Kirk Honour has over 30 years of medical device technology and entrepreneurial business experience in electrophysiology, cardiovascular, peripheral vascular, urology and hospital capital equipment. He has been involved with bringing over a dozen medical devices from concept to market by providing strategic Regulatory Affairs leadership and tactical development execution for multiple medical device companies including, Ecolab Inc., St Jude Medical Inc., American Medical Systems Inc. and Collagen Corporation. Kirk served as COO of Castlewood Surgical from 2008 to 2011 and as Vice President of Regulatory Affairs, Quality Assurance and Clinical Affairs for MedicalCV from 2006 to 2008. In these roles, Kirk oversaw and managed preclinical and clinical study design, physician training, post-market sales and corporate development. Kirk has built and supported numerous U.S. and International regulatory submissions, new product development strategies and financial market assessments.

CORE COMPETENCIES 

• Manage comprehensive medical device U.S. and international market entry strategy and submissions
• Develop complete pre-marking submissions, submission and approval of PMAs, 510(k)s, and 513(g)s and their international equivalents
• Present pre-market clinical study proposals and pre-approval proposals, including primary and secondary endpoint indication and study design justifications to gain approval from the U.S. Food and Drug Administration (FDA) for IDEs
• Strategically develop, manage and execute clinical studies for medical devices from early feasibility through confirmatory/pivotal and post-market studies
• Develop benefit risk assessments and summary of safety and effectiveness statements for Class II and Class III U.S. regulatory submissions
• Oversee device design development plans, testing, design iteration and validation studies, manufacturing processes, IQ/OQ/PQ and lean sigma implementation
• Develop COGS, manufacturing forecast schedules and budgeting, including process cost analyses
• Manage protocol development of design of experiments evaluation strategies to assess critical design functions and applicable data (preclinical) required for validation
• Implement risk management processes for compliance with ISO 14971 (risk management), ISO 60601/80601 (medical electrical equipment), ISO 62366 (application of usability engineering to medical devices)
• Conduct corporate due diligence for device company acquisitions and business combinations

RECENT PROJECTS

• Developed U.S. regulatory strategy and phased product development plan: compiled and submitted Q-Sub and conducted FDA meeting regarding preclinical studies with an emphasis on first in human early feasibility safety study design to support an IDE for a Class III permanent implantable resorbable cardiothoracic device under development by a startup company

• Oversaw indication research, submission development and subsequent filing to the FDA Office of Combination Products (OCP) of pre-request for designation (pre-RFD) for two separate combination devices with different indications utilizing nanotechnology and drugs or biologics; successful outcome of a device designation for both designs under development by a principle investigator and two additional devices with novel indications which resulted in De Novo designations
• Developed a Gap Assessment of primary preclinical animal safety testing, compliance with ISO 10993 biocompatibility requirements and identification of all applicable standards for an injectable radioisotope used in the treatment of cancer under development by wholly owned subsidiary of a large multinational medical device company
• Developed U.S. regulatory strategy and phased product development plan: compiled and submitted Q-Sub and conducted FDA meeting regarding preclinical studies with an emphasis on primary safety study design to support an IDE for a Class III permanent implantable nitinol ophthalmic device under development by a startup company