Medical devices: a new approach to the quality dilemma

This paper describes some of the processing issues for extruding salicylic acid-based polymer prodrugs into fibers for medical devices. Polymeric prodrugs, in which a drug is polymerized in a degradable polymer that delivers controlled quantity of the drug to a targeted site in the body as the device degrades, are a new approach to controlled release. Hollow fibers were produced by solution spinning. Solid fibers were formed by melt processing. The salicylic acid polymers exhibited shear-thinning behavior. The viscosity exhibited pronounced temperature dependence.

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The Crowd, the Cloud and Improving the Future of Medical Device Innovation

Forum for Health Economics & Policy ◽

10.1515/fhep-2012-0023 ◽

2014 ◽

Vol 17 (1) ◽

pp. 13-20

Author(s):

Marco Huesch ◽

Robert Szczerba

Keyword(s):

Medical Device ◽

Medical Devices ◽

Business Models ◽

Regulatory Environment ◽

New Approach ◽

Current State ◽

Development Processes ◽

Reducing Costs ◽

Innovation Practices ◽

Start Ups

Abstract Barriers and delays to medical device innovation are often solely attributable to the regulatory environment instead of both the current state of innovation practices and product development processes in the industry. Increasing the pace of innovation while reducing costs requires the creation of a new approach that fits both established medical device corporations as well as entrepreneurial start-ups. In this commentary we advance the concept of innovation platforms to facilitate ideation in the medical device space. Such platforms could also allow the full health benefits from individual medical devices to be reaped, by overcoming interoperability concerns through simulation and credentialing. Given the dramatic benefits of medical device success, such non-traditional business models for development may be potential solutions for industry, users and regulators.

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Antimicrobial activity of polyurethanes coated with antibiotics: a new approach to the realization of medical devices exempt from microbial colonization

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2004.05.017 ◽

2004 ◽

Vol 280 (1-2) ◽

pp. 173-183 ◽

Cited By ~ 45

Author(s):

A Piozzi ◽

I Francolini ◽

L Occhiaperti ◽

M Venditti ◽

W Marconi

Keyword(s):

Antimicrobial Activity ◽

Medical Devices ◽

Microbial Colonization ◽

New Approach

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A New Approach to Stress Analysis of Vascular Devices Using High Resolution Thermoelastic Stress Analysis

Applied Mechanics and Materials ◽

10.4028/www.scientific.net/amm.5-6.63 ◽

2006 ◽

Vol 5-6 ◽

pp. 63-70 ◽

Cited By ~ 2

Author(s):

James Eaton-Evans ◽

Janice M. Dulieu-Barton ◽

Edward G. Little ◽

Ian A. Brown

Keyword(s):

High Resolution ◽

Stress Analysis ◽

Medical Devices ◽

Thermoelastic Stress ◽

Thermoelastic Stress Analysis ◽

New Approach ◽

Full Field ◽

Vascular Stents ◽

Thermoelastic Response ◽

Quantitative Stress

Thermoelastic Stress Analysis (TSA) is a non-contacting technique that provides full field stress information and can record high-resolution measurements from small structures. The work presented in this paper summarises the application of TSA to two types of small medical devices that are used to treat diseased arteries; angioplasty balloons and vascular stents. The use of high resolution optics is described along with a calibration methodology that allows quantitative stress measurements to be taken from the balloon structure. A brief account of a study undertaken to characterise the thermoelastic response from Nitinol is also included and it is demonstrated that thermoelastic data can be obtained from a stent at high resolutions.

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The Legislation and Regulation of Medical Devices

10.1093/oso/9780192847546.003.0007 ◽

2021 ◽

pp. 177-194

Keyword(s):

European Commission ◽

Medical Devices ◽

Product Safety ◽

Regulatory Environment ◽

New Approach ◽

Legislative History ◽

The Core ◽

Regulatory Bodies ◽

The Impact ◽

The Eu

This chapter outlines the laws that govern the manufacture and supply of medical devices in the EU and UK, both multi-faceted and internationally well-regarded legislative regimes. It contextualises these laws within the broader framework of the EU’s new approach to product safety legislation, in which these medical devices regimes were established. It discusses the core principles and fundamental statutory concepts under the EU and UK legislation that have been reinforced and improved upon over forty years of legislative history. Recent legislative change and the impact of Brexit is discussed in detail in that regard. The chapter also describes the regulatory environment in which Europe’s substantial medical devices industry operates, an industry which is estimated by the European Commission in 2019 as being comprised of 500,000 different types of medical devices and worth €100 billion. An outline of key regulatory bodies and functions is also provided.

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Ankle Foot Orthoses with Wire Insertion

Applied Mechanics and Materials ◽

10.4028/www.scientific.net/amm.371.554 ◽

2013 ◽

Vol 371 ◽

pp. 554-558 ◽

Cited By ~ 2

Author(s):

Mircea Badescu ◽

Carmen Purcar ◽

Delia Badescu

Keyword(s):

Medical Devices ◽

Human Body ◽

Manufacturing Technology ◽

Foot Orthoses ◽

Manufacturing Costs ◽

Patient Behavior ◽

New Approach ◽

Behavior Skills ◽

Ankle Foot Orthoses ◽

Materials Used

The objective of the work is to present some researches regarding the virtual modelling of external medical devices with wire insertion. Ankle foot orthoses are used to correct and prevent different disfunctions of the human body and also in athlets recovery. The research is motivate by the problems appeared using this medical devices: durability issues, patient confort, manufacturing costs, lightweight, flexible access to shoes, inexpensive, readily available. These issues depends of the wey design, manufacturing technology, materials used, patient behavior, skills manufacturer. Wire insertion in polypropylene is a new approach of orthoses materials.

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SINGLE-MARKET REGULATION AND INNOVATION IN EUROPE'S MEDICAL DEVICES INDUSTRY

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462301106136 ◽

2001 ◽

Vol 17 (3) ◽

pp. 421-432 ◽

Cited By ~ 1

Author(s):

Horst Steg ◽

Nikolaus Thumm

Keyword(s):

Medical Devices ◽

Regulatory Framework ◽

European Market ◽

Market Regulation ◽

Short Term ◽

New Approach ◽

Single European Market ◽

The Impact ◽

Total Impact

In this article we analyze the influence of the legal regulatory framework in Europe, established by the two directives on medical devices and active implantable devices, on the performance of innovation in a single European market. First, we describe in general the possible influence of a single European market on innovation and the institutional features of the particular harmonization approach (“New Approach”) we are looking at here. The empirical results presented derive from a survey investigation involving 150 firms that we defined as best innovators in the European medical devices industry from a pre-survey. The results confirm that the total impact of the New Approach regulation on firms' innovation in the long term is positive. However, it also becomes clear that the impact of regulation on innovation is limited if the factors are looked at individually and that there is a clear difference regarding short-term effects. To improve the regulatory framework, several policy actions are recommended.

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Making the invisible visible: New perspectives on the intersection of human-environment interactions of clinical teams in intensive care

10.1101/2021.05.10.21256688 ◽

2021 ◽

Author(s):

Sheena Visram ◽

Laura Potts ◽

Neil J Sebire ◽

Yvonne Rogers ◽

Emma Broughton ◽

...

Keyword(s):

Intensive Care ◽

Medical Devices ◽

New Technologies ◽

Clinical Team ◽

Clinical Environment ◽

Healthcare Staff ◽

Human Environment ◽

New Approach ◽

Design Considerations ◽

New Interactions

Understanding human behaviour is essential to the adoption practices for new technologies that promote safer care. This requires capturing the detail of clinical workflows to inform the design of new interactions including those with touchless technologies that decipher human-speech, gesture and motion and allow for interactions that are free of contact. Many environments in hospitals are sub-optimally designed, with a poor layout of work surfaces, cumbersome equipment that requires space and effort to manoeuvre, designs that require healthcare staff to reach awkwardly and medical devices that require extensive touch. This suggests there is a need to better understand how they can be designed. Here, we employ a new approach by installing a single 360 degree camera into a clinical environment to analyse touch patterns and human-environment interactions across a clinical team to recommend design considerations for new technologies with potential to reduce avoidable touch.

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