New medical devices and technologies are being unveiled on a daily basis, as readers of Medgadget know well. Medical professionals are provided so much newly discovered knowledge that they end up creating new devices to take advantage of that knowledge. The medical device industry has a problem keeping pace, so universities are trying to pull on the slack.
One recently launched initiative to help with that is MADE at The University of Iowa. This is an innovative program that we wanted to learn more about, particularly since many other institutions are considering their own similar approaches. We spoke with Jordan Kaufmann, Director of Startups at University of Iowa, who helped us get a better idea of what MADE is and how it came to be.
Medgadget: The University of Iowa has a well known and respected reputation in medical research and MADE seems to be a vehicle to harness that research. What issues led you to start MADE that didn’t exist a decade ago?
Jordan Kaufmann: Iowa has a long tradition of innovative research leading to cutting edge technology. Our goal is to make sure that technology reaches the people it was designed to benefit. We saw two shortcomings that led to the creation of MADE: 1) Our medical faculty have reported that when they published an article that used a device manufactured in house several of their colleagues would email to ask where they could buy one. 2) We also noticed that there were a number of devices in the IP portfolio that were being manufactured at a high standard but were not being picked up through traditional licensing. We felt that both of these could be addressed through the creation of MADE in which we develop, manufacture, package and sell locally. In doing so, we are able to move product to market quicker than the traditional licensing route and also build up a customer base that would be beneficial to a licensee in the future. We are able to implement a program like MADE through the support and direction of UI President Bruce Harreld. He has been a strong advocate for innovation on campus and encourages faculty to bring their research out of the lab to help people and improve lives. We have also had strong support from department chairs who see this as a way to encourage the innovation from their clinical faculty.
Medgadget: These days clinicians often come up with their own ideas for medical products. What are some of the challenges of getting those ideas to the point of commercialization of real devices?
Kaufmann: There are three primary challenges clinicians face when developing their own devices into commercial products: 1) Resources (financial and engineering expertise) to build an initial prototype; 2) Convincing their colleagues and companies to support their devices; and 3) Having the devices manufactured to a level that can be used in clinical settings. This includes not only the manufacturing itself but also the cleaning and sterilization processes and incorporation into clinic. These process burdens can substantially derail efforts to conduct a clinical trial which is often critical to convince an external company to commercialize the technology.
Medgadget: How is MADE helping to go from idea to realization?
Kaufmann: Unlike traditional medical device companies, MADE is not concerned with making a substantial profit from the devices. This allows us the freedom to take a chance on more niche products. Our process is setup to encourage departments to fund and support early prototype development costs and to provide an initial “check” on the market need and product-market fit. If a department chair sees the device as a substantial improvement to merit allocation of development funds for the prototype, that is an initial market acceptance. Once we have a product on the market, the initial revenues that come in go to reimburse the departments for the development costs that they put into the product. This eases the burden on the department, and allows them to support the faculty in their endeavors. We also work very closely with our campus prototyping group, protoStudios to develop the initial prototypes. This reduces prototyping costs and expenses. MADE utilizes a student Quality team to conduct all of the quality procedures necessary to be compliant with the FDA and a student manufacturing team to scale the prototypes to manufacturing. This Fall we plan to bring on marketing students to serve as Product Managers. The students play a critical role in our commercialization and also develop true “real-world” experience. The devices are marketed and sold through our website, iowamade.org. By utilizing this process, we are able to mitigate the substantial challenges toward commercialization and also encourage an innovation ecosystem on campus.
Medgadget: What are the benefits of MADE for the clinicians and for the University? What about the patients?
Kaufmann: The benefits of MADE for clinicians are primarily that they’re able to bring their device to practice and improve patient care. MADE alleviates the frustration often experienced by clinicians when they see a way that they can improve patient care but don’t know how to make it a reality. This aligns with benefits for the patients and the university. The University benefits through the development of an ecosystem that encourages innovative clinicians who are constantly trying to improve patient care and minimize costs. The patient benefits from having improved care that minimizes costs and adverse effects.
Medgadget: Can you give us examples of what you’ve been working on at MADE? Any new technologies you can reveal?
Kaufmann: MADE is currently focused on simple, low risk medical devices. There are currently 2 products [shown above] available through our website– the Abrons Oral Airway and the Sindt Ophthalmic Spatula. The AOA articulates then locks in place for improved cross-sectional area for mask ventilation and improved glottic view during flexible scope exam. The device can be intubated through, disarticulated and removed without disturbing an endotracheal tube. The Sindt Spatula is used to uniformly exvert the eyelid during evaluation of the Meibomian glands or to express the glands.
We are working on additional sizes for our Abrons Oral Airway, a disposable Sindt Ophthalmic Spatula, surgical scissors, retractors, and a dental instrument.
Medgadget: Is there a medical focus area that you’re hoping MADE can help to address?
Kaufmann: The current medical focus is on hand-held instruments that improve patient care.
How are you promoting MADE among the clinical staff? How does a person with an idea get started?
MADE is currently being promoted through the departments and also through the tech transfer office, UIRF. To get started, a person can reach out to MADE or to their licensing associate for more information. All of our devices are available for license to an external company so the starting point is to submit an invention disclosure to the UIRF (University of Iowa Research Foundation).
Medgadget: What is the path for someone with an idea to get it to move forward toward development?
Kaufmann: Faculty are able to bring ideas forward at any stage and we will work with them but we require the department to be involved in the prototyping stage as a check on product-market fit. Faculty are able to work with either internal or external groups to develop a prototype. After a prototype is developed, we evaluate it for fit with MADE and if it is accepted, our student team works with the faculty to implement quality procedures and on-board the device. Our manufacturing students scale the prototype for manufacturing then implement the manufacturing process. We require that devices are used clinically before they are listed with MADE. The clinical use occurs at different stages of the process depending on the type of device, the prototype and manufacturing techniques.
Link: MADE by UI…