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

Spectrum Plastics Group: Why the merger took place

The M&A deal creating Spectrum Plastics Group is but the latest in a wave of consolidations taking place among medical device industry outsourcers. Mauricio Arellano, president of Spectrum’s medical division, thinks 2 trends are driving the consolidations: the need of OEMs to provide truly disruptive innovations to meet health providers needs for value-based care, and

Wading into parallel reviews as a reimbursement strategy

The process of gaining reimbursement is one of the most expensive and perilous activities a medical technology company will undergo. Some are exploring how (and whether) a strategy that encourages working with both FDA and CMS at the same time can help cut down the resource costs associated with reimbursement. Seth Goldenberg, director of product

Talking human factors and moonshots with Bryce Rutter

Medtech innovation is about considering small details while looking at a big picture. Bryce Rutter, president and founder of Metaphase Design, explores how human factors influences the design process, even when that information runs contrary to the designer’s thinking. He shares some tips on how to approach innovation based on company size, and answers the question of

Wellness entrepreneur explains his vision – and surviving a deadly brain tumor

Avi Yaron is no ordinary entrepreneur, but he is definitely an engineer. When diagnosed with an inoperable brain tumor, he met the challenge by inventing the solution to his own illness. Instead of optic mechanics, he used small silicon chips that mimic an insect eye. These enabled a camera to provide access to both the right and

Off-label use and medical devices: Here’s what you need to know

Promoting off-label use of a medical device – a use not included on a device’s indication with FDA – has become a dangerous practice for medtech insiders, with some facing potential prison time for alleged off-label advertising. But it is still possible to promote off-label use, if you know the rules, says Michael Drues, a

Exploring ePTFE sutures for surgical product development

Zeus Industrial Products has developed an expanded polytetrafluoroethylene (ePTFE) suture based on physicians’ needs. In this podcast, Bruce Anneaux, corporate director of research and development at Zeus, reviews the material properties of Aeos ePTFE and the company’s latest offering, a suture monofilament. The structure of the Aeos material consists of solid nodes interconnected by a matrix of

Design tips for overmolding prototypes

With the new push for faster and faster development prototyping outfits such as Proto labs have been adding a new services. A key new service is overmolding plastic for medical parts. Medical designers can now introduce overmolding early into their design process. But there are challenges. Becky Cater reviews best practices and some of the