Thank you very much for this opportunity to talk about Stanford Biodesign program, which is an entrepreneurship education for the medical devices. My name is Fumiaki Ikeno, I am Japanese. I have been in the United States since 2001, and more than half of my life after graduating from medical school is in the United States. I hope I can contribute to make a big bridge between Japan and USA, like [unintelligible] NTT Research, in the period of medical devices for the patient all over the world. Today my title is “MedTec Entrepreneurship Education at Stanford University.”

Not only academia, but also R&D in the industry sectors, sometimes struggle to generate new product, which can generate the revenue from their own research output. It is explained by three steps. The first one is the Devil River, which is a hurdle from research output to the idea which can be product eventually. The second hurdle is the Death Valley, which is a barrier from idea to commercial product. The third one is Darwin Sea, which is a hurdle to make a commercial product to become a big revenue-generating product. For the academia, the first hurdle is critical and essential to make a research output to the idea.

There are two different kind of commercial product developing process in the healthcare innovation. One is bio and biopharma, and the other one is medical device. Regarding the disciplinine, medtech is mainly mechanical engineering, electrical engineering, and the medical and the surgical. Biopharma is mainly chemical engineering, computer science, biology, and genetics. However, very important difference of these two is the innovation process. Medtech is suitable for needs-driven innovation, and the biopharma is suitable for discovery-plus-needs. In general, translational medical research between the (indistinct) from academia output to the commercial product in the medical field is called bench to bed.

It means from basic research to clinical application, but it is all bio and pharma. Translational medical research for medical devices is bed to bench and back to bed, which means quicker unmet needs to bench and back to clinical application. The difference of the process is the same as the difference of the commercialization. Our goal is to innovate the new devices for patients all over the world.

There are two process to do innovation. One is technology push-type of innovation. The other one is needs pull-type of innovation. Technology push-type innovation is typically from research laboratory. It is suitable for the pharma and the bio type of innovation. Needs-pull or need-driven type of innovation is suitable for medical devices. Either tech push-type of innovation or needs pull-type of innovation, it is important to have unmet needs. We should think about for what and its worth.

In 2001, Stanford University has started to staff the Biodesign program, which is an entrepreneurship education for medical devices. Our mission is educate and empowering health technology innovators, and leading the transition to a value-driven innovation ecosystem. Our vision is to be a global leader in advancing health technology innovation to improve lives everywhere. There are three steps in our process of innovation: identify, invent, and implement. The most important step is the first step, which is identify.

Identify a well-characterized need is the DNA of a great invention. Most of the value of medical device development is due to lack of enough unmet needs. So we focus to this identify phase the most, to find and select an appropriate need. Our fellows and students typically work in multidisciplinary team that ideally include individual with a background in medicine, engineering, and business.

How to find unmet needs. Small team will go to the hospital or clinical environment to observe the health care providers with naive eyes. The team focused to looking for the unmet needs, not technology. This method is similar to, it’s the black-car approach, which can be applied for the design thinking. The team will generate at least 200 needs from clinical unmet needs. Next step to identify phase is to select the best unmet needs. We will use four different aspects which can evaluate the unmet needs. This is background, current existing solutions, market size, and stakeholder analysis.

Once we pick up a few unmet needs from 200 unmet needs, they can move to the invention phase. Finally, they can invent the solution. Many people tend to invent at the beginning phase without carefully evaluating its unmet needs. To do so innovators tend to fall in love their own idea even if unmet needs is not (indistinct). This is why most of the medical device innovations fail, due to the lack of unmet needs. To avoid this pitfall, our approach is identify good needs first, and invention is second.

To generate the idea from unmet needs, we will use seven rules of brain storming. Be visual, defer judgment, encourage wild ideas, build on the ideas of others, go for quantity, one conversation at a time, stay focused on the topic. The brain storming is like an association game. Somebody’s idea can stimulate the others’ ideas. After generating many ideas, the next step is screening of idea. We will use five different aspects to evaluate the ideas. Intellectual property, regulatory, reimbursement, business model, and technology how.

After the selection step, we can have the best solution for the best unmet needs. And finally, team will go to the implementation phase. This phase is more business-oriented matters. The strategy of business implementations and business planning. Since 2001, more than 50 starting ups are springing up from Biodesign program. Let me show one example.

This is a case of chest palpitations. If patient feels chest pain, most of the patients go to public doctor first. The public doctor refer the patient to general cardiologist. General cardiologist refer the patient to electrophysiologist. Electrophysiologist will make a reservation of Holter ECG test. Patient will come to the clinic to put Holter ECG machine on their chest. One or two days later, patient will visit clinic to put on the Holter. After few days of analysis, patient come back to doctor to hear the result. Each step needs money to pay. This is unmet needs.

This is a rough sketch of the solutions. The product name is Zio Patch, and it can save about $620 per outpatient per year. (cheerful music)

“Narrator: Life is stressful. We all depend on our heart, the life source of our incredible machine, the body. However, sometimes our heart needs a checkup. Perhaps you’ve felt dizzy, heart racing, or know someone who has had a serious heart problem. The old-fashioned monitors they used to get from most doctors are bulky, and you can’t wear them exercising, or in the shower. If appropriate for you, SuddenLife will provide you the iRhythm Zio Patch, a two by five inch, bandaid-like patch which you can apply to your chest, in the comfort of your own home, or in the gym. It will monitor your heart rate for up to 14 days. You never have to come into a doctor’s office as you mail back the patch to us. Shortly after, you will receive an easy to understand report of your heart activity, along with recommendations from a heart specialist, to understand the next steps in your heart health. SuddenLife, bringing heart monitoring to you.”

This is from the TV broadcasting [unintelligible]. We can see something on his breast. He has a partition and a [unintelligible]. Now the company named iRhythm is in the public. Market cap of this company is more than six billion. Zio Patch is replacing (indistinct) for the ECG examination kits.

However, our main product is human. The product life cycle of medical device is less than 10 years. But if we can educate the human, this is forever, because people can educate other people beyond space and time. Beyond border. Stanford Biodesign education is now launched in India, Singapore, and Japan.

In 2015, previous prime minister Abe visited Stanford University and then he announced that Japan Biodesign will launch the Japan Biodesign program. Japan Biodesign program has started at the University of Tokyo, Osaka University and Tohoku University, collaborating with Japanese government and Japanese Medical Device Industry Association in 2015. This year, the fifth batch of Japan Biodesign [unintelligible] fellowship, and so far more than five starting up has been founded. That’s all, thank you very much for your attention.