Japan's Rapidly Aging Society "How to innovate for this?"
Fumiaki Ikeno, MD
Program Director (U.S.) Japan Biodesign
Japan is facing a super aging society and current aging rate has been already No. 1 in the world. At the same time, the young generation is getting fewer year by year due to low birth rate. We have to think some smart way to maintain this aging society. "To predict the future is to create it." From my experiences in Silicon Valley, I would like to introduce the process of medical device innovation and also some technologies.
1992 Jichi Medical University, Japan M.D.
2004 Post Doctoral Fellowship, Stanford University, Cardiovascular Medicine
2007 Graduate Student, Biodesign Certificate Program, Stanford University
May/1992 Passed the Examination of National Board
May/1992-Mar/1994 Resident in Shizuoka Prefecture General Hospital, Shizuoka, Japan Shizuoka prefectural government, department of health & welfare
Apr/1994-Mar/1997 Clinical Fellow in Department of Cardiology, Yaizu Municipal Hospital, Yaizu, Japan Shizuoka prefectural government, department of health & welfare
Apr/1997-Mar/2001 Medical Staff in Department of Internal medicine, Sakuma Hospital, Shizuoka, Japan Shizuoka prefectural government, department of health & welfare
Apr/2001- Mar/2004 Post doctoral research fellow, Division of Cardiovascular medicine, Stanford University
Apr/2004- Medical Director/Research Associate, Experimental Interventional Cardiology, Division of Cardiovascular medicine, Stanford University
Jul/2009- Japan - U.S. "Harmonization By Doing" HBD Pilot Program Initiative. Working Group 1 Committee member
Oct/2013- Chief Medical Offiicer, Medventure Partners, Inc
Jan/2014- Sep/2015 Global PDP Liaison, Stanford Biodesign, Stanford University
Oct/2015- Program Director (US), Japan biodesign, Stanford Biodesign, Stanford University
Study of Fluorescence Spectroscopy Guided Optical Biopsy Needle for Prostate Cancer Diagnosis
Speaker: Amir Tehrani
CEO, Precision Biopsy, LLC
Current prostate biopsy cores have a very low diagnostic yield. These biopsies often fail to diagnose prostate cancer since 90% of cores are histopathologically classified as benign. The concentrations of endogenous fluorophores in prostate tissue vary with disease states. Thus, fluorescence spectroscopy could be utilized to quantify these variations for identification of malignant lesions. We investigated clinical feasibility of a 14 gauge (1.98 mm) optical biopsy needle guided by fluorescence spectroscopy for real-time in vivo prostate cancer diagnosis. Built-in optical sensor has 8x100 µm fibers for tissue excitation and a single 200 µm fiber to collect spectral data. Custom-made fluorometer has 2 light-emitting diodes at 290 and 340 nm and a spectrometer. User interface for fluorometer operation and data collection was developed using LabView software. Each spectral data acquisition required ~2 seconds. The in vivo biopsies were performed during radical retropubic prostatectomy surgery on the exposed prostate with blood flow to the gland intact. A tissue biopsy core was obtained from each biopsy site after acquisition of spectral data. Above procedure was repeated ex vivo after surgical excision of the prostate. Biopsy cores were histopathologically classified as either benign or malignant and correlated with corresponding spectral data. Partial Least Square analysis was performed to determine diagnostically significant principal components as potential classifiers. A linear support vector machine and leaveone-out cross validation method was employed for tissue classification. Thirteen patients were consented to the study. Histopathological analysis found cancer in 29/208 in vivo and 51/224 ex vivo viable biopsy cores. Study results show 72% sensitivity, 66% specificity, and 93% negative predictive value for in vivo and 75%, 80%, and 93%, respectively, for ex vivo malignant versus benign prostatic tissue classification. Optical biopsy needle has a very high negative predictive value to indicate benign tissue while sufficient sensitivity for targeting areas suspicious for cancer within the prostate gland. Hence, the optical biopsy needle can increase the diagnostic yield of prostate biopsies with consequent improvement in patient care.
Precision Biopsy is led by CEO Amir Tehrani, who has over 20 years of experience in management and operations, strategy, business development, marketing, design and development for Fortune 500 and start-up medical device companies. Prior to Precision Biopsy, Amir was the President and CEO of Amaranth Medical, Inc., a bioabsorbable stent company. He has been instrumental in the formation and financing of several medical device companies, including Inspiration Medical, Inc., Corventis, Inc. (acquired by Medtronic, Inc.), Spinal Modulation, Inc., (acquired by St. Jude Medical), Sonitus Medical, Inc., and RODO Medical, Inc. Amir also led successful investments and acquisition in the medical technology sector at Guidant Compass Group. He also held several leading marketing and engineering positions at Guidant Vascular Intervention, St. Jude Medial CRM Division, Ventritex, Inc., (acquired by St. Jude Medical), and MiniMed, Inc. (acquired by Medtronic, Inc.). Amir holds a BS in Electrical Engineering from the University of Idaho and an MS in Biomedical Engineering from California State University in Sacramento, CA.
Picosecond Pulse Imaging - Promising but Challenging Modality for Wearable Functional and Structural Brain Imaging
Speaker: Joel Libove
President, Furaxa, Inc.
Ultrawideband (UWB) 10-100 picosecond wide electrical pulses can penetrate through even the deepest brain tissues, and can now be generated and detected using arrays of very low cost, high dynamic range, single chip radars. The ability to make an inexpensive helmet with hundreds of these radars, coupled with their capability for full brain penetration endows Picosecond Pulse Imaging (PPI) with the most promise, at least in theory, for enabling wearable, high resolution portable Brain Machine Interfaces (BMIs) for real time functional imaging. However, structural, vascular and functional images produced by researchers to date have been poor. Approaches will be presented here for significantly improving signal-to-noise ratio (SNR) and mitigating the effects of severe scattering that have prevented this technology from reaching its enormous potential.
Joel Libove specializes in high speed electronics, including ultrawideband amplifier circuit design, UWB pulse generation and picosecond electronic sampling. He is president of Furaxa, Inc., where he leads the development of non-invasive microwave-based real-time vascular and functional medical imaging systems. He is also Chairman of Ultraview Corporation where he architected 8 generations of high dynamic range high speed data acquisition boards. Prior to this Dr. Libove developed the first hardware-implemented zero-latency disk controller, the first automatic computer bus violation detector, and the first accurate non-contact AC voltmeter. Joel holds 13 patents (three of which were licensed) and one patent pending. He has a Ph.D. from UC Berkeley, and a BSEE from Cornell University.
Title: Interpreting the Voice of Customer (VoC): Surgeon Feedback to Design Next-Generation Medical Device Solutions
Speaker: Rachit Ohri
CEO, Enable Life Sciences LLC
Why is it so elusive to translate surgeon feedback into breakthrough medical device product concepts? This talk outlines the pitfalls and opportunities for Voice of Customer (VoC) campaigns with surgeons and physicians. Case studies are presented for converting VoC data into information, the information into insights, and the insights into product concepts. The talk also highlights the interplay between the VoC (Voice of Customer), the VoT (Voice of Technology) and the VoM (Voice of the Market). VoC data interpretation is also explored in the context of cultural and geographic differences, as well as differences between medical reimbursement ecosystems.
Rachit Ohri has more than 12 years of experience building multi-disciplinary programs for developing medical devices from concept through clinical validation. In 2013, he founded Enable Life Sciences, a medical device development services company. As CEO, Rachit has led the young company through successful completion of 6 medical device development projects for clients in Asia, Europe, and North America. Prior to founding Enable Life Sciences, he was a Program Director at Covidien, where he was engaged in the development of implantable devices for vascular therapies. Before his move to Covidien, Rachit was a Principal Engineer for Cappella Inc., and before that he was a Senior Scientist at Boston Scientific. Rachit has co-authored several publications in peer-reviewed scientific journals, as well as more than 30 patent applications (14 issued US patents). Dr. Ohri received his Ph.D. in Bioengineering (2003) from the University of Washington, Seattle and his undergraduate degree in Chemical Engineering from the National Institute of Technology (NIT), Trichy, India. Additionally, Dr. Ohri is a 2011 alumnus of the MIT Sloan School of Management's flagship programs for Executives, namely the Certificate in Innovation and Strategy and the Greater Boston Executive Program (GBEP).
Title: kV X-ray Digital Tomosynthesis Image Tracking of Respiratory Motion During The Delivery of MV Radiotherapy Treatment of Cancer
Speaker: Larry Partain
Director of Clinical Research, Silicon Valley Operations, TeleSecurity Sciences
External beam radiotherapy, widely applied in the treatment cancer, directs a constantly re-shaped beam of gamma rays (i.e. MeV photons) from outside a patient to non-surgically enter the patient's body to destroy a malignant lesion, as this focused treatment beam circles the patient's body, for a lesion positioned near the center of rotation. A priority early application is treatment of lung cancer in free breathing patients where the cancer lesion can easily move up and down a cm or more during respiratory cycles (every 4 to 6 sec.) for continuous treatments that can typically last a minute or more. Since real time viewing of respiratory motion of objects has not usually been available during radiotherapy, the standard protocol delivers this lethal dose over the total volume traversed by the lesion during multiple breathing cycles. Unfortunately this directly kills about 2% of the patients treated and seriously injures a larger fraction due to the radiation damage to healthy surrounding lung tissues, the heart, the spinal cord and other "organs at risk" including the ribs. The success of this x-ray tomosynthesis tracking technology has the potential to significantly reduce the magnitude of such collateral damage.
Larry Partain is the Director of Clinical Research, Silicon Valley Operations, Los Altos, CA for TeleSecurity Sciences headquartered in Las Vegas, NV. Much of his professional career has focused on translational research with electronic devices and systems that offer a promise to substantially improve management of cancer or other diseases. Past successes as Director of Marketing and Advanced Technology, at Varian Medical Systems, include his participation in the application of flat plate, amorphous silicon, digital imagers to the replacement of X-ray film and to their implementation in cone beam CT systems that provide image guidance for radiotherapy treatment of cancer. His recent opportunities at TeleSecurity Sciences now offer the potential to combine this imager technology with the disruptive capabilities of scanned electron beam X-ray sources that promise major improvements in the motion tracking of lung cancer in real time in free breathing patients during the administration of radiotherapy. This has the potential to substantially reduce collateral damage to surrounding healthy lung tissues and to other organs at risk including the heart, aorta, spinal cord, ribs and chest wall. He received his Ph.D. in Electrical Engineering from Johns Hopkins University. He is the recipient of 29 US Patents and the author or co-author of 72 scientific articles in journals, book chapters and conference proceedings.
Title: Early results from proof of concept clinical trials with G-Tech Medical's "EKG for the Gut"
Speaker: Steve Axelrod
CEO of G-Tech Medical
Motility, the movement through the digestive tract of what starts out as food, is usually taken for granted, until something goes wrong. There are a wide range of gastrointestinal (GI) disorders and dysfunctions that can be blamed on motility issues. Fifteen to twenty percent of the population suffer from symptoms of Irritable Bowel Syndrome - constipation, diarrhea, bloating and chronic abdominal pain - while 1.5 million live with the more serious Inflammatory Bowel Disease (IBD). In addition, regaining normal motility is key in the recovery from abdominal surgery, and determines feeding rates for patients on enteral feeding in the ICU. Yet there aren't any very good ways to measure motility of the entire GI tract noninvasively, continuously for multiple days, while under normal physiological conditions. G-Tech has developed electrode patches worn on the abdomen that read electrical signals emanating from the muscles of the stomach, small intestine and colon when they are active - driving motility - that are thin, wireless and non-invasive. The patches use Bluetooth LE to transfer raw data to a smartphone and from there on to a cloud server for analysis.
Since the previous talk in 2015 G-Tech has launched clinical trials on patients recovering from abdominal surgery at El Camino Hospital and from Whipple surgery at Stanford; together there have been nearly 100 patients tested. We have also been part of a study run by the Parkinson's Institute looking at the relationship of GI measures to Parkinson's Disease symptoms. Interesting results have been obtained in these cases and also in volunteer tests, and will be described in the talk. Additional studies are currently in negotiation and planning stages, including one on enteral feeding, two related to gastroparesis, and another looking at Crohn’s Disease patients. The logic and goals for these will be discussed as well.
Steve holds a BS in Physics from UConn and a PhD in Elementary Particle Physics from Yale. He played with technologies like particle detection and fast pulse instrumentation, sub-kelvin cryogenics, superconducting magnets, NMR and ESR, high vacuum systems and data acquisition and analysis. He remembers using Bitnet and Arpanet before there was a WWW, and sending emails to friends working at distant particle accelerators using PDP-10 and VAX terminals. After graduation he took a postdoc position at Stanford and when that ended refused to leave the Bay Area. The next 15 years were spent at Measurex (later Honeywell) developing on-line measurement systems such as nuclear and X-ray basis weight and thickness sensors, infrared moisture sensors and large electromechanical scanning systems. In 2003 he joined Xoft Inc., a startup developing a 2mm diameter 50kV X-ray source for radiation therapy applications, and has been in the medical device field ever since. He has been CEO of G-Tech Medical since joining the company in late 2011. Steve has been in individual contributor and various levels of management roles, but has never been able to fully break away from the science and technology.