Abstract:
:Introduction: Health technology assessments (HTA) are tools for policymaking and resource allocation. Early HTAs are increasingly used in design and development of new technologies. Conducting early HTAs is challenging, due to a lack of evidence and significant uncertainties in the technology and the market. A multi-disciplinary approach is considered essential. However, an operational framework that can enable the integration of multi-dimensional evidence into commercialization remains lacking.Areas covered: We developed the Lean and Agile Multi-dimensional Process (LAMP), an early HTA framework, for embedding commercial decision-making in structured evidence generation activities, divided into phases. Diverse evidence in unmet needs, user acceptance, cost-effectiveness, and market competitiveness are being generated in increasing depth. This supports the emergence of design and value propositions that align technology capabilities and clinical and user needs.Expert opinion: We have been applying LAMP to working with medical device and diagnostic industry in the UK. The framework can be adapted to suit different technologies, decision needs, time scales, and resources. LAMP offers a practical solution to the multi-disciplinary approach. Methodologists drive the process by performing evidence generation and synthesis as and by enabling interactions between manufacturers, designers, clinicians, and other key stakeholders.
journal_name
Expert Rev Med Devicesjournal_title
Expert review of medical devicesauthors
Ni M,Borsci S,Walne S,Mclister AP,Buckle P,Barlow JG,Hanna GBdoi
10.1080/17434440.2020.1743174subject
Has Abstractpub_date
2020-04-01 00:00:00pages
277-288issue
4eissn
1743-4440issn
1745-2422journal_volume
17pub_type
杂志文章,评审abstract::The surgical implantation of auditory devices to improve or restore the sensation of hearing in affected individuals is a rapidly growing area of modern ear, nose and throat, and audiological practice. Following the enormous success of cochlear implantation and set to take an increasing role in the rehabilitation of d...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.11.18
更新日期:2011-07-01 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:INTRODUCTION:First-generation drug-eluting stents (DES) were developed and indeed proved their superiority compared to bare-metal stent in minimizing neo-intimal hyperplasia and in-stent restenosis (ISR), overall, reducing target vessel revascularization (TVR). Newer-generation DES are characterized by thinner struts, ...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2018.1549986
更新日期:2019-01-01 00:00:00
abstract:OBJECTIVES:Limb lengthening by distraction osteogenesis is a technique widely used to treat limb length discrepancy resulting from trauma, congenital limb defects and long bone non-union. For decades, patients have resorted to the Ilizarov apparatus, prone to pin tract infections and scarring. Although implantable leng...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2019.1599283
更新日期:2019-04-01 00:00:00
abstract::Insertable cardiac monitors (ICMs) are leadless subcutaneous devices that continuously monitor the heart rhythm and record events over a timeframe measured in years, allowing for the diagnosis of infrequent rhythm abnormalities that can be the cause of palpitations, syncope and stroke. To date, ICMs have primarily bee...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.953059
更新日期:2015-01-01 00:00:00
abstract::Introduction: A preexisting mechanical mitral valve (MMV) is thought to be a thrombogenic risk factor after continuous-flow left ventricular assist device (CF-LVAD) implantation. We sought to evaluate the management and outcomes of preexisting MMVs in patients following CF-LVAD implantation.Areas covered: An electroni...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2020.1754190
更新日期:2020-05-01 00:00:00
abstract::With advances in endoscopic imaging tools, it is becoming increasingly possible to find, assess and treat numerous gastrointestinal (GI) pathologies at the time of endoscopy. This article focuses on the newly developed Pentax confocal endomicroscope that enables in vivo microscopic imaging of the upper and lower GI tr...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.3.5.549
更新日期:2006-09-01 00:00:00
abstract::Surgeons often encounter the challenge of treating acquired abdominal wall defects following abdominal surgery. The current standard of practice is to repair most defects using permanent synthetic mesh material. Mesh augments the strength of the weakened abdominal wall fascia and enables the hernia repair to be perfor...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.3.5.657
更新日期:2006-09-01 00:00:00
abstract:INTRODUCTION:Retinal imaging is a key investigation in ophthalmology. New devices continue to be created to keep up with the demand for better imaging modalities in this field. This review looks to highlight current trends and the future of retinal imaging. AREAS COVERED:This review looks at the advances in topographi...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1816167
更新日期:2020-10-01 00:00:00
abstract::Introduction: Catheter directed interventions (CDIs) have evolved over the past decade in an attempt to reduce the complications of systemic thrombolysis, while providing equivalent therapeutic benefits.Areas covered: CDIs include a wide array of catheters that incorporate ultrasound technology, the infusion of thromb...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1714432
更新日期:2020-02-01 00:00:00
abstract:INTRODUCTION:Introduction: Transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are noninvasive neuromodulation techniques used as therapeutic and research tools for several neuropsychiatric conditions. Given the exponential scientific growth of this field, we aimed to systematical...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1615440
更新日期:2019-06-01 00:00:00
abstract::A wearable and, ultimately, an implantable artificial kidney is a long-held aim in the treatment of patients with end-stage renal disease, provided that it would combine continuous blood purification, preventing the fluctuations in the internal environment associated with hemodialysis, while maintaining a high efficie...
journal_title:Expert review of medical devices
pub_type: 社论
doi:10.1586/17434440.2015.1053466
更新日期:2015-07-01 00:00:00
abstract::Temperature analysis has been considered as a complementary method in medical evaluation and diagnosis. Several studies demonstrated that monitoring the temperature variations of the feet of diabetic patients can be helpful in the early identification of diabetic foot manifestations, and also in changing behaviors, wh...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.1032251
更新日期:2015-07-01 00:00:00
abstract::Patients with primary and secondary liver cancers generally have a poor prognosis with limited potentially curative options. Liver-directed, intra-arterial therapies such as selective internal radiotherapy (SIRT) and trans-arterial chemoembolization (TACE) are taking a larger role in the management of these patients. ...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.2016.1164594
更新日期:2016-05-01 00:00:00
abstract:INTRODUCTION:Refinements in endovascular technology have revolutionized the treatment of intracranial aneurysms (IAs) with the development of flow-diversion technology. The first generation of the Pipelin Embolization Device (PED) has demonstrated its safety and efficacy. However, the deployment technique was a difficu...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2016.1231573
更新日期:2016-10-01 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::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:INTRODUCTION:The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthca...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2018.1418661
更新日期:2018-01-01 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:INTRODUCTION:Mechanical circulatory support (MCS) is an increasingly utilized mode of therapy in the management of advanced heart failure, both as bridge to heart transplantation and destination therapy. As MCS becomes more prevalent, it is ever more important to understand the complex hemodynamics of these devices, as...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2017.1324292
更新日期:2017-05-01 00:00:00
abstract::The subthalamic nucleus (STN) is the primary target for the chronic deep brain stimulation treatment of Parkinson's disease. STN neurons exhibit a variety of characteristic properties that may play a key role in the overall population response to deep brain stimulation. Neuroinformatics techniques, in particular compu...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.5.663
更新日期:2007-09-01 00:00:00
abstract::This article investigates various neural machine interfaces for voluntary control of externally powered upper-limb prostheses. Epidemiology of upper limb amputation, as well as prescription and follow-up studies of externally powered upper-limb prostheses are discussed. The use of electromyographic interfaces and peri...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.1.43
更新日期:2007-01-01 00:00:00
abstract::This article focuses on the surface engineering of ventricular assist devices (VADs) for the treatment of heart failure patients, which involves the modification of surfaces contacting blood in order to improve the blood compatibility (hemocompatibility) of the VADs. Following an introduction to the categorization and...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.6.1.51
更新日期:2009-01-01 00:00:00
abstract:INTRODUCTION:To improve the total knee arthroplasty (TKA) prosthesis design, it is essential to study the kinematics of the tibiofemoral joint. Many studies have been conducted in this area; however, conflicting results and incomparable testing methods make it difficult to draw definitive conclusions or compare researc...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1564037
更新日期:2019-02-01 00:00:00
abstract::Autofluorescence imaging videobronchoscopy (AFI) is one of the new systems of autofluorescence bronchoscopy designed for thorough examination of bronchial mucosa. The integration of autofluorescence and videobronchoscopy provides clear images of normal and pathologically altered bronchial mucosa. Major indications for...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/erd.10.92
更新日期:2011-03-01 00:00:00
abstract::Inferior vena cava filters are widely accepted for pulmonary embolic prophylaxis in high-risk patients with contraindications to anticoagulation. While long-term complications have been associated with permanent filters, retrievable filters are now available and have resulted in the rapid expansion of this technology....
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/erd.09.25
更新日期:2009-09-01 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 discrepancy between the number of patients on the waiting list and available donor hearts has led to the successful development of left ventricular assist devices (LVAD) as a bridge to transplantation. The conventional LVADs are designed to provide full hemodynamic support for the end-stage failing heart. However,...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.985208
更新日期:2015-01-01 00:00:00
abstract::Introduction: It is common belief that driving with an implantable cardioverter defibrillator (ICD)/pacemaker (PM) might be associated with sudden cardiac incapacitation, road traffic accidents, and chance to harm to self and others. On the other hand, the ability to drive is highly valuable in the modern era, represe...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1742108
更新日期:2020-04-01 00:00:00
abstract:INTRODUCTION:Early promising results of renal nerve denervation awakened interest in developing medical device alternatives for patients with resistant hypertension. The subsequent sham-controlled renal nerve denervation randomized trials were disappointing leading researchers and innovators to explore alternative devi...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1779054
更新日期:2020-07-01 00:00:00