David Francischelli Email and Phone Number
Medical Device R&D Leader | Delivering life-changing medical devices from concept to clinic. at
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BioScience Innovations
David Francischelli's Location
Madison, Connecticut, United States, United States
David Francischelli's Contact Details
David Francischelli work email
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David Francischelli phone numbers
About David Francischelli
Innovative, results-driven research and development leader with a progressive technical leadership career in the medical device industry. Served on executive leadership teams with a record of excellence in large and small public and private companies. Balanced background in life sciences, engineering, and business. Known for technical rigor, business acumen and delivering life-changing medical devices to the market. Whether envisioning new techniques or therapies, running clinical trials, patenting and commercializing devices, or transforming teams, I consistently deliver positive impacts to the bottom line for patients, customers and the organization.Specialties: R&D leadership, clinical trials, M&A, diligence, team building, intellectual property strategy, DRM (Design for Reliability & Manufacturability), change management, coaching for performance, product pipeline / roadmap definition, cardiac electrophysiology, ablation therapies, pulsed field ablation, atrial fibrillation, renal denervation, heart failure management, neuromodulation, combination drug / devices, and minimally invasive cardiac surgery technologies.
David Francischelli's Current Company Details
Bioscience Innovations
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Medical Device R&D Leader | Delivering life-changing medical devices from concept to clinic.
David Francischelli Work Experience Details
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President And FounderBioscience Innovations Mar 2018 - PresentMinneapolis, Minnesota, UsStart-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.
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Vice President Research, Development And OperationsFrancis Medical Jan 2020 - Jan 2022Maple Grove, Minnesota, UsFrancis 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. -
Vice President Of Research And DevelopmentAtricure, Inc. Aug 2013 - Mar 2018Mason, Ohio, UsAtriCure 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. -
Director Of Research And Development & FellowMedtronic 2000 - Aug 2013Minneapolis, Mn, UsMedtronic - 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. -
Associate Fellow And Principal ScientistMedtronic 1998 - 2000Minneapolis, Mn, UsMedtronic - 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.
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Senior Biomedical Engineer / Senior Scientist / R&D ManagerMedtronic 1989 - 1998Minneapolis, Mn, UsMedtronic - 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.
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Senior Biomedical EngineerUmass Memorial Medical Center 1989 - 1989Worcester, 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.
David Francischelli Skills
Medical Devices
R&d
Fda
Biomedical Engineering
Cross Functional Team Leadership
Catheters
Product Development
Cardiology
Capital Equipment
Commercialization
Product Launch
Electrophysiology
Iso 13485
Surgical Instruments
Cardiac Surgery
Design Of Experiments
Medical Device R&d
Clinical Trials
Market Development
Atrial Fibrillation
Medical Imaging
Ablation
Design Control
Surgery
U.s. Food And Drug Administration
V&v
Hardware Diagnostics
Clinical Research
Quality System
Patents
Capa
Research And Development
Research
Six Sigma
Heart Failure
Spine
Engineering
Business Planning
Ce Marking
Team Building
Mentoring
Pmas
Cryotherapy
Technology Transfer
Change Management
510k
Rf Engineering
Vad
Electroporation
Ultrasound Therapy
Glp
Validation
David Francischelli Education Details
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University Of St. Thomas - Opus College Of BusinessNew Venture Management / Entrepreneurship -
Wharton Executive EducationExecutive Development Program
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Penn State UniversityBioengineering
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Saint Michael'S CollegeBiology
Frequently Asked Questions about David Francischelli
What company does David Francischelli work for?
David Francischelli works for Bioscience Innovations
What is David Francischelli's role at the current company?
David Francischelli's current role is Medical Device R&D Leader | Delivering life-changing medical devices from concept to clinic..
What is David Francischelli's email address?
David Francischelli's email address is df****@****cal.com
What is David Francischelli's direct phone number?
David Francischelli's direct phone number is (513)-755*****
What schools did David Francischelli attend?
David Francischelli attended University Of St. Thomas - Opus College Of Business, Wharton Executive Education, Penn State University, Saint Michael's College.
What are some of David Francischelli's interests?
David Francischelli has interest in Children, Education, Environment, Science And Technology, Animal Welfare, Health.
What skills is David Francischelli known for?
David Francischelli has skills like Medical Devices, R&d, Fda, Biomedical Engineering, Cross Functional Team Leadership, Catheters, Product Development, Cardiology, Capital Equipment, Commercialization, Product Launch, Electrophysiology.
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