Smart Bandage Biosensors

There have been a series of smart bandages developed in recent years, and one of the latest is a bandage that changes color depending on what type of infection is present. A prime advantage of a smart bandage is early diagnosis that will assist physicians in diagnosing and prescribing the right antibiotic in the earliest stages of an infection.

For the majority of wounds, an advanced smart bandage may be a little overkill. But there is a large market for patients that could face serious risks from an infection. According to the CDC, almost 400,000 patients each year are affected by surgical site infections. Add this to the 24 million diabetic Americans that are at risk for foot ulcers and you have a market that is estimated to grow at a rate of almost 5% per year.

Smart bandages are constructed around sub-millimeter-sized silicon wafer sensors impregnated into the cloth. First-generation technologies are designed to differentiate between Gram-positive and Gram-negative bacteria. Researchers next goal is to include other types of bacteria, such as salmonella, listeria, and enteropathogenic E. coli.

However, due to costs, the technology may not be applicable everyone. But for already compromised patients, early detection could mean the difference between taking an antibiotic or a more serious intervention.

Bundled Payments Encourage Quality, Savings, and Value

CMS really got my attention with their press release on bundled payments as a method of encouraging quality of care and cost savings. We first saw bundled payments emerge in the last couple of years with imaging studies. Now, CMS Innovation Center will start to phase in the use of bundled payments as a method of encouraging a more efficient approach to managing multiple procedures with a single payment instead of a fee-for-service method of submitting separate bills for each procedure.

I asked Dr. Dennis P. Scanlon, PhD, associate professor of Health Policy and Administration at Penn State University, about the new CMS financial incentives. Dr. Scanlon said, “It is a fundamental change is to incentivize hospitals with reimbursement by paying hospitals for managing a patient’s illness as opposed to per procedure.” This is similar to how the DRG system works but for outpatients.

It’s an interesting concept, but do the studies back up the theory? In 2007, Robert Wood Johnson founded the Prometheus Project. The study looked at the effects of bundled payments for six chronic conditions and four acute conditions or procedures requiring hospitalization. It concluded that national health care spending could be reduced by 5.4% ($19 billion) between 2010 and 2019 and providers can reduce avoidable complications costs between 25 to 50% by providing higher quality, more collaborative care.

The numbers do support bundled payments as a method of improving outcomes and controlling costs. However, for hospitals to benefit from this strategy there has to be a gate keeper.The bottom line is a shift from payments based on volume to payments based on performance.

Quicker and Lower Cost Lab Technology

There is an emerging laboratory technology that is based on nuclear magnetic resonance and nanoparticles, and this combination offers the promise of identifying almost any protein, cancer, bacteria, or virus quickly at the molecular level and at a lower cost than existing technologies. One of the first target applications is Candida, a blood-borne infection with a mortality rate of 20%.

The technology mixes a raw blood, urine, or saliva sample with magnetically-charged nanoparticles that are targeted for a bacteria or cell. Then, a cassette with the sample is placed in a portable desktop magnetic resonance instrument. Depending on the test, specific results can be available in minutes even if the target molecule is in very low concentrations.

Early studies focused on magnetic resonance technology reflect its accuracy; 400 whole blood samples were tested for Candida, an often deadly hospital-acquired infection. Results showed 95% sensitivity and 98% specificity. These correlated 98% of the time with existing blood culture and lab strain processes.

What is amazing is that this is not just another new laboratory test; it is a new direction in assisting physicians by providing a quick and accurate diagnosis. Although hospital spending growth has slowed from 5% to 3% in recent years, there still is a lot of room for improvement in controlling costs. And, with a quick and accurate diagnosis, a shorter hospital stay and lower readmissions are a real target for costs savings.

An Emerging Tool in Neuroscience

Artificial neuro synapses made out of carbon nanotubes is an evolving concept being studied at NASA and universities around the world. The carbon nanotubes are designed to function as an array of micro-miniature electronic circuits using chemicals to stimulate the brain activity similar to the natural functions of a neuro system. This offers the advantage of being able to monitor and modulate electrochemical events in neural networks in real time. The ultimate goal is more effective neural prosthetics, such as cochlear implants and brain stimulators.

Studies have shown that chemical sensing nanotube’s interfaces are 1,000 times more sensitive than electrical coupling devices, which allows them to be much smaller. Additional studies have indicated that along with being very sensitive, they are capable of reconfiguring themselves in real time to meet changing conditions within the synapse. Even under these conditions, carbon nanotubes respond 10 times faster than existing interfaces.

Referring to some of the challenges of existing technologies, Dr. Mark J. Smith, MD, PhD, of the Brain Stimulation Unit at the National Institute of Health in Bethesda, Md, said,  “There is a large variety of devices that are either approved or being developed.” Some require a much involved surgical procedure to implant the electrodes deep within the brain; others utilize surface sensing electrodes, which are not very sensitive. The goal of new technologies is to mimic the natural function of the brain by simulating the electrochemical activity of a neuron.

But, this is just the tip of the iceberg. The electrical and chemical properties of carbon nanotubes allow them to have multiple applications in neuroscience. Along with the promise of stimulation and brain machine interfaces, they are already being used as scaffold to help repair damaged nerves. In the next few years, we could see these technologies in the everyday clinical use.

Amadeus Surgical Robot and the Promise of Competition

Titan Medical is starting to perform clinical studies with their Amadeus Robotic Surgical System, and if all goes well, this will be the first real competitor in the surgical market since Intuitive Surgical merged with Computer Motion. The Amadeus system is intended to allow surgeons better access to critical areas with the development of multiple articulating arms, making the system more applicable to cardiovascular procedures.

In an article on Product Design & Development, Reiza Rayman, MD, president of Titan Medical, said In my opinion, the da Vinci is primarily focused on and well-suited for prostate procedures and hysterectomies. We want to expand those capabilities to include bowel surgeries, as well as more delicate areas like the heart  specifically procedures centering on the mitral valve.

The Amadeus will be better suited for these procedures through the use of less rigid instrument shafts made from lighter-weight carbon fillers. Not only will they be easier to manoeuvre, but they will also offer a better line of sight through the laparoscopic port via advanced 3-D imaging.

Titan Medical plans to help expand the surgical market by offering the Amadeus as an option for surgical laparoscopic applications. Several hospitals in New York, Canada, and London have already begun working with the prototype, and clinical trials are projected to start in 2012 with the goal of having the Amadeus ready for market when current patents expire.

It may be a while before clinical trials verify how effective the Amadeus system really is, but adding competition is always good for the market as another player should help bring down costs and facilitate a more rapid delivery of new technology. This is good news for patients and providers.

Longer Monitoring at a Lower Cost

The Zio� Patch is an emerging FDA-approved device the size of a small calculator that can be worn under the patient’s clothes that records and stores ECG data for up to 30 days. After the ECG recordings are obtained, the device is then mailed to a national reading center to evaluate the data.

There have been multiple studies that confirm the effectiveness of outpatient ECG monitoring. One study indicated that the sensitivity for diagnosing heart patients increased from 11.5% to 46.2% when they were monitored for over seven days. Another study suggested that using Holter technology to identify atrial fibrillation early could save healthcare $13,000 per year, per patient, making this technology all the more important.

Dr. Carolyn M. Clancy, MD, director of the Agency for Healthcare Research and Quality in Washington DC, said “Because of all of the advances in biomedical science, it’s not the case that there’s one thing to do for a particular condition; there are multiple choices. The question is how you make those choices. It’s all about focusing on patients needs and applying the best of science to meet those individual needs. Some may require real-time monitoring while others do not.”

Now physicians will have a cost-sensitive option for their patients. I hope this trend continues.