Services
1. Phase 0 Product Planning
Reduce development risk before the first gram is mixed.
Phase 0 Planning helps answer:
● What should the product do? ● Which competitors already exist? ● Which raw materials are suitable? ● What testing will be required? ● What are the regulatory implications? ● What timeline and budget should be expected?
Helping companies avoid expensive surprises and accelerate innovation.
2. FRACTIONAL R&D LEADERSHIP
Senior technical leadership without the cost of a full-time executive.
Gain access to 35+ years of international experience in product development, manufacturing, quality systems, and regulatory affairs.
Support may include:
● Project leadership ● Technology scouting ● Product portfolio Strategy ● Team mentoring ● Cross-functional coordination
Accelerating innovation while reducing development risk.
3. Technical Troubleshooting
Solving difficult material, manufacturing, and performance challenges.
Helping manufacturers identify root causes and implement practical solutions for:
● Product instability ● Color changes ● Mechanical failures ● Process variability ● Polymer and composite issues ● Material compatibility
Experience includes:
● PMMA ● Composites ● Silicones ● 3D-printing materials ● Dental and medical polymers
Reducing costly trial-and-error and accelerating problem resolution.
4. Manufacturing Scale-Up Support
Bridging the gap between development and production.
Many products perform well in the laboratory but encounter problems during scale-up.
I help companies improve:
● Process consistency ● Manufacturing robustness ● Supplier alignment ● Technology transfer ● Documentation and traceability
Reducing:
● Complaint rates ● Production variability ● Delays and rework
Helping manufacturers improve reliability, productivity, and time to market.
5. FDA & MDR Compliance Support
Practical support for regulatory and quality challenges.
Services include:
● FDA readiness ● EU MDR support ● ISO 13485 alignment ● Technical documentation ● Risk management ● CER support ● Regulatory troubleshooting
Helping manufacturers avoid:
✔ Delayed submissions ✔ Audit findings ✔ Documentation gaps ✔ Costly remediation projects
6. Rapid Product & Compliance Diagnostic
Identify hidden technical and regulatory risks before they become costly business problems.
Many product failures, complaints, and launch delays originate from hidden disconnects between development, manufacturing, documentation, and regulatory expectations.
Our Rapid Product & Compliance Diagnostic helps manufacturers quickly identify these risks and prioritize practical next steps.
Ideal for:
● Product inconsistencies ● Complaint escalation ● Regulatory concerns ● Scale-up problems ● Technical documentation gaps