• 2 Significant Trends Transforming Medtech

    It comes down to digital health and the power of the consumer, Stacy Enxing Seng, former president of ev3, said Wednesday at Minnesota Medtech Week. Chris NewmarkerDoes this ever so snuggly sock represent the future of medtech? (Image courtesy of Owlet)The Provo, UT–based startup Owlet’s wearable can track an infant’s breathing and pulse—and hopefully help parents keep their newborn safe during sleeping—and the sensor is innocuously packaged in a snuggly little sock. Unlike the older...
  • PwC Dragged into $17M Burrill Fraud Suit

    Noted biotech investor G. Steven Burrill had been accused of embezzling $17 million. Now, a venture firm launched by Burrill is charging PwC with being complicit in the scheme.Qmed StaffG. Steven BurrillA venture firm created by Burrill & Co. is suing PwC as well as G. Steven Burrill, the founder of the company bearing his last name. The plaintiff, Burrill Life Sciences Capital Fund III LP, accuses PwC for failing to bring attention to fraudulent transfers that are said to have...
  • Laser Microfabrication Takes on Diagnostic Consumables: Part 2

    This article explains how lasers compare to traditional methods for fabricating diagnostic consumables.Glenn OguraIn Part 1 of this article, you learned about the benefits of miniaturization for diagnostic consumables, and that many of them are now being fabricated from polymers and glass, rather than silicon, ceramic or printed circuit boards. This brings laser micromachining into play, as it offers the features necessary for the challenges of machining consumables in fields such as molecular...
  • Lessons Learned from Theranos' Misfortunes

    Theranos has been charged with being too secretive for its own good. The firm’s founder Elizabeth Holmes is now vowing to be more forthcoming with data. Much of the recent controversy swirling around the company is related to avoidable regulatory missteps the company has made. Here’s how you can avoid making similar mistakes.Qmed StaffJust a few weeks ago, Theranos was one of the hottest companies in the medical technology field and one of the hottest Silicon Valley startups. But then, the...
  • 6 Important Quotes from Medtech Leaders

    Recent earnings calls for the largest medical device companies provide hints when it comes to the future of the industry.Chris NewmarkerMajor medtech companies have been wrapping up another series of quarterly earnings releases. In the process, calls with analysts have included several telling quotes about where some major companies are going.Here are six quotes that have caught our eye at Qmed:Gary PrudenWorldwide Chairman, Medical Devices at Johnson & JohnsonOctober 13 Transcript“The...
  • Healing Broken Bones with Biodegradable Implants

    Recent findings suggest a new synthetic biodegradable material could help heal bones in patients with orthopedic injuries.Kevin Baker (Image courtesy of Beaumont Hospital)Kristopher SturgisResearchers at Beaumont Hospital (Royal Oak, MI) and Johns Hopkins are hopeful that a new experimental material could someday become a gold standard for patients who require bone replacement surgery after instances like tumor removal, spinal fusion surgery, or fracture repair.However, the material—...
  • 6 Medtech Predictions to Watch Out for in 2016

    From home healthcare taking some baby steps to retailers driving telemedicine, there is change on the way next year, say experts at Frost & Sullivan and the design firm Nottingham Spirk.Brian BuntzGet ready for a Voltron approach to healthcare (see point #6)While 2016 will see the election of a new president, the trends that categorize the year are likely to be outgrowths of existing movements in healthcare, but by no means does that mean that 2016 will hold more of the same. Qmed spoke...
  • Theranos' FDA Headaches Could Cost Them Dearly

    Theranos’ regulatory troubles could cost them over $1 million, according to one regulatory expert. Here’s a timeline of how they got there.Qmed StaffAn image of Theranos CEO Holmes pulled from the company's website. Blood testing firm Theranos will likely have to spend considerable money to address observations addressed in two FDA Form 483 documents, which list a total of 14 observations. “I'm guessing their remediation efforts can easily approach $1 million,” says Jon Speer, founder of Creo...
  • Baxter Cuts 1400 Workers, Hires Ex-Covidien CEO

    After a rough third quarter, Baxter has announced layoffs, and its plans to name José Almeida as its new chairman and chief executive officer, effective January 1, 2016.Nancy CrottiBaxter saw its profits nosedive in the third quarter of the year, which was partly a result of costs linked to spinning off its pharmaceutical business. To help bring costs down, the company is cutting roughly 5% of its non-manufacturing payroll by the end of the year.The company also announced that former Covidien...
  • 4 Deaths Linked to Cardiac Device Infections

    Eight people treated with a medical device used in open-heart surgery in York, PA ended up getting infections.Qmed StaffAs many as 1300 patients at WellSpan York Hospital may have been potentially exposed to a bacterial strain known as nontuberculous mycobacterium during open-heart surgeries performed from October 1, 2011 to July 24, 2015. A medical device known as a heater-cooler system, which is used to heat or cool blood during heart surgery, was believed to have played a role in spreading...
  • How Nanotech Could Improve Medtech

    Considerable progress has been made in miniaturizing medical devices, says James Marti, PhD, associate program director and senior scientist at the University of Minnesota Nano Center.James MartiNancy CrottiWhere is nanotechnology going to pop up next? Medical researchers are already using it for targeted drug treatments, imaging, wearables and implantables.James Marti, PhD, associate program director and senior scientist at the University of Minnesota Nano Center, will speak on the...
  • What You Absolutely Need in a Medtech Contract Manufacturer

    Here’s a hint: it involves less hand-holding, says Olympus' Nikhil Murdeshwar.Nikhil MurdeshwarChris NewmarkerAs a principal research engineer at Olympus, Nikhil Murdeshwar’s job involves helping to scout out new business opportunities for the Japanese multinational, and then getting to work on making them a reality. His initial design input work involves helping to forge some of the early contract manufacturer and supplier relationships for medical devices of the future.So what...
  • How to Avoid Exponentially Escalating Costs with Design Controls

    Medical device companies that identify quality problems early on can prevent product development costs from spiraling out of control, while also laying the groundwork for design verification and design validation.Jon SpeerEntering into the design verification and design validation “stages” of medical device product development is a significant milestone and major accomplishment.According to the infamous design controls waterfall diagram, entering into design verification and design validation...
  • Tweaking 3-D Printers to Produce Live Heart Models

    A group of researchers from Carnegie Mellon University (CMU) have developed a technique that can transform a range of consumer-level 3-D printers into bioprinters — producing 3-D models from soft materials that assemble into common tissue. Kristopher Sturgis A coronary artery structure can be 3-D printed using the novel technology. A group of CMU researchers believe they have developed a new method for 3-D bioprinting that can be implemented on a range of consumer-grade 3-D printing...
  • Feds Open Investigation into Valeant's Contact Lens and Drug Practices

    The Federal Trade Commission is investigating whether Valeant Pharmaceuticals International has gained a monopoly on the market for one of the main components of rigid contact lenses. Last month, House Democrats filed for a subpoena for documents that would explain why the company dramatically increased the price of two drugs. Nancy CrottiHealthcare conglomerate Valeant Pharmaceuticals, which made headlines last year for its failed hostile takeover attempt of Allergan, is seeing its stock price...
  • Designing a $93M Medical Technology: A Behind the Scenes Look

     The design firm Nottingham Spirk provides the inside scoop on how a sleek advanced cardiac mapping technology was developed starting from a crude prototype.Qmed StaffThe ECVUE vest can conform to a range of patient body types. In 2006, the startup CardioInsight (Cleveland, OH) was born with hopes of commercializing a new technology known as electrocardiographic imaging that had better resolution than traditional 12-lead ECG technology. The firm had secured considerable funding, which it...
  • Medtronic Questions Masimo Pulse-Ox Patents

    Medtronic had been paying Masimo royalties for two pulse-oximetry patents held by Masimo. Now Medtronic is questioning the validity of those patents with the Patent Trial and Appeal Board of the USPTO.Qmed StaffMedtronic has filed a claim with the USPTO’s Patent Trial and Appeal Board to challenge claims made in two Masimo patents. While Medtronic is now paying royalties to Masimo for the patents, Medtronic’s move indicate that it may stop doing so if the board supports its dispute.In total,...
  • Theranos' Partnership with Walgreens Could Be in Trouble

    A Wall Street Journal exposé on Theranos’ testing methods may have caused Walgreens officials and directors to reassess. Qmed StaffWalgreens is scrutinizing the Theranos blood testing technology it uses in Arizona pharmacies, and has no concrete plans to expand it into more Walgreens pharmacies, the Wall Street Journal reports, citing an anonymous Walgreens official. The news marks a stark contrast to the pharmacy’s original plan to eventually roll out Theranos technology in all of its 8200 of...
  • Why Size Matters When It Comes to Medical Devices

    A one-size-fits-all approach can be dangerous for certain implantable medical devices. Qmed Staff“If it doesn’t fit, you must acquit,” defense attorney Johnnie Cochran told jurors in 1995, referencing the infamous bloody glove that would not fit on accused murderer O.J. Simpson’s hand. While Simpson would later be found liable in a separate wrongful death suit, Cochran’s argument helped lead to a not guilty verdict in the case, often referred to as the “trial of the century.”Size can be a...
  • More Bad News for Breast Implant Company

    Sientra’s stock has slid more than 80% from highs of over $25 per share it hit this July and August. Now, the company has announced that a fire has hit one of its manufacturing facilities, operated by the Brazilian firm Silimed.Qmed StaffAn amateur picture from Whatsapp shows the Silimed fire. It’s shaping up to be a rough year for Sientra (Goleta, CA). Sales of the company’s products have been halted in the United States, Brazil, the United Kingdom, Australia, and other countries following an...