ReviewMedical devices (Auckland, N.Z.)2014
Barriers to medical device innovation.
Review in Medical devices (Auckland, N.Z.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Investigation of Vestibular Dysfunction Requires Renewed Research Enthusiasm.Journal of the Association for Research in Otolaryngology : JARO · 2026Pooled it
- Introduction of early health technology assessment for innovators, clinicians, and funders.npj health systems · 2026Review
- How to Innovate as an Anesthesiologist: Guidance From the American Society of Anesthesiologists Committee on Innovation.Anesthesia and analgesia · 2026Article
- Development and Validation of an Optical Sensor-Based Automated Urine Flow Meter for Real-Time Patient Monitoring.Sensors (Basel, Switzerland) · 2026Article
- Clinical and economic impact of a large language model in perioperative medicine: a randomized crossover trial.NPJ digital medicine · 2025Article
- A novel translational bioinformatics framework for facilitating multimodal data analyses in preclinical models of neurological injury.Scientific reports · 2024Article
- Clinical Implementation of Tissue-Sparing Posterior Cervical Fusion: Addressing Market Access Challenges.Journal of personalized medicine · 2024Article
- Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.International journal of spine surgery · 2024Article
- A dual analysis of bougie and stylet development trend and impact of Chinese regulations on medical devices innovation.American journal of translational research · 2024Review
- Active, Actuated, and Assistive: a Scoping Review of Exoskeletons for the Hands and Wrists.Canadian prosthetics & orthotics journal · 2024Article
- Ranking Decision-Making Criteria for Early Adoption of Innovative Surgical Technologies.JAMA network open · 2023Article
- Wireless monitoring devices in hospitalized children: a scoping review.European journal of pediatrics · 2023Article
- Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study.JMIR pediatrics and parenting · 2023Article
- Experiences of medical device innovators as they navigate the regulatory system in Uganda.Frontiers in medical technology · 2023Article
- The complex landscape of TMS devices: A brief overview.PloS one · 2023Article
- Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe.Biomedicines · 2022Review
- Open-Source Hardware May Address the Shortage in Medical Devices for Patients with Low-Income and Chronic Respiratory Diseases in Low-Resource Countries.Journal of personalized medicine · 2022Review
- Pediatric Medical Devices - Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan.Circulation reports · 2021Article
- Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic.Frontiers in public health · 2021Article
- Cardiac Surgery: Increasing Access in Low- and Middle-Income Countries.Current cardiology reports · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it's purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on "implantable devices", which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.