Frank Cable, Pmp Email & Phone Number

Philadelphia

Guide Biomedical Solutions, LLC partners industry-leading consultants with med device and diagnostics OEMs to provide assured outcomes in FDA compliant, product realization and scale-up. The Guide Biomedical Solutions network provides support across all disciplines, with many of our 130+ consultants having supported USG agencies and initiatives, e.g., NIH RADx.

London, England, United Kingdom

European Bank for Reconstruction and Development (EBRD) Star Venture Programme: Mentor to Startups based in Africa, Middle East, Turkey and Eastern Europe

Minneapolis, Minnesota, United States

Leading commercialization of the world’s only active cold chain transport device, under 20kg, that can deliver vaccines and other mission-critical pharma products to patients worldwide, no matter how far from the healthcare infrastructure. The Thaddeus Marathon series of transport devices provide 100% first-pass delivery under the most extreme conditions. Additionally, full IoT capability provides 100% traceability, security, and delivery of products in a sustainable design that eliminates the cold chain packaging waste stream.

Bethesda, Maryland, United States

Project Management of multiple IVD tests and applicant companies for SARS-CoV-2, in support of the NIH RADx program, focusing on the rapid deployment and historically unprecedented scale-up of new technologies. Product realization, launch & scale-up support to over 20 firms, raising over $180 million in non-dilutive funding, providing over 1.3 million tests/ day of capacity for the U.S. market.

Danbury, Ct

PRODUCTS DEVELOPED: Capital, Reusable & Disposable medical devices for screening and Interventional Breast Radiology• Member of the R&D Leadership Team for Imaging, Ultrasound, Skeletal and Interventional Divisions• Head of R&D and Supplier Engineering for large- scale suppliers (Plexus)• R&D Technical Leader for the Brevera® Breast Biopsy System- Flagship Biopsy/Imaging system• R&D Technical Leader for teams developing next- generation Biopsy systems• Center of Excellence (CoE) Leader, responsible for global deployment of Lean/ DFSS training & processes• CAPA Team Leader for the Interventional Breast Solutions Division• Leadership of Continuous Improvement updates to the Hologic QMS utilizing Lean/DFSS best practices

Danbury, Connecticut

PRODUCTS DEVELOPED: Capital equipment & AI-based SaMD for Breast Radiology (X-Ray and Ultrasound) • Member of the R&D Leadership Team for Imaging, Ultrasound, Skeletal and Interventional Divisions• Program Management of the Hologic flagship/next- gen Breast Mammography system (Sales: $300M+)• Program Management of record 26- week launch for the flagship VieraTM Handheld Breast Ultrasound device• Program Management of AI software development project for next- gen breast imaging, cancer detection and workflow • Project Management of Business Development Core Team leading IP Landscape, Invention Disclosures and Patent Filings • Holistic Program Management, across Business Development, Marketing, R&D, QA, Clinical, RA, Enterprise and Operations for global offices of Hologic (USA, EMEAC, APAC, LATAM, ANZ) • Direct Management of Sr. PM staff, providing c-suite presentations, monthly updates to stakeholders and leadership of extended core teams of 80+ across multiple time zones and global offices

Trumball, Ct

PRODUCTS DEVELOPED: Disposable Surgical Instrumentation for the Ob/Gyn procedures• PM & R&D Technical Lead for first organically developed product: Advincula Delineator (Sales: $16M)• Leadership of external supplier development and record 7- month launch, utilizing Agile/Lean/DFSS best practices

Chicopee, Ma

PRODUCTS DEVELOPED: ECG electrodes for patient monitoring and Defibrillation ● R&D Sustaining Engineer for existing portfolio of patient monitoring ECG Electrodes (annual sales: $40M)● Systems Engineering support for a retrospective PMA submittal● Supplier R&D/ Quality Engineering for both US and Canadian manufacturing sites

Sterling, Ma

PRODUCTS DEVELOPED: Biologics substrate for growth of bioengineering living cell therapy ● PM/ Technical Lead for first sterile device supplied by SMC: the Organogenesis Apligraf® Living cellular skin substrate (FDA regulated Biologics device: annual sales: $2.5M)● PM for flagship accounts: Medtronic, Smith & Nephew, Haemonetics and Millipore portfolios (annual sales: $6M)● Technical Lead for Product Design, Tooling, Capital Equipment, Process Validation (IQ/OQ/PQ) and PPAP

East Longmeadow, Ma

PRODUCTS DEVELOPED: Microscopic, Wireless-Implantable Pulse Generator (IPG) system for cardiac rhythm management (CRM)● R&D/ Technical Lead for the EBR Systems WiCS® Wireless Cardiac Stimulator (Annual sales: $5M)● Developed proprietary, micro-assembly methods for the world's smallest, rice-sized, wireless pacing device, implanted inside the heart● IP generation of proprietary technologies and processes related to miniaturized pacemaker designs● Co-inventor of the first organically- developed Implantable Pulse Generator for Cirtec Medical● Supply chain development for ultra- high tolerance components and test methods● PM for numerous University and VC sponsored R&D projects (Concept through Market Release)

PRODUCTS DEVELOPED: Combination Drug-Delivery device for pre-operative skin preparation● Principle Researcher and co-inventor of the MerlinTM combination drug delivery device, containing a FDA-regulated, topical an-timicrobial for Preoperative Skin Preparation per 21 CFR 310.● PM/ Co-inventor of first organically developed product for this franchise (Sales: $6M)● Co-inventor of a frangible, EO sterilizable, drug-stable, plastic storage system for alcoholic- based drug products● PM for sourcing, innovation and validation of Drug Supplier and CRO-based clinical trials including:o IP and landscape review,o VOC and User needs development,o Antiseptic drug product: supplier sourcing, agreements, formulation development, validation and launch,o Clinical trials for drug safety and efficacy,o Design & Process Validation,o Design transfer and ramp-up of external supply● Inventor of a platform of combination drug- delivery devices, which resulted in significant improvements in patient safety within the OR (mitigation of surgical fire risk)

OPERATIONS ROLE: Head of Quality Assurance: High-volume, injection-molding, medical components CMO● Supervision of Quality Department staff, for this high-volume injection molding facility (Sales: $15M)● Support of Sales & NPI for major medical OEMs: Haemonetics, Smiths Medical, BD● QA representative for all customer product quality issues and QMS audits,● RA representative for any FDA issues or audits,● Authorship of the company’s QMS and registration per 9001:2000(E),● Maintenance of QMS, including authorship, training, deployment, audits and CI,● Ownership of all CAPAs and CI initiatives,● QA representative for Environmental Protection and Safety (EPS)

OPERATIONS ROLE: Head of Product Development: High-volume, injection-molding, medical components CMO● Engineering Account Manager and Technical Lead for major medical OEMs: Medtronic, Genzyme, Idexx• 24/7 Supervision of Manufacturing Engineers and Technicians• Process Development/ Tooling/ Manufacturing Technical Lead for two separate manufacturing facilities• Principal Process Development Engineer/ Author of DOEs and Process Validation Protocols & Reports (IQ/OQ/PQ)• Tooling Engineering & Automation Engineering for injection molding, ultrasonic welding, print and assembly

Bsme, Mechanical Engineering

2 Years Undergraduate, Biology

Education record