The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware […]
Outsourcing
Medtronic targets supply chain for greenhouse gas emission reductions
Medtronic (NYSE:MDT) plans to reward suppliers that help reduce greenhouse gas emissions throughout its supply chain, citing “the risks that climate change poses to human health and long-term global financial stability.” Fridley, Minnesota-based Medtronic said the efforts will help the biggest company in medtech achieve net zero emissions across scopes 1, 2, and 3 — […]
Philips wants its suppliers to get serious about climate change
Philips (NYSE: PHG) wants at least half of its supply purchasing to come from companies that commit to science-based targets to reduce carbon dioxide emissions by 2025. The health technology company said yesterday that the initiative would be seven times more impactful than Philips’ own carbon dioxide emission reductions. The move comes as medical device […]
GE warns of supply chain strain well into 2022
Medical device makers and suppliers seeking relief from the global semiconductor shortage will have to hold on a while longer. GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter, and that the pressure won’t likely let up in 2021. GE Healthcare’s business “largely is a supply chain […]
Everything you need to know about medical device creation
Medtech development is hard. Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining — and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The good news is that there is now a whole ecosystem of specialized experts serving the […]
Sandia Labs seeks partners to make reusable masks
Sandia National Laboratories has come up with its own version of a reusable respirator for frontline workers. Sandia has filed for patent protection, is testing prototypes, and seeking NIOSH approval and potential manufacturing partners for its elastomeric half-mask N95 respirator. It’s the latest entry to a small but growing category of reusable masks designed to filter at […]
Seisa Medical acquires ProtoQuick and Peridot
Seisa Medical announced that it acquired ProtoQuick and Peridot to add to its plastics and metals capabilities. El Paso, Texas-based Seisa’s acquisition of the two Bay Area companies offers added expertise in plastics and metals as well as the opportunity to leverage Seisa’s global infrastructure for high-volume production of FDA Class II and Class III devices, […]
Baxter to make Moderna COVID-19 vaccine in US
Baxter announced that its Baxter BioPharma Solutions business will make Moderna‘s COVID-19 vaccine at its fill/finish sterile manufacturing facilities in Bloomington, Ind. The plan — announced yesterday — is for Baxter to make 60–90 million doses of the Moderna vaccine in 2021. “We have seen a remarkable demonstration of scientific and health care expertise in […]
Vietnam’s Vingroup to supply ventilator parts to Medtronic
When Medtronic (NYSE:MDT) announced in April that it had tapped Foxconn to manufacture ventilators at the Chinese company’s Wisconsin plant, then-Medtronic CEO Omar Ishrak said that Medtronic is also working with “major players” in Asia to expedite ventilator production. This week, Vietnam’s largest conglomerate, Vingroup, announced that it had inked a deal for two of its companies — […]
COVID-19 lessons learned: 2 manufacturers, a healthcare system and a logistics company share their wisdom
The COVID-19 pandemic put medtech contract manufacturers, OEMs, distributors and healthcare providers in situations for which they were unprepared, particularly with their supply chains. What they learned will undoubtedly help them all going forward, especially if the world faces a second wave or another novel virus. Here are some supply chain lessons learned by a […]
UPDATE: Medtech contract manufacturers make it work during a pandemic
From coping with wild fluctuations in demand to keeping workers safe and customers satisfied, these medical device industry suppliers have managed to adapt amid COVID-19 and an uncharted business environment. Medical device contract manufacturers are finding ways to keep business going during the coronavirus pandemic. Medical Design & Outsourcing recently conducted another round of an informal survey of […]