Ann Miller Consulting

PROJECTS

Who I help

I partner with:

Medical device OEMs needing senior engineering support for new or overloaded programs
Contract manufacturers improving processes, validations, and customer support on complex assemblies
Startups that need experienced guidance on design controls, risk, and validation without hiring a full-time headcount
Engagements range from short, focused projects to ongoing support across multiple programs.

How I Can Help

1. DFM/DFX for Catheters & Disposables

Review of device concepts, drawings, and specifications for manufacturability
Input on material choices, assembly flows, and test strategies
Identification of risks early to avoid expensive changes later

2. Process & Test Method Validation

Planning and execution of process validation (IQ/OQ/PQ)
Test method validation (TMV) for new or revised test methods
Data analysis and clear reporting for regulatory and internal stakeholders

3. Risk Management & Design Controls

Support for DFMEA, PFMEA, and hazard analysis
Alignment of design inputs, outputs, verification, and risk controls
Updates to design control documentation and risk files under ISO 13485 / 14971

4. Transfer to Manufacturing & Line Readiness

Definition of assembly processes and CTQs
Support for pilot builds, line characterization, and documentation
Collaboration with operations, quality, and suppliers to ensure smooth handoff

London, UK

Completed Projects

Selected Project Experience

Supported transfer of multiple catheter-based and minimally invasive device programs from development to manufacturing, defining key assembly processes (e.g., crimping, reflow, bonding, welding), CTQs, and validation strategies.
Reduced nonconformances on an electrophysiology RF device line by leading structured root cause analysis and driving corrective actions across manufacturing and suppliers.
Developed and validated test methods (including balloon and tensile testing) to support new product introduction and ongoing design changes for disposable devices.Reviewed and updated aseptic processing procedures and design control documentation to align with evolving standards and regulatory expectations.

Continuing Professional Development

ASQ Certified Six Sigma Green Belt (CSSGB)
Ongoing training in risk management, statistics, and validation methodologies
Regular attendance at medical device and quality conferences/meetings
Independent reading and literature review on emerging technologies, MDR, and process best practices

How I Work With Clients

I focus on clear communication, realistic recommendations, and practical documentation that your team can actually use.

Typical engagement steps:

Initial Discussion – Understand your device, current challenges, and timelines.
Scope & Proposal – Define specific deliverables (e.g., validation plan, DFM review, FMEA support) and level of effort.
Execution – Work independently or alongside your team, with regular check-ins.
Handover – Provide clear documentation, findings, and recommendations for next steps.

I’m based in Louisville, Kentucky, and work with teams across the US and internationally.

About

Ann Miller Consulting LLC

I’m an independent medical device engineering consultant with over a decade of experience in R&D, process development, and quality for catheter-based and disposable devices.

My background includes work with OEMs and contract manufacturers on projects spanning catheter assemblies, RF/electrophysiology devices, and minimally invasive disposables. I’ve supported programs from early discovery through transfer to manufacturing, with a focus on DFM/DFX, process and test method validation, and risk management under ISO 13485 and ISO 14971.

I enjoy bridging the gap between design and manufacturing—helping teams make pragmatic decisions that balance clinical needs, regulatory requirements, and real-world production constraints.