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A New Direction in Medical Device Translation

Posted by Larry Kiliszewski Content on July 18, 2022

In 2019, during a visit to Seattle Children's Hospital and Research Center, I was surprised to learn of the number of ideas and innovations that are being created at institutions around the country, yet how few seem to make it out of conception.  As I continued talking with multiple institutions, educators, clinicians, and start-ups, I began to understand part of the coinciding gaps revolving around this challenge, and several forces that brought us to where we are now. This article is the history of how we got here, the current state of challenges, and the possibilities (by example) of the future. I believe, by implementing some small currents in the tide of events, we change to the course of translational development in order to achieve a higher rate of delivered device to the market. 

A Volatile-changing Environment

Since the beginning of innovation, institutions have developed ideas and passed them on to industry in order to design for manufacturing (or translate devices to production).  Internal researchers and scientists would create innovative solutions across many sectors; the institutions would patent them; and industry would come along as sweep up the ideas, then translating them to production and paying the institutions a nice royalty along the way.  This added growth to our national economy and resulted in much of our advanced technologies and medical breakthroughs in the United States were created this way, before and through the 20th century.

But as technology and science have advanced, very rapidly through the turn of the century, innovation and licensing have become easier, yet translation has become very difficult.  More regulations are being enforced on device testing, manufacturing technology has become more complex and expensive to implement, and markets have driven many manufacturing technologies offshore.  Leaving the United States with a handful of large technically advanced manufacturing and distribution companies, with demanding shareholders and investors for big returns.  Yet, having thousands of smaller to midsized private manufacturing and distribution companies without the bandwidth for access to device translation opportunity.

Conversely, as the field of alternatives for manufacturing translation have narrowed, the institutions have produced more ideas, with more advanced technology and resources therefore, developing more intellectual property along the way.  All the while, not realizing how rules to actual device production were impacting smaller manufacturer's ability to negotiate with institutions, until many of them simply decided it was impossible.

This left the institutional output limited to only a few ideas a year being cherry picked by big tech. Essentially, due to over regulation, offshoring and rapid technological advancements, along with institutional disenfranchising the small manufacturer, we have created our own bottleneck of globally valuable technology which we can license and call translation, adding value to the institution, but until it's actually a product on the market, it adds little to no value to the healthcare community.  

Adding salt to the wound, due to the global impact of COVID-19, medical institutions and schools have been hit with staff reductions and a need to not only innovate, but attempting to bring ideas to market more quickly, in order to get the same work done with less staff.  Unfortunately, the ideas with both domestic and global value, which are stuck, are either competitive with big tech, or not universally needed enough to get big techs attention.

The Right Shift, but challenging Approach

All over the country, Device Translation Departments are popping up at many institutions, hospitals, research centers and universities.  Failory.com lists twenty-three of the top accelerators, all but two started after 2000, and the majority in the last 10 years.  They have recognized the need and are addressing it internally with staff innovation, and with access to philanthropic funding generally reserved for non-profits.  But most importantly, they control the intellectual property. Unfortunately, there is one area where they are making a big mistake; we are focused on licensing the technology, and not necessarily the production of it.  And licensing without production is a sum zero game for society.

But let's take a step back and talk about what innovation is and where it comes from.  Innovation requires large sums of research, brainstorming and theoretical knowledge of what could be possible.  It requires access to institutional resources, labs, clinicians, and patients.  It is inefficient and reckless, by design, and its generally funded through philanthropy grants and government resources.  This is a recipe that allows for lack of accountability and governance of directional results.  But don't be discouraged, this is actually how we want innovation to work!  We all know requiring specific deliverables slows the innovative nature of things, and forces people to take the straight path and not recognize opportunity around them.  In fact, we intentionally use students and young doctors, for some of our best brainstorming, because they are without the knowledge of what can and can't be done in the real world.  They work with laws of physics and mathematics vs handling and processing.  They deal in materials and chemistry vs applications and costs.  And this method of innovation, results in the craziest and greatest human advancements. 

But at some point, in order to progress, someone has to say, "Stop, let's go with that", that's when translation begins, and licensing, is only the first part of it. Real translation of value requires a deep understanding of the current capabilities and limitations of manufacturing, distribution, international trade, regulatory compliance, and business tax law.  It requires an understanding of time and process as it relates to hundreds of activities that will have to occur simultaneously, between dozens of for-profit private companies, maybe states or countries and scores of people. It requires knowing how to negotiate agreements between organizations and working in a competitive space where costs and timely deliverables are critical to its success.  But most importantly, the understanding, an idea will not move organically by itself, requires a single point of contact (person or board), that has the experience and understanding to navigate all these spaces.  With personal attachment and equal benefit, owning the responsibility, day after day until success or failure.

So, when you think about it, institutional translational, is a bit of a contradiction.  Although you may be able to effectively translate the idea out of the institution through a licensing deal, getting the product on the market is quite another task.  One that we believe, is possible and more common outcome, with the right circle of partners, structure and commitment. 

Time for Change, a guided Approach

Today, many are taking another approach.  Wichita State University has proven for years that they can increase institutional creation to market by partnering with local private resources with their institutional resources, to generate results without everything under one roof.  Wichita State University's, National Institute for Aviation Research's (NIAR) growth over recent years has been nothing short of incredible.  Even with aeronautics being a highly regulated industry, like that of medical, they have created strong partnerships with both large and small manufacturing organizations.  By changing the attitude from licensing to delivering, a slightly new approach to co-oping with like-minded private companies, they have created a small city of innovative leadership on their campus and through the city of Wichita, generating real results for the university, their partners, and society.  In fact, working with outside for-profit private partners for assistance, they created the molecular diagnostic laboratory in response to COVID-19, which has been an extremely successful solution to dealing with controlling the spread of COVID during the pandemic, throughout their cities many aircraft support and manufacturing facilities.

More recently, MIT announced a 5-year partnership with research and development-focused affiliate, Northpond Ventures.  In June, MIT News, reported, “This unique program was established with the intent to couple incredible advancements in engineering and biology with innovative entrepreneurial and business opportunities. There is tremendous potential for the MIT-Northpond Program to impact human health by accelerating and commercializing visionary breakthroughs in engineering and life science,” says Anantha P. Chandrakasan, Dean of the MIT School of Engineering and Vannevar Bush Professor of Electrical Engineering and Computer Science.

In fairness, there are many hospitals and universities we are familiar with, moving in the direction of partnering with private industry as part of their programs: Cincinati Children's, Children's National, Children's Hospital Orange County, Jefferson University, Lurie Children's, Houston Methodist's (MITIE) Program, Notre Dame University, and Seattle Children's Research Center, the very place this story started for me. (Note, the children's theme, an area of products our firm is largely experienced in).  But many still haven't worked the problem from the back end, drawing the right design and manufacturing resources in, before licensing, resulting in license deals that die, due to manufacturing and design details the licensee doesn't understand.  Note: If your program has cracked the code, feel free to comment below.  I'd love to write more on specific programs in the future. 

Although now we see our role, more in the middle, in some respects, our firm historically has worked the problem from the back end.  Assisting device manufacturers and other design for manufacturing firms to bring products to life, which clinicians want to see developed.  Neotech Products LLC, a global leader in neonatal nursing and respiratory products, is one of those.  Their specialty is creating relationships with clinical inventors and support idea development from concept to production, with Neotech bearing the brunt of the upfront cost themselves and paying royalties on the back end the original inventors.  The challenge for companies like Neotech, is that they only have so much bandwidth for risk.   Which is why recently Neotech partnered with WSU, to develop a NICU-PICU product which WSU, initially investigated.  Together they were able to move at a more accelerated rate with a split risk to both organizations.  As Neotech President, Craig McCrary, says, “Our primary goal is to make a difference’, everything else is secondary.” An example of institutional and private collaboration at its best!  The program has moved so well, Dr. Rob Gerlach, PhD, a patent engineer, attorney and WSU's Executive Director of Technology Transfer and Commercialization, has since introduced other program partners to us and Neotech, with which we are currently forming additional relationships, with a goal of moving things to porduction.

Setting an Example for Others to Follow

Seeing all of the dynamics of this complex problem personally, I would be dismayed as the owner of a device design firm, if I was part of the problem and not a solution. So, in 2019, I set out to look for local solutions here in Houston and have met some amazing people. First being Dr. Nicole Pardo, M.D., Associate Director at Pumps & Pipes, business owner and innovator.  Shortly after, Nicole introduced me to Dr. Sabia Abidi, PhD., a Rice Bioengineering Professor, who was looking for some Senior Capstone ideas. After sponsoring a couple of Senior Capstone programs at Rice; I realized this was a great place to start, and to my surprise, discovered, Dr. Abidi already has already started a program for device translation at Rice.

The Rice360-SPUR (Special Unit for Respiratory Research, a subset of the Rice360 mission), led by Dr. Abidi and Dr. Rohith Malya, M.D., Director of the Maine Global Health Fellowship and contract clinician for Baylor College of Medicine, and Texas Children’s Emergency Medicine; in partnership with Dr. Nick Ettinger, M.D. Baylor College of Medicine, professor of Pediatrics-Critical Care. SPUR was developed under five core elements:  Focused Development; Targeted Solutions; Leadership and Education; Open-Source Ecosystems; and creating a Clinical and Technical Hub for implementation. They had everything they needed except a Technical Hub for implementation (at least a DFM one).

The program, again, in line with the methods at WSU, initiated a trip to Wichita for Dr. Abidi and me, to brainstorm for two days, on cross-over opportunities at both institutions, with Dr. Gerlach. Returning to Houston armed with even more possibilities, on June 13th Zewski Corporation hired the first Zewski-Rice University joint resource, where one engineer will work for both organizations, to act as a liaison between private development firm, and educational institutions to develop ideas for global health solutions. John Zhang, a 2022 Biomedical Engineering graduate from Rice, will work for Dr. Abidi, and myself at Zewski Corp. beginning the translation of Capstone Programs and other ideas driven from clinical need to production designs. John’s salary and benefits are partially paid by Zewski and part by Rice, allowing both organizations to split the cost.  His duties will include designing the product concept for volume production; creating qualified manufacturing connections, preparing alpha and beta prototypes for characterization, verification, and validation testing; working with Dr. Ettinger at the Texas Medical Center (TMC) for invaluable clinical feedback and guidance; and traveling abroad to see firsthand challenges and product needs.  His work will be guided by experienced staff at Zewski, Rice and TMC.  In this role, he will have the ability to use those relationships to make other invaluable connections, in licensing, contract manufacturing and packaging, for when the time comes to move production responsibility to a manufacturer of record, only leaving the institution oversight, when ready for production.

What makes the program so amazing is the people who all have a common goal of bringing these great ideas into the market within a community of resources.

For more information on how to work with us, or how your organization may be able to in yours, feel free to reach out to me at larry@zewski.com or the SPUR leadership: https://www.rice360.rice.edu/spur

Rice360 Institute for Global Health Technologies, is a non-profit with the goal of providing Global Heath Solutions through education and innovation in order to deal with Health Inequities across the planet.  Donations to their platform allow for progress in several programs similar to that mentioned above.  If this is a value you align with, please donate to Rice360 at the link below.

https://www.rice360.rice.edu/donate