’s success.
5. It has commercial potential
“Before investing in the protection and development of an invention, we must believe that there will be a customer who sees value in licensing the technology,” says Kralic. “Value is derived from a measureable benefit to the patient, provider and to society—it sets innovation apart from invention.” Evaluating a technology’s attributes in conjunction with the needs and competitive landscape of the marketplace helps determine the technology’s value proposition and, in turn, the appropriate strategy for development and commercialization.
Interested in learning more about the technologies being developed at Wake Forest Baptist Medical Center? View our technology portfolio or contact us by email at email@example.com or by calling +1.336.713.1111.
About Jason Kralic, PhD
Assistant Vice President of Technology Innovation, Center for Technology Innovation & Commercialization
Jason Kralic, PhD, connects inventors with the resources and expertise of Wake Forest Innovations to bring their ideas for new medical technologies to life. He brings a wealth of experience in business development—from both major corporations and innovative start-ups in the therapeutics industry—and an appreciation for research from his training as a neuroscientist.