ReviewBiomedicines2022
Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe.
Review in Biomedicines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 23 citations in OpenAlex.
- Translation of pharmaceutical 3D printing to clinical point-of-care and industrial manufacturing.Drug delivery and translational research · 2026Review
- Printing to Fight Antimicrobial Resistance Through Nano/Microstructured Platforms.Chemical record (New York, N.Y.) · 2026Review
- Bioactive PLA Filament with Antibacterial and Ion-Releasing Properties for Additive Manufacturing of Bone Scaffolds: QbD-Guided Development.Pharmaceutics · 2026Article
- Review
- Augmenting healthcare systems for pandemic preparedness: a Lean Six Sigma perspective.International journal for quality in health care : journal of the International Society for Quality in Health Care · 2026Review
- A risk-stratified framework for in-house PLA 3D printing of non-critical medical device spare parts: a cost-effectiveness analysis.Frontiers in medicine · 2026Article
- Current 3D Printing Technologies and their Potential Applications in Drug Delivery, Personalized Medicine & Pharmaceutical Sciences.Current drug discovery technologies · 2026Review
- Personalized Vaginal Drug Delivery through 3D Printing: Techniques, Challenges, and Future Perspectives.AAPS PharmSciTech · 2025Review
- 3D bioprinting in tissue engineering: current state-of-the-art and challenges towards system standardization and clinical translation.Biofabrication · 2025Review
- AI-driven 3D bioprinting for regenerative medicine: From bench to bedside.Bioactive materials · 2025Review
- Investigation of Chlorhexidine and Chitosan Gel-Based Coatings for the Prevention of Intravascular Catheter-Associated Infections Following Quality by Design Approach.Biomedicines · 2024Article
- Perspectives on medical 3D printing at the point-of-care from the new European 3D Printing Special Interest Group.3D printing in medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic. This review aims to provide an update on the current progress and emerging opportunities for additive manufacturing following the introduction of the new medical device regulation (MDR) within the EU. The advent of early-phase implementation of the Quality by Design (QbD) quality management framework in MD development is a focal point. The application of a regulatory supported QbD concept will ensure successful MD development, as well as pointing out the current challenges of 3D bioprinting. Utilizing a QbD scientific and risk-management approach ensures the acceleration of MD development in a more targeted way by building in all stakeholders' expectations, namely those of the patients, the biomedical industry, and regulatory bodies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.