In today’s technologically advanced world, medical device innovators have a tremendous opportunity to turn their concepts into prototypes that can have a profound impact on the future of healthcare. For creators, rapid prototyping of medical devices is an exciting and vital part of the product development process. It takes the concept from conceptualization to physical entity as preliminary design images are produced.
After all, bringing a clinically meaningful product to market is both hugely rewarding and satisfying. But, as Thomas Edison, the man who illuminated the world, said, it can be a complicated and arduous road from identifying market needs to actually making the device a reality.
An optimized prototyping process can improve medical manufacturing in nearly every field. Manufacturers can save money, ensure compliance, produce better-selling products, and most importantly, save lives. Medical manufacturing cannot ignore these benefits.
Rapid prototyping is a useful resource in any field. They are critical in medical manufacturing as healthcare industry responsibilities, costs and standards increase.
Modern technology has made the medical industry better. New devices can improve patient care and save lives, offering manufacturers a world of opportunity and heightened responsibility. Medical manufacturing can be a lucrative industry, but it must also meet higher standards.
Given this dynamic, rapid prototyping is a must. While creating prototypes is standard practice in all manufacturing fields, it is of unique importance in the medical field. It can improve profits, reduce risk, and even save lives.
The importance of rapid prototyping for developing new medical devices
There are many revolutionary ideas that could lead to a new generation of treatments for certain diseases and conditions, but sadly, these have never been realized – all because inventors simply don’t know where to start developing working prototypes . Likewise, the excitement of bringing new medical devices to market often leads to the temptation to bypass key procedural elements that must precede and follow rapid prototyping. This is often seen when there are financial constraints.
However, building a rough proof-of-concept prototype is an effective means of reducing expenses. During the medical device engineering process, individuals or companies have the opportunity to evaluate and evaluate their concepts and make strategic decisions to improve their designs and capabilities. Physical samples also allow manufacturers to analyze the efficacy of designs, an important part of the mass production and distribution process.
Because medical devices directly affect the health and well-being of patients, designing and developing them always carries some level of risk. Medical device design and development is more than just coming up with an idea, building it, and making it available to the masses. This is a complex process that requires careful consideration of regulations, specifications, application requirements and user needs in order to produce a safe and effective product that is successful in the marketplace.
Design & Development Regulatory & Risk Management
When designing medical devices intended to improve lives, it is important to ensure that the risk to the end user is as small as possible. Regulatory agencies such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international counterparts have developed a wide range of regulatory documents and risk management procedures to ensure that safety measures and Production. The International Organization for Standardization (ISO) is a non-governmental, global organization responsible for setting standards that ensure the quality, safety and efficiency of products, services and systems. Some of the most common ISO standards for medical device risk management include:
ISO 13485 specifies the requirements for a quality management system (QMS) that can be used by medical device developers and manufacturers. This standard provides guidance to medical device companies to help ensure the highest levels of safety and quality for these products.
ISO 14971:2007 is specifically designed to identify risks associated with medical devices and how to estimate, assess and control them.
IEC 60601-1-2 deals with ensuring that electromechanical medical equipment maintains basic safety and essential performance in the presence of electromagnetic energy.
These are the main criteria, but there are many others that must be considered when designing medical devices. In managing risk, several different techniques are employed, including a hazard and operability study (HAZOP) and a failure mode and effects analysis (FMEA).
HAZOP is a study to examine and analyze existing processes or operations to identify any potential problems or risks associated with the design of medical devices.
FMEA is a structured approach to reviewing all components of equipment, searching for any parts of the system that may fail, and analyzing the risks associated with those failures.
Choose a good medical device manufacturer
Our rapid prototyping and sewing creation process is simple: we meet with you, review product implementation documentation and recommend materials, create patterns and prototype solutions. We will immediately adjust the pattern and update the sewing solution as needed. For all sewn products, we can provide the perfect solution for your project starting from a simple sketch or DXF file. From the product realization document, we are able to efficiently determine the appropriate material and testing standards for the project.
We employ the most appropriate manufacturing techniques and advanced manufacturing methods throughout the medical device product development and engineering process. We also streamline production by working with supply chain partners early in the process to leverage their expertise.
At TPI Custom Solutions, we are always committed to working closely with our customers to provide the best possible solution. Our expertise in medical device product development and sewing allows us to develop the most challenging custom concepts. Examples of our medical equipment items include respirator bags to carry portable ventilators, CPAP headgears, and military medical bags with stretchers.
For more information, please contact us Elimold today so we can help you with your specific medical device product development requirements