Manufactory devices for control and regulation of technological processes
These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. To reach the general market, a medical device must first pass a set of standards and regulations designated by its class. Classification of medical devices and the design control process for device design. A Classification of medical devices is based on the degree of risk to the patient.VIDEO ON THE TOPIC: Medical Device Design Control
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- Why the FDA is re-framing the regulation process for AI-based medical devices
- Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices
- The Automation of FDA Medical Device Design Controls
- Medical Devices: Lost in Regulation
- Cell Therapy Manufacturing Tries “Building the Plane While Flying It”
Why the FDA is re-framing the regulation process for AI-based medical devices
However, ensuring a smooth transition requires planning, cross-functional teams, multiple checkpoints and concurrent engineering methodologies. Concurrent engineering refers to the process of designing products simultaneously, rather than consecutively, using a team-based approach. It reduces product development time, resulting in improved productivity and reduced costs. The bottom line is that you have to do both concurrently.
According to Czuba and other experts, additive manufacturing has helped streamline the early stages of product design and development, such as the proof-of-concept process. It enables engineers to create prototypes earlier and more often in a cost-effective manner. Medical device engineers are required to use a documented design transfer process. The requirements are outlined in several documents, including the U.
The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.
The plans shall be reviewed, updated and approved as design and development evolves. Making these two paths overlap as much as possible allows a development team time to improve on manufacturing methods prior to any pilot builds.
This is where new manufacturing processes, materials and technologies can be used to make impossible designs a reality. A good design must accommodate for the expected variability in manufacturing, materials and labor being used in the final product. A robust design can tolerate higher variability. Sometimes, enormous investments must be made in the manufacturing process to reduce the overall product costs.
In the medical device industry, most quality management systems include a design transfer process. Often, a checklist is a good method of tracking these activities and ensuring that nothing gets overlooked. A design transfer checklist should include a bill of materials; material handling procedures; component, subassembly and finished product specifications; assembly drawings and schematics; assembly procedures; and test and inspection procedures.
Whipple suggests starting the design transfer process as early in product development as possible. Human factors should be addressed, such as the potential for injuries due to lifting or reaching.
Cross-functional teams play a critical role in the design-to-assembly process. In addition to computer, electrical and mechanical engineers, team members should include people with diverse expertise in areas such as marketing, regulatory compliance and statistics. Medical device product development typically includes a phase-gated approach, where the entire cross-functional team must approve one phase before the project may progress to the next one. Within each phase, smaller periodic team reviews of new designs, product risks, test results and manufacturing decisions should enable input and consensus from multiple points of view.
Material selection is another important element of the design transfer process. Choosing materials with appropriate properties is critical to everything from device function and safety to manufacturability and cost. This website requires certain cookies to work and uses other cookies to help you have the best experience.
A design transfer checklist should include items such as a bill of materials, assembly drawings and schematics, and assembly procedures.
Material selection is an important part of the design transfer process. January 7, Teamwork Is Important Cross-functional teams play a critical role in the design-to-assembly process. Recent Articles by Austin Weber Airbus harnesses automation to boost fuselage production. Colorado develops grid-storage battery technology. Electric vehicle makers rethink assembly processes. He has more than 21 years of b-to-b publishing experience and has written about a wide variety of manufacturing and engineering topics.
However, ensuring a smooth transition requires planning, cross-functional teams, multiple checkpoints and concurrent engineering methodologies. Concurrent engineering refers to the process of designing products simultaneously, rather than consecutively, using a team-based approach. It reduces product development time, resulting in improved productivity and reduced costs.
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Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices
Automation , the application of machines to tasks once performed by human beings or, increasingly, to tasks that would otherwise be impossible. Although the term mechanization is often used to refer to the simple replacement of human labour by machines, automation generally implies the integration of machines into a self-governing system. Automation has revolutionized those areas in which it has been introduced, and there is scarcely an aspect of modern life that has been unaffected by it. The term automation was coined in the automobile industry about to describe the increased use of automatic devices and controls in mechanized production lines. The origin of the word is attributed to D. Harder, an engineering manager at the Ford Motor Company at the time. The term is used widely in a manufacturing context , but it is also applied outside manufacturing in connection with a variety of systems in which there is a significant substitution of mechanical, electrical, or computerized action for human effort and intelligence. In general usage, automation can be defined as a technology concerned with performing a process by means of programmed commands combined with automatic feedback control to ensure proper execution of the instructions. The resulting system is capable of operating without human intervention. The development of this technology has become increasingly dependent on the use of computers and computer-related technologies.
The Automation of FDA Medical Device Design Controls
FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that using such technologies could result in delays while FDA reviewers familiarize themselves with the new technologies and determine how they may be evaluated within the existing regulatory framework. Through the program, industry representatives can meet with Emerging Technology Team ETT members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission. Participation in the program is appropriate if a the proposed technology has the potential to improve product safety, identity, strength, quality and purity, and b the new technology includes one or more elements subject to quality assessment for which the Agency has limited review or inspection experience. Examples of such elements include an innovative or novel:.
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Medical Devices: Lost in Regulation
The implanted medical device industry was founded in the United States and has been a major economic success and the source of numerous life-saving and life-improving technologies. In the s and s, technological innovations such as the cardiac pacemaker and prosthetic heart valve meant that thousands of suffering Americans had access to treatment options where none had existed before. In addition, U. In fact, they rose to worldwide preeminence because of their pioneering work on a progression of breakthrough medical therapies.SEE VIDEO BY TOPIC: Fundamentals of Manufacturing Processes - MITx on edX - Course Video
The study is available in multiple editions including worldwide, all regions, and most major countries. The prospect of adding wireless devices to the process automation architecture is compelling due to the potential business benefits and tangible operational improvements. Owner-operators are increasingly aware of the potential to apply wireless to key challenges, such as improving process performance, reliability, and efficiency; and easing regulatory compliance. One trend that has major implications for the adoption of wireless technology is the Industrial Internet of Things IIoT. Because wireless is a key enabling technology for connectivity, it will allow the proliferation of sensors at the device level necessary to funnel data to the IIoT. Many initial applications for wireless devices in the process industries are focused on adding incremental points to improve control strategies or meet safety or environmental regulations.
Cell Therapy Manufacturing Tries “Building the Plane While Flying It”
With the global mandate to make healthcare more accessible, affordable and wirelessly connected, medical and life sciences OEMs look to their strategic outsourcing partners more than ever to co-create revolutionary advancements in technology that lower costs and improve outcomes — all without compromising quality and traceability. As the Internet of Things IoT continues to drive astounding breakthroughs in healthcare, patients are becoming more mobile, aware and self-sufficient in their care, while professionals enjoy easier access to data. Creation delivers proactive design and manufacturing innovation across these healthcare fronts, and more, all while meeting stringent regulatory requirements for ensuring product accuracy and patient safety. Creation protects your IP through secure business systems and information technology that is segregated within the production environment through a cellular manufacturing model. Life Sciences. Innovation with the Patient in Mind. Work With Us.
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections.
Early-stage medical device companies provide the innovation and intellectual property that feed the medical device industry with great ideas and life-saving devices, but understanding FDA regulations and reaching commercial markets can be extremely daunting for new companies. Operating within the FDA mandatory regulations concerning medical device design controls is the way of life for any company that wants to improve the lives of others through the design and marketing of medical devices. This bureaucracy is very important to the design process and leads to high-quality medical devices, but can add significant overhead, in terms of cost and time, to a project. Most companies simply write off this overhead to the cost of doing business without realizing the price of these inefficiencies.
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Significant technological advances are being made across a range of fields, including information communications technology ICT ; artificial intelligence AI , particularly in terms of machine learning and robotics; nanotechnology; space technology; biotechnology; and quantum computing to name but a few. These breakthroughs are expected to be highly disruptive and bring about major transformative shifts in how societies function. The technological advances in question are driven by a digital revolution that commenced more than four decades ago. These innovations are centered on the gathering, processing, and analyzing of enormous reams of data emerging from the information sciences with implications for countless areas of research and development. These advances promise significant social and economic benefits, increased efficiency, and enhanced productivity across a host of sectors.
The conference brought together researchers working in various different areas of Technology for Education and Learning with a main emphasis on technology for business and economy in order to foster international collaborations and exchange of new ideas. This proceedings book has its focus on Technology for Economy, Finance and Education representing some of the major subareas presented at the conference. Account Options Anmelden. Meine Mediathek Hilfe Erweiterte Buchsuche. E-Book ab 3.
The concept actually aims at understanding the processes by defining their CPPs, and accordingly monitoring them in a timely manner preferably in-line or on-line and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects. With this framework — according to Hinz  — the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.