Felicia Hobson
Chief Operating Officer, Managing Partner
Ms. Hobson is a medical device development expert with more than 20 years of experience in medical product development as a project manager, systems engineer and design engineer. As the chief operating officer and managing partner of CMD MedTech, she leads strategic direction and technical operations of the company, while working directly with clients to drive complex medical device development initiatives.
Ms. Hobson leads large, cross-functional teams across the full product lifecycle, from early concept through verification, regulatory submission, and post-market support. She brings a systems-level perspective to programs that require alignment across engineering, regulatory, quality, and real-world use. Her contributions on programs include systems engineering, project and task leadership, requirements and specifications development, safety and security risk management, systems integration, and verification and validation. Ms. Hobson holds a Regulatory Affairs Certification (RAC) and has a working knowledge of domestic and international regulatory requirements for medical devices.
Skills Summary
- Systems Engineering for Complex Medical Devices & Combination Products
- Cross Functional Team Leadership
- Project Management
- Security Risk Management (SW96, IEC 81001-5-1)
- Risk Management (ISO 14971)
- Requirements and Architecture Development
- Systems Integration
- Design Verification and Validation (V&V)
- Regulatory Compliance (FDA, EU)
Professional History
Position Summary: CMD MedTech develops products for the medical device and healthcare industries, with a focus on software. Ms. Hobson provides systems engineering, regulatory support, project management and product development leadership support to customers. Projects include:
Systems Engineering Leadership for Complex Device and Drug-Device Combination Products. CMD MedTech provides systems engineering leadership and support for complex electromechanical medical devices, including both a radiopharmaceutical delivery system and a colon insufflator device, including new product development and sustaining engineering efforts. Ms. Hobson serves as the lead systems engineer and technical expert, providing overall direction to the large multi-disciplinary team and overseeing safety and security risk management activities, requirements development, verification / validation, preparation of submission content and participation in meetings with both the FDA and BSI. Additionally, she supports post-market activities including ongoing cybersecurity management activities, product complaint investigations, PMCF activities, risk management and overall DHF maintenance.
Technical Leadership and Program Management Support for Imaging Bulk Package testing programs. CMD Medtech provides program management and technical consulting for several projects designed to generate the test evidence required to gain imaging bulk package indications for diagnostic drugs and their associated transfer sets and injectors. Ms. Hobson consults on the projects, contributing to testing strategies, FDA pre-submission meetings and third-party laboratory oversight for chemical compatibility (including extractables and leachables), in-use stability, biocompatibility, microbial ingress and cross-contamination studies.
Systems Engineering Team Augmentation for complex, electromechanical medical device. The project involves multiple companies working to develop electromechanical systems meant to eventually integrate into a single, complex medical device. CMD MedTech was engaged to embed and work with the teams to augment their systems engineering bandwidth and help provide this discipline to the teams. Ms. Hobson served as the verification lead for one of the companies, helping to define a verification strategy for their team. She also assisted with the development of interface requirements between two of the major subsystems for the device.
Technical Documentation Preparation for NDA. CMD MedTech supported a company with the preparation of technical summaries and documentation in support of their NDA submission for a radiopharmaceutical delivery system to the FDA. Ms. Hobson served as the lead on the program, coordinating the technical summaries being developed by CMD for the company and is the primary author of some of the technical documentation.
Technical Lead for Medical Device. CMD served as the project manager and technical lead for a Class I mechanical device meant to assist amputees to learn to walk again more quickly and with a more natural gait. CMD created a regulatory strategy for the device and its various potential implementation considerations. CMD led the mechanical prototype design effort, and requirements and architecture development.
Publications
Danhof, Scott; Hobson, Felicia; What’s Next In Inhalation Drug Delivery?. Med Device Online, January 17, 2017.
Gibson, Chad; Eubanks, Fritz; Hobson, Felicia; A Systems Approach to Medical-Device Compliance with IEC 60601-1:2005. INSIGHT (INCOSE), December 2012.
Bouton, Chad E. MS; Lombardi, Thomas MD; Hobson, Felicia R.; Stark, Gregory PhD, “Experimental Detection of Subcutaneous Contrast Extravasation Using Radio Frequency Permittivity Sensing,” Journal of Computer Assisted Tomography, November/December 2009.
Patents (Pending)
Bouton; Chad E., Ruggeri; Felicia R., Harpham; R. Reade, Held; Jeffrey R., System for Detecting Fluid Changes and Sensoring Devices Therefor. U.S. Patent 8,295,920, Oct 23, 2012.
Hack; Dennis P., Sciulli, Jr.; Francis J., Mutschler; Charles J., Harpham; R. Reade, Kramer; Daniel A., Ruggeri; Felicia R., Yates; Jan B., Atterbury; William G., Juratovac; Joseph A., Held; Jeffery R., Bouton; Chad E., Gleeson; James B., Application Systems for Use with Medical Devices. U.S. Patent 8,235,949, Aug 7, 2012.
Bouton; Chad E., Ruggeri; Felicia R., Electrical Arcing Protection Circuit. U.S. Patent 7,061,252, Jun 13, 2006.
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