Click to view larger version.The medical device industry is one of the single most important benefactors in allowing significant progress to occur in the medical field. Physicians and patients supply the demand, while medical devices supply the tools and means necessary to make their incredible advancements possible. Hence, diagnostic devices remain one of the most integral means of illustrating this important relationship. As the demand for better and more accurate diagnostics grows, the industry outlook appears promising. However, the need for accuracy is never more important, as the call for more versatile and intuitive diagnostics grows.

Point of Care
In the quest for improving patient outcomes and avoiding misdiagnosis, while lowering costs, Point of Care (POC) diagnostics is the key to overcoming these overwhelming challenges. Through real-time analytical software, clinicians are better able to track and analyze a patient’s status, thereby ensuring the best possible outcome, which in turn adds extra assurance that costs may be kept down.

As wearable devices become more advanced, POC has gone beyond the traditional boundaries of the doctor’s office. The challenges of POC testing occur as a result of this boundary cross. Therefore, the technology must have a level simplicity and accuracy such that patients, as well as caregivers, may find the device easy to use. Another challenge POC testing devices face is one of durability, since the technology must be versatile enough to use in the field in a variety of environments.

“We will see the advancement of software technologies that will be used as predictive systems, providing advanced warning to clinicians and patients that there may be an issue that needs to be addressed,” says Neal Benedict, CEO of healthcare at Verdande Technology. “The additional data that will be captured by wearable diagnostic devices will need to be able to feed into software for meaningful analysis,” Benedict concludes.

The non-profit company, Diagnostics For All (DFA), is currently developing one of the most cutting edge applications of this kind of POC diagnostics. The company seeks to provide a low-cost solution for assessing a patient’s immunization status. Cambridge Consultants is developing a mode of demonstrating this test through the use of smart phone applications.

This smart phone-enabled vaccine check begins through the collection of a simple DNA sample swab from the patient. The sample is then applied to a mini laminated paper assay device. The smart phone’s camera then views the assay device. The app establishes that the QR code indicates a valid assay within its expiry. A color calibration is then made to compensate for lighting conditions, measuring the intensity of the blue dye in six spots. The development of such novel applications as the vaccine check illustrates the promising future of POC diagnostics.

“To allow widespread use, the challenge remains to develop diagnostic applications that will perform uniformly and consistently on hardware and software platforms that vary from maker to maker, from model to model, and from one software release to the next,” says David Chastain, program manager in the Medical Technology Division at Cambridge Consultants. “This is the challenging and exciting intersection of medical and consumer technologies.”

Diagnostic Imaging
With more state-of-the-art imaging systems, physicians are better able to diagnose, track, and cure their patients. Current areas of concern in diagnostic imaging are those involving patient comfort and dose reduction.

Philips Healthcare is working to address these issues with the AlluraClarity—an interventional X-ray system designed specifically for minimal dose fluoroscopy, particularly through the imaging of obese patients. Since it has recently received FDA approval, the system is sure to see important implementations in the coming year.

Another notable imaging system soon to lift off is the SOMATOM Force from Siemens Healthcare. The SOMATOM will use up to 50% less radiation for lung cancer screening tests.

“This is major, due to a recent USPSTF recommendation in favor of CT lung cancer screening for long-term smokers,” says Mickel Phung, analyst on the Diagnostic Imaging and Healthcare IT team at MRG. “With US lung CT scans expected to increase dramatically starting 2014, low-dose CT will definitely be an emphasis for product development and marketing.”

One of the most novel areas of medical imaging is holographics. Though this technology has seen recent popularity in the telecommunications and entertainment industry, the most meaningful applications will be attributed to the medical industry. However, the universal call for more cost-efficient devices has caused a rather slow development for this type of technology, making true innovation and implementation extremely challenging.

Philips Healthcare and RealView Imaging Ltd. are currently partnering to bring holographic technology to the medical imaging world. In trials, the 3D images collected by Philips’ X-ray interventional system and RealView’s holographic video projector have shown the potential for holographic streaming of targeted anatomical structures.

“In principle, this will have major implications for how surgical procedures are planned and conducted, as well as offering a completely new field for diagnosis using holographic technology,” says Stephen Holloway, associate director of Medical Device & Healthcare IT Research at IHS Technology.

“Moreover, it also serves as an important reminder for the cost-focused healthcare industry of the importance of investing and collaborating with new technology start-ups,” Holloway adds.

According to IHS, medical imaging is forecasted to see a three to five percent growth in annual revenue in the next five years, as it receives increasing demand from emerging, cost-sensitive markets. Though holographic imaging techniques are still in their infancy, they have the potential to impact the market in the long run. In order to prove this, “vendors will need to adapt to the new paradigm shift in healthcare provision and focus on three key questions all health providers will ask—Will it improve clinical outcomes and patient care? Will it improve procedural efficiency and save money in the long-run? How much does it cost?” says Holloway.

Improving Accuracy
Devices used in diagnostic testing may fulfil the need for technological accuracy, but human error often stands in the way of absolute accuracy overall. With the chance of reader error and unreliable records risking damaging consequences, devices are challenged to meet accuracy needs beyond the level of diagnosis. Keeping track of a patient’s accurate diagnosis has not always been so foolproof, as patient mix-ups in diagnosis has been known to occur, sometimes resulting in devastating outcomes.

The know error system from Strand Diagnostics adds extra insurance in avoiding as many chances of human error as possible. The system makes use of patient-specific bar coding and DNA Specimen Provenance Assignment (DSPA) testing to identify errors before any treatment methods are performed.

The DSPA test verifies diagnosis with the patient’s identity through the comparison of the patient’s DNA reference sample with the patient’s biopsied tissue. Through the system’s integrated forensic principles, doctors can be assured of utmost accuracy in diagnosis, thereby being free to move forward with critical treatments.

“The know error system and DSPA testing will enable physicians to further safeguard their patients from occult medical errors and ensure the best treatment plan is put in place,” says Ted Schenberg, CEO of Strand Diagnostics, LLC.

The diagnostic device industry is on the cusp of significant change occurring in the medical field. In order to keep abreast of the shifting boundaries happening at the POC and imaging levels, cost-efficiency, versatility, and accuracy must be seriously addressed. Device engineers are persistently walking the fine line of balancing cost with innovation, but the new year is sure to see exciting new implementations take shape.