BRONX, NY—The Medical Device Innovation, Safety and Security Consortium has announced it is developing a set of recommended practices and profiles for securing medical systems based on the normative requirements in the widely used ISA/IEC 62443 series of standards for industrial automation and control systems cybersecurity.
For medical device manufacturing, quality is crucial. To ensure quality in production, audits of the manufacturing facilities by a government health organization are standard. The audits and inspections are not, however, standard between countries. The Medical Device Single Audit Program (MDSAP) is looking to change that.
On the assembly line, every medical device is thoroughly checked for quality and functionality. Are all the parts present? Is the needle sharp? Does the device leak? Does air flow where, when and how it’s supposed to? Do triggers and control knobs function correctly? Does the touch screen work?
Merit Medical Systems Inc. is a leading manufacturer of disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.
The past year brought blockbuster headlines for U.S. manufacturing. Taiwanese electronics giant Foxconn unveiled plans to build a $10 billion assembly plant in Wisconsin that would make liquid-crystal display panels and employ as many as 13,000 people.
MARLBOROUGH, MA—Boston Scientific Corp. has agreed to buy rival BTG Corp. for $4.2 billion to expand its offering of medical devices to treat cancer and other disorders. Boston Scientific makes stents that hold open damaged blood vessels. BTG makes medical technology for physicians, such as cryoablation products to freeze and destroy diseased cells, and radiotherapy that delivers radiation straight to tumors.
NOTTINGHAM, England—A team of Nottingham Trent University researchers are 3D printing replica human vertebrae that can act and feel like real bone tissue to help train spinal surgeons before they go into live operations.
Medical device manufacturers value silicone adhesives for their ability to bond various substrates when assembling devices such as catheters, pacemakers, cochlear implants, aesthetic implants and gastric balloons.
Many engineers will put great thought into selecting the proper type of fastener for their design, but overlook the importance of finish. When selecting the best finish for fasteners, it is wise to consider the following factors