Advancing Regenerative Medicine and Biofabrication

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Q&A with Dean Kamen, world-renown inventor, humanitarian and President of DEKA Research & Development and Founder of FIRST® 

What is your vision for how technology will benefit humanity?

As a society, we have advanced through several stages of healing disease including: identifying the issue, treating the symptoms, and in the past several decades more advanced options such as transplantation. Now with regenerative medicine – in the near-term horizon – we will build organs from our own cells.

This is where the future lies. It’s where we prevent disease not unlike using vaccines. In the case of regenerative medicine, we will build new organs from our own cells. That is the optimal solution which has the power to eradicate not only diseases such as end stage renal disease requiring life-saving kidney dialysis; but also to reduce the overall costs in treating chronic diseases. We hope to save billions of dollars annually on dialysis alone when people receive a new manufactured kidney.

If we don’t find a better way to deliver healthcare, we will bankrupt this country.

Instead of giving everyone a new smart phone, what if we could give you a new kidney when you need one, or a new liver or new heart?  We are creating an industry to give humans a chance with engineered parts suited entirely to their own body.

You’ve been involved in numerous successful science and technology ventures; tell us a little bit about your latest endeavor. Why did you choose this area to focus on?

If you look at the history of manufacturing, we have spent over 100 years to get quality up and costs down based on an entire manufacturing ecosystem. We want to do the same and create a roadmap for scaling up biologic output.

The need for organs cannot be underestimated. Every 30 seconds a patient who could have been saved with tissue replacements dies.

Advanced Regenerative Manufacturing Institute (ARMI) and BioFabUSA are not designed to create the end product, but rather to help others with whatever they need to create the product be it knowledge, technology, equipment, process and standards – anything needed to address the ecosystem for a new industry.

I believe the measure of what we are doing at ARMI and BioFabUSA is to be able to look back relatively quickly and see that we have transformed health care.

What kinds of innovations are happening right now in the lab, but are having trouble turning into manufactured products?

The research community has done a tremendous job in developing the field of regenerative biology. There have been significant breakthroughs in cell biology, biofabrication, and materials science in the last decades, which have laid the foundation for large-scale manufacturing and commercialization of engineered tissue-related technologies, including tissue and organs. Now it is time to move out of the lab and into the factory. And for that, you need a very different model, with mechanisms to overcome current roadblocks that are preventing the scale-up of viable products that are safe and effective.

Currently, researchers and scientists have taken tissue from a patient and expanded it outside of the body creating new tissues and organs that can be put back into the body.  For example, Wake Forest Institute for Regenerative Medicine in Winston N.C. made history by growing and implanting a bladder into a human patient.

There are all kinds of miracles that exist in roller bottles and petri dishes at universities and medical schools all over the country.  We sought out the best and biggest companies that do automation, controls, sensors and who understand the manufacturing process to be able to work together to reach a goal where solutions come from the ARMI members’ collaboration.

What is regenerative medicine? What is biofabrication? 

The future of healthcare and hospital care will use regenerative medicine and biofabrication.  Regenerative medicine will transform the way healthcare is delivered using highly automated, personalized patient treatments. 3-D printing will play a big role in this healthcare revolution.

Within the area of regenerative medicine, biofabrication will replace tissue constructs and restore biological function and health in a rapid fashion. Combining the body’s own regenerative capacity with bioactive factors and biodegradable biomaterials technology, it will produce patient-specific tissue and organs that will be formed into complex shapes required to restore tissue, form, and function.

You can think of biofabrication as the manufacturing process at the intersection of biology-related research, computer science, materials science, and engineering that creates innovations such as biomaterials and cell and tissue processing.

In other words, it is an alternative treatment using the body’s own regenerative capacity with a little help from technology to significantly increase better outcomes for individuals and society.

You’ve been quoted saying, “the only difference between science fiction and science is time”, when do you predict the consumer will be able to get a custom-made organ? 

Timing is everything.  When you watched Star Trek back in the last century, did you think you would ever carry the ‘communicator’ – which is now our advanced smartphone?

Building organs in the lab is not the stuff of science fiction; it is happening right now.

However, it takes a force of nature to move an idea from the lab to the factory. With collaboration among the members of ARMI/BioFabUSA, we feel there will be significant breakthroughs in the next five to ten years – maybe sooner.  Imagine how healthcare would change if we could print a new kidney or liver for you when you needed one.

In the near term, what steps need to happen in order to get this research out of the labs and into the hands of consumers?

We need to keep the focus on staying on the path to high volume. We’re reaching out to companies to look at this new field and find their place in it.  It may take the form of adapting current products or creating new lines. We will create a supply chain for this new industry.  Smaller companies can join the effort too as they find the resources they need by becoming a part of BioFabUSA. I feel that through BioFabUSA – regenerative medicine can be for entrepreneurs and others what Silicon Valley was for high-tech.

What role might standards and IEEE have in bringing about the future of this new industry – biofabrication?

Standards for human tissue will be paramount across the supply chain for success as we build high-volume manufacturing processes for tissue and organs.

Currently the small firms with ideas for truly transformative regenerative medicine therapies must spend significant amounts of time and capital, which they have neither of in excess, to develop robust processes and equipment to manufacture sufficient quantities of their innovation products for clinical trials – not to mention the amount that they would need to take them to a commercial market.

Usually, these processes and equipment fall outside of the expertise of these small firms.

Development of both documentary standards and reference materials for analytical tests through a consensus standards process understood by both industry and regulators would mean that these firms can focus on what they are good at – designing innovated regenerative medicine products.

Although there are numerous existing standards development organizations (SDO’s), each has its own niche – some on product characterization, some in manufacturing equipment, etc. and the product developers do not know about them; therefore, parallel efforts are happening in multiple SDO’s, which is not helping anyone.

Last year, a new non-profit, the Standards Coordinating Body was formed by the Alliance for Regenerative Medicine to educate the field about the use of standards and to develop public processes to identify gaps in the standards landscape and to help fill in those gaps identifying SDO’s that can best develop specific standards in that niche.  That way, both the industry and the industry standards can grow up together much the way that the microelectronics industry and its standards did in the later part of the 20th century.

As you return to the SXSW stage with a new focus area, what are you most excited about? What are you hoping to learn while you’re there?

While it is a new focus in regenerative medicine, it is not a new focus for me in the medical arena or technology innovation or in inspiring the STEM talent needed to fill the many professional and technical roles this industry will create.  In founding FIRST® (www.FIRSTInspires.org) over 25 years ago, we addressed the need to make math, engineering, and trigonometry as exciting as basketball and football.

Just as we made robotics transformational, we will lead future generations of students to rally around the healthcare system and its outcomes.

Now, add to that a personal goal – when students see their grandmother or parent suffer from a debilitating disease, they can very quickly become a part of the solution to not only cure that illness for their loved ones; but also find future solutions.

ARMI has partnered with the University of New Hampshire as the catalyst for a nation-wide Education and Workforce Development (EWD) plan.  We hope to open careers by training up a workforce from K-Grad to meet the needs of this new industry.

Dean Kamen is a prolific inventor who has been compared to Edison for his contributions to humanity. Dean holds more than 450 technology patents and has invented ground-breaking technologies that are changing lives around the world; from the first drug pumps and the iBot, a revolutionary stair-climbing, wheelchair, to Segway and the “Luke” robotic arm. Dean’s pioneering inventions in energy and water that will help end poverty in developing nations. Dean’s non-profit, FIRST® (For Inspiration & Recognition of Science & Technology) is a global program for K-12 students, designed to experientially engage and inspire the next generation of young technology innovators through mentoring, good sportsmanship and robotics competitions. Dean is an award-winning inventor, an adviser to World Leaders, and a mentor who presents remarkable insight and plan-spoken truth in a manner that inspires and challenges others.

Dean Kamen will provide insight on regenerative medicine and biofabrication at the annual SXSW Conference, 9-18 March 2018 in Austin, TX. The session, Regenerative Medicine & Human Tissue Manufacturing is included in the IEEE Tech for Humanity Series at SXSW.