Leverage Commercial Off-the-Shelf Tools to Create Verifiable Hardware and Software Solutions
The complexity of medical devices is ever increasing. Medical devices range from simple tools like a stethoscope to gene-sequencing machines and tele-operated surgical devices. As the devices become more and more complex, so does testing and risk assessment. Many are aware that the FDA’s medical device recall database reports a 17% increase from 2009. A medical device recall is the most...
Battery Fuel Gauge: Factual or Fallacy?
People often think of a battery as an energy-storage device that’s similar to a fuel tank dispensing liquid fuel. For simplicity reasons, this is somewhat accurate. However, measuring stored energy from an electrochemical device is far more complex. The battery fuel gauge is generally poorly understood, particularly in the medical field. While an ordinary fuel gauge measures liquid flow...
Be Aware of Risk Management in Batteries
A battery is a corrosive device that begins to fade the moment it leaves the assembly line. Its stubborn and unpredictable behaviour has left many users in awkward situations. Battery failure is common and up to 50% of system breakdowns are attributed to a failing battery. Much of this is avoidable, but even with the best of care, some batteries die early and scientists don’t know why....
Semiconductor Solutions Set to Revolutionize Medical Implantable Devices
With circuit miniaturization/integration, lower power processes and architectures, plus great cost savings because of the likes of the iPhone, iPad, Blackberry, etc., the semiconductor solutions contained in handheld commercial product innovations are now able to find their way into medical implantables making the seemingly impossible into a realizable and viable solution in the human body....
FCC’s Best-Kept Secret on Medical Wireless Frequencies
A great deal has been written over the past few years bemoaning the lack of dedicated frequency bands for new wireless medical devices. Likewise, with the most recent initiative between the FDA and FCC in exploring the use of a variety of narrowband frequencies for a body area network, there has been great anticipation that a dedicated FCC-approved frequency band may be made available in the near...
An Inexpensive Microscopy and Spectroscopy Hack for the iPhone
Scientists from the University of California-Davis have modified the iPhone to enable its use in microscopy and spectroscopy. The modification, which was the subject of a presentation at the Optical Society of America in October, gives the device clinical-grade performance and could help clinicians diagnose blood-borne diseases. This isn’t the first microscope created using a smartphone,...
Power Walk
Researchers at the University of Wisconsin (UW) are working on technology that could help mobile electronics take a big step forward. They’ve found a way to convert the energy generated by humans as they walk into power for devices like laptops and cell phones.  “Humans, generally speaking, are very powerful energy-producing machines,” Tom Krupenkin, a UW engineering...
IEC 60601-1 and Risk Management
When the third edition of IEC60601-1 was published, it marked the beginning of a new era. The standard now incorporates the concept and application of risk management in the design and production of devices. Implementation of risk management has implications for not only the end-product manufacturer but component providers as well, and further cascades through the entire supply chain. All parties...
FPGAs Advance Medical Imaging
Medical research can only advance as quickly as the technology that supports it. Medical imaging in particular plays a huge role in the entire clinical process—from diagnostics and treatment to surgery and research. In addition to the hurdles medical professionals encounter, “seeing” (in the medical sense) is one of the biggest challenges. Diseases are difficult to spot because...
Pyroelectric and Piezoelectric Sensors for Point-of-Care Diagnostics
What alternative signal transduction methods are emerging for the measurement of clinically relevant parameters in biological samples, and which of these are important for use at the point-of-care (POC)? This article focuses on technologies based on the piezo- and pyroelectric effects (i.e., detection methods that rely on measurement of thermal or mechanical effects). The more relevant methods...
A Tear Down of the Advantech HIT-W121 Touchscreen Terminal
Figure 1. The HIT-W121 slim, touchscreen terminal, with its “bezel-less” design is suited for use in medical environments. I’ve written my share of tear down articles before, but this is my first for a device aimed at the medical market. If you’re not familiar with the term, a tear down is an analysis of the design of a shipping-end...
Get the Lead Out
The first Restriction of Hazardous Substance (RoHS) legislation out of Europe, in 2006, provided an exemption for medical electronics. However, a second version that modifies this exemption has been released. Medical devices will be covered as of 2014, in vitro diagnostic equipment as of 2016, and industrial monitoring and control instruments as of 2017. The importance of planning for lead-free...
MEMS Technology to Improve Quality of Life for the Aging
With the Baby Boomer generation reaching retirement age, a wave of elderly citizens is about to hit the United States. As people get older, they become more likely to develop serious health conditions. The CDC reports that 1.5 million people currently reside in skilled nursing homes. The spike in elderly citizens will likely result in major shortages of caregivers and assisted care facilities....
Flexible EEG Headset Permits Home-Based Diagnosis and Care
Imagine a comfortable and lightweight headset that you put on and that immediately starts to capture your brain signals. No wires and additional electronics, everything is in the headset: a complete, flexible EEG (electro-encephalogram) system. The recorded brainwaves are processed in the headset, depending on the application. And the results are sent wirelessly to a base station, for example a...
E-readers Could Replace Clipboards in Medical Applications
The same characteristics that make e-readers popular for reading books at home or at the beach—readability and long battery life—can also make them viable clipboard replacements for medical applications. Add security features that support HIPAA and other medical reporting requirements, and e-readers with displays based on e-paper technologies offer some enticing advantages over LCD-...
Designing Wireless Foot Switches for Medical Devices
Medical equipment users and OEMs have long expressed an interest in wireless foot switches. Their interest has been kindled by: a desire to eliminate the “tripping” hazard cables may represent in the application a desire to have greater freedom in the foot switch’s location relative to the medical device it controls a desire to eliminate the potential for cable damage (the most...
Technological Advances Simplify Personal Healthcare and Peak-Performance Training
Over the past few decades, medical electronics has played a key role in supporting personal disease management and simple and advanced diagnostics. Examples range from blood-glucose and blood-pressure monitoring devices to fever management with an electronic thermometer. Several innovations that focus on increasing quality of life for users are being made in this space. The considerable progress...
The Platform Alternative: Testing Miniaturized and Highly Integrated Components
Test strategies are mandatory for every company, whether they are applying diagnostics in the development stage or ensuring quality during manufacturing. As such, it is virtually impossible to have a one-size-fits-all test strategy because there are so many variables and specifics. For example, because of their miniaturized and highly integrated components, circuit board test strategies require...
Agile Software Development Streamlines FDA-Regulated Applications
There are many discussions today regarding the application of Agile software development methods for FDA-regulated medical devices and pharmaceutical products. However, before we examine the application of Agile to a regulated industry, it’s appropriate to define what’s meant by Agile methods. It’s also appropriate to discuss whether Agile is just another flavor-of-the- month...
Dodging Counterfeit Electronic Components Is Far More Difficult Than in the Past
A counterfeit electronic component operating in a medical electronics system may make itself known when the system experiences an unexpected failure. The failure may be relatively innocuous—a monitoring device that suddenly begins to display meaningless numbers—or it may be directly life-threatening, such as a functional failure in a defibrillator. Even after the failure has occurred...
Battery Packs and Medical Devices don’t Always Make a Great Marriage
The healthcare industry has been trying to cut the electric cord since the 1950s when Earl Bakken and Palmer Hermundslie invented the first transistorized cardiac pacemaker with an internal battery. Over the ensuing decades, manufacturers have continued to introduce devices—hearing aids, digital thermometers, defibrillators, nerve stimulators, suction pumps, ultrasound equipment, all manner...
Not Complying with IEC 62304 for Software Design Could Be Detrimental on Many Levels
Medical devices have become increasingly sophisticated, now employing software-controlled applications whose failure to function correctly could result in death or serious injury. Despite this increased complexity, medical software standards continue to reflect only the rigor of low-risk applications. Notably, many of the medical device faults stem from product upgrades. An analysis of 3140...
Choosing the Right OS for your Medical Device
Medical device manufacturers understand the importance of the operating system (OS). In fact, contrary to common practice in the world of embedded systems, they often select the OS even before they choose the board. According to VDC Research, for example, in 2010, 36.4% of medical device projects chose the OS first, compared to 20.8% of telecommunications projects, and just 9.3% of transportation...
Testing Android Devices
Within three years, Android as a platform for mobile devices has made significant inroads. In fact, Android recently claimed the top position in the U.S. smartphone market, with more than 50% of smartphones in the U.S. running Android. Android, developed by the Open Handset Alliance and led by Google, is used by most mobile operators and many handset manufacturers, including Motorola, Sony-...
MSA is a key to world class manufacturing
Most of us in the medical device industry are familiar with process capability measurement terms Cp, Cpk, Pp, and Ppk. A small subset of us uses these metrics to generate process validation reports claiming to meet our customers’ capability requirements. But how many OEMs and suppliers have gone to the next level by providing the empirical evidence necessary to prove that the measured data...