Mirzazadeh, MD, assistant professor of urology at Wake Forest School of Medicine, had a clinical problem. He was frustrated by the limitations of dosing methodology that is standard in bladder surgery.
As he thought about the problem, a solution came to him—an idea to improve medication dosing with a new kind of syringe.
Mirzazadeh needed help turning his idea into a usable product. Some of his colleagues mentioned checking out Wake Forest Innovations. The group, they told him, helps Wake Forest Baptist clinicians and researchers develop their ideas into inventions.
So the urologist contacted Russell, director of medical device development in the Center for Technology Innovation & Commercialization at Wake Forest Innovations, to discuss his idea.
During Russell and Mirzazadeh’s initial meeting, the clinician laid out his problem.
He explained that during a routine procedure he injects multiple doses of the same medicine into the bladder using a long needle and a cytoscope. He must watch both a computer monitor and the rate of dosing at the same time—not an easy task. He often worked with a nurse who could watch the lines on the syringe barrel while he kept eyes on the monitor.
“Accuracy is a problem,” Mirzazadeh explained to Russell. “It is difficult ensuring the exact dose is applied.”
Mirzazadeh wanted a solution. He envisioned a different kind of syringe, one with a 10-milliliter plunger that produced resistance and sound at measured intervals for both injecting and drawing liquids. He explained the concept to Russell with the clicking of his pen.
Russell’s response was simple: “We can do that.”
The Value Proposition
Fast forward. Russell sits in the same office holding the Incremental Syringe, the end result of Mirzazadeh’s collaboration with Russell and his colleague, Philip Brown, PhD, at Wake Forest Innovations.
“The solution is so elegant and so simple,’’ says Russell, depressing the plunger of the syringe, which features tactile stops and audible clicks for each milliliter dispensed. Over the past year, Russell and Brown have transformed Mirzazadeh’s clinical observation into a manufacturing-ready prototype already licensed to a global device company.
For some clinicians and researchers, the investment needed to develop and commercialize an invention can be daunting or foreign. Russell’s philosophy behind the medical device accelerator is to borrow practices from industry in order to fast-track clinician and researchers’ ideas into commercially viable inventions.
In the 12 months it might take a doctor to file a patent application and arrange for the engineering, prototyping and marketing of an invention, Russell says his team would typically need about three months. Hence the name “accelerator.”
“We offer the opportunity for ideas and inventions to get into the marketplace,’’ Russell says. “Most universities only assist with patent applications, leaving inventors to conceptualize, engineer and create prototypes to show potential licensees on their own. Wake Forest Innovations is one of a few exceptions.”
Wake Forest Innovations steps beyond the patent process to help inventors evaluate market potential, develop commercially-valuable prototypes and market the resulting device to potential industry partners.
Evaluating Marketing Potential
Wake Forest Innovations evaluates more than 50 proposals a year from Wake Forest Baptist employees inquiring whether their ideas might be worthy of licensing to device manufacturing companies.
“About one in five proposals shows real potential,” says Russell.
The evaluation process reveals the market potential of novel medical devices. To be moved into the medical device accelerator program, the invention idea must fill an unmet clinical need. The other criterion is that the device must have intellectual property potential—a novel device or an improvement on devices already on the market.
In the case of the Incremental Syringe, Mirzazadeh made a compelling case. He demonstrated how his invention would improve both accuracy of dosing and procedure time.
“Everything we do here, anything we take on, has to be grounded in improvement to patient care,” Russell says. The Incremental Syringe easily checked that box.
After the evaluation process, the Wake Forest Innovations team takes charge of applying for patents. Case managers partner with inventors to help them navigate the two-year backlog of applicants at the U.S. Patent Office.
Developing Valuable Prototypes
With Russell’s help, medical device development at Wake Forest Innovations has leapfrogged traditional university licensing efforts—commonly known as technology transfer—by moving beyond patenting inventions to developing device prototypes that provide commercialization advantages for industry partners.
“We develop the product to the point where industry partners can see it and hold it, understand it and evaluate it for medical license,’’ Russell says.
Russell took charge of Wake Forest Innovations’ medical device accelerator in 2013 after working for more than two decades in the medical devices industry, including ownership in a spinal infusion device manufacturing company. He worked on the front line, helping clinicians design and test inventions, experience that he brings to device development at Wake Forest Baptist.
By borrowing from best practices of industry, the medical device team produces a package of engineering specs and three-dimensional drawings of inventions as well as manufacturing-ready prototypes. This suite of materials is helpful when a prospective licensee takes inventions to its consumer advisory teams for review.
A functioning prototype improves the chances that an advisory panel to a medical device company will recommend adding the invention to their product line and it is more likely to pass evaluation by the U.S. Food and Drug Administration, sparing the licensee the responsibility of getting it ready.
“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 the commercialization process with something industry engineers can begin working on immediately.”
Targeting Potential Industry Partners
Wake Forest Innovations doesn’t stop assisting the inventor once a prototype is developed. Through business development efforts and marketing strategies, the team targets companies suited for manufacturing that specific medical device. Unique tactics are considered for each project.
For the Incremental Syringe, marketing materials were targeted at medical device companies that had experience in syringe production. Multiple individuals in these companies received a direct mail piece. Inside was a flyer with information about the device and a working prototype of the syringe itself for the receivers to handle.
Putting the prototype into the hands of potential licensees worked.
“I had three engineers run into my office,’’ the president of one of the companies who received the mailer told Russell. “They said, ‘Have you seen this? We’ve got to get this.’”
Getting the prototype into the hands of potential industry partners sparked the beginning of a commercialization process that culminated in a licensing deal that will see the Incremental Syringe hit the medical device market some time next year.
Accelerating Your Ideas
Russell says he’s confident that other inventions being developed by Wake Forest Innovations will reach commercialization, but there is a sense of urgency in his voice when he talks about new ideas for medical devices.
“Ideas, just like products in the store, have a shelf life,” says Russell. “So if you have an idea for an invention, you only have a limited window of opportunity before someone else around the globe comes up with the same idea or something better.”
That’s why the medical device accelerator at Wake Forest Innovations was created: to help inventors get their commercial-ready ideas to market first.
“Our faculty and staff at Wake Forest Baptist have solid ideas for improving health care,” Russell says. “We can help get those ideas to the companies who can produce them.”
Do you have an idea for a new medical device? Contact Ken Russell to start a conversation about your idea at email@example.com or +1.336.716.3416.