One of the toughest design engineering challenges is making a medical device that works flawlessly with the human body. The unique anatomy and physiology of every patient create physical complexities and ever-shifting functional parameters that must be thoroughly accounted for when producing a therapeutic product that may need to last a lifetime.
The rapid introduction of Lab-on-a-Chip (LOC) technology is accelerating the move to Point-of-Care Testing (POCT). However, many companies are finding that perfecting LOC technology is only part of building a viable business model. The need for a complete system approach is a prerequisite to broad and rapid market adoption. The options for building a complete system are complex, confusing, and sometimes conflicting.
The innovators selected to participate in StartX MedIC were unbelievable individuals. The participants included physicians, surgeons, physicists, electrical engineers, mechanical engineers, computer scientists, data scientists, computer programmers, industrial designers, interface designers, interaction designers, start-up founders, serial entrepreneurs, inventors, PhD students, medical students, and marketing executives from all types organizations and institutions.
Telepresence has uses in a variety of environments such as large enterprise and manufacturing facilities, where a robot can help distant engineers and other team members stay connected with their team with live audio and video, eliminating costs and travel 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 molding.
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 adhesives/coatings.
According to the National Sleep Foundation, more than 18 million American adults have obstructive sleep apnea (OSA). OSA occurs when the back muscles of the throat relax while sleeping, causing the airway to narrow, resulting in snoring. These muscles could also completely block the flow of air to the lungs. When the brain detects a lack of oxygenation, it sends an impulse to the muscles forcing them to restart the breathing process.
Would you please comment on the medical device industry as we move into 2013? Contract manufacturing continues to shift from just “manufacturing” to include a full road map of your finished products, including design, test, manufacturability, and distribution.
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?