The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
Materials Testing
European scientists develop absorbable bandages
An international research group has developed a biocompatible bandage material that has antibacterial properties and will not require changing, a potential boon for burn patients. The material is self-absorbable, and a new bandage can be put directly on top of the old one, alleviating the need for the frequent and often-painful changing of a burn […]
Medical Engineering Technologies adds medtech testing space
Dover, UK-based Medical Engineering Technologies (MET) said it has begun expanding its lab capacity for ISO 10993-18 material characterization studies. The company is adding more than 50% to its physical testing area for medical device adherence to the ISO 10993 series of standards, which apply when the material or device comes into contact with the body directly […]
3 flexible electronics outfits you need to know
Want to know where flexible electronics could take the medtech space? A good bet might be to look at where NextFlex is putting its money. The San Jose, Calif.–based hybrid electronics manufacturing institute provides funding for promising projects in areas ranging from healthcare to avionics to infrastructure monitoring. NextFlex recently announced $12 million in awards to fund […]
What you need to know about medical device packaging
A recent study about recalls of foot and ankle implants included a portion that likely drew less attention than the headline. Some of these implants were recalled because they arrived at the hospital in an unsterile condition, and the authors said faulty packaging may have been the cause. Poor packaging can cause a host of problems for […]
Biomaterials: Is there a better way for FDA to regulate them?
The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials? Mike Drues thinks the answer is “yes.” “It really will encourage companies to use new materials and not be hamstrung with materials that have been […]
Nelson Labs parent Sterigenics buys Toxikon’s European lab business
Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon […]
Tela Bio touts data for OviTex hernia repair bioscaffold
Tela Bio touted data this week for its OviTex reinforced bioscaffold used for hernia repair and abdominal wall reconstruction. The device combines biologic material and polymer, allowing for free movement of fluid and cells through the mesh. Tela Bio’s chief medical officer is slated to present initial feedback from surgeons using the device since it won FDA […]
Aerospace may have something to teach medtech about materials: Here’s how
QuesTek Innovations has used advanced computer modeling to produce innovative materials in the aerospace sector. Now it’s looking to recreate the same magic in the medical device space. Medical device developers typically turn to off-the-shelf materials and then design based on the properties of the materials. But does it have to be this way? What […]
Researchers develop flexible patch with stainless steel microneedles
Researchers from the KTH Royal Institute of Technology in Stockholm have developed a patch that combines stainless steel microneedles and a soft polymer base. The team’s work was published this month in PLOS ONE. “To the best of our knowledge, flexible and stretchable patches with arrays of sharp and stiff microneedles have not been demonstrated to date,” […]
Artificial leaf produces drugs using solar energy
Researchers from the Eindhoven University of Technology have reportedly developed a leaf-inspired mini-factory to produce drugs using solar energy. The team’s work could allow medicine to be made in resource-deprived areas, as long as there is sunlight. “Theoretically, you could use this device to make drug compounds with solar energy anywhere you want,” lead researcher […]