scholarly journals Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices

2020 ◽  
Vol 110 (1) ◽  
pp. 120-161 ◽  
Author(s):  
Matthew Grennan ◽  
Robert J. Town
Keyword(s):  
Consumer Welfare ◽  
Quality Information ◽  
The European Union ◽  
Market Surveillance ◽  
Total Surplus ◽  
Post Market Surveillance ◽  
Consumer Uncertainty ◽  
Post Market ◽  
Welfare Implications ◽  
The Impact

We study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare. Product testing can reduce consumer uncertainty, but also increase entry costs and delay entry. Using variation between EU and US medical device regulations, we document patterns consistent with valuable learning from more stringent US requirements. To derive welfare implications, we pair the data with a model of supply, demand, and testing regulation. US policy is indistinguishable from the policy that maximizes total surplus in our estimated model, while the European Union could benefit from more testing. “Post-market surveillance” could further increase surplus. (JEL D43, I18, L13, L51, L64, O31, O38)

WallstentR esophageal prosthesis: Post-market surveillance study

1996 ◽  
Vol 43 (4) ◽  
pp. 339 ◽  
Author(s):  
J. Lavergne ◽  
K. Fields ◽  
J.S. Barkin ◽  
D.L. Carr-Locke ◽  
R.A. Kozarek ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market ◽  
Esophageal Prosthesis

scholarly journals MEDICAL TECHNOLOGY AT HOME: SAFETY-RELATED ITEMS IN TECHNICAL DOCUMENTATION

2013 ◽  
Vol 29 (1) ◽  
pp. 20-26 ◽  
Author(s):  
Ellen S.M. Hilbers ◽  
Claudette G.J.C.A de Vries ◽  
Robert E. Geertsma
Keyword(s):  
Risk Analysis ◽  
Medical Equipment ◽  
Field Experiences ◽  
Technical Documentation ◽  
Infusion Pumps ◽  
Home Setting ◽  
Market Surveillance ◽  
Post Market Surveillance ◽  
Post Market ◽  
At Home

Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.

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