MedTech Industry Strategic Interest Areas 2024

MEDICAL DEVICES

Disrupts an existing drug market with an unmet need

• Applications: heart failure, COPD, peripheral artery disease, vascular disease, AFIB, structural heart conditions, ECMO

Interventional tools

• Applications: radiology, pulmonology, vascular, neurovascular, stroke treatment

Minimally invasive surgical tools

• Robotic tools for endoluminal surgeries: GI tract, vascular, biopsies, surgical oncology
• Digital surgery
• Energy (laparoscopic)
• Cryoablation tools and techniques

Biocompatible materials

• Promotes wound healing
• MRI-compatible
• 3D printable
• Anti-microbial
• Applications: hernia repair, catheters

Endoscopy

• Flexible modalities
• Navigation
• Energy
• Applications: GI, pancreas, pulmonology, ENT

Innovative safety mechanisms

• Renal/dialysis products
• Injection, infusion, and transfusion devices
• Needleless and safety connector systems

Automated cell culture equipment and systems

• Stem cell growth systems
• Serum-free culture
• 3D organ culture
• Applications: cell therapy

Ophthalmic

• AR / VR
• Biosensors
• IOL
• Correction of visual access
• Diagnostics
• Modalities when central retina is destroyed

CONSUMER HEALTHCARE

• Patient education
• Self-monitoring of biometric and health behavior parameters
• Improved management of chronic diseases with severe comorbidities and predictive analytics
• Non-drug pain management solutions
• Patient empowerment tools for improved self-care

REMOTE PATIENT MONITORING AND CLINICAL STUDIES

Measure relevant biometric & behavior parameters

• Risk prevention and mitigation for efficient care and timely intervention
• Patient stratification / identifying populations
• Patient status management: nutrition, fluids, etc.
• Chronic disease management: heart failure, diabetes, obesity, metabolic diseases
• Sensors, wearables, implantables
  • Semiconductor-enabled
  • Non-invasive or minimally invasive
  • BP, ECG, hydration, sweat, temperature, fluid status, metabolites
  • Application: opioid overdose, fluid monitoring

WORKFLOW OPTIMIZATION

• Medication delivery, tracking & adherence
• Telemedicine/teleconsultation
• Hospital inventory management: asset tracking (e.g. RFID)

DIAGNOSTICS

With/without clinical decision support

• Novel osteoporosis diagnostics
• Diabetes mitigation & management
• Rapid infectious diseases diagnostics
  • Molecular diagnostics for virus/flu

IMAGING

• Narrow-band imaging
• Advanced imaging for GI

ADDITIONAL INTEREST AREAS

• Infection prevention and treatment: surgery and orthopedics
• Global health
• Sleep apnea
• Organ support
• Biomarkers

• Organ Support Devices and Therapeutics: Novel technologies and optimization of current technologies are required to provide renal support in the austere setting and treat ischemia reperfusion injury in severely injured casualties. Medical device solutions should prioritize ease of delivery and the need for reduced size, weight and power (SWAP)
• Surgical Support Technologies: This area is seeking novel solutions to extend surgical capability and enable surgical procedures to be safely performed at Roles of Care 2-3. Current surgical capabilities are relatively cumbersome and more mobile surgical capabilities typically have significantly reduced patient capacity. Novel solutions should increase surgical capacity and decrease SWAP requirements, contributing to improved mobility. This focus area includes both surgical technologies as well as technologies that enable forward surgical capability such as advanced imaging, surgical sterilization, and intelligent anesthesia capabilities
• En Route Care: This area seeks medical devices that enable high volume or prolonged patient movement. Technologies should be supported by preliminary, published data with a focus on mitigating the potential negative effects of patient movement in an operational environment while also optimizing care to multiple patients simultaneously. Additional considerations include functionality and effectiveness under conditions of vibration, acceleration, altitude and extreme environments
• Semi-autonomous Procedural Support: This area seeks technologies that enable semi-autonomous assistance for resuscitative procedures using AI and robotic technologies. These technologies should optimize the technical completion of the necessary task through speed, efficiency, and accuracy in order to improve the safe completion of the procedure while mitigating training decay and differences in provider expertise. Example technologies include facilitating venous and arterial access, as well as regional analgesia

• Medical Informatics applications that can assist in the artificial intelligence retrieval of applicable information from large data sets into actionable information at the bedside; be in a community hospital or the battlefield.  Data is largely maintained within a Cerner EHR and needs to be made available to most every clinical application within trauma, mental health, infectious disease, restorative care, and rehabilitation services
• Tele-Health applications that are bidirectional; ie; they provide information to the provider from the patient care setting be it austere clinical settings on the battlefield or within outpatient clinical settings for consultation, and/or make the information available for the patient to better understand treatment routines and outcomes.  Areas of interest are extremely broad and include most every major medical clinical treatment and indications
• Medical devices with Artificial Intelligence that can capture diagnostic data and connect back to the main Cerner EHR platform as well as provide immediate decision assistance as to the clinical treatment warranted for the patient.  This would be oriented toward trauma care in austere environments
• Autonomous Care and Evacuation: This area seeks advanced data-driven solutions for the optimization of provider(s) treatment based on dynamic monitoring of available resources and casualty status. Solutions should present an analysis of critical factors (e.g., casualty status, casualty location, number of providers, medical supplies, environmental constraints, etc.) and an artificial intelligence/machine learning (AI/ML) algorithm which optimizes casualty priority and provider alignment/assignment to increase clinical capacity at the point of injury. Solutions should focus on the clinical aspects of optimizing triage, patient management, and medical regulating, rather than logistics or re-supply. It is encouraged that the algorithmic solution be compatible/capable of being deployed with existing field medic platforms (such as BATDOK, MEDCOP, etc.)
• Psychological Health, including Psychological Disorders Treatment: Mature and integrate a scalable, digital health suite of tools that extends options for monitoring and care management of adjustment disorders to behavioral health officers (BHOs), offers self-care for Service members with adjustment disorders in garrison settings who may have limited access to clinical providers, and offers providers and leaders a more upstream evaluation and monitoring of risk-related events/problems and symptoms in members within their units. Of interest is a military-centric digital e-health platform, provider dashboard, and individual app all with military-specific content to mitigate adjustment disorders, and also capabilities for monitoring high frequency events and person-level risk factors for adjustment-related difficulties and offering evidence-based treatment/interventions for one or more of the conditions/issues commonly co-occurring with adjustment disorders (e.g., insomnia, distress) which could be self-administered where appropriate

• Hearing Protection: Hearing protection devices (HPDs) are essential safety equipment for military personnel, who are routinely exposed to high-intensity sounds that can permanently damage hearing. However, HPDs also impair situational awareness and communication. Warfighters are acutely aware of such side-effects and their impact on performance in key operational tasks, contributing to disuse in the same operational settings where injurious high-intensity sounds are common. The subsequent loss of hearing results in an immediate degradation of operational capability, impeded communications, and significant disability payments after service completion. Advancements in HPD technologies are necessary to mitigate the negative perceptual side effects of HPDs. This area is seeking enhanced HPDs in simulated operational environments (e.g., 3-dimentional multi-source sound fields)
• Individual Occupational and Environmental Exposure Monitoring: The development and refinement of a health assurance platform integration with environmental and physiological sensor technologies for individual occupational and environmental exposure monitoring. Required capabilities include the integration and testing of specialized volatile organic compound and fine particulate matter sensing capabilities; algorithms for environmental hazard monitoring and physiological effects; development of a suite of modules enabling remote monitoring of bio-fluids for examination of biomarkers and exposure levels; and operational validation of the above capabilities in at least one or more military-relevant environments
• Brain Computer Interface (BCI): Advancements in BCI for vision restoration have the potential to benefit military service members who may have acquired vision loss due to military traumatic injuries, improving their quality of life and the ability to return to duties. BCI prototypes that are within scope must stimulate part of the visual pathway, such as the retina, optic nerve, and visual cortices, to generate visual perceptions. This effort is looking to fund a human study or clinical trial focused on using BCIs, specifically visual neural prostheses, to offer a more direct approach to restore vision
• Temporary Cornea Repair (TCR): Ocular injuries are a major cause of battlefield casualty and permanent disability and represent a threat to operational readiness and a socioeconomic burden. Closure of these injuries requires surgical intervention by an ophthalmologic surgeon and most often must occur within 24 hours to preserve any amount of residual vision, with the time to primary surgical repair strongly correlated with final visual acuity. Delays in initiation of pre-operative treatment in animal models of eye injury have been shown to have a negative impact on physiological values associated with injury severity, and case studies indicate that delays in pharmacological treatment for endophthalmitis correlate with worse outcomes, suggesting that acute care in the emergency setting has the potential to improve outcomes. This area is seeking novel eye stabilization device suitable for use at point of injury
• Objective Behavioral Health Assessment and Monitoring: Non-invasive assessment and monitoring of behavioral health-related conditions and symptoms (e.g., depression, posttraumatic stress disorder (PTSD), acute stress reactions, acute stress disorder, pain, somatic symptoms) using analysis of paralinguistic features from audio recordings acquired immediately after a potentially traumatic event (e.g., car accident, assault), and the following weeks of recovery. The desired use case for this prototype would be identifying if behavioral health symptoms are improving or declining, and/or using predicting changes in symptoms from one timepoint to the next
• Effective, Scalable Treatments for Full Remission of Post-traumatic Stress Disorder (PTSD): Evaluate and refine scalable treatments or treatment regimens that maximize full remission of PTSD or Adjustment Disorders symptoms in active duty service military populations, to maintain medical readiness. Given the shortage of behavioral health clinicians in the U.S., the preferred treatments are those which are more scalable, such as portable neuromodulation, stellate ganglion block, or other non-psychotherapy treatments. Scalability includes considerations for the required personnel resources (i.e., avoid treatments that solely rely on psychologists and other highly trained and experienced behavioral health personnel to administer in a 1:1 regimen), individuals’ logistical barriers to care, highly specialized or lengthy provider training, unit cost per person, etc.
• Musculoskeletal Injury Prevention: This area is seeking validated musculoskeletal injury risk screening and assessment tools to identify individual and unit-level musculoskeletal injury risk and performance decrements. This area is also seeking advancement of imaging devices or objective assessment tools that can accurately distinguish bone, muscle, tendon and/or ligament injury and recovery