What do basketball and biomedical engineering have in common? They both are areas where universities compete.
Usability is a critical factor for all medical devices, but drug delivery devices come with their own unique challenges. Incorporating human-centric design (HCD) into drug delivery device design can minimize the occurrence of use errors that result in dosing problems and other risks to patient safety. Designing for usability requires a clear understanding of user needs and limitations, as well as the environment in which the device will be used.
Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
A medical device company developed a bioabsorbable fixation design and concept that was commended by many surgeons in the industry. Unfortunately, after several years of working with a reputable molder, there was limited consistency and success in producing the part that was in their original drawings. MTD assisted the company by guiding them through material characterization and the development of a unique tooling construction concept to reduce secondary operations. MTD’s micromolded parts achieved minimal and consistent IV loss and were much more consistent shot to shot.
Injection molding is a parts manufacturing process used for a wide range of products including medical devices, children’s toys, household appliances, and automobile parts. Sometimes a second molded part is added as a grip, handle, cover, or sleeve to cover vibration resistance, slippery surfaces, poor ergonomics, and cosmetic concerns. Instead of trying to assemble two different molded parts together, manufacturers can use a rapid overmolding process as an alternative solution. This article touches on three key elements to consider when designing injection molded parts with rapid overmolding.
Many OEMs will utilize multi-cavitation tooling to reduce piece part prices while preparing to increase the production volume of a micromolded component. While this may be a cost effective approach for simple thermoplastic parts, it may not be the best technique for micromolded parts.
The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.
Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.
Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.
Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.
New research has shown that, by selectively blocking certain immune cells, scientists may be able to prevent the formation of scar tissue on implanted medical devices, which could substantially improve their biocompatibility and extend their functional use.
Advances in technology engineered at the National University of Singapore (NUS) and Stanford University have improved the efficiency of energy transfers of electromagnetic power through tissue, effectively powering a pacemaker implanted in an adult pig.
By substituting a glass surgical needle for the endoscope, a proof-of-concept study in mice has demonstrated technology that might lead to a minimally invasive method for imaging deep brain tissue, one that could provide a better understanding of neurological conditions.
The next generation of AliveCor’s electrocardiogram (ECG) technology for mobile devices — Kardia Pro — includes an AI platform that allows for earlier detection of atrial fibrillation (Afib), a leading cause of stroke.
Each year, nearly 350,000 Americans die of some form of lung disease, with another 150,000 patients needing short- and long-term care. Unfortunately, current breathing-support technologies are cumbersome, often requiring patients to be bedridden and sedated.
Advances in medical imaging could miniaturize MRI-quality technology to the size of a wearable, says tech innovator and co-founder of Openwater Mary Lou Jepsen.
A team of surgeons and engineers of Inselspital, Bern University Hospital, and the ARTORG Center for Biomedical Engineering Research, University of Bern (Switzerland), have developed a high-precision surgical robot for cochlear implantation.
A novel oral delivery system could one day offer an alternative to injectable vaccines with a pill-sized device that releases a jet stream of water and vaccine molecules into the inner skin of the cheek.
Functional near infrared spectroscopic (fNIRS) imaging (pronounced f-nears) has led to a breakthrough in communication with ALS patients who are "Locked-In," meaning they are in advanced stages of the disease where the brain is conscious and functioning, but they are unable to move any muscles, including the eyes.
Engineers at the University of Houston (UH) are working on a millirobot prototype that can navigate the body with the assistance of a magnetic resonance imaging (MRI) scanner — technology that would both steer the robots and image the body simultaneously.