Design Engineering Resources

Project Management: We help structure development efforts by coordinating timelines, setting clear milestones, and keeping progress aligned with project goals. Support includes planning tools, documentation templates, and regular check-ins to keep things moving forward.

Design Guidance: We offer engineering feedback on early CAD models, material choices, and design considerations related to usability, manufacturability, and clinical fit. Input is tailored to match the stage of development and the needs of the end-user.

Product Development: We guide teams in translating clinical problems into engineering specifications and user needs. This includes helping define design inputs, outputs, and verification methods. We support development activities such as concept generation, space-claim development, 3D CAD and 2D documentation development based on Design for Manufacturing and Assembly (DFMA) principles, finite element analysis, early feasibility builds, basic risk assessment (e.g., FMEA), and iterative testing to evaluate core functions.

Prototype Development: We help teams develop minimum viable products (MVPs) and early-stage benchtop models to test core functions and gather user feedback. Support includes 3D printing, basic electronics prototyping (e.g., Arduino), and light coding for functional demos. We also assist with documentation and file prep for fabrication methods like laser cutting, even if offsite. The goal is to create simple, testable builds that drive meaningful design iteration and clarify next steps.

Experiment Design Setup: We support the design of benchtop studies, simulated use testing, or early preclinical work to generate useful data. This includes help with writing protocols, choosing test materials or anatomical models, identifying key performance indicators, and ensuring that results can meaningfully inform iteration, grant proposals, or investor pitches.

FDA Guidance: We assist with early regulatory planning by helping teams understand which FDA classification applies to their device, what submission pathway may be required (e.g., 510(k), De Novo), and how to begin documenting design controls. We also provide guidance on identifying predicate devices and understanding labeling, indications for use, and risk classification.

Patent Development: We support the development of invention disclosures by helping teams identify novel aspects of their technology, clarify the problem being solved, and articulate how their approach is different from existing solutions. This often includes sketches, diagrams, or technical descriptions that can accompany a submission to UVA’s Licensing & Ventures Group or external IP counsel.

Grant Development: We help identify appropriate funding opportunities, including Coulter, NIH, and SBIR/STTR programs. Support includes reviewing drafts, aligning technical goals with funding agency priorities, and helping frame commercialization plans. We can also assist with project timelines, biosketch formatting, and budgeting basics.

Skill Development Workshops Microcredentials: We offer targeted workshops focused on in-demand industry skills, each culminating in a microcredential that participants can showcase on their résumé or LinkedIn profile. Sessions are designed to be practical and compact, often running over a few hours, and are tailored for early-stage engineers and biomedical innovators.

Workshop or Guest Lecture Topics:

• DFMA (Design for Manufactoring and Assembly): A hands-on overview of how engineering decisions impact manufacturability, cost, and assembly efficiency. Lectures and activities introduce strategies for simplifying components, reducing parts, and planning for production-scale development.
• Solidworks: We provide instruction on using SolidWorks for medical device prototyping and part modeling, with an emphasis on design intent, manufacturability, and real-world constraints. Training supports students preparing for industry or research roles.
• Onshape: As a cloud-based CAD tool, Onshape is introduced for collaborative design projects and lightweight prototyping. We offer guidance on version control, team workflows, and how to use Onshape effectively in early-stage product development.
• GD&T (Geometric Dimensioning & Tolerancing): Focuses on the fundamentals of interpreting and applying GD&T in medical device design. It emphasizes how precise communication of dimensions and tolerances supports manufacturing, inspection, and regulatory expectations.
• FDA: We introduce students and early-career professionals to FDA terminology, regulatory classifications, and design controls. This content aims to demystify the regulatory pathway and encourage early awareness of compliance in design processes.
• Project Management: Our CAPM-based workshop covers the core principles of project management, including project initiation, planning, execution, monitoring, and closure. Participants will learn key concepts such as scope management, time management, cost control, and risk management, preparing them for successful project outcomes.

We provide guest teaching on various medical device development topics. These sessions can be delivered in classrooms, seminars, or boot camps and are focused on real-world application and career readiness. Lecture content can be customized to course objectives or training needs.

Structured and project-based advising for students and early-career researchers working on capstone, research, or independent device development efforts. Mentorship blends technical feedback with career-focused support and may occur through formal coursework or informal collaboration.

Project-based internships tailored to students interested in exploring medical device development. Roles may include prototyping, documentation, event coordination, or resource management, with responsibilities matched to the intern’s background and goals.