Jessica Barrett Email & Phone Number

Mountain View, California, US

• Recruited by the founders to create and execute the strategic commercialization plan from end user needs through commercial success for the MagChipR™ POC Analyzer targeting the needs of infectious disease physicians.
• Engaged world-renowned key opinion leaders as advisors, who are providing specimens for testing, clinical expertise, participating in our clinical trials, then presenting, publishing, and advocating on behalf of the.
• Created user needs for product development and worked with the teams to turn them into specifications in Design Controls.
• Creating the content for the marketing materials required for regulatory submission by gaining the recognition of potential customers and distributors

Mountain View, California, US

• US FDA Agent Services for Foreign Establishments
• Communication between the FDA and the foreign establishment as the official correspondent
• Providing FDA with information about foreign establishment's devices imported into the US
• Scheduling FDA inspections of the foreign establishment
• Establishment Registration, Medical Device Listing, and FDA 510(k) Submission
• Medical device labeling

Salt Lake City, UT, US

• Recruited by the founders to get funded and lead the company from R&D development effort into a commercialized entity ready to launch the CE marked iPap®, the world’s first cervical specimen self-collector to increase.
• Creating the strategy, strategic relationships, marketing materials, and setting up distribution

• Negotiated agreement to custom design, develop and confirm next-generation DNA/RNA amplification KoruPlex™ assays for Rapid Diagnostics ML Limited’s MiniLab Platform purchased from Enigma Diagnostics.
• Set up a laboratory at JLABS incubator in San Diego for assay development

• Developed commercial strategy, set up distribution, supported clinical evaluations with KOLs at teaching medical centers across Europe and launched the CE marked MiniLab Point-of-Care molecular diagnostic platform.
• The MiniLab was well-received; however, the company suffered from assay contamination during manufacturing and was unable to supply cartridges.

• Recruited by the CEO of a self-funded start-up to develop the product requirements for a handheld diagnostic platform and obtained government funding for product development
• Shareholder of Reliable-LFC, LLC, Grand Prize Winner of the $6M XPRIZE Rapid COVID Testing Competition

Salt Lake City, Utah, US

• Recruited by the executive management team of 21-year-old privately-held company, to bring in other revenue streams besides PCR licensing agreements and government contracts plus prepare to launch a diagnostic platform.
• In 2010, increased revenue from $12M to $18M while preparing to launch the FilmArray that was cleared mid-2011. In 2011, the total revenue was $35M.
• In 2012, revenue increased to $65M, which was 135% of the forecast.
• In 2010, started with five direct reports. By 2012, the commercial team included seventeen direct reports and greater than forty international distributors.
• Hired, trained, mentored, and led the commercial team that launched the FilmArray.
• Created the strategic commercial plan, product roadmap, materials, and programs that accelerated the FilmArray sales cycle compelling laboratory directors to provide infectious disease physicians with FilmArray's.

US

• Recruited by President/CEO to bring shareholder value and investor exit for VC-funded 8-year-old company.
• Increased revenue over two years from $5M to $13M of MAUI Microarray Hybridization Systems by forging strategic business relationships with Roche NimbleGen and Agilent.
• Launched the companion MAUI Microarray Wash System that led to Roche Diagnostics acquiring the company.

• After EMPI bought Iomed in August 2007, EMPI and McKinley & Company retained my services to spearhead the launch of the Hybresis System into a $100M market using their commercial team of >300 plus a $1.1M budget
• Created strategic commercial plan, budget, promotional and training materials, and trained the team.

US

• Recruited by President/CEO to increase stock value for a publicly-traded 20-year-old company that was weeks from delisting on AMEX.
• Increased revenue and profitability within weeks that included negotiating large OEM contracts
• Increased revenue from $5M to $22M without increasing headcount
• Developed commercial strategic plans to bring shareholder value by making the company attractive for acquisition, due to shrinking reimbursement. Developed and launched the Hybresis System, which was a 2007 Innovation.
• Launching the Hybresis System was the impetus for EMPI purchasing IOMED

• Recruited by President and Board of Directors to join a privately-funded start-up of six people to develop the product requirement for a range of Microject Infusion Pumps, work with the product development and.
• Built the team, set up distribution, and spearheaded global launch with five employees and over forty distributors
• Negotiated strategic alliances to drive sales in new market segments through Arrow International, AstraZeneca, Codman, Knoll Pharma, and Zimmer Holdings
• Revenue increased from $0 in 1996 to $35M in 2001 with international sales accounting for 70% of revenue

• Recruited by the President/CEO to replicate my regional sales and marketing success.
• Successfully created a new vascular access category, PICC lines, accounting for greater than $1B in current global sales. The Per-Q-Cath still accounts for 70% of the market share.
• Successfully challenged eighteen states to include PICC Line placements within the scope of nursing practice.
• Accelerated Per-Q-Cath sales by training and certifying nurses through the Train-the-Trainer workshops.
• Increased revenue from $3M to $21.5M in three years and sold to Bard Access Systems for $100M.