Andrea Slater Tomko Email and Phone Number

Direct the design, development and commercialization of innovative products for the diagnostics industry while ensuring compliance to Regulatory Standards.SELECTED ACCOMPLISHMENTS:Drive IVDR initiative for Laboratory Diagnostics worldwide, including management awareness, staffing and budget, impact on product portfolio and Quality Management System. Build a roadmap for implementation, ensuring overall responsibility for IVDR implementation has been established. Selected by executive management to lead program.Lead and manage cross-functional and global high performance teams for a $50 Million portfolio of products, encompassing multiple complex projects spanning all product development life-cycle phases.Preserve a $4 Billion portfolio of diagnostic products by designing and implementing a process to identify, remediate and complete over 400 diagnostic product technical files to reflect state of the art and comply with new international regulations, including two successful notified body audits.Establish and maintain effective relationships with selected strategic business partners for unique business models and revenue generation, such as product and service combinations.

Directed the translation of unmet customer and market needs into innovative and profitable solutions. Selected as a key member of Johnson & Johnson Medical Devices and Diagnostics Patent Estate Owners Committee.SELECTED ACCOMPLISHMENTS:Increased portfolio value of new growth areas, estimated at $15 Million, by creating and implementing a new innovation process that identified new opportunities and accelerated concept development. Saved the company over $7 Million in R&D costs by creating global Regulatory and Clinical roadmaps that quickly identified and navigated new markets. Prevented competitors from entering new markets while generating over $200 Million in revenue by driving an IP strategy that synthesized existing patent portfolios and generated new ideas into over 80 patent applications in one year.

Director of a start-up business within Ortho Clinical Diagnostics (J&J). Led the identification, incubation and early development of new innovation platforms, including leading small multidisciplinary teams, in the creation of new growth solutions for clinical diagnostics.SELECTED ACCOMPLISHMENTS:Developed and successfully implemented a new business opportunity assessment process including management of ideas from discovery into product development that developed future sales pipelines of companion diagnostics, estimated at $5 Billion.Successfully identified and championed multiple technology opportunities, building external innovation networks with scientific and clinical key opinion leaders that complemented internal research and supported the execution of Johnson & Johnson’s MD&D sector strategy, estimated at 4.2 Billion. Built and managed complex internal and external joint venture partnerships, resulting in long term strategic alliances. That opened doors for other joint collaboration and significantly increased both top and bottom line revenue.

Recruited by the Vice President and Venture Leader for initial 5 person team to lead new business development, project management and intellectual property for a neuromodulation medical device start-up venture.SELECTED ACCOMPLISHMENTS:Generated over $ 2 Million in sales in 12 months by leading the efforts of a multifunctional internal team and external pilot manufacturing team to develop first to market neurostimulation device.Protected a $50 Million business by creating, developing and implementing an intellectual property strategy resulting in over 18 patents filed.Saved the company over $2 Million in patent processing fees by designing, developing and integrating the first ever patent review board across multiple franchises within Johnson & Johnson, resulting in a more strategic and streamlined patent application process.Overcame a complex challenge to design and develop an ergonomic and universal tool for precise placement of a medical device by end users, thus enhancing product sales in excess of $2 Million.

Managed and developed the intellectual property portfolio for electro-mechanical devices, collaborating with patent attorneys and inventors across J&J. Supported New Business Development in acquisition and licensing activity.SELECTED ACCOMPLISHMENTS Created and managed the Intellectual Property function for the franchise, protecting a $4 Billion business. Established as patent expert in area of electromechanical devices.Developed the patent portfolio for electromechanical devices, resulting on over 20 filed patent applications and generating over $3.5 Million in revenue while protecting a $100 Million franchise. Created technology maps and assessments in support of the strategic plan resulting in three major licensing deals, increasing revenue by over 50%.

Led a multi cross-functional global team (12 members, 3 international regions) from concept to launch, to develop first internally developed Ethicon Women’s Health and Urology product, including a 510K submission in USA, in less than 10 months, generating $10 Million during first year on market. Received Johnson & Johnson Standards of Leadership Award.

Instrumental in the strategic plan resulting in the acquisition of two major North American competitors, increasing division revenue by over 50%. Grew novel women’s health and urology division within Ethicon via L&A roadmap and deal execution of numerous transactions that helped double the size of the division in 2 years.

Drove the concept, design, development and commercialization of over 7 medical device programs, including IDE, PMA and 510K submissions, results ranging from saving the company $200,000 to generating millions in sales revenue.

Directed the program management function for the development of a novel minimally invasive endovascular catheter system, the first of its kind in the industry. Promoted to Program Manager within one month of joining company. Streamlined production of the endovascular catheter system by designing and developing assembly methods and associated tooling to fabricate prototypes and clinical product, reducing cost by $500,000.

Directed New Product Development function for angiographic catheters and accessories with a $1 million budget and a staff of 12 engineers and 6 technicians, which led to a 30% increase in new product sales.

Fast tracked to management level, cultivating an extraordinary level of engineer and technician loyalty, and achieving a 5+ year tenure among 90% of employees over a 7-year period. Drove development of 21 projects in 3 distinct product lines from conception to start-up, generating over $65 Million in revenue.