Based on industry statistics, it is obvious that intensified regulatory scrutiny has become a harsh reality for medical device manufacturers. Over the last several years, medical device companies have been hit with injunctions, undergone product recalls, or found themselves operating under FDA consent decree. FDA regulations seem to impact every step of the medical device lifecycle, from properly classifying a device and developing a regulatory strategy to preparing FDA submissions. So, just how are successful medical device manufacturers cost effectively achieving compliance while at the same time meeting their product delivery targets?
In 2008, a team of academic researchers shook up the connected medical device community by presenting a paper at an IEEE Symposium, which outlined a potential attack on implanted cardiac devices through the wireless interface. While this initially raised some concern, it was not until Jay Radcliffe demonstrated a potential attack through the wireless interface of a patient-worn insulin pump that awareness of medical device security issues “exploded,” prompting a U.S. Government Accountability Office inquiry into medical device security issues, and a media blitz that continues to this day.
Dip molding may not be a term that readily comes to mind when surgeons begin complicated procedures. Yet, without this sophisticated, highly controllable process, many medical devices used daily in hospitals could not meet stringent certification requirements.
The medical industry’s continued technological progress with electronics integration requires consideration of a broad range of new connector parameters. Between smaller, more portable diagnostic equipment with advanced functionality, and ever-evolving complex machines like MRI, CAT, and other diagnostic and monitoring applications, choosing an effective connector solution takes time and careful selection of new parameters.
Medical device manufacturers have traditionally relied on their extrusion supply partners for affordable medical tubing for a variety of application areas. However, more and more, these OEMs are seeking greater capabilities and more design solutions from these same supply parterners. This article looks at how medical extrusion is impacting device development today.
While coatings can offer an array of benefits to medical device components, in certain cases, they can also come with adverse effects that impact the overall efficacy of the product. An innovative technique—microstructure engineering—enables a surface treatment to be accomplished during the component fabrication process, providing an alternative to coatings.
Wireless devices have the ability to become self-contained diagnostic laboratories, communication devices for medical records, and medical therapy devices. One of the biggest challenges facing both the consumer and the clinical wireless healthcare market is large scale adoption. Adoption is limited by the regulatory environment, current product prices, and ease of device use.
When it came to designing a multi-leaf collimator (MLC) device, ViewRay took on the challenge to produce an end product that would be more accurate than others on the market. ViewRay collaborated with Maxon Precision Motors for critical components, including a custom motherboard, motors, encoders, gearheads, and individual motor control modules, according to an engineering team member.
Catheter balloons are an important device for a variety of cardiovascular treatments. However, their manufacture can be a complicated process that, if completed wrong, can lead to waste and excess costs. This article highlights a number of innovative technologies that are being offered to help balloon manufacturers ensure their products are defect-free the first time.
New material offerings are critical to medical device manufacturers as they provide new opportunities in the development of cutting edge technologies. This three-part round-up features three new materials that are impacting medical device manufacturing in the areas of adhesives/coatings, molding, and extrusion. This part focuses on extrusion.
The next evolution is the focus on the supply chain and ensuring the detailed processes are in place and that products/processes provided by downstream suppliers are validated and real. With globalization as the post facto now, it will require more stringent supplier controls from the initial selection of suppliers through the monitoring phases. How will suppliers select and monitor their supplier base?
As external industry influences like excise taxes, longer approval process time, and reimbursement pressures bear down on device manufacturers, development partners must look to areas of opportunity and how to best support medical firms in these pursuits. While opportunities such as the growing and aging population and emerging markets are getting a lot of play, it’s also important to realize that progress (i.e., technological advances) poses perhaps the most significant area of opportunity in transforming healthcare.
Many medical device component manufacturers have to adjust their product formulations to meet growing market demand for protein-free alternatives to natural rubber and natural rubber latex (NR/NRL). As simple as this may sound, this change not only requires the use of unfamiliar raw materials, but also requires new processes and a certain amount of trial and error before manufacturers discover the best NR/NRL alternatives for their formulations. One thing they can agree upon is that not all NRL alternatives are created equally.
It’s not the journey, it’s the destination. In the case of interventional cardiovascular devices, both the journey and the destination are vital. These devices need to navigate the tortuous pathways of the vasculature in order to access and treat complex distal lesions. Getting there isn’t always easy.
When a manufacturer picks up a cardiovascular device, they literally hold someone’s life. There is no room for flaws in the quality of this product, or any other in the cardiovascular realm. These devices are shrinking, while becoming increasingly advanced—more intricate parts achieve more complex functions, within a surface area that leaves only enough space for perfection. So the case has never been greater for quality assurance. Conducting risk analysis through variation analysis software can satisfy it.