MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

7 Reasons for Medtech to Be Thankful in 2019

  • It's easy to get caught up in the doom and gloom, but in the spirit of the U.S. Thanksgiving holiday, this week we recognize the trends and events that the industry may be thankful for (in no particular order).

    Interested in seeing what medtech was thankful for in 2018? Click here. Or, for the 2017 list, click here.

    Photo by Simon Maage on Unsplash
  • Robotic Surgery Enters Its Prime

    You'd be hard-pressed to find a sector of medtech that is hotter at the moment than robotic surgery, and it's only expected to get hotter in 2020. Robotics is one of the most talked-about spaces at industry events like MD&M West and the upcoming BIOMEDevice San Jose. It's also one of the most lucrative career paths in biomedical engineering.  Even Intuitive Surgical, the company that pioneered the robotic-assisted surgery market and is on its fourth-generation of da Vinci systems with the da Vinci Xi (pictured), is bracing for the impact of new competitive dynamics as Medtronic, Verb, Johnson & Johnson, and many others look to cash in on robotics.

    Image Courtesy of Intuitive Surgical Inc.
  • A Breakthrough-Friendly Regulatory Environment

    FDA's breakthrough devices program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. The agency has been rapidly accepting devices into this pathway this year. Products that have been granted a breakthrough device designation in 2019 include an artificial meniscus, a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, an interatrial shunt for heart failure from V-Wave, B. Braun's drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronary intravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze, and two cancer diagnostic tests.

    Wondering if your product meets the criteria? Here's where you can find out.

    Image by Tumisu on Pixabay
  • Strong Leadership and Successions

    Medtech has been blessed with countless executives over the years who have helped to shape not just the company's they lead but the industry as a whole. MD+DI recognized two such leaders this year who have announced their near-term retirements. In August, Medtronic CEO Omar Ishrak announced that he will hand the baton over to Geoff Martha, on April 27. More recently, Abbott CEO Miles White announced that he will pass the torch to Robert Ford, a 23-year veteran of the company, on March 31. Both Ishrak and White have had a hand in shaping the medical device and diagnostics industries during their careers. Click here for a review of the biggest Medtronic moments under Ishrak's lead, or click here for the biggest moments under White's 21-year run as Abbott's CEO.

    Image by geralt (Gerd Altmann) on Pixabay
  • AI Is Everywhere in Medtech

    The only thing that can even hold a candle to surgical robotics in terms of popularity in the industry is the use of artificial intelligence (AI). The technology seems to be the bandwagon on which everyone in the industry wants to be, even if they're not entirely sure why they want to be on it, as a speaker pointed out at MD&M Minneapolis in October.

    "It reminds me of the time, years ago when I started my career and companies were moving into China, and I asked one of my friends, a supplier, ‘why are you going to China?’ and he said, ‘I have no idea but I think it’s the politically correct thing to say and probably do'," said  were Nikhil Murdeshwar, a senior principal research engineer at Olympus Surgical Technologies America. "So it’s the same thing with AI. It’s the politically correct thing to say and do, but like Dave [Saunders] said, AI has been around for a long time, the challenge is what are you going to do with AI? I think I know exactly what I’m going to do with AI, but I don’t think everyone else knows.”

    MD+DI put together this guide in April that characterizes the current state of AI in medtech and what the future may hold for AI in the industry. 

    Image by geralt (Gerd Altmann) on Pixabay
  • Landmark FDA Approvals

    From a vertebral body tethering system that helps kids with scoliosis, to the first device-based therapy aimed at ADHD, the industry has witnessed a lot of historic FDA approvals this year.

    In August, FDA approved The Tether from Zimmer Biomet which represented a major win for the company and, most importantly for the field of scoliosis treatment. The device is designed to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option. It is intended to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. Click here to read more about The Tether.

    The Monarch external Trigeminal Nerve Stimulation (eTNS) System made history in April after it became the first device to win a nod from FDA to treat attention deficit hyperactivity disorder (ADHD). The Monarch, developed by NeuroSigma, stood out in because typically pharmaceutical solutions are used to treat patients suffering from ADHD. Click here to read more about this device-based ADHD treatment.

    More recently, Vela Diagnostics made history by bringing to market the first test capable of detecting human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next-generation sequencing technology. The company submitted the Sentosa SQ HIV Genotyping Assay for FDA market authorization in March. Click here to read more about this first-of-its-kind HIV test.

    Last but certainly not least, FDA recently approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. Until now, traditional eyeglasses and contact lenses available in the United States have only been developed to correct blurred vision (a symptom of myopia), but not for slowing the progression of the condition. Click here to read more about the MiSight contact lens from CooperVision.

    Image by Arek Socha (qimono) on Pixabay
  • Paclitaxel-Based Devices Catch a Break

    For a while there, things were really looking bad for paclitaxel-coated balloons and paclitaxel-eluting stents. But the narrative has slowly improved and a recent FDA approval marked a turnaround in the paclitaxel story. 

    The agency approved Medtronic's IN.PACT AV drug-coated balloon (DCB) for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis. The IN.PACT AV DCB leverages technology from Medtronic’s IN.PACT Admiral platform. The device is designed to increase blood flow and reduce the thickening of the vessel wall by delivering the proven anti-proliferative drug paclitaxel. This drug penetrates deep into the vessel wall to prevent restenosis and has the potential to extend the time between reinterventions.

    Image Courtesy of Medtronic plc
  • The 3D Printing Hype Is Actually for Real Now

    Back in 2012, there were a lot of inflated expectations regarding the role that metal 3D printing would soon play in medical device manufacturing. Matt Sand is a product of that hype cycle because it was around that time that he, as an entrepreneur, started getting excited about the possibilities of 3D printing. Today, Sand is a co-founder and president of 3DEO.

    "We had a big false start. There were a lot of expectations built up in the media and a lot of really challenging parts, a lot of low-quality parts," Sand said during a session at the 3D Printing Innovation Summit, which was co-located with MD&M West 2019 in Anaheim, CA. "As a matter of fact, if you go back and read some of the headlines from 2012-2013, you see the exact same headlines today."

    That hype cycle resulted in a lot of jaded people, especially in manufacturing where a lot of people got really excited about 3D printing and possibly even invested millions of dollars into the technology only to realize that it wasn't exactly what the companies and the media were saying at the time.

    "That caused us to go through this peak of inflated expectations down to this trough of disillusionment," Sand said. "I actually think we're crawling out of that now ... which is exciting because I think when we talk about getting to production in 2019 and getting to high-volume applications, 3D printing is actually making a real dent in industry and I think that's happening now. We see it happening a lot more."

    "It's a great time to get into 3D printing because this time, I think, the hype is mostly real," Sand said.

    With 3D printing, you have unlimited design freedom and can make features that were previously impossible because you can change the physical part as quickly as you can redesign it in CAD.

    "Practically speaking, we can now design for function instead of designing for manufacturing," Sand said.

    For the medical device industry, this might translate into mass customization for things like hip and knee implants.

    3D printing also allows manufacturers to respond to market demand quickly because it allows designers to iterate quickly and manufacture on demand. That means avoiding the setup and minimum quantity costs associated with traditional manufacturing. Companies like 3DEO can manufacture on-demand in low volumes.

    "Your supply chain becomes a demand chain, and it's pull rather than push," Sand said.

    One of the most recent examples of 3D printing impacting the device industry is the Senella 3D-printed breast scaffold from BellaSeno (pictured). BellaSeno announced an agreement earlier this month that allows the company to use Evonik's Resomer polymer in its Senella products. The polymer will allow the scaffold to be absorbed in the body at a rate that matches the patient's own tissue. Click here to read more about that device.

    Image Credit: BellaSeno GmbH
Filed Under
500 characters remaining