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Measuring Up
CardioMEMS engineer Michael Fonseca uses a laser to separate pressure sensors in the company’s clean room facility in the ATDC Biosciences Center located at Georgia Tech’s Environmental Science and Technology Building. Photo by Gary Meek   After…
High-Resolution Imaging
Georgia Tech student Ashley Palmer, Ph.D., conducted experiments to validate a new cartilage-imaging technique developed by associate professors Marc Levenston and Robert Guldberg in the Georgia Tech School of Mechanical Engineering. On the computer…
Overcoming the Global Challenges
Despite the best efforts of pharmaceutical manufacturers, drug labeling is one of the greatest challenges in clinical trials, involving a complex, time-consuming process to meet strict regulatory requirements and obtain wide-ranging approvals from individual countries. That labels must…
Opening a Cellular Door
Researchers Mark Prausnitz and Robyn Schlicher use a confocal microscope to study cells whose membranes have been opened by the application of ultrasound. Georgia Tech Photo: Gary Meek   Researchers have shown how ultrasound energy can…
The Right Thing to Do
James M. Anderson
An ABC News/Washington Post survey in 2003 found that for the first time, 54 percent of Americans were dissatisfied with the overall quality of health care in the United States. In 2006, the Commonwealth Fund released results of an international survey that measured 37 areas of quality…
Molecular Imaging of a Virus
Research engineer Phil Santangelo works in professor Gang Bao’s cell culture facility in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University in Atlanta. Photo courtesy of: Phil Santangelo…
Self-Powered Nanoscale Devices
John Toon
Georgia Tech professor Zhong Lin Wang holds a sample nanowire array that can be used to power nanometer scale devices. Georgia Tech Photo: Gary Meek   Researchers have developed a new technique for powering nanometer-scale devices…
Close Encounters of an Electromagnetic Kind
T. J. Becker
In our increasingly wireless world, the air is chock-full of electromagnetic signals carrying data from one place to another. Yet, while new wireless technologies advance our options in security, commerce and entertainment, they also produce interference that may cause problems for…
New Tools
Georgia Tech postdoctoral fellow Jean-Francois Masson holds a microelectrode modified with a biosensing layer capable of measuring adenosine triphosphate (ATP), a chemical involved in energy transport in humans. It’s of interest to medical…
Fake Pharmaceuticals
A worsening epidemic of sophisticated antimalarial drug counterfeiting in Southeast Asia and Africa is increasing the likelihood of drug-resistant parasites, which yield false-positive results on screening tests and risk the lives of hundreds of thousands of malaria patients—mostly…
High-Tech Drug Delivery
Jane M. Sanders
A newly developed family of biodegradable polymers has shown potential for use in intracellular delivery and sustained release of therapeutic drugs to the acidic environments of tumors, inflammatory tissues and intracellular vesicles that hold foreign matter. These polymers have several…
Managing Diabetes
Tom Solon
Advancements in diabetes treatments By any measure, diabetes is a huge health problem. Approximately 16 million people in the United States have diabetes, and it’s a leading cause of associated medical conditions such as blindness, circulatory problems and digestive disorders. While…
High-Shear Fluid Processing
Christopher Werner
Although conventional homogenization has served the needs of the dairy industry and other industries for more than a century, the producers of pharmaceutical, personal care, chemical and food products are increasingly turning to high-shear fluid processing when highly precise processing is required…
Successful Enterprise Resource Planning
Jerry Fireman
Diagnostic Hybrids Inc. manufactures discrete units of mammalian cell cultures and diagnostic reagents—such as antibodies—that are used to grow, isolate and type viruses. The company faced complex information-management challenges because of its many different product offerings, complex…
The Prescription for Health Care Excellence
According to the Institute of Medicine, there are approximately 100,000 people per year killed in the Unites States because of medical errors. There are 100,000 families in despair because they have lost a loved one too soon. This also means that 100,000 medical professionals are losing…
Laser Scanning Helps Validate Design of New Venous Filter
Avoiding blood trauma is a concern when pumping cardiac patients’ blood during surgery. With this in mind, a medical-device manufacturer decided to reuse the flow-path geometry of an existing arterial filter that had been proven safe and effective in many patients. The problem was…
Consumers Must Drive Quality Health Care
William L. Roper
A revolution is working its way through America’s health care systems. Like many great revolutions, it’s about empowerment and the creation of a new paradigm. It won’t happen overnight, but the forces at work are irresistible and will bring new hope and new responsibilities. The agent…
Quality Assessment: Process or Outcome?
Tim Postema
The Dutch public health care system is being transformed in various ways. With an increasing focus on efficiency and consumer driven care, health institutions in The Netherlands are forced to critically evaluate their actions and processes. With recent political developments creating a more liberal…
RFID in Health Care: a Four-Dimensional Supply Chain
Marlo Brooke
The groundswell of radio frequency identification devices (RFID) in health care may be clouded by the stomping of Wal-Mart, but the biotechnology and pharmaceutical industries are quietly becoming one of the top innovators and users of RFID, and they’ll likely outpace other market segments in the…
How Experimental Design Optimizes Assay Automation
Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles…
New Biopharmaceutical Coalition Aims to Support SAFE Initiative
Laura Smith
In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for…
A Blueprint for Electronic Record Retention
Tamar June
Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become…
The Business Case for FDA CFR 21 Part 11 Compliance
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
Medical Matters
BSI
More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world.…
The Business Case for FDA CFR 21 Part 11 Compliance
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…

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