TEDMED Engineering Projects (TMEP Consulting)

The History of TEDMED Engineering and Projects

 

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 TEDMED Engineering Project Consulting (TMEP) was founded in 2011.​ Having worked in the industry for over 18 years with experience in Life Science, Biotechnology, and Pharma, working with Sponsors, Clinical Research Organization (CRO) for drug and medical device trials the founder's objective was to utilize her expertises to assist clients. 

In the last 12 years, TMEP has provided consulting services to clients in clinical research projects for both medical devices and therapeutic drugs.  Services includes quality data management, CFR 11 computerized systems validation, GMP validation, project management in regulatory submissions, QMS auditing etc. Clinical trial management from preclinical testing, FDA roadmap to submission, phase I, II, III and IV.

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Our specialty focuses on managing projects that involve drug–device combination products, such as:

    •    Drug-eluting stents

    •    Prefilled syringes or autoinjectors

    •    Transdermal patches

    •    Inhalers (device + drug)

    •    Infusion pumps with a drug reservoir

 

We oversee both pharmaceutical and engineering aspects, ensuring the device and drug components work together safely and effectively, while meeting regulatory standards from both FDA’s CDER (drug) and CDRH (device) — or under the European MDR/EMA system.

 

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🧭 Project Lifecycle Overview

We assist with:

1. Concept & Feasibility

    •    Define the intended use and primary mode of action (PMOA) — this determines if the product is regulated primarily as a drug, device, or biologic.

    •    Conduct feasibility studies (formulation + delivery mechanism).

    •    Evaluate intellectual property and market needs.

 

2. Design & Development

    •    Device side: Design controls (21 CFR 820.30), risk management (ISO 14971), usability (IEC 62366).

    •    Drug side: Preclinical formulation, stability, toxicology, and GLP studies.

    •    Integration: Compatibility testing (drug–device interface, materials, and performance).

 

3. Clinical & Regulatory Strategy

    •    Develop an integrated regulatory strategy based on PMOA.

    •    Primary Drug Component: Center for Drug Evaluation and Research (CDER) leads review.

    •    Primary Device Component: Center for Devices and Radiological Health (CDRH) leads review.

    •    Plan IND (Investigational New Drug) or IDE (Investigational Device Exemption) submissions.

    •    Align CMC (Chemistry, Manufacturing & Controls) and design history file (DHF) documentation.

 

4. Verification, Validation, and Testing

    •    Verify both device performance and drug delivery.

    •    Conduct stability testing, extractables/leachables studies, and human factors validation.

    •    Ensure traceability across drug and device design controls.

 

5. Manufacturing & Technology Transfer

    •    Coordinate GMP (drug) and QSR/ISO 13485 (device) manufacturing standards.

    •    Validate combination product assembly processes.

    •    Manage supply chain integration (drug suppliers + device component suppliers).

 

6. Regulatory Submission & Approval

    •    FDA: Combination Product submissions (per 21 CFR Part 4).

    •    EU: Follow MDR + EMA medicinal product guidance.

    •    Prepare cross-functional submission files (NDA, PMA, or hybrid).

 

7. Post-Market Activities

    •    Implement post-market surveillance for both drug and device.

    •    Handle adverse event reporting (FAERS + MDR systems).

    •    Manage product updates, line extensions, and lifecycle management.

 

🧠 TMEP Consultants Key Skills and Competencies

 

Regulatory Skills: Knowledge of FDA combination product regulations (21 CFR Part 4), ISO 13485, ICH guidelines, GxP standards etc.

Technical Skills: Understanding formulation science, delivery systems, device engineering, and risk management.

Project Management Skills: Integrated planning across R&D, clinical, QA/RA, manufacturing, and marketing.

Communication Skills: Translating technical details between pharma and engineering teams.

Quality Systems:  Implementing a hybrid QMS to meet both drug GMP and device QSR requirements.

 

🎓 TMEP Consultants Professional Background

 

Typical Education:

    •    Degree in Biomedical Engineering, Pharmaceutical Sciences, or Chemical Engineering.

    •    Advanced degree (MS, MBA, or PhD).

 

Certifications:

    •    PMP (Project Management Professional)

    •    Regulatory Affairs Certification (RAC)

    •    Lean Six Sigma Green/Black Belt

    •    Combination Products Training (AAMI/FDA)

    •    ISO 13485. GLP, GCP GMP Compliance Courses and certification.

 

 Project Management Approach

 

Because of the dual nature of combination products, our project managers often use:

    •    Hybrid Waterfall/Stage-Gate approach for regulatory compliance.

    •    Agile or iterative methods for device design and software components.

    •    Risk-based project management to handle overlapping compliance frameworks.

 

Key deliverables include:

    •    Integrated Development Plan

    •    Regulatory Strategy Document

    •    Risk Management File

    •    Verification & Validation Plan

    •    Clinical Evaluation Report

    •    Post-Market Surveillance Plan

 

 Career Roles in our Specialty

    •    Combination Product Project Manager

    •    Program Manager, Drug–Device Integration

    •    Regulatory Project Manager (Combination Products)

    •    Technical Operations or CMC Program Manager

    •    Director of Product Development