MY SERVICES
I am ready to support you through every step of the medical product development process, leveraging scientific, clinical and commercial expertise to help you maximize value at each stage.
Development Strategy
Assist clients with a "Conecpt to Market" strategy based on the statutory requirements dictated by FDA and for CE Mark
Establish a Design History File (DHF) containing the records necessary to demonstrate that the design was developed in accordance with the approved design plan
Design & Engineering
Maximize client and user input to design for efficiency and cost effectiveness without sacrificing aesthetics
Engineering capabilities include: structural and thermal analysis, technology evaluation, fully parametric modeling, design for injection molding, packaging, and QC drawings to GD&T standards
Project Managment
Develop project timelines and resourse allocation for each development phase
Establish effective communication channels between management, engineering, manufacturing, marketing, and other functional areas
Develop breakdown structure work packages including newtwork diagrams, Gantt charts, and flow diagrams
Design of Experiments
Development of bench, animal and clinical testing protocols, justify sample size requirements, and interpretation of results
Identification and implementation of necessary general control standards and procedural regulations (ISO, ASTM, IEC, etc.)
Provide startegy and test requirements for biocompatibility, sterilization, aging, ship studies, etc.
Report Writing
Provide technical reports which include statstical analysis, diagrams, and references when necessary
Provide FDA and CE Mark friendly formatting for all technical reports to ensure expeditious review
Regulatory Affairs
Prepare or assist in the preparation of regulatory submissions for medical devices, including: 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs
Offer FDA and Notified Body advisory panel preparation and meeting support
Assist with responding to FDA deficiency letters and informal/formal communications
MY EXPERIENCE
I have 16 years of experience in R&D, Product Design, Regulatory & Clinical Affairs, and Manufacturing Operations. I started my career at a medical device startup where I held positions as both Senior Development Engineer and Project Leader simultaneously. This has allowed me to take a lead role in projects from immersion and concept generation through to detailed design, development, and commercialization. My background in biomedical engineering enables me to balance user requirements with technical and biological considerations whilst developing commercially viable products.
CONTACT ME
If you have questions or would like more information, please email me.