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Bio

Bio


Dr. Josh Makower will be nominated for professorship at the Stanford University School of Medicine. Starting August 1, 2021, he will assume the role of Director of the Stanford Byers Center for Biodesign, the program he co-founded with Dr. Paul Yock twenty years ago. Josh helped create the fundamental structure of the Center?s core curriculum and is the chief architect of what is now called ?The Biodesign Process.? Over the past 20 years since Josh and Paul founded Biodesign, this curriculum and the associated textbook has been used at Stanford and across the world to train hundreds of thousands of students, faculty and industry leaders on the Biodesign process towards the advancement of medical innovation for the improvement of patient care. Josh has practiced these same techniques directly as the Founder & Executive Chairman of ExploraMed, a medical device incubator, creating 9 companies since 1995. Transactions from the ExploraMed portfolio include NeoTract, acquired by Teleflex, Acclarent, acquired by J&J, EndoMatrix, acquired by C.R. Bard & TransVascular, acquired by Medtronic. Other ExploraMed/NEA ventures include Moximed, NC8 and Willow. Starting August 1st, Josh will also transition from General Partner to the role of Special Partner at NEA where he will continue to support their healthcare team and medtech/healthtech investing practice. Josh serves on the board of Allay Therapeutics, NC8, Setpoint Medical, DOTS Technologies, Eargo, ExploraMed, Intrinsic Therapeutics, Moximed, Willow and Coravin. Josh holds over 300 patents and patent applications. He received an MBA from Columbia University, an MD from the NYU School of Medicine, a bachelor?s degree in Mechanical Engineering from MIT. Josh is a Member of the National Academy of Engineering and the College of Fellows of The American Institute for Medical and Biological Engineering and was awarded the Coulter Award for Healthcare Innovation by the Biomedical Engineering Society in 2018.

Academic Appointments


Administrative Appointments


  • Board of Directors, Allay Therapeutics (2016 - Present)
  • General Partner, NEA (2003 - Present)
  • Executive Chairman & Founder, ExploraMed, Inc. (1995 - Present)
  • Executive Chairman & Founder, Willow Innovations (2014 - Present)
  • Board of Directors & Founder, NC8 (2019 - Present)
  • Chairman of the Board & Founder, Moximed, Inc. (2007 - Present)
  • Board of Directors, Setpoint Medical, Inc. (2017 - Present)
  • Chairman of the Board of Directors, Eargo, Inc. (2015 - Present)
  • Chairman of the Board of Directors, DOTS Technologies (2015 - Present)
  • Board of Directors and Co-Founder, Coravin, Inc. (2002 - Present)
  • Board of Directors, Intrinsic Therapeutics, Inc. (2000 - Present)

Honors & Awards


  • Coulter Award for Healthcare Innovation, Biomedical Engineering Society (2018)
  • Member of the College of Fellows, The American Institute for Medical and Biological Engineering (2017)
  • M.I.T. Award for Excellence in Undergraduate Teaching, M.I.T. (1985)

Boards, Advisory Committees, Professional Organizations


  • Member, National Academy of Engineering (2021 - Present)
  • Member, College of Fellows of the American Institute of Medical and Biological Engineering (2019 - Present)

Professional Education


  • MBA, Columbia University, Business (1993)
  • M.D., NYU School of Medicine, Medicine (1989)
  • S.B., M.I.T., Mechanical Engineering (1985)

Patents


  • Joshua Makower, et al. "United States Patent 10,702,295 Methods and apparatus for treating disorders of the ear nose and throat", Acclarent, Inc.
  • Joshua Makower, et al. "United States Patent 10,702,371 Absorber designs for implantable device", MOXIMED, INC.
  • Joshua Makower, et al. "United States Patent 10,716,709 Silent effusion removal", Acclarent, Inc.
  • Joshua Makower, et al. "United States Patent 10,722,624 Breast pump assembly with breast adapter", ExploraMed NC7, Inc.
  • Joshua Makower, et al. "United States Patent 10,736,746 Extra-articular implantable mechanical energy absorbing systems", MOXIMED, INC.

Research & Scholarship

Current Research and Scholarly Interests


Dr. Josh Makower has been appointed to an endowed full Professorship at the Stanford University School of Medicine starting August 1, 2021 and at that time will also assume the role of Director of the Stanford Byers Center for Biodesign, the program he co-founded with Dr. Paul Yock twenty years ago. Josh helped create the fundamental structure of the Center?s core curriculum and is the chief architect of what is now called ?The Biodesign Process.? Over the past 20 years since Josh and Paul founded Biodesign, this curriculum and the associated textbook has been used at Stanford and across the world to train hundreds of thousands of students, faculty and industry leaders on the Biodesign process towards the advancement of medical innovation for the improvement of patient care. Josh has practiced these same techniques directly as the Founder & Executive Chairman of ExploraMed, a medical device incubator, creating 9 companies since 1995. Transactions from the ExploraMed portfolio include NeoTract, acquired by Teleflex, Acclarent, acquired by J&J, EndoMatrix, acquired by C.R. Bard & TransVascular, acquired by Medtronic. Other ExploraMed/NEA ventures include Moximed, NC8 and Willow. Starting August 1st, Josh will also transition from General Partner to the role of Special Partner at NEA where he will continue to support their healthcare team and medtech/healthtech investing practice. Josh serves on the board of Allay Therapeutics, NC8, Setpoint Medical, DOTS Technologies, Eargo, ExploraMed, Intrinsic Therapeutics, Moximed, Willow and Coravin. Josh holds over 300 patents and patent applications. He received an MBA from Columbia University, an MD from the NYU School of Medicine, a bachelor?s degree in Mechanical Engineering from MIT. Josh is a Member of the National Academy of Engineering and the College of Fellows of The American Institute for Medical and Biological Engineering and was awarded the Coulter Award for Healthcare Innovation by the Biomedical Engineering Society in 2018.

Publications

All Publications


  • Need Statements in Healthcare Innovation. Annals of biomedical engineering Mokarram, N., Denend, L., Lyon, J., Rait, D., Brinton, T., Makower, J., Yock, P. 2021

    View details for DOI 10.1007/s10439-021-02782-3

    View details for PubMedID 34100147

  • Inspiration, Perspiration, and Perseverance: An Innovator's Perspective MEDICAL INNOVATION: CONCEPT TO COMMERCIALIZATION Makower, J., Denend, L., Behrns, K. E., Gingles, B., Sarr, M. G. 2018: 251?60
  • Needs-Based Innovation in Interventional Radiology: The Biodesign Process TECHNIQUES IN VASCULAR AND INTERVENTIONAL RADIOLOGY Steinberger, J. D., Denend, L., Azagury, D. E., Brinton, T. J., Makower, J., Yock, P. G. 2017; 20 (2): 84?89

    Abstract

    There are many possible mechanisms for innovation and bringing new technology into the marketplace. The Stanford Biodesign innovation process is based in a deep understanding of clinical unmet needs as the basis for focused ideation and development. By identifying and vetting a compelling unmet need, the aspiring innovator can "derisk" a project and maximize chances for successful development in an increasingly challenging regulatory and economic environment. As a specialty founded by tinkerers, with a history of disruptive innovation that has yielded countless new ways of delivering care with minimal invasiveness, lower morbidity, and lower cost, interventional radiologists are uniquely well positioned to identify unmet needs and develop novel solutions free of dogmatic convention.

    View details for PubMedID 28673651

  • Inspiration, perspiration, and execution: An innovator's perspective SURGERY Makower, J. 2017; 161 (5): 1187-1190

    Abstract

    Josh Makower, MD, is a General Partner at New Enterprise Associates, Consulting Professor of Medicine at Stanford University Medical School, Co-Founder of Stanford's Biodesign Innovation Program, and Founder and Executive Chairman of the medical device incubator, ExploraMed Development, LLC.

    View details for DOI 10.1016/j.surg.2016.06.060

    View details for Web of Science ID 000400318000003

    View details for PubMedID 28438272

  • Outcomes from a Postgraduate Biomedical Technology Innovation Training Program: The First 12 Years of Stanford Biodesign ANNALS OF BIOMEDICAL ENGINEERING Brinton, T. J., Kurihara, C. Q., Camarillo, D. B., Pietzsch, J. B., Gorodsky, J., Zenios, S. A., Doshi, R., Shen, C., Kumar, U. N., Mairal, A., Watkins, J., Popp, R. L., Wang, P. J., Makower, J., Krummel, T. M., Yock, P. G. 2013; 41 (9): 1803-1810

    Abstract

    The Stanford Biodesign Program began in 2001 with a mission of helping to train leaders in biomedical technology innovation. A key feature of the program is a full-time postgraduate fellowship where multidisciplinary teams undergo a process of sourcing clinical needs, inventing solutions and planning for implementation of a business strategy. The program places a priority on needs identification, a formal process of selecting, researching and characterizing needs before beginning the process of inventing. Fellows and students from the program have gone on to careers that emphasize technology innovation across industry and academia. Biodesign trainees have started 26 companies within the program that have raised over $200 million and led to the creation of over 500 new jobs. More importantly, although most of these technologies are still at a very early stage, several projects have received regulatory approval and so far more than 150,000 patients have been treated by technologies invented by our trainees. This paper reviews the initial outcomes of the program and discusses lessons learned and future directions in terms of training priorities.

    View details for DOI 10.1007/s10439-013-0761-2

    View details for Web of Science ID 000323736800002

    View details for PubMedID 23404074

  • A Role for Entrepreneurs An Observation on Lowering Healthcare Costs via Technology Innovation AMERICAN JOURNAL OF PREVENTIVE MEDICINE Gottlieb, S., Makower, J. 2013; 44 (1): S43-S47

    View details for DOI 10.1016/j.amepre.2012.09.006

    View details for Web of Science ID 000311636100011

    View details for PubMedID 23195166

  • Applying a Structured Innovation Process to Interventional Radiology: A Single-Center Experience JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY Sista, A. K., Hwang, G. L., Hovsepian, D. M., Sze, D. Y., Kuo, W. T., Kothary, N., Louie, J. D., Yamada, K., Hong, R., Dhanani, R., Brinton, T. J., Krummel, T. M., Makower, J., Yock, P. G., Hofmann, L. V. 2012; 23 (4): 488-494

    Abstract

    To determine the feasibility and efficacy of applying an established innovation process to an active academic interventional radiology (IR) practice.The Stanford Biodesign Medical Technology Innovation Process was used as the innovation template. Over a 4-month period, seven IR faculty and four IR fellow physicians recorded observations. These observations were converted into need statements. One particular need relating to gastrostomy tubes was diligently screened and was the subject of a single formal brainstorming session.Investigators collected 82 observations, 34 by faculty and 48 by fellows. The categories that generated the most observations were enteral feeding (n = 9, 11%), biopsy (n = 8, 10%), chest tubes (n = 6, 7%), chemoembolization and radioembolization (n = 6, 7%), and biliary interventions (n = 5, 6%). The output from the screening on the gastrostomy tube need was a specification sheet that served as a guidance document for the subsequent brainstorming session. The brainstorming session produced 10 concepts under three separate categories.This formalized innovation process generated numerous observations and ultimately 10 concepts to potentially to solve a significant clinical need, suggesting that a structured process can help guide an IR practice interested in medical innovation.

    View details for DOI 10.1016/j.jvir.2011.12.029

    View details for Web of Science ID 000302396300009

    View details for PubMedID 22464713

  • Biodesign: The Process of Innovating New Medical Technologies Yock, P., Zenios, S., Makower, J., et al Cambridge. 2010
  • FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. Makower, J., Meer, A., Denend, L. AdvaMed and the National Venture Capital Association. 2010
  • Inventing our future: training the next generation of surgeon innovators. Seminars in pediatric surgery Krummel, T. M., Gertner, M., Makower, J., Milroy, C., Gurtner, G., Woo, R., Riskin, D. J., Binyamin, G., Connor, J. A., Mery, C. M., Shafi, B. M., Yock, P. G. 2006; 15 (4): 309-318

    Abstract

    Current surgical care and technology has evolved over the centuries from the interplay between creative surgeons and new technologies. As both fields become more specialized, that interplay is threatened. A 2-year educational fellowship is described which teaches both the process and the discipline of medical/surgical device innovation. Multi-disciplinary teams (surgeons, engineers, business grads) are assembled to educate a generation of translators, who can bridge the gap between scientific and technologic advances and the needs of the physician and the patient.

    View details for PubMedID 17055962

  • Principles of Innovation Interventional Cardiology Makower, J., Nayak, A., 2006; Chapter 71
  • Percutaneous transvenous cellular cardiomyoplasty - A novel nonsurgical approach for myocardial cell transplantation JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Thompson, C. A., Nasseri, B. A., Makower, J., Houser, S., McGarry, M., Lamson, T., Pomerantseva, I., Chang, J. Y., Gold, H. K., Vacanti, J. P., Oesterle, S. N. 2003; 41 (11): 1964-1971

    Abstract

    The study evaluated a nonsurgical means of intramyocardial cell introduction using the coronary venous system for direct myocardial access and cell delivery.Direct myocardial cell repopulation has been proposed as a potential method to treat heart failure.We harvested bone marrow from Yorkshire swine (n = 6; 50 to 60 kg), selected culture-flask adherent cells, labeled them with the gene for green fluorescence protein, expanded them in culture, and resuspended them in a collagen hydrogel. Working through the coronary sinus, a specialized catheter system was easily delivered to the anterior interventricular coronary vein. The composite catheter system (TransAccess) incorporates a phased-array ultrasound tip for guidance and a sheathed, extendable nitinol needle for transvascular myocardial access. A microinfusion (IntraLume) catheter was advanced through the needle, deep into remote myocardium, and the autologous cell-hydrogel suspension was injected into normal heart. Animals were sacrificed at days 0 (n = 2), 14 (n = 1, + 1 control/collagen biogel only), and 28 (n = 2), and the hearts were excised and examined.We gained widespread intramyocardial access to the anterior, lateral, septal, apical, and inferior walls from the anterior interventicular coronary vein. No death, cardiac tamponade, ventricular arrhythmia, or other procedural complications occurred. Gross inspection demonstrated no evidence of myocardial perforation, and biogel/black tissue dye was well localized to sites corresponding to fluoroscopic landmarks for delivery. Histologic analysis demonstrated needle and microcatheter tracts and accurate cell-biogel delivery.Percutaneous intramyocardial access is safe and feasible by a transvenous approach through the coronary venous system. The swine offers an opportunity to refine approaches used for cellular cardiomyoplasty.

    View details for DOI 10.1016/S0735-1097(03)00397-8

    View details for Web of Science ID 000183219100010

    View details for PubMedID 12798567

  • Percutaneous in-situ coronary venous arterialization (PICVA) improves survival in response to acute ischemia in the porcine model Oesterle, S. N., Yeung, A. C., Lo, S., Virmani, R., Van Bibber, R., Flaherty, J. C., Lamson, T. C., Kim, S. W., Garibotto, J. T., Tumas, M. W., Makower, J. ELSEVIER SCIENCE INC. 2000: 61A?61A
  • New Approaches and Conduits: In Situ Venous Arterialization and Coronary Artery Bypass. Current interventional cardiology reports Fitzgerald, Hayase, Yeung, Virmani, Robbins, Burkhoff, Makower, Yock, OESTERLE 1999; 1 (2): 127-137

    View details for PubMedID 11096617

  • The Characterization of the Dexterous Hand Master Index Finger in Flexion and Extension The Association for the Advancement of Medical Instrumentation Makower, J.,, Parnianpour, M., Nordin, M. 1990; May: 61
  • The Validity Assessment of the Dexterous Hand Master: A Linkage System for the Measurement of Joints in the Hand The Annals of Biomedical Engineering and Biomedical Instrumentation and Technology Makower, J.,, Parnianpour, M., Nordin, M. 1990; August

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