Bob Luzzi Email & Phone Number

Louisville, Co, Us

Eximis Surgical Inc., develops innovative technologies for the removal of large specimens during minimally invasive procedures. Eximis Surgical proprietary technology is designed to provide surgeons a fully automated and contained system to segment large tissue specimens for removal through a small incision.

Emeryville, Ca, Us

Lucira Health is an innovative medical technology company, changing how infectious diseases are being detected and treated. Lucira Health is focused on the development and commercialization of transformative infectious disease test kits, revolutionizing the at-home diagnostic industry for a wide range of diseases. We have developed a miniaturized testing platform that fits in the palm of a hand producing centralized-laboratory-accurate molecular testing in a simple single-use and consumer-friendly test kit

Louisville, Colorado, Us

Bolder Surgical, was founded to revolutionize minimally invasive surgery in children by providing right-sized instruments that improve access and visibility in the tiniest patients. Today, we still put the patient first, leveraging our technical expertise in micro device technology and energy delivery to elevate expectations for surgical procedures.• Led $6MM product development effort, built team, infrastructure and processes. Managed program of 6 products of first laparoscopic and open vessel sealing devices from concept to global commercialization within 2.5 years.• Led Operations from product design transfer to ramp up of new single use devices and capital equipment for internal manufacturing and external contract manufacturing partners.

Manchester, Ct, Us

Woven Orthopedic Technologies is a medical device business that designs and develops orthopedic technologies (biotextile implants and surgical instruments) to treat the rapidly aging global population affected by orthopedic conditions (OrthoGeriatrics)• Led $4MM product development effort, managing R&D, QA, RA, and Manufacturing, from product concept to global commercialization within 1 year of novel orthopedic implants and instrument systems for the trauma and spine markets.• Created Quality and Regulatory strategies for US and EU. Authored and managed US 510(k) and EU CE mark regulatory filings within 10 months. Implemented full Quality Management System and received ISO 13485 and CE MDD certification within 9 months.• Managed IP portfolio of over 50 US and International patents and applications. Inventor on 5 US and PCT applications, and 3 US provisional applications within 12 months.

Consulting services for the medical device industry. Product Development, Program and Project Management, Product Development and Design Control Process Development, Technical Feasibility Assessment, Clinical Needs Assessment, Market Opportunity Analysis, Intellectual Property Development (Freedom to Operate and Patentability Searches, Patent Applications, Patent Landscape Analysis), Concept and Prototype Development.• As Sr. Director, Product Development, Hansen Medical, managed 35, $7MM budget, with 4 of 8 vascular robotic programs reaching global Regulatory approval and global commercialization within 11 months. Created new product development strategic roadmap, streamlined product development process that reduced timelines by 15% and budget by 20%.• As SVP R&D/Operations, Ouroboros Medical (acquired by Integrity Implants), managed $2MM product development effort of MIS spine system from feasibility to EU clinical trial, IDE submission and CE mark in 9 months.• As Acting CEO, Jan Medical (acquired by BrainLab), managed feasibility clinical trial of neuro diagnostic system in 10 months, and led $2MM fundraising for Series A financing.• As Patent Agent/IP Strategy Consultant, 60+ projects across 15 medical device market segments including prior art searches, US and International patent applications, IP landscape analysis for freedom to operate and patentability. Managed patent counsel for 5 companies.• As COO/Consultant. Management Consulting projects for 12 early to mid-stage companies in urology, neurology, endoscopy, general surgery, orthopedics, and spine, which included business strategic and product portfolio planning, identifying clinical needs with Key Opinion Leaders, Product Development program and project management, Risk Management, new product development process optimization, and cross-functional project management.

San Jose, Ca, Us

A venture capital funded minimally invasive spine company in the kyphoplasty space. • Built and led company from ground up with seed financing and no IP to 50 people through Series C total $18.9MM within 3.5 years.• Managed R&D and Operations from concept through commercialization with budget $13MM and staff growth to 32. Authored and managed US 510(k) and EU CE mark regulatory filings. Completed EU clinical trial, 510(k) and CE Mark, and world-wide commercialization within 2 years of company inception.• Created, developed and implemented R&D, Regulatory, Quality, Clinical, and IP strategies, Recruited and formed Medical and Scientific Advisory Boards of Key Opinion Leaders. Implemented full Quality Management System and received ISO13485 & CE MDD certification within first year.

A leading manufacturer of endovascular devices and supplier of medical components.• Identified clinical needs and business opportunities across 4 markets. Developed intellectual property, business models, development strategies, and conceptual products. Created, developed, and championed 11 early product concepts for ranging from surgical instruments to catheter based implants.• Created and implemented product development concept evaluation and selection process within first 6 months to evaluate over 25 concepts and 50 invention disclosures within first year.

A venture capital funded surgical device company utilizing a radio frequency energy-based tissue sealing technology.• Created product development strategic plans and product portfolio. Identified clinical needs, defined customer requirements and designed early prototypes for clinical needs assessment, transferred 3 new products into Product Development across 3 market segments within 1 year.

• Built R&D department from ground up to staff of 12 within first year of company. Led $3 MM product development effort from concept to worldwide commercialization of 3 General Surgery sealing devices and FDA clearance of 1 bipolar Thoracic Surgery device within first 14 months.• Implemented full Quality Management System and received ISO13485 & CE MDD certification within first 14 months. Managed transfer of design control from contract manufacturing firm to internal QMS while ramping manufacturing to 10K/year.

Ms, Bioengineering

Ms, Mechanical Engineering

Bs, Bioengineering