David Francischelli Email & Phone Number

Minneapolis, Minnesota, Us

Start-up stage venture developing a direct-to-consumer, wearable, wireless, non-invasive device for transcranial neuromodulation. Applying Western technology to Eastern practices of yoga, meditation and mindfulness to improve human health and welfare. Additionally, provides professional consulting services to the Medical Device Industry.• Established university relationships to design and build functional hardware, software and mobile app prototypes.• Partnered with MN Technology Association to target NIH-SBIR funding.• Created pitch deck and presented to accelerators and VCs to secure financial backing.• Expanded FDA indications for publicly-traded client company's existing product line by identifying appropriate in vitro testing.• Testified as expert witness in lawsuit involving medical device company and contract developer/manufacturer.CONSULTING SERVICES:• Special Technical Projects – independent perspective for design reviews, product feasibility, audits and market readiness.• Pre-Clinical Studies – ranging from benchtop feasibility to GLP studies.• Clinical Trials – study strategy, design, execution, analysis and submissions.• Technical / Scientific Diligence – advising venture capitalists and investors in the medical device space. • Innovation / Brainstorming – IP strategy, coordination of team brainstorming, documentation and legal liaison.• Contract Development/Manufacturing – act as liaison / project manager with vendors and internal design teams.• Litigation – advise legal council and act as expert witness in matters involving medical device R&D, clinical studies and intellectual property.• Project Management - advance key strategies forward through project leadership, oversight, and execution.• Voice of the Customer – gather customer inputs, prioritize and translate to product needs and design requirements.• Scientific Publications – analyze scientific data, create technical abstracts, manuscripts, white papers and marketing materials.

Maple Grove, Minnesota, Us

Francis Medical is a venture-backed, clinical stage medical device company committed to developing urological cancer treatments that are safer and more effective than current standards of care.Executive Leadership Team member. Lead all aspects for realization of the company’s single-use disposable and capital products, including the research, design, development, testing, supply chain, manufacturing, validation, and documentation for commercialization in the U.S. and international markets.• Supported multi-center US clinical trial to demonstrate safety and efficacy of cancer therapy by vapor ablation.• Identified external hardware and software strategic partners and established relationships to develop Vanquish - an image-guided system and procedure to treat prostate cancer.• Through testing and collaboration with KOLs, identified features and requirements for next generation systems and created product roadmap to guide company’s go-to-market strategy.• Secured $65M in financing from strategic partners and venture capital investors.

Mason, Ohio, Us

AtriCure is a publicly-traded (NASDAQ: ATRC) medical device company and a leader in cardiac surgical ablation systems for the treatment of atrial fibrillation (AF), exclusion of the left atrial appendage and Cryo Nerve Block Therapy (cryoNB).Executive Leadership Team Member - reporting to the CEO, responsible for global Research, Product Development and Sustaining Engineering for the corporation, located at four sites.• Developed a product roadmap and established a cadence of annually launching multiple new, innovative systems (disposable, implantable, software and capital), which is the foundation to a 5-year CAGR of greater than 20%.• Grew R&D function from a team of 20, to over 60 within 3 years. Resulted in a shift in the corporate innovation culture and a greater than 30-point increase in Vitality Index.• Established a Research & Technology division to evaluate new and innovative whitespace technologies and market opportunities that dovetail with current product offerings. Resulted in a 5x increase in issued patents and a new cryoNB franchise which currently accounts for 12% of company revenue.• Conducted due diligence and integration of two acquisitions, valued at over $175M, within two years.• Established a cross functional governing board to review and provide guidance and oversight to New Product Development teams while improving communication with executive team.• Championed company diversification into pain management, electrophysiology and combination drug/device therapies.• Led a DFM (Design for Manufacturability) initiative to organization, which enhanced new product transition from PD to Operations. Resulted in a 30% reduction in parts and 50% reduction in COGS on cryoablation product line.• Established the EUREKA! program to provide seed funding for company-wide innovative initiatives. Three proposals funded in inaugural year.• Regularly interacted with regulatory agencies such as BSI and FDA during submissions and audits.

Minneapolis, Mn, Us

Medtronic - Structural Heart DivisionProgressively responsible positions, ultimately directing all aspects of research and development for cardiac radiofrequency, cryogenic and PFA ablation technologies, including novel devices & generator systems, new approaches to lesion creation, enhancement & evaluation and expanded therapy applications. Responsible for organizations of up to 19 direct/indirect reports and annual budgets upwards of $8 million.• Developed multiple generations of the Cardioblate irrigated ablation system to continuously improve customer acceptance and patient outcomes. This family of products generates over $60 million in annual revenue.• Board Member of cross-functional management team focused on developing and executing a strategy to position the company as a leader in the fields of ablation and arrhythmia management.• Conducted due diligence assessment prior to ATS Medical acquisition and successfully integrated CryoMaze R&D ahead of plan.• Core Team Leader of a 13-member Six-Sigma initiative to establish a lean product development process and improve R&D efficiency. Estimated 25% savings in project cycle time and cost.• Developed an endoscopic procedure and suite of instruments, including the Cardioblate Closure Atrial Appendage Isolation System, to reduce the incidence of stroke.• Identified and evaluated potentially disruptive ablation technologies, including HIFU, microwave, laser, electroporation, and chemical approaches to advance market leadership position.• Led company's PFA (pulsed-field ablation) R&D, which laid the groundwork for this multi-billion dollar growth platform.• Successfully represented company during regulatory audits, including FDA, TUV & Anvisa.• Team lead to identify new market opportunities and define 10-year corporate vision & strategy to guide technology development and investment. • Regularly invited speaker and faculty at numerous medical, academic and industry symposia.

Minneapolis, Mn, Us

Medtronic - Atrial Fibrillation DivisionConducted foundational research & clinical trials, developed business plan and sourced manufacturing & distribution for an innovative ablation platform.• Created new technologies business with revenue of $650+ million.• Championed the design, development and evaluation of disposable surgical and catheter-based tools for the management of atrial fibrillation using RF ablation technology.• Initiated and coordinated cross-divisional efforts to define, develop and test innovative ablation catheters for company’s early entrance into the AF Market.• Collaborated with Key Opinion Leaders to define and execute a strategy for developing radio frequency ablation as standard of care for atrial fibrillation.

Minneapolis, Mn, Us

Medtronic - Ventures DivisionProgressively responsible positions within the Cardiac Assist Venture, leveraging neuromodulation approaches to develop therapies for heart failure and cardiac arrhythmias. Ultimately managed all R&D for The Americas.• Managed research initiatives with external consultants and institutions to ensure that $1 million in annual research funding was applied to fulfill divisional objectives and that defined milestones were met.• Facilitate transfer of research projects and technology to Product Development, including the development of Transform, an implantable Cardiomyostimulator/Defibrillator. Promoted an environment of information sharing and project collaboration between research and development groups.• Designed, managed and conducted in-vitro, in-vivo GLP and IDE clinical evaluations of VADs, blood pumps and implantable pulse generators for FDA and CE mark submissions and subsequent market release.• Collaborated closely with cardiac surgeons to develop tools and techniques for minimally invasive cardiomyoplasty and aortomyoplasty procedures.• Recognized as Medtronic’s Technical Contributor of the Year for 1996.

Worcester, Ma, Us

• Provided technical leadership in projects involving the design, modification and installation of medical instrumentation.• Directed biomedical/clinical engineering activities such as pre-purchase evaluations, bid specifications, maintenance and repair of medical equipment, risk management and staff training.• Specified and installed remote patient monitoring system on cardiac step-down floors.

Mba, New Venture Management / Entrepreneurship

Executive Development Program

Ms, Bioengineering

Ba, Biology