Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Dr. Sheehy is an award winning entrepreneur and healthcare innovator with >15 years of technical entrepreneurial expertise in the optical & ophthalmic engineering realm, numerous scientific publications / invited presentations and lectures, and direct clinical research experience with neurodegenerative patient populations at top research institutions, like UC Berkeley and UCSF. She is the Founder/CEO of C. Light Technologies, Inc. - an AI-driven health tech startup with the big vision to create digital technologies and solutions to tackle eye and brain health. Dr. Sheehy successfully acted as the Principal Investigator for three NIH SBIR/STTR grants - a Phase I grant entitled, “Retinal eye-tracking as a diagnostic tool for traumatic brain injury and concussion,” which came with recent follow-on Phase II funding for $2.25M, and a Phase I STTR grant investigating fixational eye motion as a prognostic and monitoring tool for multiple sclerosis. She has successfully brought in >$7.5M from venture capital, angel, and grant funding to her organization to date. As of May 2023, her team has introduced a groundbreaking, new technology, the Retitrack (originally Dr. Sheehy's PhD dissertation work from UC Berkeley) into the clinic as an FDA-cleared device.

I thrive at the intersection of engineering, biology, and design while leading the development of innovative, commercially successful medical diagnostic devices. I strive to use my abilities and 24+ years of professional experience to do the most good for the most people and am drawn toward opportunities that stretch and encourage growth. Learn more at https://www.devonccampbell.com

Highlights:
• Ambitious, energizing, experienced product development executive with long history of developing award-winning medical diagnostic devices and pharmaceutical companion diagnostics backed by a demonstrable track record of repeatedly delivering commercially successful RUO and FDA approved in vitro diagnostic products
• Unique, 360° multidimensional experience with balanced background including a successful IPO, start-up and mature organizations, medical device and pharma development environments, development and manufacturing situations, and both sides of M&A deals

• Capable of building a robust culture which motivates internal and external teams using a clear vision, straightforward communication, projecting an enthusiastic yet authentic presence, and adopting state-of-the-art organization tools
• Widely recognized holistic, unifying leader adept at providing direction, support, coaching, and guidance to development teams by setting goals and creating an environment of cooperation and trust between internal and external teams (including development partners or manufacturers overseas)

Customer-success-obsessed, hands-on leader with over a decade of experience in services sales management driving revenue growth while reducing operational costs. Excels at establishing strong client and partner relationships, developing new business opportunities, mentoring high-performance teams, and leading organizational change. Strategic thinker who thrives on opportunities to deliver customer satisfaction, standardize operational processes, create innovative sales and service plans, and exceed established goals by leveraging broad business development and go-to-market strategies. Core competencies include:
• Software & Services Sales
• Sales Management
• SaaS Conversions
• Customer Experience 
• Customer Success
• Life Sciences & Fintech Professional
• P&L Management 
• Partner Management
• Team Building

Joanne Lebrun is the Vice President of Quality Systems at MDC Associates. Joanne has over 22 years of experience designing and implementing quality systems, managing clinical trials, and leading regulatory submission projects that win market access for medical device companies worldwide. She holds a Master of Business Administration degree (MBA) from Carnegie Mellon University and a degree in Industrial Management and Music Performance, followed by a master’s degree in Music from Rice University. In addition to strategy and project management, Joanne also attends and leads audits on behalf of clients for Local and FDA Center inspectors and notified bodies for ISO/MDSAP/IVDR/MDR certifications.

Specialties:
- 28 years experience in Medical Device field.
- Complex AIMD System Engineering
- Domestic and International Standards: 13485, 14971, 60601-X, 10974, 62304, FDA CFRs
- International Project Team Management
- Over 10 years served as Management Representative and General Manager of Quality

General:
- Electrical Engineering: Electrical Hardware Design / Component & Circuit Identification / PCB Layout & Design / Vendor Identification / ISO13485 Vendor Audit & Approvals
- Project Management: Intradivisional Team Management / International Team Management / Class I to Class III Projects
- Process Development IQ/OQ/PQ
- Site Operations Management: Personnel Management / Forecast / Budget / Spend Management / Lean Manufacturing Structure / Resource Allocation / Shift Structure / OSHA Compliance

Goal: To manage a forward thinking, technologically advanced company and/or R&D group, whose goal is to create and market safe and effective medical devices for those in the greatest need for improvement of their quality of life.

𝗚𝗿𝗲𝗮𝘁 𝘄𝗼𝗿𝗸 𝘁𝗲𝗮𝗺𝘀 𝗮𝗿𝗲 𝗹𝗶𝗸𝗲 𝗴𝗿𝗲𝗮𝘁 𝘀𝗽𝗼𝗿𝘁𝘀 𝘁𝗲𝗮𝗺𝘀. We work hard together every day, develop chemistry, play the game correctly with integrity, have high aspirations, make contributions on and off the field, and consistently achieve our goals.

I'm an operations executive specializing in operations management, quality management systems, and process improvement. My leadership experience spans Test, Inspection, and Certification (TIC), manufacturing, and education. Functionally, I'm focused on Quality and Operations. I've built an organization from 1 employee to 500—and have also led from the middle.

𝗦𝘁𝗿𝗲𝗻𝗴𝘁𝗵𝘀: Strategic Planning | Operations Management | Coaching and Mentoring | Quality Management Systems | Product Improvement | Process Improvement | Portfolio Development | Sales Human Resource | HR Development | High Performing Teams | Change | Turnaround | Customer Service | Systems Thinking | Organizational Learning | Project Management | Continuous Improvement | Lean | Six Sigma | Malcolm Baldrige | ISO 9001