It is uncommon for someone to have experience with the full lifecycle of multiple medical devices and accessories from beginning to end. My background provides me with expertise across the entire process. I can assist with any part of bringing a medical device to market, or provide guidance through the full journey. My experience encompasses:
- Technology Research: I have researched emerging technologies and evaluated their applicability for new medical device development. This allows me to provide insights into technology trends and advise on technology selection.
- Product Development: I have led cross-functional teams through the product development cycle, from conceptualization to commercialization. This includes writing product requirements, designing products, verification and validation testing, and launching finished medical devices.
- Quality Systems: I have implemented quality systems, procedures and protocols to ensure compliance with regulatory standards such as ISO 13485 for medical devices. This includes establishing robust documentation, change control, risk management, and corrective and preventive action processes.
- Clinical Testing: I have developed clinical evaluation plans, setup and run testing sites, and conducted clinical studies to gather safety and efficacy data required for product improvements and regulatory submissions.
- Worldwide Regulatory Clearance: I have prepared regulatory submissions and obtained approvals to market Class I and Class II medical devices in over 100 countries worldwide. This includes FDA (USA), CE (Europe), PMDA (Japan), Roszdravnadzor (Russia), Anvisa (Brazil), CFDA (China), and many more.
- Manufacturing Setup: I have set up production lines, selected equipment, and developed processes to manufacture medical devices in the US and overseas. This includes managing relationships with internal sites and external suppliers.
- New Product Introduction: I have developed procedures to hand-off products from development to commercial manufacturing, ensuring a smooth transition to production.
- Supply Chain Setup: I have established supply chains to procure materials, components, and services for medical device manufacturing. This includes qualifying suppliers, negotiating contracts, and managing inventory.
- Distribution Setup: I have set up distribution networks and logistics to deliver medical device products to customers worldwide. This includes shipping, warehousing, and order fulfillment.
- Customer Support: I have created complaint and service call centers to provide technical support and repair services for medical device customers worldwide. This includes RMA and return processes.
- Operations Management: I have expertise managing medical device operations end-to-end to deliver products efficiently, on-budget, and on-time around the world. This allows me to optimize processes, reduce costs, and improve quality.
In summary, I can provide invaluable expertise and guidance across the full lifecycle of bringing medical devices from concept to post-sales support globally. My comprehensive experience enables me to help set up, execute, and manage any part of the medical device product realization process effectively.