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 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.

Populations 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.

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.

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 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.

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 about proposing a new FDA approval pathway that prequalifies innovative materials.

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 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 outcomes per dollar spent – or better care through less costs, according to Hughes. 

Two categories of value based evidence include clinical effectiveness – outcomes-based data – and cost effectiveness – delving into what the health providers are billing payers for their products and services. 

Find out more from Hughes in Medical Design & Outsourcing's latest podcast.

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 imposing those kinds of fees, specifically on the de novo," Drues said.

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, it can be someone nebulous, somewhat overwhelming. ... That's where the intended use helps with that," Speer says.

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 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 microinnovation can be disruptive because it offers a new and value-conscious way to think about healthcare product development. Find out why there is potential for microinnovation to upend the healthcare ecosystem.

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.Listen to Drues discuss the importance of label design – as well as his four-step design process.