Abstract:
:Models are abstract representations of reality that are built, analyzed and manipulated to augment the understanding of that reality. They can either be mental or codified but, in both cases, they contribute to good decision-making by ensuring that the right people use the right information at the right time. In order to reduce time to market, companies commonly adopt product development processes (PDP) and the medical device sector is no different. However, one can question which is the most adequate PDP model to follow or what information that model should contain, or even how the information should be represented. Here, the authors review the existing PDP models dedicated to medical devices. The model's representation and usability are also debated in order to assist developers to select the most suitable model and adapt it to their needs and reality.
journal_name
Expert Rev Med Devicesjournal_title
Expert review of medical devicesauthors
Santos IC,Gazelle GS,Rocha LA,Tavares JMdoi
10.1586/erd.12.36subject
Has Abstractpub_date
2012-09-01 00:00:00pages
537-43issue
5eissn
1743-4440issn
1745-2422journal_volume
9pub_type
杂志文章,评审abstract::Clinical applications in the developing world, such as malaria and anemia diagnosis, demand a change in the medical paradigm of expensive care given in central locations by highly trained professionals. There has been a recent explosion in optical technologies entering the consumer market through the widespread adopti...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.1075388
更新日期:2015-01-01 00:00:00
abstract:INTRODUCTION:Anastomotic leak (AL) after colorectal surgery is a devastating complication; decreased blood perfusion is an important risk factor. Surgeons rely on subjective measures to assess bowel perfusion. Fluorescence imaging (FI) with indocyanine green (ICG) provides a real-time objective assessment of intestinal...
journal_title:Expert review of medical devices
pub_type: 杂志文章,meta分析,评审
doi:10.1080/17434440.2017.1265444
更新日期:2017-01-01 00:00:00
abstract::Nanotechnology is increasingly applied to the field of medicine, particularly for the treatment of cancer. In this regard, gold nanoparticles can mediate hyperthermia induction and kill tumor cells upon laser irradiation, thereby functioning as a 'thermal scalpel'. Recent developments in gold nanoparticle design have ...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.2.131
更新日期:2007-03-01 00:00:00
abstract::This article reviews the current status of cochlear implantation in both adults and children, including expanding candidacy groups, bilateral implantation, advances in speech processing software, internal and external device hardware, surgical techniques and outcomes. Promising advances, novel therapies and evolving c...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.11.12
更新日期:2011-05-01 00:00:00
abstract::The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction betwee...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.12.5
更新日期:2012-05-01 00:00:00
abstract::Neurodegeneration in Parkinson's disease (PD) affects both the fine motor control of the fingers and gross movement of the upper limb. Handwriting examinations are commonly performed in the analysis of tremor in PD and there is validity in subjective assessment in the clinic. However, there is clinical need for a more...
journal_title:Expert review of medical devices
pub_type: 社论,评审
doi:10.1586/17434440.2014.900437
更新日期:2014-05-01 00:00:00
abstract::Powered instruments have been introduced into otorhinolaryngology practice over the last decade. These instruments were accepted immediately by many institutions, and continuing development has led to the current use of microdebriders in a variety of surgical procedures in otorhinolaryngology. In clinical rhinology, t...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.10.7
更新日期:2010-05-01 00:00:00
abstract:INTRODUCTION:Approximately one-third of all ischemic strokes and the ensuing health and economic burden can be attributed to the presence of atrial fibrillation (AF). The global prevalence of AF continues to rise, thus making it by far the most common diagnosed cardiac arrhythmia. Percutaneous left atrial appendage (LA...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1837621
更新日期:2020-11-01 00:00:00
abstract::Liver biology, liver disease and its management present a myriad of challenges to clinicians. Difficulties arise in determining liver functional capacity, which must be effectively measured in a quantitative reproducible manner. Measurement of indocyanine green (ICG) clearance, an exceptional tool that has been used f...
journal_title:Expert review of medical devices
pub_type: 社论
doi:10.1586/17434440.2016.1126178
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:The Ovation stent-graft uncouples the steps of fixation and sealing via a pair of polymer-filled inflatable rings. Apart from the well-documented early results, newer data emerged for mid-term results of Ovation and are presented in this review. AREAS COVERED:Aim of this article was to report all current ...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1555467
更新日期:2019-01-01 00:00:00
abstract::To reduce the toxic effects, related clinical problems and complications such as bleeding disorders associated with systemic anticoagulation, it has been hypothesized that by coating the surfaces of medical devices, such as stents, bypass grafts, extracorporeal circuits, guide wires and catheters, there will be a sign...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.3.2.245
更新日期:2006-03-01 00:00:00
abstract:INTRODUCTION:Type B aortic dissection (TBAD) is a threatening event that may lead to death for aortic rupture or multivisceral malperfusion in the acute phase and offers a poor prognosis for long term survivors. Thoracic endovascular aortic repair (TEVAR) has become the preferential therapy in acute and chronic complic...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1782735
更新日期:2020-07-01 00:00:00
abstract::The rescue of autogenous angioaccess for hemodialysis can be performed surgically or radiologically. For the latter, there is current debate as to whether a mechanical hydrodynamic device confers a clinical advantage over a rotational thrombectomy. The evaluated article describes a single center retrospective cohort s...
journal_title:Expert review of medical devices
pub_type: 评论,杂志文章
doi:10.1586/erd.12.75
更新日期:2013-01-01 00:00:00
abstract::Considerable research efforts have recently been dedicated to the establishment of various drug delivery systems (DDS) that are mechanical/physical, chemical and biological/molecular DDS. In this paper, we report on the recent advances in site-specific drug delivery (site-specific, controlled, targeted or smart drug d...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.1091722
更新日期:2015-01-01 00:00:00
abstract::Minimally invasive, catheter-based treatment of valvular dysfunction has become an integral part of clinical routine. As left heart valvular disease is much more common and thus commercially of interest, transcatheter solutions for the treatment of aortic and mitral valvular defects were the first to become broadly cl...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.985654
更新日期:2015-03-01 00:00:00
abstract::Although implanted for over 40 years, finger prostheses have failed to match the success achieved by artificial hip and knee prostheses, despite a myriad of designs having been proposed and implanted. This article looks at the currently available designs of metacarpophalangeal prosthesis, both single-piece and multico...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.1.2.193
更新日期:2004-11-01 00:00:00
abstract:INTRODUCTION:Spinal cord stimulation has emerged as a state-of-the-art evidence-based treatment for chronic neuropathic pain and mixed nociceptive-neuropathic pain. In recent years, several newer devices and treatment algorithms have provided unique and effective ways of treating chronic pain by spinal cord stimulation...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1567325
更新日期:2019-02-01 00:00:00
abstract::This paper discusses a new class of robots known as concentric tube robots and their application to transnasal skull base surgery. The endonasal approach has clear benefits for patients, but the surgery presents challenges that strongly motivate the use of robotic tools. In this paper, the concentric tube robot concep...
journal_title:Expert review of medical devices
pub_type: 社论
doi:10.1586/17434440.2013.854702
更新日期:2014-01-01 00:00:00
abstract::Conventional ultrasonography represents the first diagnostic imaging modality for the study of pancreatic tumors. Contrast-enhanced ultrasound has significantly improved the accuracy of first-line examination and may influence the choice of second-line investigations: multidetector computed tomography is considered th...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.09.67
更新日期:2010-03-01 00:00:00
abstract::Total hip resurfacing has long been conceptually attractive to both surgeons and patients. However, historically it has been plagued by limited durability and marked acetabular bone loss. The recent development of wear-resistant bearings, such as metal-on-metal, has led to renewed interest in hip resurfacing in the or...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.3.6.755
更新日期:2006-11-01 00:00:00
abstract::Left atrial appendage device occlusion for the preventions of systemic thromboembolism and stroke represents a major breakthrough in the field of cardiovascular disease. The wide prevalence of atrial fibrillation with devastating consequences of thromboembolic stroke as a result of thrombus arising from the left atria...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.940315
更新日期:2014-11-01 00:00:00
abstract:INTRODUCTION:Coronary artery disease affecting myocardial perfusion continues to be the leading cause of cardiovascular morbidity and mortality worldwide. While invasive evaluation based on coronary angiography and flow measurements still is considered the reference technique for assessing myocardial perfusion, technol...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1834844
更新日期:2020-11-01 00:00:00
abstract:BACKGROUND:With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections us...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2018.1421942
更新日期:2018-02-01 00:00:00
abstract::In the last decade, bicomponent fibers have been proposed to fabricate bio-inspired systems for tissue repair, regenerative medicine, medical healthcare and clinical applications. In comparison with monocomponent fibers, key advantage concerns their ability of self-adapting to the physiological conditions through an e...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2016.1126505
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:Bronchoscopic lung volume reduction with endobronchial valves is a recently acknowledged treatment option in patients with severe emphysema and absence of interlobar collateral ventilation. In endobronchial valve treatment, implantation of one-way valves leads to deflation of a hyperinflated lung lobe. Mul...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2018.1538780
更新日期:2018-11-01 00:00:00
abstract::The shortage of appropriate donor hearts and the expanding pool of patients waiting for a heart transplantation have led to growing interest in alternative strategies, particularly in mechanical circulatory support. With expanding clinical experience and continued technical advances, continuous-flow pumps are evolving...
journal_title:Expert review of medical devices
pub_type: 历史文章,杂志文章,评审
doi:10.1586/erd.11.62
更新日期:2012-01-01 00:00:00
abstract::Malignant biliary obstruction results in jaundice, often with symptoms that decrease the quality of life. Biliary stent placement has largely supplanted surgical bypass for palliation of malignant biliary obstruction. Traditional rigid plastic stents are commonly used, inexpensive and easily removed, although with lim...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.10.36
更新日期:2010-09-01 00:00:00
abstract::Patellofemoral arthroplasty has been utilized as a treatment for isolated patellofemoral arthritis for more than 30 years. However, the use of this procedure remains controversial, as many surgeons prefer to use total knee arthroplasty, even for isolated patellofemoral arthritis. While historically, the results with t...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/erd.09.53
更新日期:2010-01-01 00:00:00
abstract::Carotid stenosis is responsible for approximately 30% of strokes, and carotid endarterectomy is considered to be the gold-standard treatment. Carotid angioplasty and stenting (CAS) has been proposed as an alternative to surgery but the risk of neurological complications and brain embolism remains the major drawback to...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.5.5.591
更新日期:2008-09-01 00:00:00
abstract::Vitreoretinal surgery has recently undergone remarkable developments. The introduction of micro-incision vitrectomy surgery using 25- and 23-gauge techniques has led to minimally invasive, faster, safer, and more accurate surgeries. Similarly, intraocular illumination and observation systems have advanced from light p...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.882226
更新日期:2014-03-01 00:00:00