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

You should be worried about St. Jude Medical’s cybersecurity woes; here’s why

The dust up between St. Jude Medical and Muddy Waters is nothing short of a cybersecurity nightmare – even for companies that have a solid security plan in place. The medtech community needs to better understand it and keep a close eye on the developments. Essentially, it represents an ethical gray area on the part of cybersecurity

How adaptive clinical trials save medtech time and money

Adaptive clinical trials are not a new concept, but they are new to medical device technology. The practice of conducting adaptive clinical trials has the potential to save manufacturers time and money, as well as help them get to market quicker. FDA has released guidelines recommending that medical device companies use adaptive designs in clinical

Bundled payments are the future of medtech

Bundled payments in orthopedics may not directly influence medical technology companies yet, but the smart firms are paying attention. The process will very likely soon be used in procedures beyond hip and knee, such as spine surgeries and neurosurgery, and future iterations of the program could include commercial risk-sharing. It is the future of many

RenovaCare president discusses regenerating stem cells using SkinGun

Thomas Bold is the President and CEO of RenovaCare. RenovaCare is developing first-of-their-kind therapies for regenerating human organs by using a patient’s own stem cells. With extensive business experience in biotechnology, device manufacturing, stem cell research and regenerative medicine, Thomas is streamlining RenovaCare’s flagship technology, the SkinGun. The SkinGun is a revolutionary technology that uses

Millennials shine light on a mobile future for clinical care

Jonathan Draper is the director of Product Management in the healthcare division at Calgary Scientific. Calgary Scientific provides advanced web-enablement, mobility, and visualization solutions for industries wanting secure access to their data or graphic intensive applications. In this episode Jonathan discusses how mobile devices are gradually being integrated into the health industry.

ARC Experts and MasterControl exec talks mobile health innovation

Walt Murray, ICLA, CSSMBB, is the CEO of ARC Experts and a strategic partner for MasterControl Quality & Compliance Consulting who recently gave a presentation on “Identifying and Conquering Your Design Control Risks Specific to Your Mobile Health Innovation” at MD&M East. His presentation highlighted design and development, along with best practices. Walt joins us