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Related Experiment Video

Updated: Jun 19, 2026

Tissue Engineering: Construction of a Multicellular 3D Scaffold for the Delivery of Layered Cell Sheets
09:24

Tissue Engineering: Construction of a Multicellular 3D Scaffold for the Delivery of Layered Cell Sheets

Published on: October 3, 2014

Product development in tissue engineering.

M J Lysaght1

  • 1CytoTherapeutics Inc., Brown University, Providence, Rhode Island 02912.

Tissue Engineering
|November 3, 2009
PubMed
Summary
This summary is machine-generated.

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Tissue engineering applies biomedical engineering to living cells, bridging medical devices and pharmaceuticals. Navigating distinct regulatory pathways is crucial for commercializing these hybrid products.

Area of Science:

  • Biomedical Engineering
  • Cell Biology
  • Pharmacology

Background:

  • Tissue engineering integrates biomedical engineering, cell biology, and pharmacology.
  • Success hinges on effective interdisciplinary function.
  • Regulatory and commercialization challenges exist for hybrid products.

Purpose of the Study:

  • Compare and contrast development cycles for medical devices and pharmaceutical products.
  • Highlight key development issues for tissue engineering products.
  • Inform strategies for successful commercialization of tissue engineering innovations.

Main Methods:

  • Literature review and comparative analysis.
  • Examination of regulatory frameworks for medical devices, pharmaceuticals, and biologics.

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Last Updated: Jun 19, 2026

Tissue Engineering: Construction of a Multicellular 3D Scaffold for the Delivery of Layered Cell Sheets
09:24

Tissue Engineering: Construction of a Multicellular 3D Scaffold for the Delivery of Layered Cell Sheets

Published on: October 3, 2014

Core/shell Printing Scaffolds For Tissue Engineering Of Tubular Structures
05:52

Core/shell Printing Scaffolds For Tissue Engineering Of Tubular Structures

Published on: September 27, 2019

Tissue Engineering of a Human 3D in vitro Tumor Test System
11:12

Tissue Engineering of a Human 3D in vitro Tumor Test System

Published on: August 6, 2013

  • Identification of critical development junctures and challenges.

    • Main Results:

    • Medical device and pharmaceutical development pathways differ significantly.
    • Tissue engineering products face unique regulatory hurdles due to their hybrid nature.
    • Expertise in both device and drug/biologic regulatory processes is essential.

    Conclusions:

    • Effective integration of diverse scientific principles is vital for tissue engineering.
    • Understanding and navigating distinct regulatory landscapes is paramount for commercialization.
    • Addressing interdisciplinary challenges is key to advancing tissue engineering from research to clinical practice.