Daniel Lanois Email & Phone Number

Dallas, Texas, United States

- Independent product development, project management, and regulatory consulting services for medical device manufacturers. - Develop class I and class II products from concept-to-market in the sports medicine, spine, and extremity markets with activities including project management, design engineering, mechanical testing, product labeling, material/manufacturing sourcing and logistics, quality management, packaging design, patent and trademark guidance, verification/validation, FDA regulatory submission (creation, filing, and communications). - Design and launch of 15 class II medical devices, numerous class I devices, while achieving approval of 12 novel patents with additional patents 5 pending.- Manage FDA inspections remotely and on-site, generating new and revised documentation, submitting gap improvement responses, and modifying existing procedures as applicable for regulation compliance.- Provide services to facilitate startup medical device business entities.- Administer clinical product support and training. - Produce, implement, and provide training for Quality Management Systems. - Establish third party supplier relationships.- Extensive travel to customer meetings.- Four start-up companies (served as President and CEO, Director of R&D, Quality Manager).

Charlotte, North Carolina, United States

Frisco, Texas, United States

Marietta, Georgia, United States

- Managed investor relations through quarterly updates, capital raises, and board meetings.- Customer management through client meetings, trade shows, and sales calls.- Provided representation and support for new surgeon initial cases.- Directed sales, manufacturing, engineering, accounting, and quality departments to maintain a cohesive business direction.- Managed sales forecasting to meet revenue goals.- Planned budget allocation.- Created a surgeon advisory board to vet product inventions, product improvements, patient safety initiatives, surgical technique/instrument improvements and other clinical related efforts.

Marietta, Georgia, United States

- Worked with key opinion leaders to design five initial product lines.- Gained FDA clearance on initial five product lines in 53 weeks.- Established third party supplier relationships. - Set up initial Quality Management System in compliance with 21 CFR Part 820.- Recruited personnel for key positions in startup business.- Planned and conducted cadaver labs with new customers.- Collaborated with CFO on managing Misys ERP and QuickBooks integration for streamlined business operations.

Marietta, Ga

- Performed classroom, cadaver lab, and clinical product education and support.- Planned production activities across manufacturing, engineering, and purchasing departments.- Provided product expertise for clinical field representatives and surgeons during first and subsequent surgeries.- Collaborated with surgeons to develop custom instruments to ease and expedite surgical procedures and increase patient safety.- Prepared annual product forecasts for evaluating requirements to meet projected demand growth.- Maintained the Product Release Goals report to track supply and demand levels by product family to meet company revenue targets.

Marietta, Georgia, United States

- Scheduled manufacturing activities to achieve optimal utilization of the company’s resources. Increased average equipment utilization from 45% to 88%.- Developed and executed plans to manufacture and deliver new and broadening product launches. - Created assembly methods and work instructions. - Collaborated with quality assurance to verify consistent, safe, and accurate device manufacture.- Built a database of machine setup instructions for all products manufactured in-house.- Restructured the tooling inventory management system to allow for optimal manufacturing throughput.- Reported capital utilization metrics to the executive management team for consideration during expansion activities.- Led multiple product launch programs including a Pedicle screw system, Cervical plate system, and Lateral lumbar interbody system.- Led capital resource planning programs including annual forecasting of equipment purchase requirements with proposals of a $3.5 million equipment purchase in 2012, a $2.5 million equipment purchase for 2013, and the necessary product supply levels for both years by monthly volumes.- Reduced the monthly backorder volume by 90%.

Marietta, Georgia, United States

- Applied quality assurance principles to manage product variation in the design and production of spinal medical devices. - Collaborated with design and applications engineers to analyze, prevent, and correct product variation. - Performed in-process, secondary and final product inspections. - Coordinated finishing processes and purchasing specifications with 3rd party vendors. - Performed vendor qualification audits and approvals. - Organized and performed assembly process, assembly inspections, and final assembly approvals. - Reviewed and released engineering drawings for manufacture.- Developed the company’s first manufacturing production schedule, leading to accurate supply and demand objectives.

Bachelor Of Science (Bs), Industrial Engineering

Industrial Engineering

Activities and Societies: Sigma Alpha Epsilon Fraternity