Manufacturing & Operations
Build and optimize world-class manufacturing capabilities
Manufacturing Engineering & Operations
Build World-Class Manufacturing Capabilities
We help medical device companies build and optimize their manufacturing engineering organizations. From talent development to process optimization, we deliver sustainable improvements that drive quality and efficiency.
Expected Outcomes
Key Offerings
What we deliver in this service area
- 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
Equipment & Mold Maintenance
Maximize Equipment Uptime and Performance
Effective maintenance programs are critical to manufacturing success. We help companies implement preventive and predictive maintenance strategies that maximize equipment availability and extend asset life.
Expected Outcomes
Key Offerings
What we deliver in this service area
- Preventive maintenance program development
- Mold maintenance standards and procedures
- CMMS (Computerized Maintenance Management System) selection and implementation
- Spare parts inventory optimization
- Equipment lifecycle management
- Maintenance team training and development
- TPM (Total Productive Maintenance) implementation
- Equipment reliability analysis
Quality & Compliance
Navigate regulatory requirements with confidence
Quality & Regulatory Compliance
Navigate Regulatory Requirements with Confidence
With director-level quality management experience, we help companies build robust quality systems that satisfy FDA, ISO, and global regulatory requirements while remaining practical and efficient to operate.
Expected Outcomes
Key Offerings
What we deliver in this service area
- ISO 13485 Quality Management System implementation
- FDA 21 CFR Part 820 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)
Process & Technical Excellence
Master the science of manufacturing processes
Injection Molding Process Excellence
Master the Science of Injection Molding
As recognized internal molding subject matter experts, we bring deep technical expertise in scientific molding methodology, process development, and troubleshooting. We help companies achieve consistent, validated processes that deliver quality parts.
Expected Outcomes
Key Offerings
What we deliver in this service area
- 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
Facility Design & Infrastructure
Design Facilities Built for Manufacturing Excellence
We've built facilities from the ground up. From greenfield site selection to cleanroom design, we help companies create manufacturing environments that support quality, efficiency, and regulatory compliance.
Expected Outcomes
Key Offerings
What we deliver in this service area
- 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
Strategy & Supply Chain
Build resilient operations and strategic advantage
Supplier Development & Global Supply Chain
Build a Resilient Global Supply Network
With experience developing suppliers across six continents, we help companies build robust supply chains. From supplier qualification to ongoing development, we ensure your supply base meets quality and delivery requirements.
Expected Outcomes
Key Offerings
What we deliver in this service area
- 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
Strategic Advisory & Expert Services
Expert Guidance for Critical Decisions
We provide strategic advisory services for complex situations requiring deep expertise. From technology transfer to M&A due diligence, we help companies navigate critical decisions with confidence.
Expected Outcomes
Key Offerings
What we deliver in this service area
- 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
Why Work With Us?
What sets SIDEC Consulting apart from other consultants
Cross-Functional Expertise
Experience spanning manufacturing, quality, design assurance, and R&D means we understand your challenges from every angle.
Hands-On Approach
We don't just advise—we work alongside your team, building internal capabilities that last long after our engagement ends.
Regulatory Confidence
Director-level quality experience means we know what auditors look for and how to build systems that satisfy requirements.
Practical Solutions
No ivory tower recommendations. Every solution is grounded in 25+ years of real-world manufacturing experience.
A Proven Process for Success
We follow a structured methodology that ensures your project delivers measurable, sustainable results
We begin with a comprehensive assessment of your current state, challenges, and objectives. This includes stakeholder interviews, process reviews, and gap analysis.
Key Deliverables
Based on our findings, we develop tailored strategies and detailed action plans aligned with your business goals and regulatory requirements.
Key Deliverables
We execute the plan with hands-on support, working alongside your team to implement solutions while building internal capabilities.
Key Deliverables
We verify results against defined objectives, document outcomes, and ensure your team has the knowledge to maintain success independently.
Key Deliverables
Flexible Engagement Models
We tailor our engagement approach to match your needs, timeline, and budget
Medical Device Manufacturing Focus
We specialize in medical device manufacturing across all risk classifications and product categories
Device Classifications
General controls, exempt from 510(k) in many cases
Examples
- Bandages
- Examination gloves
- Hand-held surgical instruments
General controls + special controls, 510(k) required
Examples
- Powered wheelchairs
- Pregnancy test kits
- Infusion pumps
General controls + premarket approval (PMA) required
Examples
- Heart valves
- Implantable defibrillators
- Drug-eluting stents
Product Categories We Support
Drug Delivery Devices
Combination products, inhalers, injectors, pumps, and drug-device systems
In-Vitro Diagnostics
IVD consumables, test cartridges, reagent systems, and diagnostic instruments
Surgical & Therapeutic
Single-use instruments, reusable devices, and therapeutic equipment
Implantable Devices
Class III implants, active implants, and long-term contact devices
Respiratory & Sleep
CPAP/BiPAP devices, masks, humidifiers, and respiratory therapy equipment
Packaging Components
Sterile barrier systems, primary packaging, and container closure systems
Capital Equipment
Medical imaging, diagnostic equipment, and durable medical equipment
Combination Products
Drug-device combinations, biologic-device combinations, and prefilled systems