Fibrosis: How to prevent it in medical device implants

Massachusetts Institute of Technology (MIT) and Boston Children’s Hospital researchers have discovered a way to prevent fibrosis from forming around medical device implants. The body’s immune system usually attacks implanted medical devices that are used for drug delivery, sensing or tissue regeneration. Defense cells in the body try to isolate the foreign material from devices

Electric medical device regulatory standards have changed: Here’s how

Dirk Smith, Co-founder of Minnetronix Medical devices in 2016 continue to benefit from dramatic technology developments across engineering disciplines. Electronic-based devices, in particular, are increasingly employing cutting-edge technologies to meet user demands for fast, multi-function, usable, safe and cost-effective products. As complexity in devices and technology rapidly evolve, regulatory requirements are following suit, with significant

Donald Trump: 5 questions medtech needs to ask

From tax breaks to Obamacare repeal, medtech companies are likely due to experience major changes under President Donald Trump. The situation, though, remains unpredictable. “I don’t think that there has been a scenario, not since I’ve been a professional and in politics, where we really know so little about exactly what the key priorities are

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Medtech patenting: How you might be leaving money on the table

Jackie Hutter, The Hutter Group Entrepreneurs bringing innovative new medical devices to market often make a significant mistake when they go to patent their work. I frequently find that these entrepreneurs focus their patenting efforts on the particular medical device product without also recognizing that a wider scope of coverage for their innovations may be

Medtech cybersecurity: Why you should still be scared

  Medical devices have turned out to be an Achilles’ heel for a healthcare industry still bombarded by cybersecurity breaches, according to TrapX’s “2016 Year-End Healthcare Cyber-Breach Report.” In 2015, healthcare data security breaches became more than a growing concern—they became a new reality. There were 57 attacks, and hackers breached more than 111,812,172 data records. The

Cogmedix expands medical device manufacturing space

Cogmedix, a medical device engineering and manufacturing company and wholly-owned subsidiary of Coghlin Cos., announced that it is near completion of a renovation project at its Worcester, Mass. facility. The expansion will increase Cogmedix’s medical device manufacturing space by several thousand square feet. “Continued growth of existing customers combined with several new OEM’s coming on

MasterControl reports innovation and continued growth

MasterControl, a leading global provider of enterprise quality management systems (EQMS) and quality and compliance consulting services, says it has experienced a stellar year in terms of company growth and customer success and delivering new advancements to the market. “If I had to categorize the scope of 2016 for MasterControl, I would call it a

Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical

Cosmed Group acquires ethylene oxide sterilization operation

Cosmed Group has bought an ethylene oxide sterilization operation from iuvo BioScience, ending an 12-year break from the marketplace. Ethylene oxide (ETO) is a colorless, flammable and explosive gas that is used as a low-temperature sterilant, according to a 2008 Disinfection and Sterilization Guideline article relayed by the CDC. Alkylation contributes to the microbicidal activity

New imaging technique could better spot ortho implant infections

Prosthetic joint infection is becoming a costly and rising problem in the U.S., simply because of the rising numbers of joint replacements occurring. University of California San Diego engineers suspect they have a new non-invasive method to detect the infections early, in orthopedic implants as well as prosthetics used by amputees. The new prosthetic infection

FDA and ‘emerging signals’: what you need to know

FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week. The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to

How Proto Labs is helping the blind to see—with their tongues

Injection-molded polycarbonate parts from Proto Labs played a significant role when it came to Middleton, Wis.–based Wicab ramping up production of its BrainPort “oral electronic vision device.” The BrainPort V100 received FDA de novo marketing approval last year for use among the profoundly blind. It uses a small headset-mounted video camera to capture visual information. The