Peter Hinchliffe

Peter Hinchliffe Email and Phone Number

Expert Consultant @ www.peterhinchliffe.com
Yarmouth, MA, US
Peter Hinchliffe's Location
West Yarmouth, Massachusetts, United States, United States
Peter Hinchliffe's Contact Details
About Peter Hinchliffe

Medical Device development expert, consultant and expert witnessExperience:• Built and driven multi-disciplinary teams in product development, manufacturing, quality assurance, regulatory approval through marketing and direct and distributor sales successes. • Successfully advanced multi-billion dollar, multi-million dollar and startup companies.• Experience rooted in engineering with over 110 issued US medical device patents and over 100 more still pending.• Knowledgeable and fluent in many medical specialty devices including;o Cardiac and vascular surgery implants and devices.o Interventional cardiology and radiology implants and devices.o Laparoscopic, robotic and minimally invasive devices o Orthopedics including spinal fusion and carpel tunnel procedures and devices.o Oncology including breast, liver, kidney and bowel treatment devices. • Driven to speed unique products to market and technology sale.• Creative regulatory strategy and clinical management for US PMA and 510K, Japanese PMDA and European CE Mark devices.

Peter Hinchliffe's Current Company Details
www.peterhinchliffe.com

Www.Peterhinchliffe.Com

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Expert Consultant
Yarmouth, MA, US
Peter Hinchliffe Work Experience Details
  • Www.Peterhinchliffe.Com
    Expert Consultant
    Www.Peterhinchliffe.Com
    Yarmouth, Ma, Us
  • Medlumics, S.L.
    Chief Executive Officer
    Medlumics, S.L. Jun 2024 - Present
    Es
  • Www.Peterhinchliffe.Com
    Expert Consultant
    Www.Peterhinchliffe.Com Mar 2015 - Present
    Medical Device development expert, consultant, North American representative, expert witness and/or board member as needed.
  • Calon Cardio-Technology Ltd
    Chief Executive Officer
    Calon Cardio-Technology Ltd Sep 2022 - Jun 2024
    Swansea Vale, Wales, Gb
  • Navigate Cardiac Structures, Inc.
    President And Ceo
    Navigate Cardiac Structures, Inc. Jan 2022 - Aug 2022
    Lake Forest, California, Us
  • Radius Innovation & Development
    Global Business Development
    Radius Innovation & Development Mar 2021 - Dec 2021
    Clinton, Massachusetts, Us
    Radius Innovation in combination with parent company Jabil provide complete and full service contract research, engineering, design, development and manufacturing worldwide.
  • Jarvik Heart Inc.
    President And Coo
    Jarvik Heart Inc. Nov 2015 - Dec 2020
    Raised non-dilutive working capital toward continued growth.• Won a $1m international Grant with Leviticus-Cardio to develop a fully wireless implantable system.• Increased global distribution by adding key international regional distributors.• Doubled potential manufacturing volume without increased headcount.• Outsourced manufacturing bottleneck processes.• Brought multiple triple digit offers to the board for acquisition.
  • Getinge
    President And Ceo, Cardiac Systems (Cardiac Surgery & Cardiac Assist)
    Getinge Dec 2010 - Mar 2015
    Gothenburg, Se
    President and CEO Cardiac Systems (Cardiac Surgery and Cardiac Assist) President and CEO Cardiac Surgery Vice President, R&D Vascular Interventions • Awarded promotions multiple times in 5 years to increasingly critical and senior roles over 4 manufacturing facilities in the US and one in Europe.• Cardiac Surgery, Vein Harvesting, IABP businesses - Created 5 year strategic plans for each business unit including organic growth and acquisition targets.• Analyzed, proposed and executed cost reduction plans including facility moves and staff reductions.• Optimized two of the highest margin business units grossing over $400m sales annually.• Positioned and sold product line to streamline business unit offering. (Safeguard femoral and radial artery closure device for example)
  • Www.Peterhinchliffe.Com
    Founder
    Www.Peterhinchliffe.Com Jun 2010 - Dec 2010
    Medical Device Consultant:- Board memberships- Business Plan development and support- Fund Raising support and introductions- Medical Device IP analysis and support- R&D planning, support and management- Device testing support (animal and cadaver)- Manufacturing Engineering support- Vendor selection and recommendations- Regulatory and Quality Engineering support- Market and Reimbursement support- Sales and distribution recommendations worldwide- Business development support and introductions
  • Deep Vein Medical, Inc.
    Founder
    Deep Vein Medical, Inc. Apr 2009 - Dec 2010
    Medical device start-up, spun out of ISI, LLC to focus on a percutaneous venous valve for chronic venous insufficiency. • Awarded multiple patents.• Secured multi-million dollar partnership offers from large strategic partners.
  • Interventional And Surgical Innovations, Llc
    Founder
    Interventional And Surgical Innovations, Llc Jan 2007 - Dec 2010
    Campbell Hall, Ny, Us
    Venture funded medical device incubator accelerating development of multiple technologies in general and cardiovascular surgery.Awarded multiple patents supporting the continued development of many concepts.• Raised the founding and operating venture funding • Drove contract design and manufacturing toward US and European regulatory approval of a unique Guidewire product. (Parodi Guidewire)• Attracted interest and proposals for partnerships with multiple large strategics.• Spun out the venous valve product due to the significant development successes and market interest.Responsibilities Include:Identify and license technologies from doctors aimed at unmet clinical need.Manage all aspects of the business from market analysis, IP analysis and regulatory strategy to IP filings, prototype to production development and testing to FDA and CE regulatory approvals.Develop unique technologies for spin out, global product launch or technology sale.
  • Datascope Corp. Maquet Cardiovascular Cardiac Assist
    Group President
    Datascope Corp. Maquet Cardiovascular Cardiac Assist Dec 2002 - Nov 2006
    Group Vice President, R&D IPD & IV divisions (During Datascope corporate sale)Group President IPD & IV divisions President IV division Vice President, R&D & Operations (IPD) & Vice President, R&D (IV) Group Vice President, R&D for the IV & Interventional Products divisions (IPD) Vice President, R&D for the InterVascular Division (IV) Datascope was a multi-million dollar public medical device company providing products to cardiac and vascular surgeons as well as interventional cardiologists and radiologists. • Awarded promotions multiple times in 5 years to increasingly critical roles.• Created 5 year strategic plans for each business unit including organic growth and acquisition targets.• Executed business development and organic development plans expanding product offerings.• Analyzed, proposed and executed cost reduction and process improvement plans including staff reductions.• Optimized two of the highest margin business units grossing over $200m sales annually.• Part of the senior management team supporting company sale.
  • Rex Medical
    Vp, R&D
    Rex Medical 1999 - 2002
    Medical Device “Start-up” focused initially on interventional radiology and cardiology products • Started and build the initial infrastructure and development team.• Awarded multiple patents for;o Interventional radiology productso Interventional cardiology productso General surgery products o Oncology products• Secured multi-million dollar sale for Thrombectomy device in first 14 months to major strategic.
  • United States Surgical Corporation
    Director, Research And Development
    United States Surgical Corporation Jan 1992 - Jan 1999
    Director, Research and Development Program Manager (Minimally invasive CABG program) Program Manager (Trocar Systems) Senior Design Engineer (orthopedic products) Design Engineer (laparoscopic products) Results Achieved:Developed many products for cardiac and peripheral vascular surgery including:The One-Shot anastomotic device.Heart Stabilizer system for beating heart bypass procedures.Chest retraction system for minimally invasive IMA harvesting.Minimally Invasive mitral valve replacement, suturing device.Worked closely with some of the worlds leading vascular and cardiac surgeons.Responsibilities included:Administering a multi-million dollar R and D budget.Managing multiple product development teams.Evaluating clinical test protocols.Supervising production schedules.Supporting the Marketing team with technical sales and live animal product demonstrations including:Fully endoscopic IMA dissection.Minimally invasive arterio-venous fistula creation with an automated anastomotic device.Beating heart bypass anastomosis using prototype suturing and surgical clipping devices.

Peter Hinchliffe Skills

Medical Devices Fda Product Development Commercialization R&d Product Launch Iso 13485 Market Development Cross Functional Team Leadership Cardiology Surgery Design For Manufacturing Biomedical Engineering Manufacturing Vascular Start Ups Surgical Instruments Quality System Global Marketing Capital Equipment Design Control Orthopedic Surgeons Strategy Biotechnology Product Design Design Of Experiments U.s. Food And Drug Administration Validation Engineering Spine Research And Development Working With Surgeons Troubleshooting

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