Matt Havener Email & Phone Number

Norfolk, Virginia, United States

Norfolk, Virginia, United States

Acquired by Zimmer Biomet in February 2023.• Delivered four 510(k) clearances, 3 successful product launches, and over $3 Million in non-dilutive grant funding in 2 years.• Supported extensive due diligence as a member of the executive leadership team and achieved a successful $275 Million exit for Embody shareholders.• Developed, scaled, and optimized manufacturing equipment and procedures for 2 novel biomaterial production processes from benchtop to 2,500 sq. ft. of newly constructed Class 8 cleanroom space with $250M worth of production capacity.• Worked with commercial leaders and development surgeons to build brand strategies and develop collateral for marketing, sales rep training, and medical education• Responsible for Research and Product Development from concept through commercialization, with a focus on implants and instruments for soft tissue repair in Sports Medicine and Orthopedics.• Collaborated with surgeon consultants and advisors to develop the new product pipeline and collect feedback throughout the development cycle.• Managed a department of 12 engineers, scientists, and project managers.• Developed and maintained New Product Development systems and processes including a business-facing phase gate process, design controls, and risk management.• Collaborated with Quality and Regulatory leaders to build a scalable QMS, culminating in successful ISO audits and ISO 13485 certification.• Negotiated development and supply agreements with external vendors and Contract Manufacturing Organizations.• Worked closely with external IP attorneys to develop and manage the Embody IP portfolio.• Applied for and oversaw execution and reporting on research funding from multiple sources, including DARPA and AFWERX SBIR grants.

Norfolk, Virginia, United States

Exton, Pennsylvania, United States

• Worked with the commercial team, and cross-functional leaders to scope, evaluate, and prioritize internal and contract new product development opportunities.• Created new DSM Biomedical Project Management Processes to increase implementation and improve efficacy of project management across the organization.• Trained and mentored project managers throughout the organization.• Responsible for cross-functional program management for natural materials technology platforms.• Led an effort to improve the quality, reliability, and efficiency of internal and external manufacturing processes for DSM’s cell concentration technology platform.• Supported business development efforts by conducting due diligence for potential acquisition targets and evaluating venture opportunities through DSM Ventures.• Supported the commercial team as a technical resource for customer visits, sales calls, and contract negotiations.

Malvern, Pa

• Responsible for internal Orthobiologics new product development from feasibility to commercialization across multiple Stryker selling divisions.• Led a team of 5 full-time engineers, scientists, and project managers, along with multiple temporary employees.• Managed the department budget and worked closely with marketing, advanced operations and finance to develop and update detailed financial plans for new product development projects.• Maintained and ensured the effective implementation of design controls procedures and business facing new product development phase gate procedures.• Built and prioritized the Orthobiologics pipeline with input from surgeon consultants, marketing and sales from various divisions, and senior leadership.• Supported business development in technology scouting and due diligence efforts.• Gathered user needs by collecting voice of customer with surgeons, O.R. staff and sales representatives.• Oversaw all design verification and design validation activities including physical and chemical characterization, mechanical testing, preclinical studies and simulated use.• Collaborated with advanced operations and manufacturing engineering to develop robust and efficient commercial scale manufacturing processes.• Assisted in writing and reviewing domestic and international regulatory submissions, including 510(k) notifications, Investigational Device Exemption (IDE) Applications, Premarket Approval Applications (PMA), Requests for Designation (RFD), Technical Files, and Design Dossiers.• Served as the Intellectual Property Liaison for the Orthobiologics R&D team.• Supported sales and marketing by authoring white papers, creating sales collateral, leading sales rep training and surgeon education at training courses, conferences, dinners, and/or field visits.

Malvern, Pa

Malvern, Pa

Malvern, Pa

Malvern, Pa

Malvern, Pa

Bachelor Of Science (B.S.), Biomedical Engineering

Activities and Societies: Alpha Chi Rho

Master Of Science (M.S.), Biotechnology Enterprise And Entrepeneurship

Education record