Who’s afraid of the big, bad PMAs?

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 who has worked with both medical device companies and FDA. There are many myths around premarket approval, such as the idea that PMAs always require

Medical devices: When should you make them smarter?

The drive toward value in healthcare has increased demand for smarter medical 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

Is 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.

This technology allows package sterilization of silicones with in-situ curing

New 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

Medical device reimbursement: How it’s a brave new world

Populations in developing countries are aging. Healthcare systems are feeling even more financial pressure. In response, there’s been a shift toward payment models in the U.S. and elsewhere that emphasize “value.” In other words, health providers need to run more efficiently and effectively to get paid. Medical device reimbursement will never be the same. “This

Medical device companies need to worry more about liability: Here’s why

Mike 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

Biomaterials: 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

Medical device value: Here’s how you work it into your design

Public 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

Did 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

How medical device risk management is connected with design controls

Medical 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,

Microinnovation: what paper towels have to teach us about medtech

How 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 device labeling: You need to design it, too

When 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. Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives

How medtech can create value in connected care

A cost-conscious healthcare system is increasingly driving toward value, creating both a challenge and an opportunity for medtech. There is a big difference, though, between what is an intuitively good idea in a care setting and what will actually resonate with hospital systems. Influential designer Aidan Petrie, who was a recent presenter at DeviceTalks Minnesota, discusses the complexities of

How can medical device designers and engineers get along?

Medical device designers are increasingly involved in the earliest stages of the product development process. But with this trend comes a new challenge: How can designers and engineers get along in the medical device creation process? “Some good collaboration between design teams and engineering teams has really started to change that perspective,” Tom KraMer, founder and

Fitness trackers versus medical devices: What’s the difference?

Recent research studies have been calling into question the accuracy of fitness trackers. So when would FDA step in and regulate them as medical devices? It all comes down to the difference between low-risk general wellness devices and medical devices – a distinction covered in an FDA guidance document last year, said Michael Drues, a Boston-based