As a result of the European Union's new Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) adopted earlier this month, many adjustments will be required in the roles and responsibilities of medical device companies, manufacturers, importers, distributors, and authorized representatives.
This article is the second 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 design phase.
I previously wrote about phase one of the Coulter Foundation's Translational Research Partnership Program, which assists universities in developing and commercializing medical technologies by forming working partnerships and promoting translational research. Today, I focus on phase two, going inside the Coulter Foundation for perspective, exploring how the second phase benefited from the experiences of the first, and visiting with program leaders from one of the phase two schools.
The common approach to designing and developing an Instructions For Use (IFU) has been largely unchanged for years: once a product is designed and made ready for manufacturing, an IFU is then written and tested. When errors are found, changes are made, and the cycle repeats until there is an acceptable IFU version that most users will be able to comprehend. Clearly, this approach is often time consuming and costly.
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.
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.
Hill-Rom has unveiled an airway clearance system that is integrated into a mobile vest and allows patients more freedom of movement while receiving their respiratory therapies.
Successfully miniaturized multimodal optical technology combines three nonlinear imaging techniques into one probe, said German scientists.
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.