Proven leader with strong record of building global, high-performance teams that deliver innovative medical devices. Demonstrated expertise in technology development, strategic technology planning, program management, licensing and acquisition integration, clinical relationship management and all phases of product commercialization. Successful due diligence, licensing and acquisition integration projects across multiple clinical spaces.
Core Competencies
• Managing Complexity – Led technology development, commercialization and acquisition teams in multiple invasive peripheral vascular and neurosurgical spaces. Responsible for technology strategy, design control and intellectual property management. Deep expertise in technology conceptualization and product development.
• Delivering Innovation – Drove realization of industry’s first flat panel digital x-ray detector for mammography and world’s first three dimensional ultrasound transducer able to fully capture the beating heart. Passion for delivering on ideas thought to be impossible.
• Driving Execution & Results – Strong program management and risk mitigation skills. Deep understanding of medical device design control process. Creative, collaborative and engaging problem solver. Ensure market readiness, including clinical & regulatory.
• Building Global Teams – 20+ years leading global, culturally diverse teams. Enjoy the challenge of empowering, engaging, developing and motivating team members and reports. Strong track record of developing reports to fill roles of increased responsibility.
• Personal Traits – Enjoy change and challenge, comfortable with ambiguity, prefer to wear many hats, possess high emotional intelligence and seek entrepreneurial, “hands on” environment with similarly motivated individuals.
Group Vice President of Research and Development, Breast Health & Skeletal Imaging @ From September 2014 to Present (1 year 4 months) Chief Technology Officer @ OmniGuide is a leader in the development and marketing of advanced surgical energy solutions for minimally invasive surgery that improve precision, access and control in Gynecology, Head & Neck Cancer, Neurology and Ear, Nose and Throat Surgery.
As Chief Technology Officer, I am responsible for all aspects of advanced research, concept development, product development and commercialization activity across Gynecology, Ear, Nose and Throat, Head & Neck Cancer and Neurosurgery platforms, including both laparoscopic and robotic applications. Lead a collaborative, focused “Customer-First” team that drove 3X improvement in overall product yield, 40% improvement in overall reliability and 50% improvement in product COGS. Launched high performance instrumentation systems into the Robotic Gynecology and Robotic Transoral surgery markets. Delivered an innovative and ergonomically inspired platform into the ENT and H&N markets that enables aggressive ablation, cutting and coagulation, leveraging a fiber system 4x more robust than existing market offerings.Lead corporate initiatives in portfolio management, strategic planning, technology road mapping and intellectual property management. Key member of leadership team; frequent interactions with physicians, board members, investors and industry executives. From June 2012 to June 2014 (2 years 1 month) Vice President, Global Research & Development, Venous Vascular @ Led a global team of 142 engineers in the development of interventional devices and complex electro-mechanical systems. Teams were based in two US locations (CA & MA) as well as Japan. Responsible for products spanning the thrombosis prevention and treatment spaces, as well as acute and chronic dialysis catheters and vein ablation devices.
Responsible for all aspects of advanced research, technology assessment, product development, intellectual property management, design for quality and manufacturability, regulatory compliance, technical due diligence and R&D talent development From April 2007 to October 2011 (4 years 7 months) Vice President, Global Research & Development @ Led a team of 110 engineers in the development of complex electro-mechanical devices for neurosurgical applications including hydrocephalus and neuromodulation. Teams were based in the US, Switzerland and India. Re-energized the in-house product development process, introducing 11 new products in 2004 and 15+ new products in 2005 and 2006, up from three each in 2002 and 2003. Developed strong organizational focus on innovation and incorporated "voice of the customer" and "Design for Six Sigma" tools in all aspects of product development. From November 2003 to April 2007 (3 years 6 months) Vice President, Research & Development @ Led a 200-member technical team in the development of diagnostic ultrasound systems for use in Cardiology and Shared Services applications. Team members were located in Andover, MA, Bothell, WA and Bangalore India. Simultaneously released two new ultrasound product lines in late 2002, on time and under budget. Introduced the first ultrasound system capable of obtaining real-time, three-dimensional images of the beating heart as well as a revolutionary, low cost, extremely high quality system for the global shared services market. From April 2001 to November 2003 (2 years 8 months) Director, eBusiness @ Led a global team of 60 engineers in the development of e-business applications for GE's diverse commercial and financial businesses.The team - based both in the United States and India - delivered innovative software technology products for internet-based electronic commerce. Produced systems that established new standards for inter-business electronic commerce in terms of both ease of use and reliability. From 2000 to 2001 (1 year) Manager, Global Service Technologies @ From 1998 to 2000 (2 years) Greater Milwaukee AreaChampion, Six Sigma Quality Program for GE Healtcare Service Division @ From 1997 to 1998 (1 year) Manager, Global X-Ray Service Engineering @ From 1996 to 1997 (1 year) Manager, X-Ray Digital Detector Programs @ From 1994 to 1996 (2 years) Manager, Ultrasound Computer Engineering @ From 1991 to 1994 (3 years) Manager, Control Systems Engineering @ From 1987 to 1991 (4 years) Supervisor, Advanced Courses in Engineering & Computers @ From 1985 to 1987 (2 years) Edison Engineer, Mechanical Engineering @ From 1981 to 1985 (4 years)
MS, Mechanical Engineering @ Rensselaer Polytechnic Institute From 1981 to 1983 BS, Mechanical Engineering @ Carnegie Mellon University From 1977 to 1981 Tracy Accardi is skilled in: Medical Devices, R&D, Product Development, DMAIC, Design for Manufacturing, M&A due diligence, Intellectual Property Strategy, Medical Diagnostics, Technology Development, Technology Transfer, Global Management, Team Building, Development Of People, Customer Focus, Cross-functional Team Leadership