Interim CEO Medical Devices

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Summary

A highly successful Interim CEO with significant experience primarily in the Medical Device Industry at identifying opportunities for growth and delivering success in start-ups to multi-billion-dollar companies. A visionary and collaborative leader who builds trusting relationships with senior executives from life science companies, healthcare providers, academic institutions, global thought leaders, and government organizations. Leader and developer of high-performing cross-functional teams. Strong foundation in investments, strategy, and execution. Cross-cultural global business acumen includes Europe and emerging countries. Strong interest in Medical Devices, Healthcare, Medical Technology, and Life Sciences.

Highlights
• Business & Corporate Development
• Fundraising | Strategic & Angel Financing
• Strategic Development & Planning
• Mergers & Acquisitions
• Strategic Relationships
• Global Executive | Influential Leadership
• Leading Profitable Negotiations
• Market & Business Opportunity Assessment
• P & L Management | Budget | Finance
• Product Innovation
• Exits
• Global Commercialization
• Government Relations
• Marketing Strategies
• Clinical Trials & Regulatory
• Executive Advisor

Relevant Accomplishments

• Developed a medical device company that was recognized as one of the Top 50 most innovative medical technology start-ups.
• Executive Advisor to numerous C-Suite leaders and Board of Directors.
• Within 9 months of starting a company, closed an angel financing round on favorable terms. Closed additional financing with a corporate partner and family offices. Received multiple VC term sheets.
• Achieved $78M sale of a company to Boston Scientific by demonstrating the strategic investment value, as well as ideal fit.
• Achieved $78M sale of a company to Boston Scientific by demonstrating the strategic investment value, as well as ideal fit.
• Persuaded the only three likely strategic market players that the company’s technology would impact market share by more than 40%. Resulted in multiple bids from each of the three market players.
• Successfully established two new businesses through detailed analysis and evaluation of 40+ emerging opportunities and developing the strategy and business plans behind both endeavors. Advised portfolio companies on strategy and value proposition. Currently both companies received FDA approval and are on the market.
• Successfully established two new businesses through detailed analysis and evaluation of 40+ emerging opportunities and developing the strategy and business plans behind both endeavors. Advised portfolio companies on strategy and value proposition. Currently both companies received FDA approval and are on the market.
• Raised capital during difficult investment climate by effectively, consistently, and directly communicating fund’s strategy to high net-worth individuals referred by the founder and Board of Directors.
• Received non-dilutive SBIR Grant Award to advance technology and therapy development. Wrote grant application and became Principal Investigator on the grant. Managed the grant execution and reporting.
• Completed successful $42M acquisition, enabling the company to maintain its leadership position in the therapeutic area.
• Personally evaluated and executed investment decisions on three public small-cap companies, six clinical trial-stage startups, and eight preclinical stage ventures, receiving 100% approval on recommendations.
• Successfully negotiated complex deal terms resulting in deal execution within the established timelines and budget.
• Lead development and implemented the necessary wireless communications (telemetry) and connections to support “connected healthcare” of patients and their medical devices in the Cath Lab, Clinic, and Home – The CareLink Network;
• Designed a clinical trial, prepared regulatory submissions for PMA product and received FDA approval of the trial protocol (IDE). Led all communications with FDA during the trial.
• Led 100-patient randomized pivotal trial at 10 clinical sites in the U.S. Selected and developed relationship with gastroenterologists at preeminent institutions to serve as clinical investigators. Assembled Data Safety and Monitoring Board. Managed the pivotal study without CRO involvement.
• Developed and implemented Direct-To-Consumer marketing to speed up patients’ recruitment in the clinical trial. The majority of patients were recruited through these innovative strategies.
• Received CMS coverage (all MACs) for device and procedure reimbursement while in the clinical trial, before FDA approval.
• Negotiated technology transfer, licensing and manufacturing agreements critical to company’s success.
• Recruited and built top-notch experienced and highly efficient team.
• Recruited and built top-notch experienced and highly efficient team.
• Coordinated the strategic planning behind a $1.8B business unit that secured Board approval and delivered 15% annual growth.
• Identified and overcame market barriers for a $1B Cardiac Rhythm therapy, including developing guidelines for country managers that enabled double-digit growth in Europe.
• Led the multifunctional team to design growth strategy for a new Remote Monitoring business and drive global revenue from $40M to $500M within seven years.
• $250M loss averted by preventing an overpriced acquisition through leading all due diligence and researching the true valuation of the company.

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