Xavier is a former startup founder, inventor, VP, and chief scientific officer with over 30 years of experience in biomedical device development.
Intellectual Property: Xavier holds over 25 patents in devices and methods. See: Hugo X Gonzalez - Google Patents.
Scientific Publications: Xavier has authored (or co-authored) over 50 abstracts and 13 scientific publications. See: H Xavier Gonzalez - Google Scholar.
Professional Organizations: Xavier is a former member of the following professional organizations: American Thoracic Society, European Respiratory Society, American Association of Bronchoscopy & Interventional Pulmonology, and Heart Rhythm Society.
Volunteer Organizations: Xavier is currently a mentor for Washington Innovation Network (Life Science Washington Institute).
Medical Device Development
Ideation
Discovery and intellectual property
Feasibility, initial market research, and business planning
Pre-development: Initial engineering design and prototyping
Development: Engineering development phases, bench testing, pre-clinical, and pilot clinical work
Manufacturing and Clinical development
Product approval
Commercialization
Regulatory Classification
Development of the following classes of medical devices per FDA classification:
Class I: Low-risk, do not require a 510(k) clearance
Class II: Moderate-risk, require a 15(k) clearance
Class III: High-risk devices, requiring a Pre-Market Approval (PMA) for clearance
Compliance Requirements
FDA and regulatory guidelines
Device history file
Good Laboratory practices (GLP)
Good Clinical Practices (GCP)
User needs, ergonomics, and human factors
Design failure mode and effect analysis (DFMEA)
Quality systems corrective and prevention action CAPA
Types of Medical Devices
Wearable: Monitoring and diagnostics
Implantable: Temporary and permanent
Energy: Ablation
Catheters
Sampling device tools
Surgical tools
Diagnostic devices
Procedural Approaches
Surgical (open and laparoscopic)
Interventional
Robotic
Endoscopy
Clinical Areas
Cardiovascular
Cardiothoracic (including surgery)
Pulmonary and respiratory
Gastrointestinal
Clinical Affairs
Scientific Advisory Boards
Clinical Consultants
Clinical protocols and implementation
Clinical sites and training
Adverse Events Committee
Clinical Monitoring Committee
Clinical Research Organizations