Clinicians trying to diagnose a patient’s ailment have a range of tools to assist them, but many of those are slow (culturing samples in petri dishes for days), inaccurate (yielding high rates of false results) or incomplete.
Draper’s Biomedical Solutions capability centers on the application of microsystems, miniaturized electronics, computational modeling, algorithm development and image and data analytics applied to a range of challenges in healthcare and related fields. Draper fills that critical engineering niche that is required to take research or critical requirements and prototype or manufacture realizable solutions. Some specific examples are MEMS, microfluidics and nanostructuring applied to the development of wearable and implantable medical devices, organ-assist devices and drug-delivery systems. Novel neural interfaces for prosthetics and for treatment of neurological conditions are being realized through a combination of integrated miniaturized electronics and microfabrication technologies.
Draper combines specific domain expertise and knowledge of how to apply the latest analytics techniques to extract meaningful information from raw data to better understand complex, dynamic processes. Our system design approach encompasses effective organization and processing of large data sets, automated analysis using algorithms and exploitation of results. To facilitate user interaction with these processed data sets, Draper applies advanced techniques to automate understanding and correlation of patterns in the data. Draper’s expertise encompasses machine learning (including deep learning), information fusion from diverse and heterogeneous data sources, optimized coupling of data acquisition and analysis and novel methods for analysis of imagery and video data.
Draper continues to develop its expertise in designing, characterizing and processing materials at the macro-, micro- and nanoscales. Understanding the physical properties and behaviors of materials at these various scales is vital to exploit them successfully in designing components or systems. This enables the development and integration of biomaterials, 3D printing and additive manufacturing, wafer fabrication, chemical and electrochemical materials and structural materials for application to system-level solutions required of government and commercial sponsors.
Draper has designed and developed microelectronic components and systems going back to the mid-1980s. Our integrated, ultra-high density (iUHD) modules of heterogeneous components feature system functionality in the smallest form factor possible through integration of commercial-off-the-shelf (COTS) technology with Draper-developed custom packaging and interconnect technology. Draper continues to pioneer custom Microelectromechanical Systems (MEMS), Application-Specific Integrated Circuits (ASICs) and custom radio frequency components for both commercial (microfluidic platforms organ assist, drug development, etc.) and government (miniaturized data collection, new sensors, Micro-sats, etc.) applications. Draper features a complete in-house iUHD and MEMS fabrication capability and has existing relationships with many other MEMS and microelectronics fabrication facilities.
Such tools are of limited use to a doctor who needs to choose an effective course of treatment for a patient urgently. For a critically ill person, such shortcomings in diagnostic tools can be life-threatening.
Draper is designing and developing a range of solutions to enable medical device makers to provide clinicians with diagnostic tools that quickly diagnose conditions at the bedside accurately. Draper is applying its engineering expertise to diagnostic issues that will make a difference in treatment: assessing antibiotic resistance, predicting likelihood of surgical success, minimizing the use of stressful invasive procedures such as biopsies, and objective measurement approaches to replace current subjective estimation practices.
Analyzing Breath to Detect Infection/Disease Markers
Patients with compromised immune systems who contract invasive aspergillosis, a fungal infection with nonspecific symptoms, face a mortality risk of up to 58 percent, primarily due to delays in diagnosing the fungus. Existing tests are slow to yield results and often incorrect; use of invasive measures, such as lung biopsy and bronchial lavage, may be unsafe for such patients. It is important for clinicians to know who is not infected with this fungus, as the medications to treat this fungus have potentially toxic side effects and are costly.
Draper and Brigham & Women’s Hospital (BWH) are collaborating on a breath-based diagnostic test that could yield results at a patient’s bedside within minutes, rather than the days or weeks typical of existing tests, without the risks of invasive acquisition methods. This test is being developed using Draper’s microAnalyzer™, a device that measures volatile organic chemical compounds in air samples via Compact Gas Chromatography – Differential Mobility Spectrometry (GC-DMS). The microAnalyzer™ is in operation aboard the International Space Station, where it monitors cabin air quality for astronauts’ health and safety.
During ongoing clinical studies with a prototype version of the Breath-Based Diagnostics system, Draper and BWH have demonstrated the ability to correctly diagnose patients with invasive aspergillosis. The GC-DMS system includes a breath-sampling tube, disposable mouthpiece, and pressure and carbon dioxide sensors that measure whether the patient is providing enough breath to serve as an adequate breath sample.
Smaller, less complex and less expensive than a mass spectrometer, a GC-DMS device performs similar high-quality chemical measurements immediately in situ. As a “tunable ion filter,” a GC-DMS device can step through numerous “tuning” parameters to reject interferents and to select compounds of interest, significantly reducing rates of false positives and false negatives. Unlike other technologies, the GC-DMS does not require hardware modifications (coatings, wavelength changes, etc.) to detect new compounds of interest. Draper’s microAnalyzer™ can be reprogrammed to add or remove specific chemical signatures to measure.
Draper is working on making the device simpler and more user friendly so that it can be operated by hospital personnel other than certified lab technicians, which would help reduce the cost of operating it. Draper and BWH are also studying use of this diagnostic capability to distinguish between bacterial and viral pneumonia infection.
Draper and BWH are currently seeking a transition partner to take the diagnostic device through clinical trials, which could occur within the next few years.
Rapid Pathogen Diagnostics to Target Treatment
Existing tools to diagnose bacterial infections and assess their antibiotic susceptibility require days in a lab to grow enough bacteria to reach a diagnosis threshold. If a patient’s condition precludes waiting for such lab results, the clinician will be forced to prescribe treatment based on outcomes of previous patients or simply use broad spectrum treatments. The results of even a well-educated guess can be negative, including death, prolonged illness, propagation of antibiotic-resistant bacteria and collateral damage to healthy microflora, resulting in additional infections.
Prescribing an antibiotic to treat an infection without knowing whether or not the bacteria causing the infection are susceptible to that antibiotic can foster resistance to that antibiotic; not only will the patient not benefit, but the bacteria that are not susceptible will continue to grow and spread. Since no new class of antibiotics has been released to market since 1987, it is vital that physicians be equipped with tools to enable them to use existing antibiotics more effectively.
Draper’s Identification and Antimicrobial Susceptibility Test (IDAST) will be able to diagnose pathogens and to measure antibiotic susceptibility—in less than one hour, within a portable device, at the point of care. IDAST will equip physicians with the means to select effective medication and dosage amounts promptly, potentially saving the lives of critically ill patients. Beyond the medical benefit to the individual patients, IDAST will benefit the health care system financially—rapid diagnosis before treatment will avert costs incurred by multiple treatments for sicker patients while trying to find an effective treatment.
Draper’s proprietary IDAST technology uses probes that evaluate the identity and physiological state of bacterial cells to determine whether an antibiotic is having a lethal effect on them and at what drug concentration. The testing device uses microfluidics for purifying bacteria from clinical samples such as blood and employs optical detection.
Draper’s technology has demonstration detection with as few as 2 bacterial cells; it can discriminate drug sensitivities for some fast-acting antibiotics in 20 minutes, while others take closer to an hour. IDAST technology has proven effective for all classes of antibiotics, which will enable doctors to make evidence-based treatment decisions at the onset of therapy and at the point of care.
IDAST will begin clinical testing in 2017.
Determining Quantitatively Which Patients Will Benefit from Eye Surgery
Clinical investigators studying new treatments for dry macular degeneration rely on eye-chart readings by their patients to assess the efficacy of these therapies. The FDA considers such visual acuity testing subjective. Doctors also don’t have data to help them predict which patients would benefit from invasive retinal surgery, which carries a risk of negative outcomes.
Draper is developing a rapid objective assessment tool for use in a doctor’s office which uses images (Optical Coherence Tomography or OCT) taken to diagnose and treat the patient. To assess and predict efficacy of treatment, Draper's image-based software tools compare OCT images of a patient’s retina taken before and after treatment. The software identifies and classifies key biologically relevant features in the images. The software can identify image features that correlate with improvement in a patient’s retina.
An effective user interface allows clinicians to view image analysis results in a few minutes within their current workflow. The tool's automated image analysis accuracy rate compared to manual analysis was validated at 95%, and its accuracy at predicting the response to therapy was 88%.
- Unless indicated, Draper diagnostic platforms are for research use only.