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Overhaul of FDA's approval process for medical devices overdue, but balanced approached needed

The Food and Drug Administration has announced plans to overhaul its system for approving a certain category of medical devices, which critics have said fails to protect consumers from risky implants and medical instruments.   George Ball, assistant professor of operations and decision technologies and the ArcelorMittal Supply Chain Faculty Fellow, at the Indiana University Kelley School of Business, studies the medical device industry, in particular medical device recalls.   There are two primary approval pathways for medical devices. “510(k)” clearances are reserved for products that demonstrate substantial equivalence to a previously approved device. Clinical trials are normally not required and this method is much faster and cheaper than the other pathway, a “Pre-Market Approval (PMA).”   PMA new product submissions are reserved for those products that are new or substantially modified from previously approved devices. Clinical trials in humans and laboratory study data are normally required to demonstrate safety and efficacy. In comparison to 510(k) clearances, PMA approval pathways are time-consuming and expensive.   “The FDA’s announcement regarding an overhaul of the 510(k) approval process seems to be warranted, as medical device product approvals are currently on two ends of an extreme spectrum,” Ball said. “New PMA products can require years and millions of dollars to successfully obtain approval by the FDA. Conversely, 510(k) clearances are significantly faster and cheaper, as the manufacturer has to simply demonstrate equivalence with similar, already approved products.   “As 510(k) products represent the bulk of new product approvals, they also represent the bulk of medical device recalls, unsurprisingly,” Ball said. “In the last decade, 510(k) products were recalled at a ratio of 17-to-1, compared to PMA products.”   “However, the method of approval currently practiced for 510(k) products has many benefits for manufacturers as well,” he said. “Demonstrating equivalence with prior approved similar devices makes the development time exponentially faster compared to PMA product approval times.   “A middle-ground here seems logical and advisable. For example, the FDA approves products using a two-pronged approach: safety and efficacy. While efficacy may be easily established by demonstrating similarity to prior products, evidence of safety for 510(k) products may require additional verifications and tests. Doing so may help ensure that new 510(k) products, which are often much more technologically advanced than the ones they are compared against for approval purposes, are also safe for patients.”   Ball can be reached at 812-856-0625 or gpball@indiana.edu

Guinness World Record Holder Jon Bruney To Speak at Biohacker Summit in Toronto

(Toronto) Renowned Strongman and Fitness Expert to speak at Spark Biohacker Summit at Metro Toronto Convention Center on October 15th, 2018 Jon Bruney, creator of the “Pressing the Limits” motivational strength program, will appear in Toronto at the Spark Biohacker Conference.  A devoted researcher in the pursuit of finding the edge in performance, Jon will speak about his experience using transcranial and intranasal light therapy. Jon, one of a number of elite athletes, has been working with Technology developed by Dr. Lew Lim, NMD, MBA and Founder & CEO of Vielight in Toronto. Dr. Lim will be on hand to answer questions about the broad base of international research behind photobiomodulation and what we know so far about it's mechanism. "With photobiomodulation, you can tap into the secrets of the nervous system, helping your body to push farther, to push harder, to push longer than you ever believed you could." Jon Bruney using Vielight photobiomodulation device at his Performance Training Center in Indiana  Jon Bruney and Dr. Lew Lim, Founder and CEO of Vielight, will be available for questions at the Vielight exhibition booth held alongside the Biohackers Summit. For one-to-one interviews, please contact Edward D'Mello on 647-865-2803. Session Details Monday Oct. 15, 2018    1230PM - 130PM Metro Toronto Convention Centre South Building (Hall G) 222 Bremner Boulevard Toronto, Ontario M5V 3L9 About John Bruney John's work with competitive athletes includes Olympians and NFL players. He has been featured in Ripley’s Believe it or Not, The Guinness Book of World Records, shown nationwide on NBC’s America’s Got Talent, The Today Show, ABC’s To Tell the Truth, and TruTv’s Guinness World Records unleashed. A true renaissance man in the realm of strength-development, Jon Bruney is a best-selling author, world-class trainer, coach and motivational speaker.  He is the author of the best-seller Neuro-Mass: The Ultimate System for Spectacular Strength and The Neuro-Grip Challenge: A Radical Program For Building Strength and Power in Your Upper Body. He also writes a training series called “Foundations”, featured in MILO, widely considered the world’s most prestigious strength training journal. Jon has been responsible for the design of numerous pieces of cutting-edge training equipment now in use around the world. Jon is a veteran of multiple trainer certification courses and was the first to achieve the grueling Battling Ropes Level 2 Certified status. He is also the co-owner of Submit Strength equipment. About the The Biohacker Summit The Biohacker Summit is the largest biohacking event in the world that connects well-being companies with medical professionals, technology experts, investors, entrepreneurs, health and nutrition enthusiasts, and other pioneers. Biohacking - better living through science, technology and nature - is a fast growing international trend. The aim of the conference is to make the world healthier and happier place, prevent disease, and extend human capabilities and lifespan. Media Contact Edward D'Mello M: 647-865-2803 E: edward@vielight.com #photobiomodulation #light #therapy #Toronto #Canada #Ontario #wellness #health #mentalhealth #quantifiedself #biohack #biohacker #mental #brain #body #sport #performance 

Are Smart Speakers the next must have for Canadian connected consumers?

With Smart Speakers all the rage, connected adds-ons, extras and accessories are the logical next step in building a meaningful smart home. After all, what’s the point of an expensive smart speaker with an assistant built into it if it can’t do more than help you search for a song? Smart Speakers seem to be the trending topic for most smart homes – Google and Amazon have already established their presence in the market. Sonos and JBL aren’t far behind and are now offering their alternatives; with heavyweight, Apple standing on the sidelines waiting to enter the arena. However, with home assistants still building out interconnectivities with partnering brands, does the current ecosystem of partners limit the market’s potential to grow or does it open the flood gates for more supported devices to come? How influential will the ecosystem of supported devices be in smart device adoption? Do partnering device manufacturer’s care which home assistant is used to control their device or just that smart home devices market continues to grow? As smart-homes devices continue to proliferate and home assistants become more commonplace, competition will be fierce and it will be interesting to see who prevails. IDC launches a new Worldwide Smart Home Device Tracker this week sizing up the shipment market of such connected devices as consumers continue to build the smart home of their dreams today! Manish Nargas is a research analyst specializing in consumer and mobile research. He is an expert in emerging consumer technologies with a focus on usage trends and adoption. Simply click on Manish’s icon to arrange an interview. Source:

Will Samsung Reclaim the Smartphone Throne with the S9?

It’s coming on March 16 – and after some early reviews, it appears Samsung’s latest offering – the Galaxy S9 – has its sights set on the Apple X. With a lot of serious bells and whistles including a leading-edge camera, intelligent scanning for locking and unlocking, AR avatars mapping the user’s face to create a 3D image, and a jack (lesson learned) for the headphones Samsung has given consumers just about every reason to com back into the fold. There’s also one more, it’s a premium device – but also substantially cheaper than Apple’s latest offering. And if you still can’t afford it – there’s monthly financing available. Will the S9 see Samsung return as the go-to provider for smartphones? How will Apple and others like Google react? Or, is the idea of a premium phone costing close to a thousand dollars a unit getting too expensive for limited marketplace? That’s where the experts from IDC Canada can help. Steve Yang analyzes the Canadian communications market, specifically focusing on mobility. He provides insights to Canadian wireless players around mobile phones and tablets. Simply click on Steve’s icon to arrange an interview to learn more. Source:

Is there any room left in the crowded home assistant market?

The tech world is abuzz with rumours that Spotify is potentially wading into the ‘home assistant’ marketplace. It’s a billion dollar business and could be the future for consumers wanting ‘smarter’ houses – but it is already a crowded market. The rumours are based on speculation as job postings for a project manager and analyst for a new hardware project to be developed and released. For Spotify to enter this space – it makes sense. However, is Spotify just a little too late to the party? As well, when you are last on the field and your opponents are Amazon, Google and Apple – the task ahead is daunting if not dangerous for the hundreds of millions of dollars in development and marketing that will be required. Is this just speculation for attention or will Spotify jump in and try to stand out? It’s not easy to decipher or decide. But that’s where the experts from IDC Canada can help. Jean Philippe (JP) Bouchard is Vice-President, Mobility and Consumer Research and is an expert in the areas of modeling and market forecasting, mobile device and platforms, go to market strategies, strategic marketing and product management. Simply click on JP’s icon to arrange an interview. Source:

Looks Like ‘X’ Marks the Spot as Apple Cashes in on a $1300 Smartphone

No doubt there were worries and concerns about Apple’s latest offering - the iPhone X; it’s a smartphone like no other, but one that also comes with a hefty price tag of C$1,319 for the 64GB and C$1,529 for the 256GB model. The phone features some very serious upgrades including facial recognition technology and an edge-to-edge screen. For Apple, it appears the bet has paid off. The demand for this luxury item has so far exceeded expectations. Around the globe from Tokyo, to Toronto to Toledo – customers showed up early, lined up and handed over close to a thousand dollars US for the device. But what will this mean for the industry? Has a new price-point been set? Instead of competition driving down costs – can customers expect premium prices for must have items? Can we expect Samsung, LG and others to step up with a first-class product as well? Or, will there buyer’s remorse? The bells and whistles of the iPhone X are impressive – but is it really worth it? There are a lot of questions people need to ask before buying – and that’s where the experts from the IDC Canada can help. Steve Yang is the Senior Analyst, Communications & Mobility for IDC Canada. He’s an expert in the Canadian communications market, specifically focusing on mobility. He provides insights to Canadian wireless players around mobile phones and tablets, along with related communications from a unique Canadian perspective. Steve is available to speak with media regarding the new iPhone X and what this means for the mobile industry. Simply click on either of their icons to arrange an interview. Source:

Experts Available for Commentary on Calls to Remove the Medical Device Tax

3D Communications have experts available to comment on calls by Reps. Suzan DelBene (Washington), Kyrsten Sinema (Arizona) and Scott Peters (California) to repeal the medical device tax. Source: