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Steve Weisner

Greater Boston Area

Product Engineering and Business Development Executive with outstanding experience in executive management, product life cycle, partner relationships, professional software product management and development experience with global life-science leaders and startups. • Driving Revenue Generation and Sales Growth • Identifying New Business and Product Offerings • Building High Performance Cross-Functional Teams • Understanding and Exceeding Customer Expectations • Recognized Expert in Medical Device Solutions A team leader with expertise in physiological meas...

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Areas of Expertise

  • Transition to commercialization

    I have developed dozens of medical devices in the area of patient monitoring & clinical information system from requirements assessment through product development, product launch & customer implementation. I focus on transforming that 'Research project' into a manufacturable & commercially viable product. I have successfully cleared 17 Class II 510k)products, CE marking & clearances in South Amer

    • Manufacturing
    • Product design
    • manufacturability
    • Regulatory and Compliance
    • FDA
    • CE Mark
    • product launch
    • Medical Software
    • Disposables
    • Patient Monitoring App
    • noninvasive patient monitoring
    • clinical information systems
  • Partnership management and outsourcing

    There are lots of smart people in the world, but they don't all work at your company! I have partnered with most of the small to large vendors in the medical device community. I have successfully integrated software & hardware components into a base product including disposables, sensors & monitors. Integrated multiple geography teams. Vetted, jointly developed & released 2 projects in China

    • Manufacturing
    • Production manufacturing
    • outsourcing
    • China
    • Partnerships
    • cross-geographic teams
    • Medical Software
    • Sensors
    • Disposables
    • Patient Monitoring App
  • Evaluation of clinical utility and workflow

    You won't get a yes/no answer from me on how to implement a particular feature. I have always tried to educate any engineer on how a particular piece of software or hardware will be used by the user whether that clinician is a front-line '69-Whiskey' Army medic, an ED nurse or a cardio-vascular surgeon. I understand & have experienced worldwide clinical practices in 150 hospitals & all care units

    • Healthcare Delivery
    • Inpatient care
    • Clinical utility
    • clinical workflow
    • Clinical Trial
    • Usability

Reviews

  • LB
    Steve was an outstanding VP to work. With his medical industry knowledge he provided a view that was always accurate. Passing that knowledge on was second nature. He is fair and cares about the people who work for him. It would be most beneficial for any company to have Steve within their employ.
    Lance Borders
  • GE
    During the many opportunities I had to work with Steve, he demonstrated an deep understanding of medical technology and devices. Steve's medical device segment knowledge and ability to develop customer relationships enables him to be a tremendous contributor to an organization.
    Glenn Edwards
  • PC
    While working with Steve he showed leadership, the ability to develop consensus among competiting groups, and a sense of humor that served all well. He has a vision for Healthcare and the ability to drive toward what needs to be done in order to achieve this vision.
    Paul Coss
  • DB
    I have known Steve for well over 20 years starting with HP Medical and most recently with Draeger. Steve possesses a unique wealth of worldwide Healthcare knowledge from product development - including clinical workflow - through to strategic planning and 3rd party business management. Always professional, Steve is very straight forward with his partners and drives for results. I highly recommend Steve.
    Dan Barton
  • EG
    Steve is very technically capable. His knowledge in standards and how to work with his business partners in all functions --- Regulations, Manufacturing, Supplier Managment and Marketing. He is well respected by all functions and always gives a good balanced decision using technical, clinical and business risks in his decision process. He is also well respected by customers --- they respect his opinions and solicit his input when issues arise.
    Elisabeth George
  • JN
    A person of integrity, someone highly intelligent and an effective communicator are just three of the many qualities that come to mind when I think of Steve. His ability to accurately articulate today’s market needs, and then include variability and trended information, enable him to provide the best approach to impacting one’s success. In today’s market, Steve’s broad talents allow him to function and contribute effectually at an executive level. His gifts, combined with his sincere desire to help, make him not only a valued employee but a valued friend. I highly recommend Steve and look forward to working with him again in the years ahead
    Joe Noto
  • WS
    It has been a great pleasure to work with Steve for 3 years at Draeger Medical. Steve possesses a rare combination of clinical knowledge and technical expertise. He understands the market drivers in healthcare. Steve has continually demonstrated the ability to identify partnership opportunities to increase revenue and market presence. He has worked very effectively at Draeger dealing with multiple cultures and managing diverse groups across the States, Europe and Asia-Pacific.
    Wolfgang Scholz

My Interests

Health Sectors
Medical Devices, Health IT

Experience

  • VP of Engineering

    Reflectance Medical Inc. | June 2011 - Current

    Reflectance Medical Inc. is an early stage company developing new technology to revolutionize the care of critically ill patients by reducing medical costs and deaths associated with conditions which result in poor tissue perfusion and acidosis. The company's noninvasive CareGuide™ patient monitor continuously and quantitatively displays levels of microvascular oxygen and pH to provide treatment goals to assure rapid and successful reversal of microvascular abnormalities associated with internal bleeding, trauma, cardiac failure and sepsis. • Transition the company to commercialization for military and non-military indirect hospital sales. • Oversee the technical and business/contract implementation of CareGuide as part of a partner end-product offering. • Engineer and manage hardware, software, mechanical and disposable components for Mobile CareGuide device through in-house and contract/partner engineering; responsible for managing operating expenses. • Manage all product development, documentation and testing through regulatory approval and product launch including 5 cleared 510(k) submissions and Mil-spec/air worthiness testing. • Identify Key Opinion Leaders and initiate clinical evaluations in support of product launch and adoption. • Develop additional corporate partnerships through the technical and business evaluation of partners. • Establish regulatory compliant quality system including CAPA, MDR and customer complaint support.

  • Senior Director OEM Development / Senior Advisor to President-CEO

    Draeger Medical | December 2008 - April 2011

    • Responsible for Board of Director level mid to long-term strategic planning for all patient monitoring and information systems (~$240M yearly sales and a positive growth for 2011). • With Executive Staff, manage all functional business teams in Andover (~400 personnel). • Established 4 new business development inbound relationships with key 3rd party domestic and international companies including complete product development in China. • Identify external businesses or partners for potential inbound ODM & OEM relationships with Dräger Patient Monitoring and Information Systems as a provider of conceptual ideas, intellectual property, partial product implementation or developed product implementations with growth potential of ~$140M. • With R&D and Product Marketing staff, drive company 5 year roadmap and allocation of R&D resources for 2011-2015. • Lead team to determine approach for wireless technology integration in all Dräger Medical products. • Evaluate new measurements and other technologies for future product development. • Appointed monitoring and information system business representative on Dräger Strategic Technical Board, determining yearly Research investment for all Dräger Medical

  • VP Software Development

    Radianse, Inc. | December 2006 - Current 2008

    • Responsible for all company software: Indoor Positioning System for patient, staff and asset tracking; real-time Patient Flow systems targeted for hospitals; open interface software for 3rd party integrators. • Create material for VC funding road-show; pitched technology to current VC's. • Developed software for and supported 30+ customer installations. • Software VP of 9 staff including development engineers, QA engineers and technical writers; $1.3M (direct) annual R&D budget; doubled staff and stayed within budget for each year. • Presented for the company at board meetings, venture-capitalist reviews, prospective company investors, key customer deals and professional meetings. • Established bug management, software development build and release processes, QA processes and staffing for the company. • Worked with hospital C-Suite level, clinical department heads and individual clinical staff to match product capabilities to solve customer needs • Drove future product direction and specific architectural product decisions. • Worked with 3rd party software integrators using Radianse interfaces. • Represented company on RFID, Interoperability and Healthcare Information Technology standards groups.

  • Director of Clinical Applications

    Philips Medical Systems | December 2003 - Current 2006

    • Clinical applications section responsible for the clinical content of all of Philips patient monitoring devices and clinical information systems -$980M sales with a 50% U.S. and 35% worldwide market share. • R&D Director of 22 staff including project managers, development engineers, clinical staff, researchers and learning products developers; manager of 5 physician consultants; $4M (direct), $30M (indirect) annual R&D budget; increased staff and stayed within budget for each year. • Directed internal research activities and collaborative efforts with Philips Research, physician consultants and 3rd parties to successful implementation into products. • Directed needs assessment, product specifications and clinical application implementation across R&D and Marketing. • Introduced early clinical review participation in product design, greatly decreasing latent product defects. • Provided guidance for successful clinical field trials in U.S., Europe, China for patient monitoring products • Key Philips technical expert participating in major customer visits involving $100M annual sales.

  • Clinical Applications Architect / Software Manager / Project Leader

    Hewlett-Packard | December 1993 - Current 2003

    • Appointed Project Leader of Technology Leadership Council providing in-depth understanding of competitive positions and applicability of current and new technologies to future Patient Monitoring product timeline; directed individual product architectural approaches & project schedules across multiple R&D organizations. • Project leader and co-project manager of several nursing central station & real-time data management embedded software development projects – responsible for teams of up to 7 software engineers’ product, schedule integration & clinical field trials. • Project leader nursing central station user interface & data acquisition software. • Primary liaison between Company & 3rd party vendors for software/hardware integration. • Researched, specified and drove relationship with major paging vendor resulting in increase of 350 units/yr and eventually acquisition by Philips. • Defined bedside, central station, information management & network product portions of business 5-year plan. • Assisted in worldwide patient-monitoring system needs finding team with world-wide hospital visits. • Provided direction and feedback for applicable clinical use models & clinical content of Patient Monitoring products. • Provided consultation feedback to R&D Director: budget, regulatory issues, product approaches, future directions. • Drove decision making and conflict resolution on product implementation across telemetry, network, central station and application server products. • Provided direct feedback to Patient Monitoring Technical Marketing and Quality for customer issues and patient incident reports. • Provided content for 10+ FDA/worldwide regulatory submissions and competent authorities’ reports. • Drove decisions for system interactions between U.S. and Germany R&D teams. • Recognized authority on HIPAA product implications and Sarbanes-Oxley relationship review. • Provided expert testimony (court deposition) for medical litigation issues.

Education

  • Continued Education

  • Cornell University

    B.S. | Neurobiology and Behavior / Computer Science

  • University of Wisconsin-Madison

    M.S. | Biomedical Engineering