Market approval processes for new types of spinal devices: challenges and recommendations for improvement

Bisschop, Arno; Tulder, Maurits W. van

doi:10.1007/s00586-016-4606-1

Cited by 9 publications

(3 citation statements)

References 54 publications

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“…At health care institutes the equipment represents fixed costs and booked among capital costs, while consumables and ad hoc maintenance expenses are variable costs and booked among operating costs. As the average cost is dependent on the economies of scale, it is not easy to calculate the actual cost per intervention of complex MDs with high upfront costs and unpredictable maintenance costs (43).…”

Section: Issue 2: Economic Value Assessment Challenge 21: Cost Calcumentioning

confidence: 99%

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Daubner-Bendes¹,

Kovács

Niewada

et al. 2021

Front. Public Health

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Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence.Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020.Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs.Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.

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Section: Issue 2: Economic Value Assessment Challenge 21: Cost Calcumentioning

confidence: 99%

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Daubner-Bendes¹,

Kovács

Niewada

et al. 2021

Front. Public Health

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“…Although the Dynesys system was considered to be substantially equivalent, it should have been regarded as a new dynamic stabilization technique as opposed to a new type of posterior technique (Bisschop and Van Tulder 2016). The Dynesys system thereby received its 510(k) approval long before the first and only randomized control trial was conducted (Bisschop and Van Tulder 2016).…”

Section: Case Studies Of Failed Spinal Products In the United Statesmentioning

confidence: 99%

“…During this time period where there was little published research, the device was in clinical use in Europe since 1999 with over 40,000 patients receiving implants. Consequently, there was not enough evidence in the period between the 510(k) approval and the rejected PMA application to determine whether this device resulted in improved health outcomes compared to standard treatments (Bisschop and Van Tulder 2016). Indeed, short-term clinical results seemed favorable, while long-term complications arose: screw loosening, adjacent segment degeneration, late infection.…”

Section: Case Studies Of Failed Spinal Products In the United Statesmentioning

confidence: 99%

Spine Products in Use Both Outside and Inside the United States

Karnati¹,

Kim²,

Ebinu³

2020

Handbook of Spine Technology

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The spine product market in the United States and that of the rest of the world shares many similarities but also has significant differences. The FDA approval process of medical devices in the United States has a more stringent, often inconsistent, and prolonged pathway to final approval than when compared to the CE marking process in Europe. In fact, a large number of spinal implants have not yet been either approved or used as widely in the United States as compared to the rest of the world. There are three main spine product categories, namely lumbar artificial discs, interspinous spacers, and dynamic stabilization systems that can be identified as "new" and not as widely used in US markets. After analyzing why some of the products in these categories failed the FDA approval process, we present other unique spine products widely used in European and other international markets but not so commonly seen in US markets.

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