David Francischelli

About David Francischelli

Innovative, results-driven research and development leader with a progressive technical…

Experience

1. President and Founder

   Bioscience Innovations

   Mar 2018 — Present

   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.

Education

• University of St. Thomas - Opus College of Business

  MBA, New Venture Management / Entrepreneurship

• Wharton Executive Education

  Executive Development Program

• Saint Michael's College

  BA, Biology

• Penn State University

  MS, Bioengineering

Skills

• R&D
• Cross-Functional Team Leadership
• Biomedical Engineering
• V&V
• Six Sigma
• Ultrasound Therapy
• Atrial Fibrillation
• Clinical Research
• Medical Imaging
• Engineering
• Electrophysiology
• Capital Equipment
• Catheters
• Technology Transfer
• Research
• Product Launch
• Capa
• Change Management
• Business Planning
• 510k
• Commercialization
• Medical Devices
• Ce Marking
• Electroporation
• Rf Engineering
• Heart Failure
• Vad
• Ablation
• Surgical Instruments
• Quality System
• Pmas
• Glp
• Cryotherapy
• Validation
• Mentoring
• Iso 13485
• Team Building
• Medical Device R&D
• Fda
• Cardiac Surgery