Business and Technical Advisor with SafeView a Single-Use Robotic Duodenoscope with innovative electronic drive system platform

Fractional CxOBusiness and Technical Strategy AdvisorUrology / Single-Use Endoscopy / Lasers & Laser Fibers / Focal TherapyDue-DiligenceProject ManagementProduct DevelopmentStrategic PartnershipsNew Business DevelopmentPre-Clinical Testing ServicesContract Manufacturer LiaisonManage your Strategic PartnersPrivate Equity and Venture Capital PartnerPortfolio Planning and optimization, Development & Execution

Innovative High Intensity Endoscopic Laser Light

Built Single-Use Endoscopy strategy and optimized portfolio for the entire business (GI, Urology, Respiratory and ENT) that included organic development, strategic partnerships and M&A. Built a high functioning cross functional multinational team to optimize strategy, portfolio and revenue to define requirements and deliver world class global single use scopes.

Responsible for product development and BD including strategy, portfolio and the management of strategic partnerships. Designed and built Dornier consumable strategy and portfolio with focus on flexible ureteroscopy and BPH through organic development, partnerships and M&A. Negotiated all contracts and pricing and optimized product designs of all consumables that included such devices as single use scopes, balloon catheters, stents, wires, baskets, laser fibers, and RF bi-polar resection for BPH.

Managed product development of disposables and capital equipment for the Surgical Division treating various womens heath conditions including tissue resection of polyps and fibroids, fluid management and abnormal uterine bleeding.

• Manage the Urology Systems Engineering team including managers, Program managers, and interim lead of international R&D team. • Built 5-year portfolio strategy thar includes active internal & external development efforts for multiple programs at various stages. • Leverage off shoring development partnerships in Israel, Germany, India and China.• Developed franchise strategy that included the successful due-diligence, acquisition and remediation of a laser company. • Developed technology roadmaps and portfolio cadence that includes capital equipment and disposables for therapies to treat BPH and Stone disease. • Incorporated Critical Chain program management philosophy. • Lead for integration, gap analysis and remediation of aquisition of RF system for resecting & removing uterine fibroids.• Co-championed Corporate Capital Equipment Committee for sharing and standardizing practices across the company. • As Franchise owner (2005 - 2013), manage the Urology franchise, including Stone & BPH. Products include stents, wires, baskets, laser fibers, tools and systems for fURS, etc. • Chaired the multi-functional Franchise P&L team which included portfolio strategy and cadance optimization, Development & Sustaining budgets, VIP’s, OEM strategy and relationships, product rationalization as well as divesture recommendations. • Negotiate development agreements with physicians and other strategic partners.• Authored detailed integration plan for PMA system and assembled multifunctional teams to manage the integration of a MIT microwave therapy for BPH; Efforts included due-diligence, sustaining the product line (both capital & disposables), remediation and transition of business systems as well as a “transition services agreement” that included employee retention and transition agreements.• Negotiated deliverables with acquired technology CEO’s that led to two successful, on time, on budget integrations and subsequent product launches.

• Program manager and technical lead of the Antimicrobial Foley catheter program as well as the mechanical and microbiology labs. Responsible for all technical program deliverables including design inputs, design outputs, test methods with appropriate sensitivity, design, DF, DV, DV&V, etc. • Supervise two direct reports and direct activities of a multifunctional team of over ten team members. • Authored project business plan, developed screening methods, evaluated over 20 antimicrobial and hydrophilic technologies, optimized final technologies, conducted DV testing and completed technical package for 510(k) submission. • Negotiated technology and coating agreements including first rights of refusal to potential technologies. • Key contact for physicians, consultants, Manufacturing, Marketing, Sales and QA. Responsible for training sales force on product use and anatomy and physiology.

• Implemented design modifications of an athrectomy system, inclyuding disposable motor drive unit and completed DMR. • Wrote Specifications, protocols and procedures for bench and animal pre-clinical testing. • Planned and coordinated activities for device builds, p-spec bench and animal testing, biocompatibility and packaging testing and sterility validation that led to IDE approval for both peripheral and coronary investigations. • Originated or approved ECR’s, MRB’s and final test reports. • Trained clinical investigators on device use and monitored clinical trials.