Align hardware, software & assay workstreams
Align engineering, assay development, and software on an integrated milestone plan, exposing dependencies before verification.
Industries · Diagnostics & medical devices
Diagnostic & medical device products
Diagnostic instruments, medical devices, test kits, reagents, consumables, and integrated hardware and software systems developed for U.S. and international markets.
Context
Program management for regulated product development
Diagnostics and medical device organizations must coordinate hardware, software, assays, and applicable quality and regulatory requirements. I help teams strengthen execution and coordinate development activities across FDA-regulated products, ISO 13485 quality systems, and international frameworks such as the EU IVDR/MDR, where applicable.
My approach combines structured program management with practices tailored to each organization’s maturity, development stage, and applicable requirements.
Support
How I support product development
De-risk verification & validation readiness
Integrate verification and validation (V&V) planning and design-control evidence early to support submission readiness.
Prepare for manufacturing scale-up
Coordinate manufacturing transfer and readiness activities to support scale-up and reduce late-stage design and quality issues.
Categories
Product categories I support
Diagnostic & analytical instruments
Benchtop and point-of-care instrument platforms built for regulated clinical or professional use.
Medical devices & diagnostic test kits
Medical devices and in vitro diagnostic test kits progressing through design controls, verification, and validation.
Reagents & consumables
Companion reagents and consumables coordinated with the instrument’s development, manufacturing, and applicable quality processes.
Integrated hardware & software systems
Platforms requiring coordinated development and evaluation of instrument, software, and assay performance.
Deliverables
Typical deliverables
Integrated development plan
Align hardware, software, and assay workstreams in one integrated schedule, making dependencies visible and establishing a credible delivery path.
Verification & validation readiness
Plan verification and validation evidence and traceability early to support development reviews and submission readiness.
Regulatory submission planning support
Coordinate development milestones with applicable 510(k), PMA, and international technical-documentation timelines.
Risk & assumption register
Document technical, supply, and schedule risks, with assigned owners and mitigation actions.
Roles, responsibilities & decision rights
Define responsibilities, decision authority, and escalation paths across engineering, quality, regulatory, and manufacturing.
Manufacturing readiness & scale-up plan
Establish manufacturing transfer activities, readiness criteria, and milestones to support a controlled scale-up.
Challenges
Challenges I help solve
Hardware, software & assay integration gaps
Hardware, software, and assay workstreams reach integration milestones without a shared view of technical readiness and dependencies.
Unpredictable development cycles
Milestones slip when schedule risks and cross-functional dependencies are identified too late.
Scaling manufacturing while maintaining compliance
Manufacturing scale-up can outpace the processes and controls needed to maintain consistent product quality.
Unclear decision-making & governance
Unclear decision rights delay resolution when engineering, quality, and regulatory priorities conflict.
The goal is an integrated development and manufacturing-readiness plan that aligns technical milestones, applicable regulatory activities, and business delivery commitments.
Next step
Let’s discuss your needs
Have a program management challenge, a critical initiative, or an opportunity to improve execution? Get in touch to explore how I can help.