Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe

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.

Empowering Precision Medicine: The Impact of 3D Printing on Personalized Therapeutic

“…Regulatory agencies may demand compelling evidence regarding the compatibility, stability, and controlled release profile of the integrated agents before approving their clinical use. To overcome these challenges, it is of utmost importance to address regulatory considerations and engage in close collaboration with regulatory bodies to facilitate the seamless translation of 3D-printed drug delivery systems into clinical practice [99]. In conclusion, the integration of therapeutic agents into 3D-printed structures signifies an exciting and promising avenue for advanced drug delivery systems.…”

“…These materials can minimize the reliance on fossil fuels and reduce the carbon footprint associated with 3D printing processes [156]. [193] Life Cycle Assessment (LCA) -Analysis of the entire life cycle of 3D-printed products, from raw material extraction to disposal -LCA results for key environmental impact categories -Evaluation of environmental impacts throughout the product life cycle [153] Material Selection -Consideration of biodegradable and bio-based materials as alternatives to petroleum-based polymers -Percentage of biodegradable materials used -Environmental benefits of using biodegradable materials [194] -Reducing the reliance on fossil fuels and minimizing the carbon footprint -Carbon footprint per unit of material -Comparison of carbon footprints with conventional materials [195] Regulatory Framework -Establishing guidelines for environmentally conscious 3D printing practices -Number of regulatory guidelines or standards -Impact of regulatory guidelines on sustainability [66,99] -Encouraging the use of eco-friendly materials and promoting energy-efficient printing processes -Number of eco-friendly material certifications -Effect of eco-friendly materials on resource consumption [196] Material Recycling -Implementation of recycling and reusing strategies to minimize waste generation -Percentage of recycled materials used -Comparison of waste reduction through recycling [132] Regulatory Framework and Standards…”