A survey by Northwestern University found that small companies report more challenges than large companies in the FDA's 510(k) review process. The predictability of regulatory requirements is a crucial factor in deciding whether to invest in developing new products, with only 8% of respondents believing the US system is predictable.
Researchers will examine strategies hospitals use to evaluate and purchase implantable medical devices for cardiac, spinal, and orthopedic procedures. The study aims to shed light on how hospitals can balance innovation and affordability in selecting medical devices.
A national survey found that 76% of people would take a predictive test to learn about their future health risks, with willingness to pay varying by disease type and accuracy. Respondents were more likely to pay for tests related to breast and prostate cancer, and were willing to alter lifestyle choices after receiving positive results.
The study aims to assess how hip replacement affects older adults' ability to work, thereby easing financial pressure on pension systems. The research will examine data from various studies to compare patients who received a hip replacement with those who didn't.
Researchers at Northwestern University and Duke University will study opportunities for improving the FDA's 510(k) product review process and examine the lifetime benefits of implantable devices. The studies aim to build evidence-based policy and improve patient outcomes.
Researchers at USC, Northwestern and Stanford will study the role of clinicians in medical technology innovation and the value of devices in treating diabetes and chronic wounds. The grants aim to develop objective data on the social and economic impact of therapeutic medical devices.
The Stanford researchers' five-phase stage-gate model describes a process applicable to various medical technologies and innovation settings. It outlines phases including initiation, formulation, design, final validation, and product launch, with decision gates at each phase.
A new study from Duke researchers demonstrates the positive impact of total knee arthroplasty (TKA) on physical functioning and motor skills in older patients with osteoarthritis. TKA recipients experienced significant improvements in mobility, motor skills, and limitations in activities of daily living.
Researchers at five universities will examine the economic and social impact of diagnostic and therapeutic medical devices, including insulin pumps, hearing aids, and genomic diagnostics. The studies aim to provide objective evidence on the value of medical technology to inform health policy.
Researchers found that total hip replacements improve physical functioning and increase ability to care for oneself in seniors with osteoarthritis. The study also showed cost savings for the healthcare system due to reduced long-term disability costs.
Researchers found that elderly patients with ICDs had a 38% lower mortality rate compared to those without, with 13% dying in the first year after implantation. The study also showed that health care costs associated with ICDs were comparable to other treatments for congestive heart failure after six months.
Researchers at Stanford University have released a comprehensive review of US medical device regulation, highlighting the differences between regulations guiding medical devices versus pharmaceuticals. The report emphasizes the complexity of the approval process and post-market surveillance administered by the FDA.
Researchers used industrial modeling to examine access to head cooling devices and found better availability can reduce permanent damage from hypoxic-ischemic encephalopathy by 23%, saving lives and reducing severe neurodevelopment impairment. The study also estimated annual savings of $4.4 million in Massachusetts.
Diabetic patients using cutting-edge technologies like insulin pumps and blood glucose monitoring devices experience better disease management with reduced daily pain. However, the lack of strong scientific evidence and insufficient patient-education resources hinder their widespread adoption.
The study found total hip and knee replacement surgery to be safe with low post-operative complications, while patient satisfaction levels remained high at 85-90%. However, disparities in utilization exist across race and gender lines.
A Duke University study found that hearing loss contributes to a decline in quality of life, particularly among the elderly. The study also revealed that approximately six million people in the US use hearing aids, but 35-50% of users are not satisfied with their devices.