Consulting Services
Expert solutions for injection molding & medical device manufacturing
From thermoplastics and LSR injection molding process development and quality systems to facility build design and supplier development — 25+ years of hands-on experience.
Manufacturing & Engineering
Our consulting services
Deep, hands-on expertise across the full injection molding and medical device manufacturing lifecycle.
Manufacturing Engineering & Operations
Build world-class manufacturing capabilities
We help companies build and optimize their manufacturing engineering organizations — from talent and process to sustainable, repeatable improvement.
What we deliver
- Manufacturing engineering team development and organizational design
- Process optimization and continuous improvement programs
- Lean manufacturing and Six Sigma implementation
- Equipment selection, qualification, and optimization
- Manufacturing cost reduction strategies
- Production capacity planning and scaling
Typical outcomes
Quality & Regulatory Compliance
Navigate regulatory requirements with confidence
With director-level quality experience, we build robust quality systems that satisfy FDA, ISO, and global requirements while staying practical to operate.
What we deliver
- ISO 13485 Quality Management System implementation
- FDA 21 CFR Part 820 / QMSR compliance programs
- EU MDR (2017/745) transition and compliance
- MDSAP certification preparation
- 510(k) submission support and strategy
- Design controls and risk management (ISO 14971)
- CAPA system optimization
- Audit preparation (FDA, Notified Bodies, customers)
Typical outcomes
Injection Molding Excellence (Plastics & LSR)
Thermoplastics & LSR molding for medical devices
As recognized molding subject-matter experts, we bring deep expertise in scientific molding, process development, validation, and troubleshooting for both thermoplastics and Liquid Silicone Rubber (LSR) medical device components.
What we deliver
- Scientific molding methodology implementation
- Process development and optimization
- Design of Experiments (DOE) studies
- Process validation (IQ/OQ/PQ)
- Mold qualification and capability studies
- Process troubleshooting and root cause analysis
- Automation and robotics integration
- Material selection and qualification
Typical outcomes
Equipment & Mold Maintenance
Maximize equipment uptime and performance
Effective maintenance is critical to manufacturing success. We implement preventive and predictive programs that maximize availability and extend asset life.
What we deliver
- Preventive maintenance program development
- Mold maintenance standards and procedures
- CMMS selection and implementation
- Spare parts inventory optimization
- Equipment lifecycle management
- Maintenance team training and development
- Total Productive Maintenance (TPM) implementation
- Equipment reliability analysis
Typical outcomes
Facility Design & Infrastructure
Design facilities built for manufacturing excellence
We've built facilities from the ground up — from greenfield site selection to cleanroom design — that support quality, efficiency, and compliance.
What we deliver
- Greenfield and brownfield facility planning
- Cleanroom design and classification (ISO 7/8)
- Production floor layout optimization
- Utility systems design (compressed air, cooling, electrical)
- Material flow and logistics optimization
- Environmental monitoring systems
- EHS (Environmental Health & Safety) compliance
- Facility expansion and renovation planning
Typical outcomes
Supplier Development & Supply Chain
Build a resilient global supply network
With experience developing suppliers across six continents, we help build robust supply chains — from qualification to ongoing development.
What we deliver
- Global supplier strategy development
- Supplier qualification and approval programs
- Supplier quality management systems
- Supplier audits and assessments
- Supply chain risk management
- Dual-sourcing and localization strategies
- Supplier performance management (scorecards, reviews)
- Contract manufacturing management
Typical outcomes
Strategic Advisory & Expert Services
Expert guidance for critical decisions
We provide strategic advisory for complex situations requiring deep expertise — from technology transfer to M&A due diligence.
What we deliver
- Technology transfer planning and execution
- Due diligence for mergers and acquisitions
- Expert witness services for litigation
- Custom training program development
- Manufacturing strategy consulting
- Make vs. buy analysis
- Competitive benchmarking
- Organizational capability assessments
Typical outcomes
Smart Manufacturing & Applied AI
Data-driven optimization for molding floors
We integrate IIoT connectivity, predictive maintenance, and explainable AI/ML models on the molding floor to optimize cycle times, scrap, and quality validation.
What we deliver
- AI-augmented process development & ML-driven optimization
- Validated AI/ML control & inspection systems (ISO 13485/FDA)
- Automated / vision-based defect detection & predictive quality
- IIoT architecture, predictive maintenance, and data foundations
- LLM-based knowledge management and operator assistants
Typical outcomes
Why SIDEC
Why work with us
Cross-Functional Expertise
Experience spanning manufacturing, quality, design assurance, and R&D — we understand your challenge from every angle.
Hands-On Approach
We don't just advise — we work alongside your team, building internal capability that lasts.
Regulatory Confidence
Director-level quality experience means we know what auditors look for and how to satisfy them.
Practical Solutions
No ivory-tower recommendations — every solution is grounded in 25+ years of real manufacturing.
Our Approach
A proven process for success
A structured methodology that delivers measurable, sustainable results.
Discovery & Assessment
A comprehensive assessment of your current state, challenges, and objectives — stakeholder interviews, process reviews, and gap analysis.
Solution Design
Tailored strategies and detailed action plans aligned with your business goals and regulatory requirements.
Implementation
We execute with hands-on support, working alongside your team while building internal capability.
Validation & Handoff
We verify results, document outcomes, and ensure your team can sustain success independently.
How We Work
Flexible engagement models
Project-Based
Defined-scope engagements with clear deliverables and timelines
Retainer
Ongoing access to expertise for continuous support and guidance
Training
Custom training programs to build your team's capability
Sectors We Serve
Medical device as the premium tier — and beyond
Full quality and regulatory rigor for regulated medical device manufacturing, and the same engineering methods for other precision molders.
Medical Device
Full quality and regulatory depth under ISO 13485, FDA, and EU MDR across all device risk classes and combination products.
Within the medical tier — all device classes
Including combination products, in-vitro diagnostics, drug-delivery devices, and sterile packaging components.
Automotive
High-volume process optimization, scrap and cycle-time reduction, and predictive maintenance.
Packaging
Throughput, energy, and quality optimization at scale across high-cavitation tooling.
Electronics & Connectors
Precision-part defect prediction and automated vision inspection for tight tolerances.
Get Started
Ready to get started?
Every engagement begins with understanding your unique challenges and goals. Let's schedule a discovery call to explore how we can help.