Bringing Value to Medical Device Development

When Wake Forest Baptist Medical Center neurosurgeon Charles Branch Jr., MD, found a better way to break up blood clots during traumatic brain injury surgery, he turned to Wake Forest Innovations for help. Over the past year, the Medical Device Accelerator program has transformed his invention into a working prototype of stainless steel, springs and seals that’s now being evaluated for licensing by several device manufacturers.

Ken Russell, director, Medical Device Accelerator at Wake Forest Innovations

Seems simple enough. However, the journey from idea to commercialization at academic medical centers can be tedious. Medical device companies working with academic medical centers have come to expect good intellectual property protection, but few expect to receive a working prototype for proof of concept studies.

Medical device industry veteran Ken Russell, director of the Medical Device Accelerator at the Center for Technology Innovation & Commercialization of Wake Forest Innovations has brought a fresh new approach to preparing innovative medical devices for assessment by medical device companies.

Advantages in Medical Device Development

Medical device companies often turn to academic medical centers for new product ideas because they know clinicians who treat patients every day frequently discover innovative solutions for medical problems.

Our Medical Device Accelerator helps clinicians and researchers at Wake Forest Baptist turn their innovative ideas into validated technologies that can be licensed by industry. Due to the work of Russell and the team around him, this novel program creates advantages for the licensee as well as inventors like Branch.

What are these advantages? Russell’s résumé includes more than 20 years working in the medical device industry and has used that knowledge to facilitate a development process at Wake Forest Baptist that reduces investment risk at the outset. His philosophy is to mine ideas that match industry’s needs and then to fast-track early development, not just to focus on intellectual protection.

“If you think you have a really good idea, you can bet someone else around the globe has the same idea,’’ says Russell. “The first to market is the first to win.’’

Here are four advantages to licensing medical devices developed by Wake Forest Innovations:

1. We accelerate ideas, giving more sales exclusivity during the patent’s life.

Without the help of a development program, it can take a clinician or scientist more than 12 months to file a patent application and arrange for engineering and prototyping. Marketing the invention to potential licensees takes even longer. The Wake Forest Innovations team can shorten these processes by half or more. We evaluate the device’s market potential and whether it needs to be altered for medical or commercial reasons and then take charge of making a prototype and filing for intellectual property protection. We are also responsible for marketing to potential licensees.

The less time spent preparing technologies for licensing, the sooner the licensee can prepare it for production, then the longer the products can maintain exclusivity in the market before patent protection expires.

“We offer the opportunity for academic ideas and inventions to get into the marketplace quickly,’’ Russell says, “which is good news because we remove barriers that academic and industry partners often face such as who is going to build the first prototype.”

2. We provide a functioning prototype that speeds up the decision to license.

The prototypes produced by Wake Forest Innovations are typically manufacturing-ready. Most often a potential licensee can hold the device or even test it before signing a contract.

Russell explains, “We know that sometimes you have to feel or hear a device before its value becomes apparent. By supplying a prototype for evaluation, a potential licensee can answer the question; will our customers buy this new device? We never want the absence of a prototype to be the reason a good idea doesn’t make it to the marketplace.”

Russell and Dr. Majid Mirzazadeh discuss their final prototype for the Incremental Syringe.

Each device is treated uniquely. Prototypes are tested in state-of-the-art labs to determine efficacy and safety before they are ever marketed to industry. Also, we can provide clinical evaluations that may include clinical focus groups to review the new device, hospital evaluations including cleaning and sterilization trials or recruiting individual doctors to test the invention. Once a device is approved for licensing by the development team, a licensee can be confident that the technology is not just conceptual and that it has real, potential value for the end-user—your customer. 

3. Licensees receive a comprehensive engineering package that expedites your pre-production process.

When the Wake Forest Innovations team creates a prototype, the result is a package of engineering specs: three-dimensional drawings, computer models, material specifications and test results. We catalogue every step in the design process—from idea to invention—and help prospective licensees evaluate the device.

In many cases, these specs are put together through collaborations with the Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences and local manufacturers, which means the designs are top-notch—created by leaders in the field.

The engineering package goes with the company that licenses the invention. These materials are helpful when seeking U.S. Food and Drug Administration clearance and incorporating the devices into good manufacturing practices.

“If you are a licensing company and you like one of our devices, you’re not going to have to create it from a piece of paper or take out calipers and measure it,’’ Russell says. “We cut time off of your commercialization with something your engineers can begin working on right then.’’

Nobody knows the invention better than the inventor and the original design team, so in addition to the specs, Russell, his team and the inventor are willing to collaborate with the licensee when needed to create the best possible product.

4. We focus on devices that have “real” value and give you a competitive edge.

Russell evaluates more than 50 proposals a year from our doctors, nurses and other clinicians inquiring whether their ideas might be worthy of licensing to device manufacturing companies. “About one in five proposals show real potential,” he shares.

All technologies developed by Wake Forest Innovations must fill an unmet clinical need, and they must be new or improve upon devices already on the market. Wake Forest Innovations has a rigorous evaluation process that ensures the product meets all of the standards.

“Everything we do here, anything we take on, has to be grounded in improvement to patient care,’’ Russell says. “We are looking for industry partners with the same drive to develop devices that improve real-life clinical practice.”

Open for Business

“We are proud of the strides we have taken to match our device development process to industry’s needs, but the true test of our technologies is how potential licensees respond to what we have created,” Russell explains.

He encourages medical device companies to build a relationship with him and the commercialization team at the Center for Technology Innovation & Commercialization so that they can better meet industry product needs with promising technologies.

“We believe in collaborative innovation, which extends beyond our Center and our academic inventors into industry partnerships. That collaboration can start before a technology is fully developed and doesn’t stop when a contract is signed,” Russell says. Together, academia and industry can build better medical innovation, and at Wake Forest Baptist, that mission is enhanced by our professional, industry-standard medical device development program.

For more information about the Medical Device Accelerator at Wake Forest Innovations, contact Kenneth Russell at +1.336.716.3416 or kwrussell@wakehealth.edu. To discuss our full portfolio of medical devices available for licensing, contact John Druga at +1.336.716.4421 or jdruga@wakehealth.edu.


About Kenneth Russell
Director of Medical Device Development, Center for Technology Innovation & Commercialization

Kenneth RussellKenneth Russell helps inventors turn their ideas and inventions into licensable medical devices. After more than 25 years in the medical devices industry, his expertise aids academic inventors in creating quality devices that are valuable to industry partners by using the resources of Wake Forest Innovations to design, test and develop commercially-ready medical devices. The guiding principle of his work is improving patient care by connecting the medical device industry to academic inventors.