The incorporation of AM in medical devices manufacture brought some innovations that show its benefits to the industry.
Additive manufacturing (AM) is the process used in industrial production to create parts and systems layer by layer to make one final part. The process is also known as 3D printing. Additive manufacturing means the addition of materials to create objects. Materials are added layer by layer to bring out the final object. Materials used in the manufacturing process entail plastic, metal, and concrete. Also, scientists think that in the future, human tissue can also be used in additive manufacturing. There are chances that scientists might be able to produce human tissues. Many industries such as aerospace, motor vehicle, medicine, and dental use the 3D printing process. Additive manufacturing comprises processes like photopolymerization, material jetting, and material extrusion, among others. Although 3D printing has simpler ways of making parts faster, the production cost is very high. However, the medical field has incorporated additive manufacturing in creating medical devices, bringing some innovations that show its benefits to the industry.
Innovation in medical devices For some years, additive manufacturing in medicine has mainly entailed medical models, surgical implants, surgical guides, external aids, and biomanufacturing. 3D printing technology in medical models involves incorporating other objects through computer-aided design (Javaid & Haleem, 2018). Patients have individual models that are in 3-dimensional sections (3D), which are developed through customized software. The said patient models include implants, soft tissues, and foreign bodies. The AM involves Magnetic Resonances Imaging (MRI) used for model-data capturing (Javaid & Haleem, 2018). Fabrication is an AM process used after a patient product is customized and designed to create an ideal fit for the implant. After the ideal fit of the implant is created, the virtual mode is completed. The completion of the virtual mode then leads to the translation of data. Data is translated into a certain format which increases prototyping through machines (Javaid & Haleem, 2018). Besides, satisfactory skeleton models are achieved through AM, which are used to show the basic ideas in medicine.
Besides, AM has been very successful, and that is why scientists are coming up with innovations to modify it. Recently, there has been a need to improve additive manufacturing to serve medicine in many areas. One of the recent innovations of the AM in medicine has been improving Rapid Manufacturing (RM). Improved RM has greater design freedom whereby models and shapes can be in many designs. Also, improved RM has the tooling absence (Robinson et al., 2019). AM machines can produce complex designs that other manufacturing machines cannot. Tooling absence means that AM reduces the time spent on marketing for low-quantity products. Advanced AM has enabled rapid manufacturing, which has been used in dentistry to create patient dental aligners (Robinson et al., 2019). In addition, in hearing, there has been the production of patient-specific hearing aids. Improved RM is beneficial since some medical devices like hearing aids that are patient-specific are of major help to the deaf community.
Moreover, a new antibacterial compound for 3D printing parts is another AM innovation. The 3D printing parts that can kill common bacteria were created by adding a silver-based antibacterial compound at the production phase (Bell, 2020). The process of incorporating the compound into existing 3D printing materials is believed to have the capability to be used in developing medical device products. Again, the innovation can be used in hospital settings and other environments to kill bacteria. The innovation is helpful as it kills bacteria that would otherwise cause harm to people’s health. AM improvement in the medical devices is of great help because other medical devices are made with an error which does not guarantee killing of all bacteria in a surrounding. So, the antibacterial compound can protect susceptible patients in clinics and home care by stopping infection spread.
Further, the COVID-19 test swab is another innovation. The COVID-19 pandemic discovered in 2019 has been challenging to manage since it affected millions of people worldwide. Tests were being taken in small quantities hence the excess spread of the virus. AM made it easier for quick COVID-19 test swab production when the American company, Markforged, presented its 3D printed nasopharyngeal swab (Bell,2020). The swab was designed through a combination of a 3D printed nylon base and a wrapped rayon tip. The combination was used to gather viral specimens. When comparing the results taken through the 3D printed swab and the commercial swabs, the 3D printed was seen to be effective since the correct results were obtained.
In addition, 3D printing has made it possible to print sensors directly on moving organs and accessible prosthetic arms. The process was managed by printing hydrogel-based sensors on organs like the lungs (Bell,2020). Lungs were used because they have the capability of contracting and expanding. Thus, the AM innovation can diagnose and monitor patients with lung problems or patients with COVID-19. Also, the accessible prosthetic arm was made available via a 3D printing remote process (Bell, 2020). The prosthetic arm and the patient-specific hearing aid are meant to help people whose arms were amputated and those with hearing problems.
Benefits of 3D printing First, 3D printing is beneficial in the medical field as it is used in product development. In the production of medical devices, AM helps in reducing the product development cost and time used (Javaid & Haleem, 2018). Also, AM is a useful tool that increases product development. In addition, AM explores diverse uses in medicine. For instance, the technology is employed in new organ creation and operation practice (Javaid & Haleem, 2018). Second, a reduction in the need for manufacturing products in parts is attained through the use of AM. In short, AM enables one to produce the components in a single piece rather than in many pieces. Third, 3D printing creates higher quality medical device products than the other methods used in product development. High-quality device products are useful as they are used in hospitals to help cure patients or reduce their vulnerability. Most importantly, 3D printing creates shapes and components that would not be possible using the other manufacturing techniques. Lastly, AM speeds up the process of prototyping since changes can be made and corrected quickly. Besides, the speed of making changes in AM makes it ideal for mass customization.
Moreover, AM has been largely beneficial in the medical field because it has helped in complex operations. That has been achieved by training future doctors through 3D imaging to see what they will be working on. Also, 3D printing shows the image of actual organs, which makes it easier for doctors to be trained. In addition, AM largely assists in the preparation of future operations. Preparation is made simpler since 3D printing provides models that look real; hence doctors in practice have the knowledge and understanding of what they will deal with. Besides, 3D printing has brought about advanced technology which enables doctors to increase their skills. The skills can be increased through practice on 3D printing organs (Javaid & Haleem, 2018). Also, intricate care has been another benefit of AM. AM has enabled the creation of affordable and accessible prosthetics for people who need them. For example, many people lose their feet or legs in warzone areas due to bombings and shootings. The amputated legs and feet can be replaced with prosthetics (Bell, 2020). Finally, 3D printing is accessible even in remote areas whereby the medical equipment is printed.
ConclusionThe incorporation of AM in medical devices manufacture brought some innovations that show its benefits to the industry. One of the innovations of AM in medical devices is improving rapid manufacturing. Improved rapid manufacturing has been seen to have broader design liberty and the nonexistence of tooling. Advanced AM has also enabled the creation of patient-specific hearing aids and specific dental aligners. Other innovations have been manufacturing COVID-19 test swabs, a new antibacterial compound, and printing sensors directly into moving organs. COVID-19 test swabs were manufactured through 3D printing nylon combination with rayon tips. Besides, AM has been beneficial in the medical field in many ways. One of the benefits brought about by AM is that it is used in product development. In the production of medical devices, AM helps in reducing the costs and time used. Also, a reduction in the need for manufacturing products in parts is achieved through additive manufacturing. One product is made instead of the creation of a lot of product parts. Again, AM creates shapes and components that would not be possible using the other manufacturing techniques. Other benefits of 3D printing in the medical field include enabling complex operations, advanced technology which improves doctor skills, provision of intricate care, and accessibility in remote areas. AM has enabled intricate care through the creation of affordable prosthetics for amputees. Finally, 3D printing makes medical equipment accessible even in remote areas without having to transport them.
Register for these designing and manufacturing industry webinars and then watch them live or on-demand later – the choice is yours!
Automating operations on one platform How adopting a single platform for business delivers unified best-of-breed CRM, manufacturing, and quality management solution for the entire organization. Wednesday, October 13, 2021 @ 12PM ET
Building a foundation for strategically scaling smart manufacturing operations Gain insights from this live panel as they discuss a case study of selecting, deploying, and scaling digitalized, smart manufacturing operations and lay out a roadmap for manufacturers to follow as they adopt, scale, and realize the benefits of their own digital facilities and processes. Thursday, October 14, 2021 @ 12PM ET
Highly optimized parts, greater design freedom, reduced support build strategies 3DXpert software advances metal AM capabilities to expand your design envelope with features such as multi-exposure and thermal blades and no supports. Wednesday, October 20, 2021 @2PM ET
Richard Aboulafia Aerospace Markets Update, Fall 2021 Aboulafia will update his 2021 aerospace markets forecast and offer his latest insights as the industry strives to recover its momentum. Thursday, October 21, 2021 @12PM ET
Announced at the MedTech Conference, the startup receives $350K for a real-time, wearable stroke monitor for older Americans living with high stroke risk.
MedTech Innovator announced Alva Health as the winner of its 2021 Global Competition. The winning company was determined by a live audience vote on Sept. 29, 2021, during The MedTech Conference, powered by AdvaMed.
Alva Health, a medical technology startup based in New Haven, Connecticut, is developing a real-time, wearable stroke monitor for older Americans living with high stroke risk.
"Alva Health's mission is to develop, commercialize, and make accessible a first-in-class medical device that accurately detects strokes using patient-worn wearables,” says Sandra Saldana, Ph.D., CEO and co-founder of Alva Health. “This award represents a recognition of the tremendous clinical unmet need for patients, and an important milestone in Alva Health's journey. We are grateful to the MedTech Innovator community for their support and for the opportunity to receive mentorship from top leaders in the medical device industry, as we work toward fulfilling our mission to deliver this much needed technology to the millions of people who are at high risk for stroke."
MedTech Innovator received over 1,100 applications in this year’s cycle. 195 companies were invited to pitch during the MedTech Innovator Road Tour, with 50 companies ultimately receiving a slot in the 2021 Cohort. Alva Health is the recipient of the $350,000 grand prize which will be used to advance its business goals and objectives. The company has also been awarded a one-year AdvaMed Accel membership and will be profiled in the MedTech Strategist. BioDevek, Caretaker Medical, Cooler Heads Care, and Nutromics were runners-up and received a prize of $25,000 as finalists selected from this year’s MedTech Innovator Accelerator program.
“There was a general feeling of electricity and gratitude being back at The Medtech Conference in person this year. It was an honor to announce Alva Health as the grand prize winner after a live audience vote for their wearable stroke monitor that promises to up level the stroke care space,” says Paul Grand, founding CEO of MedTech Innovator. “Each year, we are on a mission to find the most promising startups from around the globe and connect them with the right stakeholders with the goal of reaching patients and improving lives. I can say with full confidence that not only Alva Health, but all of this year’s finalist companies are on track to bring life-changing health solutions into the hands of clinicians and their patients.”
Alva Health participated in the MedTech Innovator 2021 Accelerator program, which provides early-stage companies with in-depth, customized mentorship from key leaders in the medtech industry, exclusive virtual networking opportunities and workshops, and pitch sessions with investors, manufacturers, providers, and customers.
Currently in its ninth year, the MedTech Innovator competition awarded more than $500K in cash prizes and in-kind awards. Participating companies gained increasing amounts of exposure to industry leaders through online application reviews, online pitch sessions, and virtual competitions.
Judges of the 2021 final competition included: Christos Monovoukas, vice president, Global M&A Leader / Business Development, Olympus; Tonja Curtis-Danowski, vice president, Business Development, Johnson & Johnson; Arvind Shresta, director of Innovation, Urology & Critical Care, Becton Dickinson; Jacob Goble, innovation leader, medical products division, W.L. Gore & Associates.
“Congratulations to Alva Health for being named the 2021 MedTech Innovator grand prize winner,” says Susan Morano, vice president, business development and strategic operations for the Johnson & Johnson Medical Devices Companies. “All 50 companies selected for this year’s MedTech Innovator Showcase and Accelerator program show great promise in elevating patient care in their respective fields, and we look forward to watching these entrepreneurs bring value to the industry."
“As with every year of MedTech Innovator’s competitions, this year was extremely inspiring and featured cutting-edge innovations from around the world,” says Christos Monovoukas, vice president and Global M&A Leader, Business Development, Olympus. “Congratulations to Alva Health on this major accomplishment – we are eager to follow their progress in the stroke care field.”
MedTech Innovator also announced winners of the in-kind awards. Caira Surgical and Neurent Medical each received the JLABS Award, valued at $25,000. Kairos Technologies received the Oliver Healthcare Packaging Award, which provides exclusive technical and consultation services in the development of the sterile barrier system for their device, valued at $25,000. Evren Technologies was voted the winner of the $10,000 Best Video Award for their one-minute pitch video.
A new option in ToolRoom cures runout woes and helps to increase tool life and productivity.
Total indicator runout (TIR) is a term often used in manufacturing, especially when dealing with rotating parts such as cutting tools, particularly endmills and drills. TIR is defined as the difference between the maximum and minimum values measured across an entire rotating surface about a reference axis.
Manufacturing high quality, high performance tools requires the Total Indicator Runout to be perfect or minimal for overall tool life and surface finish. Runout on blanks before grinding can be achieved by either spending a certain amount of time for work holding setup or alternatively, compensating the runout in software. The latest software update of ToolRoom has an option to apply complete tool runout compensation when needed.
Runout creates uneven chip loads due to uneven contact on the workpiece. The result, as pictured above, is that some flutes get way too much load and wear fast while others get too little. This is not an optimal situation for endmills during machining. Not only do tools with runout have shorter tool life, they tend to be unbalanced and more prone to breaking. Additionally, they vibrate and cause chatter, increase spindle load and result in a bad surface finish on the workpiece.
On the contrary, even cutting flutes result in longer tool life, better surface finish and accurate finished parts.
Circular runout controls only a particular circular cross section of an endmill, while total runout controls the entire surface of the endmill which includes the outer diameter and endface. There are two kinds of runout: Radial and Axial. Radial runout is when the axis of rotation is off-center from the main axis, but still parallel. Axial runout is when the axis of rotation is tilted to some degree from the main axis, meaning the axis of rotation is no longer parallel to the main axis.
On an ANCA tool and cutter grinder, runout is measured by rotating the blank around the A-axis (headstock) and using the Renishaw touch probe. The latest update in ToolRoom RN34.1 release contains the total tool runout measurement and compensation operation in iGrind as an option. This is an addition to the existing axial runout compensation.
The runout measurement and compensation can be performed on a blank or a pre-formed blank. A pre-formed blank is a tool that has flutes ground, for example tools requiring re-sharpening. Endface compensation is used for axial runout by digitizing a single point close to the end of the tool. Only the endface operations are supported for this type of compensation.
Total runout or full compensation will measure and compensate radial and axial runout. This is mainly used while manufacturing and two points are digitized. One is near the end of the tool and the other at shank end. With the digitizing results, users are able to convert the grinding to the centerline of the blank rather than the centerline of the A-axis.
When an endmill is in rotation it is important that each tooth cuts at the exact same spot along the workpiece for longer tool life and efficient cutting. Every tool in the batch can be measured and compensated for runout to ensure the entire batch is within tolerances.
Runout in drills and reamers will result in oversized holes. This can be avoided by using the runout compensation. The chart below shows the compensation test results.
It is important to note that accuracy starts with the quality of blank. Contrary to popular belief, carbide blanks can be out of round bent or tapered. Ensure that the blanks are checked for size and accuracy, cleaned, and chamfered at insertion end. Blanks should be within 0.001mm (0.00004”) in straightness and 0.0005mm (0.00002”) in roundness to achieve the above accuracy.
Manufacturing challenges due to runout is a persistent pain point for many precision tool manufacturers. This new feature addresses this problem and will give users the assurance they need to manufacture high quality tools - ensuring that the hundredth endmill produced will be equally as good as the first.
The new complete tool runout measurement and compensation operation is now available as an option in the latest ToolRoom update for RN34.1 release. Customers will benefit from increase in productivity due to the reduced collet and collet adaptor setup time, and reduced scrap from zero rejections due to runout.
LINK Product Development and The Quick Company announce launch of new medical device – designed & developed in Denver.
LINK Product Development (LINK) and The Quick Company announce the launch of Microtray Universal, a new-to-market dental assistance tool designed and developed in Denver.
The Microtray line was developed by LINK in collaboration with Dr. Jack Nguyen, founder of The Quick Company and a Denver-based dentist. The tool is a small, molded plastic tray that adheres to surgical gloves allowing dentists and dental assistants quick access to commonly used materials and disposables during various dental procedures. It is the first product of its kind developed for the dental field.
“We are very excited to help bring the Microtray product to market after a thoughtful design and prototyping process that was based on problem solving, observation and the first-hand experience of Dr. Jack Nguyen,” says Marc Hanchak, founder, LINK Product Development. “Our team visited Dr. Jack’s dental office to experience and observe the problem in person. Filming and studying the activities performed gave us detailed insight into the parameters for the product. We took ergonomics, safety, and ease of use into consideration throughout the design process. The end result is an innovative solution for storage and workflow during a wide array dental procedures that will truly enhance the profession.”
Microtray is being manufactured in the U.S. using rapid tooling injection molding and assembled in Denver.
“Prior to my career as a dentist, my background is in research, which gave me the skills to identify what I saw as a challenge in my profession and to think through a solution,” says Dr. Jack Nguyen, MS, DDS, founder of The Quick Company. “I partnered with LINK to collaborate on the project, ask questions, help refine the initial concept, and deliver the final product to market. This concept is a true collaboration and an exciting advancement in the medical field.”