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November 2024
The 3D Printed medical devices market size is estimated to grow from USD 3.41 billion in 2022 at 17.94% CAGR (2023-2032) to reach an estimated USD 17.76 billion by 2032 as a result of rising demand for customized 3D printed solutions.
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Customization and Personalization in 3D Printed Medical Solutions are Causing Massive Growth in the Medch Field.
The solutions provided by the 3D printing industry cover a wide range of revolutionary medical and industrial applications. 3D printing has progressed from its beginnings as a prototyping technology to a feasible choice for end-use regions and larger-scale manufacturing applications. 3D printing has expanded beyond consumer markets in the past few years, developing itself as a commonly utilized commercial method of production. In the past two years industry developments have positioned the technology to move beyond its applications in effective prototyping and become an appropriate approach for end-use regions and serial manufacturing.
The COVID-19 pandemic emphasized 3D printing's distinctive capacity to rapidly respond to production as well as supply chain requirements. Because parts and products can be manufactured locally and on-demand, 3D printing has emerged as an appealing option to new and constant challenges.
During the COVID-19 pandemic manufacturers used 3D printing to manufacture medical devices and protective equipment (PPE) such as ventilator valve replacement parts, face shields, and others at a rapid pace. The use of 3D printing in medical device manufacturing could help manufacturers overcome supply chain issues and shortages that occurred due to the pandemic. Additionally, manufacturers started 3D printing nasal swabs for COVID-19 detection, which illustrated the viability of mass production. Due to this 3D printed medical devices market experienced a boom during the COVID-19 pandemic.
Since patient care is at stake, many crucial considerations exist in 3D-printed medical device manufacturing. Because of this, the value chain for 3D-printed medical devices is particularly complicated and calls for the participation of actors with varied backgrounds. Developing the value chain for 3D-printed medical devices requires close coordination between all the important players. The various actors in the value chain lack coordination and cooperation. As a result, collaboration is also hampered by the use of various 3D printing processes and interfaces.
Additionally, manufacturers of medical devices ought to be more aware of the effects that the upstream and downstream processes have on the finished product. In its new complete guidance for medical device manufacturers, the US Food and Drug Administration (FDA) adamantly emphasizes this significance. Currently, instead of operating in cooperation, activities frequently run in competition.
The healthcare industry has experienced a revolutionary transformation with the advent of 3D printing technology. The healthcare industry has been ultimately impacted by the high cost of medical devices over the years, as traditional medical device manufacturing follows expensive and lengthy processes which accelerates the overall cost of production. On the other hand, 3D printing provides an efficient and cost-effective alternative in which medical devices are directly manufactured with the help of digital designs. This eliminates a number of labor-generated steps and complex processes involved in traditional manufacturing.
In order to create precise prototypes of medical devices as well as equipment and tools to streamline testing, more than 90% of the biggest medical device manufacturers use 3D printing. Cost savings of up to 70% were reported by one medical device manufacturer. In addition, according to a different medical research organization, using 3D-printed models in 10-15% of cases could result in annual savings of up to $1,750,000.
Custom-fit prosthetics are frequently expensive and only available to patients in developed nations who have insurance. To overcome these financial obstacles, prosthetics are increasingly utilizing the adaptable design of 3D printing. Making surgical instruments with 3D printing is an efficient and affordable way to manufacture in-demand medical supplies. Even for complicated instruments, it is effortless to alter designs for surgical requirements.
Furthermore, 3D printing offers customization and personalization which involves the creation of patient-specific medical devices. This reduces the need for costly replacements and improves patient outcomes. Surgery guides and implants that precisely fit a patient's anatomy are made using 3D printing. This lessens the possibility of issues, expensive modifications, and protracted hospital stays. By enabling on-demand and localized production, 3D printing eliminates the need for vast shipping and warehousing networks, which can be expensive.
3D Printed medical devices are usually produced in limited quantities, and patterns can be modified continually to reduce costs, weight, and component counts to produce small, lightweight medical devices with internal performance. Medical devices that are specifically designed for a patient enhance comfort, fit, and outcomes while lowering the risk of complications. With numerous applications in interbody, dental, surgical, orthopedic, and personalized devices, 3D printing earnings in the medical devices sector have been increasing continuously since 2018.
Custom implants and prosthetics can be made using 3D printing to better fit a patient's needs and increase comfort and functionality. Using surgical guides that were 3D printed, surgeons can perform complex procedures like spinal replacements and joint replacements with greater precision and accuracy, increasing their chances of success and speeding up their recovery. This leads to devices that are better matched to the patient and their particular anatomy.
For instance, 3D-printed personalized medical devices include:
In addition, the marginal cost of customization in 3D printing is another benefit included, as 3D printing allows end-to-end, automated, and scalable workflows for personalized products from right from designing to production. Furthermore, 3D printing allows the ultimate creation of biologically relevant structures. Such organic structures are unique and are impossible to manufacture with the help of traditional methods. Medical professionals can create unique-to-patient personalized implants using metal additive manufacturing techniques like SLM by using medical imaging data—from CT scans, for example—as the foundation for a CAD 3D model. The implant can be created using a non-toxic, biocompatible titanium 3D printing alloy (like Ti64).
Moreover, rising investments in 3D printing medical devices for the improved availability of customized products augment the market growth. For instance, in March 2023, the National Science Foundation (NSF)'s Leading Engineering for America's Prosperity, Health, and Infrastructure (LEAP-HI) program awarded the researchers a $2 million grant that will enable them to take on the challenge of designing and 3D printing smart devices using various materials. Together, they intended to create pediatric ventilation masks and other medical devices that can be customized and shaped differently while being used using 3D printing technology. On top of it, there is a lot more to come in the upcoming years as Many medical devices must be able to be customized, and being able to change their shape as the patient grows or heals is a game-changer. Finding a quick, affordable way to do that could greatly simplify life for both patients and medical professionals.
The FDA's Centre for Devices and Radiological Health regulates devices, the most prevalent type of 3D-printed product at the moment. Devices are divided into one of three regulatory categories, or classes. The FD&C Act and its implementing regulations found in Title 21 of the Code of Federal Regulations (CFR) establish regulatory controls for devices in the United States. In overall, businesses that produce, prepare, multiply, compound, assemble, or process medical devices for the benefit of humans, including 3D printing businesses, must register with the FDA and list the medical devices they produce, prepare, multiply, compound, assemble, or process on their registration form.
The FDA continues to uphold a custom device exemption. If a custom device satisfies the criteria outlined in Section 520(b) of the Federal Food, Drug, and Cosmetic Act, it may be exempt from 510(k) or prior to market submissions. For example, these specifications might state that the manufacturer can only produce five units of the device annually or that it must be made to treat a specific pathology or physiological condition that no other device on the domestic market is capable of treating. In 2017, the FDA issued recommendations on what details need to be included in applications for 3D-printed medical devices, including those that are patient-matched and include things like joint replacements and cranial implants.
3D printing provides customizable and affordable solutions for the making of anthropomorphic radiotherapy phantoms through in vitro methods. Such phantoms are significantly used for the treatment planning of cancer patients and make sure that innovative radiation procedures are subject to quality assurance (QA). These phantoms make use of 3D printing technology to allow preliminary confirmation of customized radiation doses and to lessen the adverse effects of ionizing radiation on nearby healthy tissues.
In addition, the increasing rate of commercial accessibility and availability especially in case of medical technology with the intervention of 3D printing, ave created extensive growth opportunities in the medical technology sector. 3D printing also provide opportunities for inexpensive producers of personalized medical devices for radiotherapy phantoms as well as radiotherapy devices consisting of bolus & compensators to attain customized dose distribution intended for electron beam shielding devices, irregular surfaces, brac, brachytherapy and several others. This further bolsters the extent of growth opportunities in the 3D-printed medical devices market. Furthermore, market players can further expand their capacities and avail themselves of more profits in the field by establishing collaborations with other healthcare and technology market players. In June 2022, Adaptive Medical Technologies, Canada based firm in software and medical device development, collaborated with Varian (Siemens Healthineers Company) and HP Inc. to use 3D-printed medical devices to improve the standard of and patient access to personalized cancer care in the United States. Adaptive Medical Technologies have developed software that aligns with 3D printing technology to make medical devices that can be effectively used in radiation oncology.
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