Would you please comment on the medical device industry as we move into 2013? The need for medical device manufacturers to have product recall plans in place was reaffirmed by the release of the latest figures on medical device unit recalls. According to the quarterly ExpertRECALL Index released August 22, 2012, over 123 million medical device units were recalled in the second quarter of 2012...
Since 2013 brings uncertainty with it due to a number of issues and concerns, MDT sought out the industry’s supplier side to see where their thoughts were focused. Speaking with a number of service providers and component suppliers, this “industry forecast” highlights five areas: contract manufacturing, design, molding, power, and test.
The team at Vessix had previous experience with Product Lifecycle Management (PLM) software as a tool to automate product design and development processes. They wanted to implement PLM early on as a best practice for managing BOMs, engineering changes, product documentation, training records, and Corrective and Preventive Actions (CAPAs).
With the wide range of sensors on the market, selecting the best pressure measurement device for medical equipment in applications that require liquid sensing or condensing humidity can be a big challenge for medical OEMs. Designers need to choose sensors that offer the right balance of technical features, reliability, and cost for their specific applications.
Medical devices and man-made materials have achieved major advances over recent decades. However, a new drumbeat is sounding in healthcare, as the steady growth in the use of biologics in medical procedures is gaining traction. Man-made materials will always have a place in the case of acute trauma, but biologics have the potential to take over as the most effective solution for degenerative conditions.
As concerns over many implant materials, including metals, grow, medical device engineers are increasingly looking to biomedical textiles to aid in device design and implant performance. The advantages for more biomimetic functions are vast, but in order to satisfy performance requirements, there are a number of key considerations engineers must be prepared to address. Every decision, from biomaterial selection to processing technique, must be carefully assessed by a contract manufacturing partner with specialized medical textile expertise to develop a device that both delivers clinically and meets all compliance standards for regulatory approval.
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.