The Mountain's 11 Consortium
Our trusted network of regulatory and quality experts provides comprehensive support to streamline your path to market. From FDA strategy to commercialization, our consortium members bring decades of specialized experience to accelerate your medical device innovation.
Ben Trapp
Materials Science & Device Development Expert
Ben has over 25 years of experience designing and developing medical devices for a variety of applications, including 24 years at WL Gore and Associates. He has a BS in Materials Science from Drexel University and relies on a deep materials and mechanical engineering background and a skillset in marrying novel technologies with customer needs to solve complex clinical problems. Ben has over 25 issued patents, and has brought multiple devices to market in both technical and leadership roles.
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Tina Ching
Commercial Transactions Attorney
Tina is a seasoned commercial transactions attorney with over 25 years of experience spanning innovation, research and product development, medical devices, gene therapy, data privacy, real estate, and technology. Known for her creative and strategic approach, she brings a rare blend of law firm, in-house, and solo practice experience, equipping her to guide clients through complex deals and forward-thinking solutions. Tina also advises start-up entrepreneurs and teaches experiential contract drafting to law students.
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Alex Hobson
Patent Agent
Alex provides quality and affordable patent preparation, filing (US and worldwide) and patent prosecution services. Supporting small to mid-size companies, particularly start-up companies as well as individual inventors. His expertise spans the full spectrum of intellectual property protection for medical device innovations.
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Nathan Friedman
Business Development & Innovation Leader
Nathan has over 20 years in Medtech Innovation resulting in several successful device development and commercialization efforts. He has a BS in Mechanical and Materials Engineering from RPI and complemented his skillset in product design with new market discovery and business leadership during his 19 years at WL Gore and Associates. Nathan has supported multiple M&A efforts and also successfully founded, grew, and sold a company in the beverage industry.
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Patrick Norris
Clinical Development & Regulatory Expert
Patrick has 20 years experience as a Product Development R&D Engineer and Leader at W.L. Gore & Associates. He specializes in early phase product development for First in Human (FIH) studies including phase gate design control, product development, rapid design change and iteration, and regulatory submission. He has taken several products from early stage development through the Early Feasibility Study (EFS) process in the United States. Patrick has served on multiple ISO standards committees for Vascular and Cardiac devices.
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Marc Cooper
Financial Strategy & Wealth Management
Marc Cooper brings a CFO-level perspective to wealth management. Over the last decade Marc has built his practice at Raymond James from the ground up to oversee approximately $200million in client assets. He applies rigorous financial oversight - from strategic budgeting and risk management to sophisticated capital allocation - to help individuals, families and business owners reach their long term objectives. Marc's disciplined, data-driven approach ensures every financial decision is grounded in sound analysis.
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Jason Nackard
Quality & Development Engineer
Jason has over 17 years of experience as a quality and development engineer in the medical device industry. He has a BSc in mechanical engineering from the Colorado School of Mines with a minor in materials science. He has worked on resorbable periodontal devices, cardiovascular and hernia patches, catheter based cardiovascular and neurological therapies, and targeted catheter based oncology devices. He is co-inventor on several US and International patents and owns two patents related to musical instruments.
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Joseph Armstrong
Technology Leadership & Program Management
Joe has focused on medical device technology and product development for over thirty years. Bringing diverse product development skills, the last twenty years has been focused on program/project management and technology leadership. He has developed products from concept to prototyping, through Design Control and successful clinical evaluations, and into profitable commercialization. He has also spent years partnering on international projects and is an inventor in over thirty unique patents.
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Steve Bruun
Regulatory Affairs Professional
Steve is a Regulatory Affairs professional with 31 years of medical device experience. At the start of his career as an engineer at W. L. Gore and Associates, he developed a strong knowledge of validations, device testing, and design control documentation for vascular grafts and stent-grafts. With a love of technical writing and working with interdisciplinary teams, he found his ultimate calling in Regulatory Affairs and provided global Regulatory support to several commercial and development-stage implantable vascular devices, including authoring an IDE, a PMA, PMA supplements, and numerous international submissions.
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Jenn Zuba
Quality Management Systems Expert
Jenn has almost 20 years of experience in medical device product development and quality. With a background in biomechanical engineering and passion for patient safety, she offers tailored quality management system (QMS) consulting solutions to meet client needs. Whether you're looking to implement a new QMS, improve your existing QMS, or find fractional Quality Assurance services, Jenn can help. She serves on multiple ISO standards committees for medical devices and holds 2 patents for optical and orthopaedic medical device design.
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We're always looking for exceptional professionals who share our passion for accelerating medical device innovation. If you have deep expertise in regulatory affairs, quality systems, clinical development, or specialized engineering, we'd love to hear from you.