Pratap Khanwilkar

Pratap Khanwilkar
Home/Faculty/Pratap Khanwilkar
Pratap Khanwilkar
Pratap Khanwilkar
pratap@iimnagpur.ac.in
Area Academic Affiliation Qualification
Strategy and entrepreneurship Faculty MBA, PhD, MS in Biomedical Engineering (University of Utah), and BTech Hons in Electrical Engineering (IIT Kharagpur)
  • Overview
  • Research & Publications
  • Teaching
  • Training and Consulting
  • Administration
  • 38 yrs experience and accomplishments in:
        • Innovative medical device development, clinical deployment and commercialization in academia, start-ups, public companies in roles ranging from Board Chair, CEO, President, CTO, Founder, Advisor, Professor , VP (Product Development, Business Development, Marketing)
              • 16 start-ups with 2 exits: 1 public company acquisition, 1 IPO
              • Raised > $500MM in financing for projects
        • Education of entrepreneurs, clinicians, service providers, engineers/scientists from undergraduates to faculty and working professionals. Related courseware development adapted for USA-wide use by the National Institutes of Health
              • Engineering, Business, Medical Schools, Technology Commercialization/Transfer and in broader community
        • Innovation and entrepreneurship ecosystem development: USA (including regionally in Utah, Western Pennsylvania, South/Central Texas), Canada, South Korea, Japan, China, Greece, and India.
        • Innovation: Several seminal patents issued worldwide on implantable blood pumps, control systems, biomaterials, surgical devices, and on implantable neuromodulation
              • Only 3-time international award winner in innovation from relevant Society
              • Elected Fellow, American Institute of Medical & Biological Engineering (AIMBE)
              • Only 1 of 2 people worldwide to have conceived, designed, developed and brought to clinical use and revenue-generation an implantable left ventricular assist device (LVAD) with full magnetic levitation of a centrifugal pump- both as technical contributor and business lead from garage start-up to public company
        • Leadership development: Many hired and mentored employees, colleagues and students have become leaders in their own right as CEOs, VPs, founders
        • Start-up Investor: Individual, with Angel group (Alamo Angels), and as deal -flow venture partner for VC fund.
  • Olympic distance triathlete, bolo tie jewelry designer and fabricator, mountain climber, river rafter and kayaker, social justice group founder, advocate and activist, wild tiger and habitat conservationist
  • Degreed education: University of Utah (MBA, PhD, MS in Biomedical Engineering), and IIT Kharagpur (BTech Hons in Electrical Engineering)

  • Seminal and international award-winning research and development in:
        • Mechanical circulatory support for adult and pediatric patients: Total artificial hearts and left ventricular assist devices for long-term implant and support
                • Fluid balance, physiological control, system integration, transcutaneous energy transmission, anatomic fit, pre-clinical testing, clinical study
        • Biomaterials: Hemocompatible coating development and applications
        • Electrosurgical electrodes: Single-use disposable titanium nitride coated electrodes used for cutting, coagulation, dessication in invasive surgical procedures
        • Implantable neuromodulation: Novel neuromodulation to restore urinary bladder function to those with Spinal Cord Injury- development through pre-clinical testing
  • Representative Publications and Key Abstracts: >100 peer-reviewed publications, >10 patents, >200 presentations
        • Cai H, Morgan T, Pace N, Shen B, Wang JC, Roppolo JR, Horlen K, Khanwilkar PS, DeGroat WC, Tai CF. Low pressure voiding induced by a novel implantable pudendal nerve stimulator. NeuroUrology and Urodynamics 38(5):1241-1249, June 2019
        • Pratap S Khanwilkar, Gill B Bearnson, Phillip Miller, James Lee, Jeff Geisler, Karl Nelson, James W Long. Levacor VAD: System Development Leading to Initiation of US BTT Trial. (Abstract) ISRBP Congress Proceedings, Berlin, Artificial Organs, 2010.
        • Khanwilkar P, Miller P, Bearnson G, et al. The Levacor VAD. Invited chapter in surgical handbook/textbook on ‘Mechanical Circulatory Support: Principles and Applications’, Editors: Joyce L, Joyce D, and Loebe M, McGrawHill, pp. 235-237, November 2011
        • Kumar BA, and Khanwilkar PS. Long-Term Implantable Ventricular Assist Devices (VADs) and Total Artificial Hearts (TAHs). In: P. Ducheyne, K.E. Healy, D.W. Hutmacher, D.W. Grainger, C.J. Kirkpatrick (eds.) Comprehensive Biomaterials, vol. 6, pp. 389-402 Elsevier, September 2011.
        • Antaki J, Arnold D, Bachman T, Bearnson G, Drummond A, Johnson C, Kameneva M, Keller B, Khanwilkar P, Kirk J, Kormos R, Kouretas P, Li C, Long J, Maher T, Morell V, Paden B, Paden D, Ricci M, Shaddy R, Shu F, Snyder S, Snyder T, Vandenberghe S, Verkaik J, Wagner W, Wearden P, Webber S, Woolley J, Wu J and Borovetz H. Development of the PediaFlow™ ventricular assist device for infants and small children. Third International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion, May 17 – 19, 2007, p. 52.
        • Khanwilkar P. The HeartQuest MagLev LVAD. Rotary Blood Pumps-New Devices Panel abstract, 13th World Congress of the International Society for Artificial Organs, Osaka, Japan, 2001
        • Maslen EH, Bearnson GB, Allaire PE, Flack RD, Baloh M, Hilton, E, Noh MD, Olsen DB, Khanwilkar PS, and Long JD. Feedback Control Applications in Artificial Hearts, IEEE Control Systems Magazine, December 1998, pp. 26-34
        • Kim HC, Khanwilkar PS, Bearnson GB, Olsen DB. Development of a microcontroller-based automatic control system for the electrohydraulic total artificial heart. IEEE Trans Biomed Eng 44(1):77-89, 1997.
        • Khanwilkar P, Olsen D, Bearnson G, Allaire P, Maslen E, Flack R, Long J. Using hybrid magnetic bearings to completely suspend the impeller of a ventricular assist device. Artificial Organs 20(6): 597-604, 1996
        • Khanwilkar, Pratap, India Presents R&D Opportunities for U.S. Device Companies, Overseas Expansion Column, Medical Devices & Diagnostics Industry (MDDI), Canon Communications, January 1996.
        • Khanwilkar PS, Olsen DB. Future prospects for a totally implantable artificial heart. Cardiac Surgery: State of the Art Reviews, Hanley & Belfus, Inc., Philadelphia, 7(2):457-470, 1993.
        • Khanwilkar PS, Crump KR, Bearnson GB, Smith JK, Olsen DB. Development of the physiological control scheme for an electrohydraulic total artificial heart. Proceedings of the 11th Annual International Conference IEEE Eng Med Biol Soc 11(1):149-150, 1989
        • Price RH, Jacobsen SC, Khanwilkar PS. Oscillatory Stabilization of Micromechanical Systems. Proceedings of the IEEE Micro Robots and Teleoperators Workshop, Hyannis, MA, November 8-11, IEEE Robotics and Automation Council, 1987.

Positions

  • 2023- Present Professor (Adjunct), Strategy & Entrepreneurship, Indian Inst. of Mgt, Nagpur
  • 2021- Present Professor (Adjunct), Dept. of Biomedical Engineering, University of Texas-San Antonio
  • 2015-Present Professor (Adjunct), Department of Bioengineering, University of Pittsburgh
  • 2011-2014 Founding Coulter Program Director, Coulter Translational Research Partnership II, and Professor, University of Pittsburgh, www.engineering.pitt.edu/coulter
  • 2006-Present Faculty, Department of Bioengineering, University of Utah, Salt Lake City, Utah
        • Adjunct Assistant Professor, 2006-2008
        • Adjunct Professor, 2008- Present
  • 1994-1999 Faculty, Technology Management MBA, University of Phoenix, Salt Lake City, Utah
  • 1994-1997 MBA Field Study Faculty Advisor, Dept. of Marketing, David Eccles School of Business,
    University of Utah

Graduate Courses Developed/Taught for Business, Engineering, Law, Medical schools

  • MBA Field Study, Capstone Course, MBA Program
  • New Venture Cost Management, MBA/Technology Management Program
  • Project and Program Management, MBA/Technology Management Program
  • Strategic Management of R&D, MBA/Technology Management Program
  • Strategic Planning & Technological Forecasting, MBA/Technology Management Program
  • Applications of Technology Management, Technology Venture Business Plan Capstone Course, MBA/Technology Management Program
  • Medical Device Design, BME 6123, UTSA, Spring 2022. Graduate-level core course for MS in Bio-Medical Engineering in Medical Technology Commercialization. Combination of pedagogic learning focused on 1) Problem finding, 2) Problem Solving and 3) Connecting the Dots with individual student-selected project work in all these areas culminating in a complete development and commercialization project plan.

Consulting

  • As Founder/CEO of Ignition Key LLC, (www.ignitionkey.biz) since 2010, have consulted >30 medtech organizations based in USA, China, Australia, and the United Kingdom in areas of 1) organizational development including staffing, hiring, leadership, and educating top and middle management, 2) Strategic planning including business model and plan development, project planning, successful financing including non-dilutive funding, seed and Series A and B rounds and partnering, brand development, corporate and product marketing, 3) Product development including plan, portfolio development, intellectual property strategy and execution including freedom-to-operate, licensing, and landscape analyses, 4) Life-cycle planning and management for medtech including market analysis, unmet clinical need identification, clinical trials and regulatory approval strategy, pre-clinical testing, manufacturing, product and technology development.

Advising/Training

  • Bench to Bedside, Office of Enterprise Development, Pitt Innovation Institute, University of Pittsburgh
    This course developed to be taken by a team comprising an engineering/scientist faculty and a clinical faculty has been recognized as a best practice by the Coulter Foundation and other Coulter Translation Partnership universities (Columbia, Johns Hopkins, U of Southern California, Michigan). The U.S. National Institutes of Health have adopted and adapted the curriculum and course design for Phase I SBIR awardees applying for Phase II SBIR grants.
  • A partial list of projects that moved on to being selected for pitching and getting funded, with some becoming start-ups or licensed to an existing company is:

    - Orthopedic devices

    • Bone fixation plates and screws (bioresorbable)
    • ACL reconstruction screws and regenerative scaffolds (bioresorbable)
    • Artificial cervical disc

    - Bioresorbable Stents: AV fistula stents for hemodialysis, and tracheal stents
    - Neural regenerative therapies using carbon nano-tubes (CNT)
    - Handheld X-ray generator for portable medical use
    - Microvascular repair: surgical device therapy
    - Diagnostic device for vesico-ureteral reflux
    - Resorbable Putty for Dental, Long Bone, Spinal and Craniofacial applications
    - Recruitment of Lymphocytes for Periodontal Disease
    - NanoVision Diagnostics: Nano-Resolution Optical Microscopy for Cancer Assessment
    - Hand- Held Force Magnifier: Surgical Instrument to Amplify Sense of Touch
    - Extra-Cellular Matrix for TemperoMandibular Joint (TMJ) disorder
    - Injectable Antibiotic loaded gel to prevent infection in implantable devices
    - Bioabsorbable Conduits for Nerve Gap Repair and Regeneration
    - Foot patch-based Neural Stimulator for Over-Active Bladder
    - Improved Prostate Cancer Biosensor
    - Adjustable Cannula for Liposuction
    - Point of Care Molecular Diagnostics for Sexually-Transmitted Diseases
    - Improved diagnosis of inflammatory bowel disease (Crohn’s Disease) using enhanced ultrasound
    - Early and accurate detection of vulnerable Atherosclerotic Plaque using enhanced ultrasound
    - MicroFlow: a real-time untethered implantable flow monitor
    - Steerable Laser Ureteroscope for Kidney Surgery
    - Micro-Bubbles for Enhanced Targeted Ultrasound Imaging and Therapy Delivery
    - Skinject: Skin Cancer Treatment with a Band-Aid
    - EV3 Therapeutics: FBXO3 Anti-Inflammatories for Acute Bronchitis
    - Pro-TECT: Targeted temperature-controlled cushioning surface for pressure ulcers
    - Body Explorer: Virtual Reality Simulator for Training & Education
    - Pivot: Quantitative Assessment of ACL function with Mobile Technology
    - SoundSentinel: Safer Skull Surgery
    - SHARP: AI-based Machine Learning System for Hospitals- Adaptive Readmissions Prediction
    - Reliable, chronically implanted neural interface electrodes
    - InterACTion: Remotely monitored home-based physical rehabilitation

  • Developing and Clinically Introducing Medical Technologies. Conceived and implemented community-wide 4- month workshop series with 40 participants (university engineering faculty, clinicians, product development engineers, health care marketers, research administrators, patent attorneys, investors, distributors, hospital administrators), as part of proposed Knowledge Base Program initiative for the Health Cell, Oct 2016-Feb 2017
  • The HealthTech Bootcamp, http://thehealthcell.org/sitepage/healthtech-bootcamp/ , Piloted community-wide, weekend-long event to develop an idea for a HealthTech startup (a company that uses digital technology to improve health). Conceived, developed and implemented for 28 participants, the Health Cell and Geekdom, April-May 2018. Top 3 teams developed ideas for apps and business models for: 1) visually impaired kids, 2) displaced LGBTQ patients seeking medical care, and 3) training moms in breastfeeding
  • Invited Selection Committee member and Presenter/Facilitator of final Workshop: ‘Get Ready to Hit the Road with your Startup Pitch’, Bio Global Accelerator, VelocityTX, San Antonio TX, July-October 2021. https://velocitytx.org/speakers/
  • Invited Judge and Mentor, MedTech Innovator Pitch Event, JLABS@TMC, Houston, TX, March 2017, 2018, 2022, 2023). One of 11 regional pitch events held in US, EU, Israel and Canada in March and April. Also 2021 (virtual, global judge panels and pitching companies). Evaluate pitches from and mentor best-in-class medical device, diagnostic, and digital health companies vying to win the MedTech Innovator Showcase at the MedTech Conference powered by Advamed.
  • Invited Innovation and Entrepreneurship Workshop speaker, National Conference of the Society of Asian Scientists and Engineers, Philadelphia, PA, October 2014.
  • Department of Bioengineering Advisory Board, University of Texas at San Antonio, January 2014- Present.
  • Member, Industrial Advisory Board, PATHS-UP (Precise Advanced Technologies and Health Systems for Underserved Populations) Engineering Research Center (ERC) funded for up to $40MM over 10 years by the National Science Foundation, Department of Bioengineering, Texas A&M, College Station TX. In collaboration with Rice University and UCLA. February 2020- Present. https://pathsup.org
  • Innovation/Entrepreneurship Curriculum Reform Committee, Swanson School of Engineering, University of Pittsburgh, Feb 2013-Nov 2014
  • University of Utah Office of Technology Venture Development, recognized in 2007-2009 as #1 in the US at starting companies per dollar of federal research funding and second in the US for the number of inventions it generates per dollar of federal funding. Recognized in 2010 and 2011 by AUTM (Association of University Technology Managers) as number one in both categories nationwide. In April 2017 as #1 by Milken Institute in ‘Concept to Commercialization: The Best Universities for Technology Transfer.’
  • University Commercialization Advisory Board, 2005- 2012.
  • Lassonde New Venture Development Center Board, 2003-2008.
  • Entrepreneur-In-Residence, 2008-2010.
  • Technology Commercialization Review Board, 2005-2006.
  • India Business Advisory Council, Chairman, 2007-2011. Invited participant in Governor of Utah’s first Utah trade delegation to India, Fall 2007. Facilitated MOU for collaboration between the Indian Institute of Technology, Kharagpur and the University of Utah.
  • Invited session chair and speaker, 2nd Annual Meeting of the International Federation of Artificial Organs and the 45th Annual Conference of the Japanese Society of Artificial Organs, Osaka, Japan, 2007.
  • Trustee representing USA, Board of Trustees, International Society of Rotary Blood Pumps (ISRBP), 2007-2014.
  • State of Utah Executive Steering Committee for Utah Futures. Appointed by Utah Governor Gary Herbert, 2011-2014. One of four business individuals appointed to this Committee chaired by the Utah Commissioner of Higher Education to assist K-12 students (and their counselors) prepare better for post-secondary education and careers. Served in July 2014 on Governor’s Panel to evaluate Utah Futures.org, the online career counseling program.
  • BioInnovations Gateway (BiG). A first-in-US life science business incubator combined with hands-on training for high school students. Collaboration between Granite School District and Granite Technical Institute of Salt Lake County, Utah Science Technology and Research Initiative (USTAR), Utah Governor’s Office of Economic Development and the United States Department of Labor.
  • Advisory Board Founding Member, 2009 -2012.
  • Member, Mechanical Circulatory Systems Standards Committee, American Association of Medical Instrumentation (AAMI), 2004-5.

Positions
1984 Group Management Trainee, Tata Group, and Switchgear Manufacturing Line Manager, Voltas Ltd (a Tata Group company), Mumbai, India.

1984-1987 Research Assistant, Center for Engineering Design, University of Utah, Salt Lake City, Utah.

1988-1996 Artificial Heart Research Laboratory, Institute for Biomedical Engineering, University of Utah, Salt Lake City, Utah.

  • Manager, Electrical Design & Testing, 1988-1989
  • Project Manager, Senior Project Engineer, and Manager, Electronics & Reliability Department, 1989-1993
  • Assistant Director of Engineering, 1992-1993
  • Director of Engineering, 1993-1996

1991-1993 Founder and Principal, ConFlow Inc., Salt Lake City, Utah.

1993 Founder and Director, MedQuest Manufacturing Inc., Salt Lake City, Utah.

1993-1996 Founder, Director, Corporate Secretary, Treasurer, MedQuest LLC, Salt Lake City, Utah.

1993-1996 Founder, MedQuest Testing Inc., Salt Lake City, Utah. Successor, operational and revenue-generating companies are Thrombodyne (for-profit) and MDEC (not-for-profit) based in Salt Lake City, Utah.

1993-2005 MedQuest Products Inc., Salt Lake City, Utah

      • Co-Founder, 1993
      • President/CEO, and Director, 1993-2002
      • Sr. Vice President & Chief Technology Officer, Chairman, 2002-2004
      • President, CEO, Board Chairman, 2004-2005

1997-2010 Board Member, Heart and Lung Institute LLC, Salt Lake City, Utah

2004-2005 USA Representative & Expert Member, Circulatory Support Devices Standards Committee, International Standards Organization (ISO), 2004-5.

2005-2010 Vice President, Rotary Systems & Business Development, Officer of World Heart Inc. (NASDAQ: WHRT), Salt Lake City, Utah

      • Successful First-In-Human studies of co-invented maglev LVAD in Europe (2006).
      • Pivotal trial IDE filing, FDA Approval for US Bridge-To-Transplant trial (2010) and 14 patients enrolled.
      • Moved headquarters to Salt Lake City, Utah from Oakland, CA (2009). WHRT acquired in 2012 by NASDAQ: HTWR (HeartWare Inc.). HTWR acquired by Medtronic in 2016 for $1+BB.
      • Part of management team that raised $150+ M financing post- acquisition

2010-Present Founder/CEO, Ignition Key LLC, a healthcare consultancy advising on healthcare technology development, commercialization and deployment

2010-2011 Program Director, National Science Foundation-Engineering Research Center on ‘Revolutionary Metallic Biomaterials’, a collaboration between the University of Pittsburgh, North Carolina A&T University and the University of Cincinnati

2011-2014 Founding Coulter Program Director, Coulter Translational Research Partnership II, and Professor, University of Pittsburgh, www.engineering.pitt.edu/coulter

Professor of Bioengineering, Swanson School of Engineering, University of Pittsburgh. Non-tenure track. Remain an adjunct professor in Bioengineering (2015-present).

Professor, McGowan Institute for Regenerative Medicine, University of Pittsburgh/UPMC

Professor and Commercialization Program Director, Clinical and Translational Science Institute (2013-2014), University of Pittsburgh Schools of the Health Sciences.

Executive-In-Residence, Office of Technology Management

Executive Committee, Board of Advisors, Center for Medical Innovation (CMI)

2014- 2022 Vice President, Product Development, InCube Labs LLC, San Jose CA & San Antonio TX
Leadership team member responsible for product development including the engineering, manufacturing and quality assurance functions. Build and manage the engineering and related support organizations. Provide technical and business leadership in product research and development. Collaborate with the pharmaceutical, biology and chemistry group to develop and implement pre-clinical and clinical studies for incubated companies including:

      • VP, Product Development, Fe3 Medical: An iron delivery system for iron deficiency anemia using a platform of a patented biphasic iontophoretic topical drug delivery technology. From bench prototype to First-In-Human studies (40 patients), controlled manufacturing, and Pre-Submission with FDA for future 510k submission. Supported closing of $14.5M Series B round in early 2016.
      • Miran Medical: Implantable neuromodulator to restore bladder function to those with Spinal Cord Injury- co-founder and President/CEO.
      • Rani Therapeutics: Breakthrough oral drug delivery platform for biologics. Co-founder and contributor to early clinical studies of the RaniPill. Rani had its IPO on the NASDAQ stock exchange in July 2021.

2015-2019 Board member and President (2018), the Health Cell, http://thehealthcell.org. A San Antonio-based non-profit dedicated to the personal and professional growth of the leaders driving San Antonio’s healthcare sector. Membership includes payors, providers, biotech and MedTech industry, investors, executives, entrepreneurs, and service providers.

2016- Present Cofounder and Board Director. Wild Tiger, a 501c3 non-profit whose mission is to save India’s wild Bengal tigers and their habitats (www.wild-tiger.org )

2017- Present Angel Network member and Investor, Alamo Angels (formerly San Antonio Angel Network) www.alamoangels.com. Invested in a variety of start-ups with growth potential in MedTech, IT, SaaS and service sectors through participation in investment syndicate.