Assay Development & Troubleshooting
Support assay concepts, PCR/qPCR and NGS workflows, DNA/RNA extraction, sample preparation, experimental design, optimization, root-cause analysis, and corrective-action planning.
Biomedical Products · Molecular Diagnostics · Laboratory Systems
Biomedical & Laboratory Consulting
MicroFab helps biomedical, diagnostic, laboratory, and medical-technology organizations translate biological and clinical needs into practical products, controlled workflows, and testable solutions.
Build and Launch Your Biomedical Laboratory
MicroFab can support the complete laboratory-development process—from location and site evaluation, layout planning, and facility retrofitting through equipment selection and procurement, assay development, workflow setup, testing, validation, staff training, and certification or accreditation readiness.
When Clients Call Us
- A biomedical or diagnostic product needs clear biological, laboratory, instrumentation, or verification requirements
- An assay or molecular workflow needs development, optimization, transfer, or troubleshooting
- A laboratory is being planned, built, retrofitted, launched, or expanded for NGS, PCR/qPCR, or other high-complexity testing
- Quality, SOP, LIMS, inventory, training, or operational systems need improvement
- A laboratory instrument, automation platform, or diagnostic product needs workflow integration and verification planning
- A company, investor, or partner needs an independent scientific and technical assessment
Organizations We Support
- Biomedical, diagnostic, and biotechnology startups
- Clinical and research laboratories
- Medical-technology and life-science companies
- Laboratory-instrument, automation, and workflow-software developers
- Universities and research organizations
- Investors, acquirers, and strategic partners
What We Can Build, Develop & Improve
Laboratory Planning, Buildout & Launch
Support location and site evaluation, layout and workflow planning, facility retrofitting requirements, equipment selection and procurement, SOPs, staffing, training, inventory, budgeting inputs, and operational readiness for high-complexity testing.
Quality Systems & Readiness
Support quality-system implementation, documentation, workflow controls, process improvement, and CAP, CLIA, and NYSDOH readiness and gap assessment.
LIMS & Laboratory Information Flow
Evaluate sample tracking, LIMS implementation, inventory systems, operational reporting, data handoffs, process bottlenecks, and laboratory information workflows.
Biomedical Product & Engineering Integration
Translate biological and laboratory needs into product and engineering requirements for instruments, diagnostic devices, workflow software, automation platforms, consumables, electronics, sensors, and interfaces.
Scientific & Technical Assessment
Evaluate scientific validity, technical feasibility, competing technologies, development maturity, evidence, risks, validation needs, scalability, and implementation readiness.
How We Work: From Planning to Launch
Define
Clarify the scientific question, business decision, current workflow, available evidence, constraints, stakeholders, and desired work product.
Assess
Review methods, data, protocols, equipment, quality records, laboratory systems, literature, risks, and gaps relevant to the engagement.
Develop
Create prioritized recommendations, requirements, workflows, test plans, SOPs, implementation steps, or corrective actions.
Support
Work with laboratory, scientific, engineering, quality, operations, and management teams through implementation, testing, and review.
Clear professional boundaries: MicroFab provides scientific, technical, laboratory-workflow, quality-system, and product-development consulting. Services do not constitute patient-specific medical advice, clinical testing, legal advice, regulatory certification, or a guarantee of regulatory approval or laboratory accreditation. The client retains responsibility for clinical decisions, validation, compliance, accreditation, and regulatory submissions.
Projects We Support & What We Deliver
Representative Engagements
- Define biological, laboratory, and verification requirements for an early biomedical or diagnostic product
- Evaluate an early molecular assay and create a roadmap toward a repeatable commercial workflow
- Plan a new NGS or molecular-testing capability from equipment selection through operational readiness
- Investigate inconsistent assay performance or laboratory bottlenecks and prioritize corrective actions
- Define scientific, sample-handling, performance, and verification requirements for a laboratory instrument
- Assess a biomedical, molecular-diagnostic, or laboratory technology for development, investment, acquisition, or partnership
Typical Deliverables
- Scientific or technical feasibility memorandum
- Workflow map and gap assessment
- Biological and engineering requirements specification
- Technology or equipment evaluation matrix
- Development, implementation, or automation roadmap
- SOP, protocol, test-plan, or training-document package
- Technical risk register with prioritized recommendations
Lead Biomedical & Laboratory Consultant
Amany Abdel-Motaleb, MS, ASCP-Certified in Molecular Biology
Molecular Biology — ASCP Board of Certification #7942
Amany Abdel-Motaleb is an experienced clinical-laboratory supervisor with more than ten years of clinical, research, teaching, assay-development, and laboratory-operations experience. She holds an M.Sc. in Biotechnology from The American University in Cairo and a B.S. in Biology from Northern Illinois University.
Her background includes building and launching a clinical NGS laboratory; developing and performing high-complexity molecular assays; quality systems in CAP-, CLIA-, and NYSDOH-regulated environments; LIMS and inventory implementation; staff training; cancer genomics; and published research in molecular diagnostics, microbiology, nanotechnology, and rapid pathogen detection.
MicroFab's multidisciplinary advantage: Biomedical, molecular-diagnostics, and laboratory expertise can be combined with MicroFab's electrical, electronic, instrumentation, product-development, modeling, testing, and technical-assessment capabilities when a project crosses scientific and engineering boundaries.
Discuss Your Biomedical, Diagnostic, or Laboratory Project
Send a short description of the scientific or operational problem, the present development stage, the available data or workflow, and the decision or result your organization needs.
Request an Initial Discussion