Mary Wentorf

Mary Wentorf is the Owner of Springboard Medical Device Consulting, LLC. Mary brings boundless energy and over 25 years of global experience developing medical devices. With a B.S. in Mechanical Engineering from the University of Minnesota, Mary has held various leadership roles in new product development, marketing, regulatory, quality, operations, clinical application engineering, and business development.

Mary is honored to have lead the development of many medical implants, instruments, sterilization cases, sterile packaging configurations, and medical device software, holding over 40 US patents. She is an expert in the development of total joints (hips, knees, shoulders, fingers) with a specialization in revision; trauma and deformity correction implants and instruments; pacemaker/defibrillator leads with a specialization in heart failure therapies, catheters, and guidewires; as well as single use and reusable surgical instruments, sterilization cases, and sterile packaging development and manufacturing. Mary also has experience in neurological drug delivery, stereotactic guidance systems, small bore connectors, syringes and infusion devices, organ perfusion systems, digital health devices, and cochlear implant accessories.

In her last in-house role, Mary served as Chief Technology Officer at a start-up specializing in orthopedic medical devices for children where she was responsible for building product development, quality, and regulatory departments as well as responsibilities for surgeon compliance/relationship management and business development. Having worked at companies of all sizes, Mary is passionate about helping clients solve problems, navigate design controls, apply risk management principles, coordinate across business functions, secure regulatory approvals/clearances, and bring products to market quickly with high quality standards.

Mary has recently joined Lifejoint Orthopedic Solutions, Inc as a fractional Chief Technology Officer, facilitating the development of a total finger joint replacement system.

Common requests from clients include training, templates, and consulting in the following areas:

Product Development & Design Controls:
o All aspects of design controls and risk management, especially the start-up mindset – how much to do, when, & how. Facilitates development of requirements based off of unmet needs & user needs (Minimum Viable Product definition), & preliminary risk management assessment to highlight project, budget, and technical risks.
o Quality Management System establishment and optimization; assistance with eQMS selection and configuration.
o Independent reviewer for Design Reviews, Technical Reviews. Design assessment and strategic recommendations, in particular, recommending detailed test plans optimized for regulatory submissions.
o Human factors / usability engineering strategy and deliverables.
o Sterile packaging and reusable instrument case strategy, lessons learned, and technical assessment.

Regulatory Affairs & Regulatory Compliance:
o Regulatory strategy, pre-submission facilitation, and regulatory submissions (mainly US FDA, strategy for ROW).
o Establishment and optimization of Post Market Surveillance programs, both proactive and reactive.
o Medical Device Reporting, Establishment Registration, Unique Device Identification, and GUDID maintenance
o Small Business Designation, navigating pediatric submissions and leveraging FDA support programs
o Audit preparation and response, compliance to US FDA regulations and ISO 13485, ISO 14971, including Microbiology audits for sterile packaged product.

CMO / CRO Liaison:
o Advisor for distribution agreements, private label agreements, as well as supply quality agreements. A frequent request from clients is my Purchase For Resale ownership matrix; establishing clear roles and responsibilities.
o Design Transfer expert; liaison for assessing Contract Manufacturing Organizations (CMOs) and navigating translation of US FDA requirements within OUS CMOs. Experience in operations, process validation, process monitoring and statistical process control, and manufacturing auditing.
o Strong ties to multiple Contract Research Organizations (CROs) & engineering colleges; support for pre-clinical bench testing, animal testing, & human clinical trials.
o Consulting for strategies and logistics for pre-clinical testing plans/methods and Test Method Validation.

Business Development Mentoring:
o Connection and collaboration with others in the consulting and medtech incubator communities.
o Assistance with business agreements, surgeon consulting/compliance programs, due diligence, organizational structure, QMS/eQMS set-up.
o Assistance with budget and schedule proposals for engineering, testing, and regulatory resources for all phases of investment and growth. Fractional CTO support.