ArticleInternational journal of technology assessment in health care2015
HEADROOM APPROACH TO DEVICE DEVELOPMENT: CURRENT AND FUTURE DIRECTIONS.
Article in International journal of technology assessment in health care, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Headroom Analysis for Early Economic Evaluation: A Systematic Review.Applied health economics and health policy · 2023Pooled it
- Health Technology Assessment in the Early Phases of Development of Medical Devices: A Catalyst for Sustainable Growth and Innovation.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2025Article
- Article
- Molecular Testing as Triage in Cervical Cancer Screening: Economic Evaluation Using Headroom Analysis.Cancers · 2025Article
- An early economic evaluation of active surveillance for low-risk ductal carcinomaFuture oncology (London, England) · 2024Article
- Perceptions and Attitudes Regarding Medical Device Development in Canada Among Canadian Innovators: A Qualitative Study.PharmacoEconomics - open · 2023Article
- Image-guided navigation for locally advanced primary and locally recurrent rectal cancer: evaluation of its early cost-effectiveness.BMC cancer · 2022Article
- Early Health Economic Modeling of Novel Therapeutics in Age-Related Hearing Loss.Frontiers in neuroscience · 2022Article
- How can we discover the most valuable types of big data and artificial intelligence-based solutions? A methodology for the efficient development of the underlying analytics that improve care.BMC medical informatics and decision making · 2021Article
- Benefits and obstacles to cell therapy in neonates: The INCuBAToR (Innovative Neonatal Cellular Therapy for Bronchopulmonary Dysplasia: Accelerating Translation of Research).Stem cells translational medicine · 2021Review
- A Scoping Review of Different Methods of Assessing the Impact of New Medical Technologies at Early Stages of Development.Medical journal of the Islamic Republic of Iran · 2021Article
- The potential of real-time analytics to improve care for mechanically ventilated patients in the intensive care unit: an early economic evaluation.Cost effectiveness and resource allocation : C/E · 2020Article
- How Useful Are Early Economic Models? Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modelling".International journal of health policy and management · 2020Article
- How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development.Micromachines · 2020Article
- Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling.International journal of health policy and management · 2019Article
- Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature.PharmacoEconomics · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe headroom approach to medical device development relies on the estimation of a value-based price ceiling at different stages of the development cycle. Such price-ceilings delineate the commercial opportunities for new products in many healthcare systems. We apply a simple model to obtain critical business information as the product proceeds along a development pathway, and indicate some future directions for the development of the approach.
methodsHealth economic modelling in the supply-side development cycle for new products.
resultsThe headroom can be used: initially as a 'reality check' on the viability of the device in the healthcare market; to support product development decisions using a real options approach; and to contribute to a pricing policy which respects uncertainties in the reimbursement outlook.
conclusionsThe headroom provides a unifying thread for business decisions along the development cycle for a new product. Over the course of the cycle attitudes to uncertainty will evolve, based on the timing and manner in which new information accrues. Within this framework the developmental value of new information can justify the costs of clinical trials and other evidence-gathering activities. Headroom can function as a simple shared tool to parties in commercial negotiations around individual products or groups of products. The development of similar approaches in other contexts holds promise for more rational planning of service provision.
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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.