Manager Medical Device

317-***-**** (m) 937-***-**** (h)

abpcfw@r.postjobfree.com

ANDREW D. COTHREL

MEDICAL PRODUCTS EXECUTIVE/CONSULTANT

Over 20 years of experience spanning start-ups to giants and across all phases of the business cycle has produced the

right combination of operational, financial, commercial, technical, and organizational know-how to lead innovative medical

products companies to success.

Areas of Expertise:

Business driven decision making and risk taking Building high-performing teams/Performance turnarounds

Change management Strategy, analysis, & synthesis that lead to execution

Managing growth, planning/implementing change Structuring, staffing, aligning, & orchestrating organizations

Medical devices, diagnostics, life sciences Due diligence, M&A assessment/integration

Manufacturing process development Coaching, advising, Board roles

SUMMARY

17 years of corporate giants experience in medical products/life sciences, rising through roles in R&D, engineering,

manufacturing, strategy, global projects, and general management at Abbott Laboratories, Boehringer Mannheim, and

Roche Diagnostics, culminating in a five-year VP/Site Manager role at Roche.

5 years of entrepreneurial experience, most intensively in the last 2+ years via Blue Marble Medical, a consultancy

focused on C-level executive/advisory and investor/M&A services for medical products innovators.

Experience with diagnostic, orthopedic, and emergent/intensive care medical devices, and research tools/reagents.

BS and MS degrees in engineering, complemented by an MBA-equivalent business education and extensive corporate

training in areas such as new product commercialization, FDA/QSR, supply chain management, statistics and quality

tools/systems, advanced manufacturing methods, business strategy, negotiating, and people/team leadership.

EXPERIENCE

BLUE MARBLE MEDICAL LLC 2007 - current

Blue Marble Medical is a consulting firm to the medical products industry. www.bluemarblemedical.com

Founder and President of this consultancy specializing in Board and C-level executive/project roles with medical product

innovators of all sizes, and investor/M&A services. Mid- to long-term engagement highlights include:

SonarMed Inc., President (early-stage airway monitoring medical device company) [current]

Bringing this early stage instrument/disposable company to 1st launch by completing product development and clinical

trials/510(k) (submitted), and conducting a $2.5MM Series A capital raise to fund initial commercialization

Developing and executing a corporate partnership strategy and outsourced design and supply chains

TriMas Inc., General Manager (diversified holding company focused on highly engineered products) [6 mo.]

Full P&L responsibility for a contract manufacturer of spinal/trauma orthopedic devices (Dew Technologies)

Brought in new talent, processes, and systems to professionalize this newly acquired organization

Business Development Focus: doubled the number of customers to begin to diversify/stabilize revenue stream

Point man for driving an acquisition-based orthopedic growth strategy (global credit crisis 3Q 2008 shelved this

strategy and prematurely ended the project)

Client B LLC, CEO (early-stage human autoimmune chemistry company) [16 mo.]

Assessed IP, created business plan, led efforts to raise seed capital

Led 1st product development/commercialization via internal efforts and partner company collaborations

Client C Inc., COO CEO (early-stage research/in-vitro diagnostic system company) [14 mo.]

Negotiated license & key agreements/contracts, developed business plan, raised seed funding

Built a team for 1st product development, created 1st prototypes, renovated/equipped/staffed R&D facility

Short-term (1 4 month) engagement highlights include:

Currently advising a novel breathing-mask company on capital formation and technology out-licensing

Currently advising an early stage therapeutic company on formation and technical/business feasibility issues

Advised a rapid prototyping/molding company on a broader medical device strategy (orthopedic focused)

Assisted a medical device reprocessor in key contracts/collaborations to allow low capitalization start-up

With Director Manufacturing & CFO of an in-vitro diagnostics company, created detailed costing models &

projections, then guided Director Manufacturing on manufacturing process re-design for scale-up & cost reduction

Ongoing Board/Advisory Roles:

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Director on two Boards (early-stage medical device, mid-stage health IT companies)

Advisory Board member for two early-stage medical device companies

Supporting a venture capital firm and an intellectual property law firm on matters pertaining to life sciences

Andrew D. Cothrel Page 2

ROCHE DIAGNOSTICS CORPORATION, INDIANAPOLIS, INDIANA 1994 2007

Roche Diagnostics is the #1 worldwide supplier of medical diagnostics and the #5 provider of life science research tools.

Vice President, Operations & Site Manager - Applied Science (2002 - 2007)

Led the Applied Science U.S. Business Area (manufacturing, R&D, quality, finance, logistics, sourcing, business

development, product/process support). Global sales of ~$400MM, of which ~$70MM originated from Indianapolis

products. High mix, low volume batch processing of research products under ISO 9001:2000 certification.

Business growth: Championed new product developments and strategic collaborations in custom products with

multiple successful launches, re-populated a previously empty pipeline. Custom revenue up 150% over three years.

Product availability: Stock-outs reduced by 80%, on-time in-full delivery to affiliates improved by 18 points. Formal

supply agreements put in place for key raw materials.

Cost control: R&D rate reduced 55% as hours declined & launches increased. COGS reduced 21% over three

years, operational period expenses declined 40%. Labor rate held flat as total hours declined 20%.

Organizational development and leadership: Implemented new organizational structures, brought in new skill

sets. Contributed outside the job boundaries via leading global operations strategy projects (including integration of

an acquired company), facilitating Leadership Conferences, and acting as champion for diversity in recruitment.

Named as a Corporate Officer for Roche Diagnostics Operations, Inc.

Led the U.S. site closure project/transfer of operations to Germany, finished the transfers ahead of schedule and

under budget. Desire to remain U.S.-based led to my decision to leave Roche.

Director, Process Improvement Patient Care business (1998 - 2002)

Led process development and product support functions for Diabetes and Coagulation monitoring products manufactured

in North America (representing $1.1BB in worldwide sales). Team of 80 engineers, scientists, and technicians.

Environment of low mix, high volume, highly automated processes under FDA cGMP.

Key member of the Accuchek Advantage Life Cycle Management Team, shaped product portfolio and strategies,

then created/ championed multiple projects/teams to deliver life cycle objectives and maximize profitability:

Product Features: Extended platform life by improving critical product characteristics.

Capacity: More than doubled through efficiency and yield improvements as well as expansion projects. Oversaw

design, fabrication, and validation of over $40MM in custom high-volume production equipment/facility.

Cost: Implemented cost reductions exceeding $35MM/year direct savings (> 25% product cost reduction).

Brought structure and systems to manufacturing process development and product improvement, drove best

practices adoption at multiple production sites.

Assessed companies and technologies for potential license/acquisition deals.

Played a broader role via Global Strategic Procurement Project and Divisional Strategic Vision Process.

Project Leader, Apollo Project Diabetes Care business (1997 - 1999)

Led international project team to create manufacturing capability in Ponce, Puerto Rico, for the Advantage product.

Profit contribution of the project exceeded $100MM.

Created a high-performing 20-person global project team from multi-functional, multi-cultural groups.

Launched first phase 4 months early on 20 month schedule, overall $0.5MM under on $21MM capital budget.

Exceeded 1998 new plant production commitments by 50% (and met unforecasted high demand as a result).

Created and implemented manufacturing/quality systems for 1st time dual site production of one product.

Manufacturing Strategy Principal Patient Care business (1996)

Staff to V. P. Operations to create actionable operations strategies for North American/Global Business Unit Operations.

Created global production strategy for #1 product line, optimizing infrastructure, financials, and risk.

Authored Global Operations Principles to steer worldwide business unit, site, and production strategies.

Recommended global consolidation of manufacturing processes, closure of one site, all of which were executed.

Created Supply Chain Risk Management framework from suppliers suppliers to end user.

Manufacturing Manager Diabetes Care business (1995 - 1996)

Headed manufacturing for the Advantage product line. 140 persons, 6 days/three shifts. Led team to performance

improvements during time of intense change and exponential volume growth. Team driven improvements included:

Led operator team that drove yields from 78% to 87% in three months.

Member of staff team that turned around 1H95 cost trends and beat planned 1995 year-end product cost.

Implemented culture change through operator driven and participatory teams, dealing with issues such as functional

group cooperation, staffing, new equipment start-up, training, and systems compliance.

Manager, Process Development Patient Care business (1994 - 1995)

Led engineering group/teams in process development and manufacturing engineering for three product lines.

Led recovery of the CoaguChek product from shut-down to full production, yield from

Coordinated/coached several project leaders to achieve 25% cost reduction on another product line in 18 months.

Involved in business assessment & integration for an acquired coagulation company and their product/technologies.

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ABBOTT LABORATORIES - DIAGNOSTICS DIVISION, ABBOTT PARK, ILLINOIS 1990 1994

Abbott Labs is a diversified healthcare manufacturer and was the #1 (now #3) worldwide supplier of medical diagnostics.

Project Manager, New Technology Development (1991 - 1994)

Led R&D project teams in new product development/launch and manufacturing process development/start-up for

disposable (self-performing) diagnostic assays, targeted primarily at the Physician Office Lab and OTC markets.

Brought three new devices and their related manufacturing processes from R&D prototype to successful launch

(including 510k approval), including a joint development with an outside partner (Johnson & Johnson) and an

international development (Japan). Focused on pregnancy, fertility, and infectious diseases.

Led the technical assessment of the new system disposables of an acquired hematology company.

Initiated/led Process Characterization Group, increased fundamental understanding of process/product relationships.

Section Manager, Device Process Development Lab (1990 1991)

Provided technical/managerial leadership in product and process development, pilot manufacturing, and technology

transfer for in-vitro diagnostic devices. Led team of 30 scientists, engineers, technicians, and operators.

Created focused directed work teams, introduced merit compensation for technicians and operators.

Increased lab s technical role, reduced pilot production defects 70% and cycle times 60%, during 200% growth.

Created a customer-focused environment by introducing internal customer concepts, clarifying paperwork and

eliminating opportunities for error, and improving customer service systems.

ADDITIONAL EXPERIENCE

Cothrel Enterprises, Owner/President. Created/headed a small, part-time sales/marketing/distribution organization in

order to gain first-hand experience with sales, marketing, and business management.

Recruited, trained, and managed an all part-time sales group that grew to 20 persons in 1.5 years.

Grew sales volumes at a 300% per year CAGR in that same time.

Turned a net profit in year three (1994) and every succeeding year. Moved to passive management in 1995, then

sold the business in 2000. Annual RONA averaged 28%.

Exxon Chemical Company, Performance Products Division, Baton Rouge, Louisiana.

Team Leader, Fixed Equipment Quality Assurance Team

Mechanical Technical Services Engineer, promoted within position to Plant Engineer

General Motors, Delco Products Division, Dayton, Ohio. Product Engineer

Accenture (formerly Arthur Andersen & Co. M.I. Consulting Division), Columbus, Ohio. Staff Consultant

EDUCATION

Roche Horizons Programme, London Business School, 2001. Intensive course in business/marketing strategy and

leadership, followed by a global project assignment (regarding global strategic procurement) with delivery of

recommendations to the Divisional Executive Committee.

Executive Management Programme, Cranfield University School of Management, Cranfield, England, 1998. This

intensive certificate program, supplemented with extensive MBA coursework at Butler University (1995 2000) and

University of Michigan (1996 1999) provides the functional equivalent of a Master s degree in Business Administration.

Extensive corporate/seminar training in new product commercialization, FDA/QSR, supply chain management (Penn

State, Ohio State), statistics/quality/problem solving tools (former ASQ CQE designation, SPC, DoE, Root Cause, etc.),

advanced manufacturing methods (6, TPS/Lean/5S, etc.), business strategy, negotiating, and people/team leadership.

Previous study of basic conversational Spanish and German.

Master of Science in Engineering, University of Michigan, with a focus on technology management (e.g. statistics, project

management, design of experiments, labor/tort/business law) as well as biomechanics and alternative energy/energy

conversion. National Science Foundation Fellow.

BS Mechanical Engineering, The Ohio State University: Summa cum Laude, With Distinction. Undergraduate Research

Fellow, thesis option; President, Tau Beta Pi; Membership chair, ASME; National Merit Scholar.

AFFILIATIONS AND COMMUNITY INVOLVEMENT

Indianapolis Private Industry Council (Marion County Workforce Development Board), appointed by the Mayor s Office to

serve on the Board of Directors, served two terms, chaired the Industry Programs subcommittee.

Indiana Health Industry Forum (IHIF), member of the BioFuture Initiative (created a 2-year biotechnology degree state-

wide in Indiana), served on the Entrepreneurial Assistance Panel (reviewed/commented on local life/health-science

related start-up business plans), served on the Innovention Planning Committee (annual conference/expo)

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Guest lecturer, Ivy Tech Community College (Root Cause Analysis, Ethics in Biotechnology)

Recipient of Roche s 100 Volunteers service award in recognition of community involvement (2005)

Past President of the Board of Directors, Gregory Hancock Dance Theatre (a non-profit professional dance company)

Numerous roles in Junior Achievement and youth sports programs

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