This article is the third in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the verification phase.
What do basketball and biomedical engineering have in common? They both are areas where universities compete.
As the need for innovative, wearable medical devices increases, so does the importance of new prototyping methods to expedite development time and reduce the time to market. Within soft goods development, digital knitting allows for intricately detailed 3D shapes, and for multiple materials to be integrated into a single, production-level prototype.
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.
Rapid overmolding sidesteps assembly hassles, simplifies product design, and can improve the characteristics of many injection-molded parts.
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.
A team of Australian scientists has just completed a phase one human clinical trial with an ingestible biosensor that can measure gas produced by the gut, and potentially transmit results to a connected smartphone.
Scientists in South Korea are mining the biomedical potential of both gold and graphene to design a more flexible brain-machine interface (BMI) that can transmit clearer signals while causing minimal damage to brain tissue, said researchers.
With Verily’s new “investigative watch,” the only information the clinical trial participant can view is the time and date, but researchers have access to a host of physiological data and biomarkers, including heart rate, activity data, and electrocardiograms (ECGs).
Toyota Motor Corporation will launch a rental service for the Welwalk WW-1000 robot from the fall of 2017.
Scientists from the Mayo Clinic have introduced new research in support of combining spinal cord stimulation (SCS) with physical therapy to restore movement for people paralyzed by injury.
Melbourne-based Bionic Vision Technologies (BVT) has raised US $18 million from Hong Kong-based investors China Huarong International Holdings and State Path Capital Limited to proceed with clinical studies testing the company's bionic eye for patients with retinitis pigmentosa, a degenerative condition that is the most common cause of inherited blindness.
Researchers from the Memorial Sloan Kettering Cancer Center (MSK) have introduced cancer monitoring nanotechnology that they say is a “major step forward” compared to traditional biopsies.
Advances in soft robotics technology are showing promise in diverse applications by doing away with the sharp edges of traditional implants and surgical tools, and replacing them with more flexible materials and actuators.
Baxter International Inc. is committed to advancing surgical innovation and unveiled new designs that enhance the company’s FLOSEAL and TISSEEL hemostatic products at the Association of periOperative Registered Nurses (AORN) Global Surgical Conference and Expo, which is being held April 1-5.
A man from Cleveland, Ohio became the first in the world to have movement restored in his previously paralyzed arm and hand with the help of a temporary brain implant, said scientists from Case Western Reserve University (CWR).