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Sally Bowden
Cicero,USA
Summary
Sally Bowden is the co-founder and partner at The P3 Acceleration Group, Inc. Sally has over 30 years of experience in quality, regulatory and operations in medical devices, companion diagnostics, education and health care systems. She has served in executive positions as COO and co-founder RenalytixAI, Vice President of Regulatory, Operations and Quality at Vigilant Biosciences, Inc., General Manager at OncAlert Labs, Vice President of Quality Systems and Process Improvement at Ventana Medical Systems and as Vice President of Quality and Regulatory Compliance at Roche Diagnostics Corporation. She has served as an Associate Professor for Purdue University School of Engineering and Technology where she developed the Quality Management Curriculum within the Mechanical Engineering Technology department. Sally is a graduate of Purdue University School of Engineering and has also achieved her MBA. Sally co-founded The P3 Acceleration Group, to provide strategic leadership for companies interested in translating research into commercially available products that meet FDA and global regulatory requirements. Decades of building strong relationships with supplier-partners coupled with swift execution, results in high value creation for clients. In addition, Sally has helped to pioneer the Companion Diagnostic process in collaboration with pharmaceutical and diagnostic firms while building strong relationships with the applicable regulatory agencies. Sally champions unique approaches to improving the regulatory process with FDA. She has been involved in a pilot program between FDA and New York State for 3rd party review of IVD submission to enable more efficient review times. Additionally, she is helping to define the single site IVD submission process which voluntarily submits laboratory developed tests to FDA for clearance or approval, facilitating reimbursement and commercialization opportunities. She is also a global leader in breakthrough device designation. Sally is an effective communicator and educator – developing and delivering training in all areas of regulatory, quality and process improvement, providing statistical guidance and analysis in all applicable areas of the quality system.
Overview
2026
2026
years of professional experience
Work History
Founder, Partner
The P3 Acceleration Group, Inc.
02.2009 - Current
- Company Overview: Co-founded The P3 Acceleration Group, to provide strategic leadership for companies interested in translating research into commercially available products that meet FDA and global regulatory requirements
- For start-up and emerging companies, provided strategic and operational leadership at the C-suite level
- Quality system development, regulatory remediation, liaison with regulatory agencies, and develop regulatory strategies
- Provide due diligence in area of regulatory and quality system for acquisition or contract assessment
- This includes the pursuit of FDA’s Breakthrough Device Designation, and the successful granting of that status on several occasions; four of which have been made public
- Regulatory expertise extends to single-site IVD’s and the creation of alternative revenue streams throughout the submission process
- For emergent responses to global adverse health events, provided regulatory insight to companies operating under FDA’s Emergency Use Authorization (EUA)
- Aided companies in bringing their diagnostics to market in an effort to identify and contain H1N1 in 2009, and COVID-19
- Co-founded and supported the formation of Kantaro Biosciences, a Sars-CoV-2 serology spin off company from Mount Sinai Health System
- Established and maintained strong relationships with customers, vendors and strategic partners, including Greenlight Guru
- Expert at ISO 13485, ISO 27001, CLIA/CAP, MDSAP, IVDR, and MDR
- Global regulatory expert in submissions in numerous countries
- Adept at building organizations, teams, and relationships to meet corporate objectives
- Managed P&L for both clients and the business
Vice President of Quality and Regulatory Compliance
Roche Diagnostics Corporation (Ventana Medical)
06.2004 - 10.2009
- Responsible for all corporate and global facilities, new product development quality engineers, manufacturing quality engineers, CAPA, Corrections and Removals, Adverse Incidents, Management Review, Audits, Document Services, Final QA release, pharma services, and competitive excellence
- Managed $3.5 million P&L to plan
- Monitored key business risks and established risk management procedures.
- Designed and staffed the quality organization to meet the strategic growth needs of the organization from 2 employees to 50++
- Developed a Competitive Excellence strategy, department and two-year deployment plan
- Led complete quality system redesign to ensure maximum organizational ownership, successful FDA and ISO audits, and efficiency to support achieving corporate key results which included significantly reduced development cycle time
- Executive Sponsor for life cycle management software implementation that incorporates all quality system documents, provides for paperless system with electronic signature capability
- Member of executive product approval committee that oversaw new product development programs
- Improved employee satisfaction from being the “worst” to the “best” in the organization globally
- Leader in Culture of Accountability transition with highest scores from employee survey
- Led quality system upgrade to ISO 13485 and CMDCAS
- Proactively developed relationship with Regional FDA office to ensure alignment and partnership with quality system redesign project
- Successfully passed multiple FDA audits and ISO audits with minimal findings
- Developed process metric strategy for key quality system processes
- Implemented new management responsibility and management review processes to maximize communication, alignment and resource utilization
- Reduced past due CAPA’s by 91%, increased percent complete by 60%
Associate Professor
Purdue University School of Engineering and Technology
- Instructed full-time in the area of industrial engineering technology for Purdue University School of Engineering and Technology
- Courses include: Engineering Economics, Applied Statistics, Industrial Organization and Management, Statistical Process Control, Design of Experiments, Metrology and Senior Design
- NSF grant co-principal investigator for new degree/curriculum development proposal
- Grant recipient to develop new curriculum to support Six Sigma Black Belt into Quality Certificate Program
- Reviewer of new technology textbooks for Prentice Hall Publishing Company
- Lead continuous improvement effort related to ABET certification within Mechanical Engineering Technology Department
- Lead new curriculum development and implemented new texts for IET 150, 104, 364/240, 454 and 474
- Office for Professional Development Grant Recipient for Summer 2002
- Participated in strategic planning process for the School of Engineering and Technology, and IUPUI Center for Young Children
- Research and creative activity at International Truck and Engine included Kaizen training, leading a Kaizen project team and the result was an $8.2million dollar savings to the company
- Presented Six Sigma presentation to the Advanced Manufacturing sub-committee of the Dean’s Industrial Advisory Committee (DIAC)
- Presented to the ASQ Quality Education committee on Six Sigma curriculum at the college level
- Taught Six Sigma Executive training at the EMCWA conference in fall 2003
- Consulted with local company to develop their quality system to ISO-9000 registration requirements
- Company did receive registration on their first audit by third party registrar
- Consulted with local environmental company to develop ISO-14001 quality system
- Partnered with St Francis Hospital Network on Six Sigma Black Belt projects, bringing students and medical community together to implement Six Sigma in a healthcare environment
- Judged international quality team competition with Rolls Royce
Education
BS - Engineering
Purdue University
MBA - undefined
Indiana Wesleyan
J.D. - Health Law
Loyola University of Chicago
Chicago, IL08-2026
Skills
- Revenue development
- Marketing
- Investor relations
- Strategic planning
- Goal setting
- Operations management
- Product definition
- Regulatory Affairs
- Quality Systems
- Partnership building
- Policies and procedures development
- Team leadership
Clients Include
- Eli Lilly
- HepQuant
- MercyBio
- StataDx
- RenalytixAI
- PreciseDx
- LungLife AI
- VericiDx
- KantaroBio
- CodettaBio
- Whispersom
- Mount Sinai Innovation Partners
- OnxCerna
- High Throughput Genomics
- Vela Diagnostics
- Corgenix
- Quanterix
- Innovative Health Solutions
- Vigilant Biosciences
- Ferrer inCode
- Baylor
- OPKO
- Exosome Dx
- Memorial Sloan Kettering Cancer Center
- Paige.ai
- EKF Life Sciences
- Mahuro
- BARD1
- Xylem
Company
The P3 Acceleration Group, Inc.
Personal Information
Title: Founder, Partner
Professional History
- The P3 Acceleration Group
- New Precedents, Inc.
- Bowden Consulting Group, Inc.
- Samco & Associates, Inc.
- Roche Diagnostics Corporation
- Ventana Medical Systems, Inc.
- Indiana University Purdue University at Indianapolis
- Hill-Rom
- Cummins Engine Company
Interests
Timeline
Founder, Partner
The P3 Acceleration Group, Inc.
02.2009 - Current
Vice President of Quality and Regulatory Compliance
Roche Diagnostics Corporation (Ventana Medical)
06.2004 - 10.2009
MBA - undefined
Indiana Wesleyan
Associate Professor
Purdue University School of Engineering and Technology
BS - Engineering
Purdue University
J.D. - Health Law
Loyola University of Chicago
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