Medical Device and Combination Product Development Consultancy
Combination Products
Device Strategy & Architecture
- Primary container selection (PFS, cartridge, vial systems).
- Injection system architecture.
- Platform strategy vs. bespoke development.
- Design for manufacturability (DFM).
Early Feasibility & Risk Reduction
- Concept generation and down-selection.
- Rapid prototyping & proof-of-concept builds.
- Mechanism design and tolerance analysis.
- Risk management (ISO 14971 aligned).
Verification & Validation
- Design verification strategy.
- Test method development.
- Verification Protocol development.
- Reliability and robustness testing.
- Design validation planning.
Technical Leadership
- Cross-functional integration (drug, device, regulatory, quality).
- CMC interface support.
- Supplier technical oversight.
Medical Devices
Mechanical Engineering & Design
- Mechanical design.
- Tolerance stack analysis.
- Plastics design for injection molding.
- Design reviews and optimization.
Remediation & Optimization
- Root cause analysis.
- Failure investigations.
- Cost-down initiatives.
- Product redesign under regulatory constraints.
New Product Development
- Phase-gate development planning.
- Design inputs & requirements definition.
- Design outputs and traceability.
- Verification planning & execution.
Design Controls Execution
- DHF structuring.
- Risk file integration.
- Trace matrix development.
- Engineering change management.
Supplier & Manufacturing Support
- Transfer to manufacturing.
- Tooling strategy & qualification.
- Design for assembly (DFA).
- Technical supplier audits.
Project Management
Program Planning
- Integrated project plans.
- Critical path development.
- Resource forecasting.
- Milestone planning.
Recovery of At-Risk Programs
- Timeline re-baselining.
- Risk re-assessment.
- Stakeholder realignment.
- Technical gap identification.
Cross-Functional Leadership
- R&D, Quality, Regulatory alignment.
- Executive communication.
- Risk tracking & mitigation.
Stage-Gate & Governance
- Development phase definition.
- Design reviews facilitation.
- Executive readiness packages.
DHF Remediation
Gap Assessments
- DHF completeness review.
- Traceability audits.
- Risk file evaluation.
- Regulatory readiness assessment.
Remediation Planning
- Structured remediation roadmap.
- Prioritized action plans.
- Evidence reconstruction strategy.
Execution Support
- Retroactive design input/output alignment.
- Risk management updates.
- Test justification documentation.
- V&V documentation correction.
Inspection Preparation
- FDA/Notified Body readiness.
- Technical file strengthening.
Mergers & Acquisitions
Technical Due Diligence
- Design maturity assessment.
- Risk exposure analysis.
- DHF completeness review.
- Manufacturability assessment.
Product Viability Evaluation
- IP & design defensibility review.
- Development stage validation.
- Regulatory pathway realism check.
Post-Acquisition Integration
- Technical integration roadmap.
- Development plan stabilization.
- Risk mitigation strategy.
Contract Services
Experienced technical leadership, embedded within your team.
For organizations that need immediate capability without adding permanent headcount, we provide flexible contract support on an hourly basis. we integrate directly into your development team and operate as a contributing engineer, technical lead, or project leader. This model is ideal when you need execution, continuity, and hands-on contribution.
Engineering Execution
- Mechanical design and CAD development.
- Tolerance analysis and design optimization.
- Design changes and ECO support.
- Supplier technical coordination.
Design Controls & Documentation
- Authoring and updating design inputs/outputs.
- Verification protocol development.
- Risk documentation updates.
- DHF maintenance.
Technical Leadership
- Leading design reviews.
- Cross-functional alignment (R&D, Quality, Regulatory, Operations)
- Mentoring junior engineers
- Acting as interim technical lead
Project Support
- Driving timelines and deliverables.
- Risk tracking and mitigation.
- Coordinating internal and external stakeholders.
Engagement Model
- Hourly contract basis.
- Remote support.
- Short-term surge support or long-term embedded role.
- Rapid onboarding into existing systems and processes.
Best Suited For
- Teams experiencing resource gaps.
- Programs approaching key milestones.
- Companies scaling quickly.
- Projects requiring experienced oversight without permanent hiring.
Technical Consulting
Targeted expertise for complex or high-risk challenges.
For organizations facing a specific technical, regulatory, or strategic challenge, we provide structured consulting engagements focused on defined deliverables and outcomes. This model is best when you need clarity, direction, and independent expert assessment.
Technical Assessments
- Combination product feasibility evaluations.
- Design architecture reviews.
- Mechanism risk assessments.
- Manufacturability evaluations.
DHF & Compliance Reviews
- Gap assessments.
- Risk file evaluations.
- Regulatory readiness reviews.
- Inspection preparation support.
Program Recovery & Risk Mitigation
- At-risk project assessment.
- Root cause analysis.
- Development plan restructuring.
- Risk reduction strategy.
M&A Technical Due Diligence
- Design maturity evaluation.
- Development stage verification.
- Manufacturability and risk exposure review.
Deliverables May Include
- Written technical assessment reports.
- Risk summaries and prioritized action plans.
- Development roadmap recommendations.
- Executive briefings.
- Strategic decision support documentation.
Engagement Model
- Fixed-scope work packages.
- Clearly defined objectives and deliverables.
- Structured timeline and reporting cadence.
- Executive-level communication when needed.
Best Suited For
- Early-stage biotech evaluating device strategy.
- Companies preparing for audit or acquisition.
- Leadership teams needing independent technical perspective.
- Programs requiring rapid risk assessment.
Contract Services vs. Technical Consulting
Contract Services
Technical Consulting
Embedded within your team
Independent advisor
Hourly engagement
Defined-scope packages
Ongoing execution
Targeted problem-solving
Hands-on engineering
Strategic & technical evaluation
Integrated into daily operations
Focused assessment & recommendations
Get in Touch
We’re here to help answer your questions and discuss how we can support your engineering and product development needs.
info@servicero.net
Phone
Contact us for direct phone consultation
Location
Global service delivery Remote and on-site consulting available
About Us
Servicero is a specialized engineering consultancy focused on the design, development, and remediation of medical devices and drug–device combination products.
With over 16 years of industry experience across mechanical engineering, technical leadership, and project management, our consultancy supports pharmaceutical, biotech, and medical device organizations in navigating the complexity of regulated product development.
We provide hands-on engineering expertise and strategic technical guidance across the full development lifecycle — from early feasibility and architecture definition through verification, validation, transfer to manufacturing, and post-market remediation.
Our experience includes the development of:
- Auto-injectors and injector pen systems.
- Pre-filled syringe and dual-chamber delivery systems.
- Complex mechanical drug delivery platforms.
- Regulated Class I–III medical devices.
We understand the intersection of engineering, quality systems, regulatory requirements, human factors, and manufacturing constraints. Our approach integrates technical rigor with practical execution to ensure that products are robust, compliant, and commercially viable.
Unlike general consulting firms, we operate with deep technical fluency and real-world development leadership experience. We do not provide abstract recommendations — we deliver actionable, defensible solutions grounded in design controls and regulatory expectations.
Our services support organizations that need to:
- De-risk combination product development.
- Strengthen or remediate Design History Files.
- Recover at-risk development programs.
- Prepare for audit or acquisition.
- Conduct technical due diligence.
We engage as embedded technical partners or as independent advisors on defined work packages, providing flexibility to match the needs and maturity of each program.
Our objective is simple: reduce technical and regulatory risk while accelerating development toward successful commercialization.