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MedicalDesign&OutsourcingThis medtech expert survived a brain tumor: Here's what he learnedBill Betten has developed medical devices for decades, but he gained a deeper understanding after hearing a doctor speak the words "brain" and "tumor."
"It's a little different when it's going to be done to you," Betten recalled today during Medical Design & Outsourcing's latest podcast. (Hear more from Betten as editor Chris Newmarker interviews him at DeviceTalks Minnesota, Sept. 9–10 in Minneapolis. Go to minnesota.devicetalks.com and use the code “25OFF” to save 25% on the cost of registration.)
Betten's tumor, fortunately, was a benign meningioma, and he's presently four and a half months into a...2019-09-0600 minMedicalDesign&OutsourcingHow to produce more medical devices for kidsFDA recently reported a startling fact: Most of the pediatric medical devices approved in fiscal 2017 were originally intended for adults.
Health providers, especially in NICUs, are continually altering devices in order to do all they can to save infants and children, but the situation is not ideal, Michael Drues, a regulatory consultant based in Southern California, recently told Medical Design & Outsourcing in its latest podcast. Simply put, children grow; adults don't.
"Clearly there needs to be more incentives. ... But I'd like to put the impetus on industry as well," Drues said.
Drues suspects the trend toward personalized med...2019-08-3000 minMedicalDesign&OutsourcingArtificial intelligence and medical devices: Why you need to careArtificial intelligence presents a whole host of regulatory challenges when it comes to medical devices.
Regulatory consultant Mike Drues says he has had clients forced to dumb down their AI technology, with U.S. FDA requiring they lock the algorithm. Drues sees locking the machine learning algorithm is a Band-Aid solution — not a longterm fix.
Drues offered some ideas about how to better regulate AI in medical devices during Medical Design & Outsourcing's latest podcast.2019-06-1400 minMedicalDesign&OutsourcingFDA Form 483s could get easier for medical device companies: Here's howFDA in the U.S. is in the process of setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, in which agency inspectors raise potential manufacturing process problems.
The proposed process actually standardizes what some in the industry have been doing for a long time: seeking nonbinding feedback from FDA about inspection results and proposed solutions, in the same way a company might hold a presubmission meeting, according to Mike Drues, a Southern California–based regulatory consultant who has worked with both companies and FDA.
Drues discussed the draft guidance during his latest po...2019-04-2200 minMedicalDesign&OutsourcingAt-home digital health: Here's what you need to knowDemand is increasing for at-home digital health systems, where sensors follow people's health data and automatically turn them into real-time insights for themselves and their health providers.
From ResMed and its connected CPAP technology to Clarify Medical getting user feedback for its light therapy system for skin conditions, medical device companies have started to score successes in at-home digital health, according to Scott Thielman, CTO of Product Creation Studio (Seattle).
"We really need to focus on cultivating user experience — a great user experience that will be sticky, that will overcome the downsides of having to live with whatever this tech...2019-03-0400 minMedicalDesign&OutsourcingMedical device industry regulation is changing: What you need to knowThe medical device industry has been taking a lot of heat lately when it comes to patient safety.
There's the recent International Consortium of Investigative Journalists' "Implant Files" report, as well as the documentary "Bleeding Edge" on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants.
Veteran regulatory consultant Michael Drues thinks the problems outlined in the reports echo concerns going all the way back to when the FDA started regulating medical devices in 1976.
They raise similar questions, too. "What do we do to prevent them...2018-12-1700 minMedicalDesign&OutsourcingWhat does the U.S.-China trade war mean for medical device companies?The ongoing trade war between the United States and China affects everything from tooling and mold-building to commodity medical devices when medtech is concerned, according to Mark Bonifacio of Bonifacio Consulting Services.
Bonifacio, though, thinks China is too big for medical device companies to ignore: Even if the labor costs savings aren't as attractive, there is simply too much potential for the country's domestic medical device market to grow as an expanding middle class seeks better healthcare.
Listen to Bonifacio describe the pros and cons when it comes to medical device companies doing business in China in the present environment.2018-12-0300 minMedicalDesign&OutsourcingWho's afraid of the big bad PMA?PMAs at FDA are often a scary process for medical devices developers. But that doesn't have to be the case, according to Michael Drues, a regulatory consultant based outside Boston.2018-07-1200 minMedicalDesign&OutsourcingMedical devices: When should you make them smarter?The drive toward value in healthcare has increased demand for smarter devices able to provide information for real-time feedback, as well as after-the-fact analysis.
So when does it make sense to actually make a medical device smarter? And how do you go about it? Tom KraMer, CEO of Kablooe Design outside Minneapolis, has a warning: "Never fall into the trap of having a technology that's looking for a place to be used."
Medical device creators, according to KraMer, need to start out by figuring out what might be useful and actionable for patients, health providers, health insurers and...2018-06-2000 minMedicalDesign&OutsourcingIs FDA's easing of medical device malfunctioning reporting a good thing?The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA.
"I think that's simply embarrassing as an industry," regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing.
FDA's solution has partly been to propose an easing of the reporting requirements. Medtech companies would be able to provide malfunction medical device reports (MDRs) in a summary format on a quarterly basis – instead of filing each individual MDR within 30 days.
Drues — a regulatory consultant based outside Boston who has worked with both medical device compani...2018-05-0200 minMedicalDesign&OutsourcingThis new technology allows package sterilization of silicones with in-situ curingNew methods of sterilization have made customizable implantable silicones a possibility.
This exciting technology advance could allow better sealing, occlusion, and repair or support within a patient's body. Avantor has developed packaging to sterilize the silicone so that the material can be cured in-situ.
Julie Cameron, VP of business development and marketing for the Nusil brand of Avantor, describes the benefits and limitations of the new technology — and how it can be used in the medtech space effectively — in the newest Medical Design & Outsourcing podcast.2018-03-2800 minMedicalDesign&OutsourcingMedical device reimbursement: How it's a brave new worldPopulations in developing countries are aging. Healthcare systems are feeling even more financial pressure. In response, there's been a shift toward payment models that emphasize "value." In other words, health providers need to run more efficiently and effectively to get paid.
"This is a brave new world when it comes to reimbursement," said Tom Hughes, senior principal adviser for health economics and reimbursement at Minneapolis-based RCRI.
Listen to MDO's newest podcast and find out from Hughes how medical device companies can adapt.2018-03-1900 minMedicalDesign&OutsourcingEurope's new MDR: Is it as scary as you might think?The European Union's regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is trying to become friendlier to innovators.
In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside Boston.
Listen to Medical Design & Outsourcing's latest podcast as Drues takes a dive into what the MDR means and how medical device companies can strategize around it.2018-03-0200 minMedicalDesign&OutsourcingMedical device companies need to worry more about liability: Here's whyMike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don't fear FDA; fear the product liability attorneys.
"You should fear the product liability attorneys because they could impose a heck of a lot more damage on a company than the FDA ever could. And by the way, product liability attorneys are much better at finding documentation than the FDA ever would be," Drues said.
Find out more from Drues in Medical Design & Outsourcing's latest podcast.2018-01-0300 minMedicalDesign&OutsourcingBiomaterials: Is there a better way for FDA to regulate them?The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials?
Mike Drues thinks the answer is "yes."
"It really will encourage companies to use new materials and not be hamstrung with materials that have been ... used for decades or in some cases even a century," said Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA.
In MDO's latest podcast, Drues discusses how the medical device industry might go ab...2017-12-0500 minMedicalDesign&OutsourcingMedical device value: Here's how you work it into your designPublic and private payers are increasingly demanding that health providers manage their patient populations more effectively and efficiently. That means that medtech companies can no longer merely rely on the strength of their technology to achieve reimbursement.
They need to demonstrate "value," too.
"There's a lot going on with the healthcare payment delivery systems to reform healthcare, and that's primarily quality and cost," said Tom Hughes, senior principal advisor at the Regulatory and Clinical Research Institute outside Minneapolis. (Meet with RCRI officials at booth #302 at DeviceTalks Boston on Oct. 2.)
But was does value mean? Value means outc...2017-09-1100 minMedicalDesign&OutsourcingDid Congress just kill medical device innovation?The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston.
That's because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests for de novo device classifications. Drues, who has worked with both device companies and FDA, has clients speeding up de novo applications to get them turned in before the fees take effect on Oct. 1.
"I can think of no better way to stifle or kill innovation than by imp...2017-09-0600 minMedicalDesign&OutsourcingHow medical device risk management is connected with design controlsMedical device design controls play an important role when it comes to risk management, but the relationship isn't always immediately clear.
Intended use is especially important, says Jon Speer, founder of Greenlight.guru (Indianapolis), which markets a cloud-based quality management software.
"If you don't have a clear order or boundaries for conducting your risk management activities, it can be someone nebulous, somewhat overwhelming. ... That's where the intended use helps with that," Speer says.2017-09-0100 minMedicalDesign&OutsourcingMicroinnovation: What paper towels have to teach us about medtechHow can you double the efficiency of a paper towel? Turns out you don't need to reformulate or make the paper thicker. Instead, you find a simple concept that offers users a new way to think about the product. That's what happened when paper towel manufacturers began producing the half-sized sheet.
Roger Smith thinks the medical industry is ripe for this type of innovation. Smith is chief technology officer for Florida Hospital’s Nicholson Center for Surgical Advancement. In this podcast, he discusses a concept called "microinnovation" with Medical Design & Outsourcing senior editor Heather Thompson. He says mi...2017-08-2200 minMedicalDesign&OutsourcingWhy you need to design your medical device labelingWhen designing and developing a medical device, companies often consider labeling down the road, but they shouldn't, says Michael Drues, a regulatory consultant based outside Boston.Listen to Drues discuss the importance of label design – as well as his four-step design process.2017-08-0300 min