Med Device Online: Advancing human health by connecting people, organizations, and ideas in the design and development of medical devices.

Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks

It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.

FDA Releases Draft Guidance On Medical Device Accessories
The FDA has recently released draft guidance related to medical device accessories, which includes how those products are defined. Classification of these devices uses a risk-based framework, and the guidance describes the process for identifying where an accessory fits within that framework. The document was only released to elicit comments from industry and other parties, and is not final or in effect at this time.
Immobile Sperm Cells Swim Again Thanks To Light
For the first time, the function of sperm has been controlled by optogenetic processes. By inserting a light-activated enzyme into mouse sperm, researchers from the Max Planck Society turned previously sterile mice into fertile ones. This work illustrates how optogenetics can be used outside the area of neuronal cell research.
Portable Stimulator Could Improve Balance, Motor Skills Of Parkinson’s Patients
New research has shown that a small electronic unit may help restore balance to patients suffering from Parkinson’s disease by applying electric noise stimulation. The device provides electrical stimulation to the organs that monitor balance, which compensates for shortages of dopamine and restores motor skills and balance. Originally tried in rats, the technique has now shown some benefit in humans.

Success in today’s medical device industry requires innovative ways of thinking about traditional and evolving problems. To this end, Med Device Online is pleased to bring you Med Device Insights, a new digital publication that imparts fresh perspectives and strategies from your peers and other thought leaders in the space. Our first issue includes original articles about:

A revolutionary new approach to rapid prototyping
The unintended consequences of new payment paradigms
Factors to consider when developing your India strategy
Using Internet-of-Things-style protocols for connected devices
Steps to identify the right clinical outsourcing partner
A company developing laser-based tumor ablation systems
And more...

Check out Med Device Insights today!

Why You Need Cybersecurity (Even If You Think You Don’t)
Does your medical device present a threat to hospital network security? If you haven’t baked cybersecurity into your device design, the answer may be yes.
U.S. Minimally Invasive Spinal Implant Market To Outpace Growth In Traditional Spine Market
Growth in the spine market today is largely driven by the rapid rise in popularity of some motion preservation devices, most notably artificial discs, and vertebral compression fracture devices. Certain traditional fusion markets are expected to show strong rates of growth, but the overall market will eventually begin to stabilize in value as minimally invasive spine (MIS) procedures become increasingly popular among surgeons. Though the minimally invasive spine market will see the highest rates of growth, many traditional spine market segments are expected to continue to increase over the next few years.
Medical Device Design Controls: Following The Regulation Vs. Understanding Its Intent
When it comes to design controls, one of the most common problems I see medical device companies make is focusing on following the regulation rather than understanding its intent. In other words, they focus on what the words say, and not what the regulation is trying to accomplish.

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How To Develop A Quality Culture In Your Medical Device Manufacturing Operation
The lengths to which medical device companies go to deliver a quality product vary widely, but clearly there are some commonalities with regard to the development and maintenance of a quality management system that produces consistently excellent products. One of these has to do with the amount of attention given to manufacturing operator and technician training.

The 12 Questions To Ask When Outsourcing Medical Devices

The decision to outsource a medical device has serious consequences for your business and for your ultimate customer. This article will help you design a Q&A checklist for choosing the right outsourcing partner. In the article, you will learn the 12 questions that are most likely to elicit information critical to identifying a partner with the quality, experience, capacity (current and future), and financial stability to produce those products which are proudly labeled with your company name and logo.

Optimal Data Analysis In Medical Device Trials

The United States is the acknowledged world leader in medical devices and diagnostic products. As the largest medical device market in the world, representing around $110 billion, The U.S. market is expected to reach $133 billion by 2016. In 2012, the U.S held about 38 percent of the global medical device market.

3 Key Questions When Doing A "Product Refresh"

Today’s healthcare environment is pressuring medical device manufacturers more than ever to demonstrate value for low cost. As a result the focus in new product development has become less on brand new innovation and more on incremental improvements, or the “product refresh”.

Stimulating Development: Best Practices For Accelerating Neurotech Medical Device Commercialization

The time and cost of bringing neurostimulation devices to market are significant challenges. Here are some ways to overcome them.

Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks
It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.
Nearshore Or Offshore? How To Decide Where You Should Manufacture Your Medical Device
Nearshoring has become a major buzzword in recent years. But despite all the hoopla, nearshoring is not the right approach for everyone, warns medical device manufacturing consultant Mark Bonifacio, a 25-year veteran of the industry. During a recent conversation, Mark shared four questions medical device companies need to answer before making the decision to nearshore or offshore production of their products.
Google, Apple, & Other New Medtech Players: If You Can’t Beat Them, Join (Or Copy) Them
The U.S. healthcare sector is currently engaged in a bizarre game of musical chairs. Traditional participants are snatching up seats they haven’t historically occupied, while still clinging desperately to their own, and new players are constantly jumping into the fray. When the music finally stops, will medical device incumbents still have chairs to sit on?

Precision Linear Servo Motor Table: 400LXR Series

The 400LXR series of linear motor driven, high-speed, high-precision tables combines quick response, high acceleration, high velocity, and fast settling time with micron and sub-micron-level positioning. They’re offered in 100, 150, and 300mm widths with travel lengths and have been designed to accommodate the size and performance requirements typically associated with applications involving medical device design.

Prototype Tooling Services

PTI’s tooling division has the ability to produce high quality prototypes in 2-5 week windows (in some cases, even faster). This type of turnaround is possible for both single-component and multi-part programs.

Selective Laser Sintering (SLS) for Additive Manufacturing

Selective laser sintering is an additive process that draws on a bed of thermoplastic powder to create a fully sintered, Nylon-based part. This technique is ideal for parts with highly complex geometries.

Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products

For the person with diabetes in need of insulin, the heart patient awaiting a monitor or the individual expecting critical lab results, a delay of even one day isn't acceptable. Timely delivery of medical supplies or medication could mean the difference between recovery and relapse.

Ultra-Broadband Low Loss Power Divider

Corry Micronics has developed a 6-way ultra-wide band power divider that has a typical insertion loss of 2 dB with a frequency range from 800 MHz to 18 GHz. The 6 way power divider is rated at 30W CW or 5W CW per input channel. The design is compact and rugged.

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Could Ventricular Assist Devices Help Cure Heart Failure?
Recent cutting-edge research has shown that left ventricular assist devices may help regenerate heart tissue. Prolonged use of these devices cuts down on certain forms of oxidative cell damage, enabling significant cardiac cell proliferation in humans.
Medtronic Makes Significant Strides Toward Artificial Pancreas
Medtronic’s new insulin pump, the MiniMed 640G, has been approved for use in Australia with other markets around the world expected to follow. The advanced technology mimics human pancreatic function, and Medtronic is calling the launch a breakthrough towards the development of an artificial pancreas.
Judge To Rule On J&J-Boston Scientific Dispute Over Guidant
A federal court judge will soon rule on whether or not Boston Scientific owes Johnson & Johnson billions of dollars over the acquisition of heart device maker Guidant. This comes after the end of the non-jury trial of the case in New York federal court. The ruling will be announced at an unspecified date.
FDA Releases Draft Guidance On Medical Device Accessories
The FDA has recently released draft guidance related to medical device accessories, which includes how those products are defined. Classification of these devices uses a risk-based framework, and the guidance describes the process for identifying where an accessory fits within that framework. The document was only released to elicit comments from industry and other parties, and is not final or in effect at this time.
Immobile Sperm Cells Swim Again Thanks To Light
For the first time, the function of sperm has been controlled by optogenetic processes. By inserting a light-activated enzyme into mouse sperm, researchers from the Max Planck Society turned previously sterile mice into fertile ones. This work illustrates how optogenetics can be used outside the area of neuronal cell research.
Portable Stimulator Could Improve Balance, Motor Skills Of Parkinson’s Patients
New research has shown that a small electronic unit may help restore balance to patients suffering from Parkinson’s disease by applying electric noise stimulation. The device provides electrical stimulation to the organs that monitor balance, which compensates for shortages of dopamine and restores motor skills and balance. Originally tried in rats, the technique has now shown some benefit in humans.
New Nanoparticle Works With Six Types Of Medical Imaging
Scientists have developed a nanoparticle that is compatible with six different kinds of biomedical imaging tests, which could lead to a more comprehensive diagnostic image than any existing machine can currently produce. If the technology is safe, it could reduce the number of tests necessary for clinical diagnosis.
Manufacturers Invited To Join Medical Device Single Audit Program Pilot
Medical device manufacturers from around the world were recently invited to participate in a single quality audit program to streamline inspections. The pilot program aims to minimize disruption in manufacturing operations and simplify the process of meeting similar regulatory requirements across borders.