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Varshney N.,Simon Kucher and Partners | Gilbert M.,Loughborough University | Walon M.,Honeywell | Schiller M.,Akdeniz Kimya Sanayi Ve Tic. A.S.
Journal of Vinyl and Additive Technology | Year: 2012

Plate-out is an extrusion phenomenon that causes formulators and processors significant problems when processing poly(vinyl chloride) (PVC). It is an unwanted deposit that forms on the die, calibration, and degassing sections of extrusion equipment that can cause unacceptable streaking and scoring on the final product through continued deposition. In a previous paper, the authors used a range of analytical techniques to identify inorganic and organic components found in samples of industrial plate-out. This paper describes a laboratory methodology to determine the statistically significant properties of polyethylene wax lubricants that contribute to plate-out. A small-scale twin-screw extruder equipped with a plate-out-sensitive die was used to analyze lead-based window profile formulations containing various homopolymer grades of polyethylene wax and oxidized polyethylene or high-density polyethylene lubricants. The influence of these waxes on plate-out is explained in terms of generally accepted lubricant theory, as well as theory proposed by other workers, such as Lippoldt. © 2012 Society of Plastics Engineers.

Schaefer E.,InsuLine Medical GmbH | Schnell G.,Simon Kucher and Partners | Sonsalla J.,Simon Kucher and Partners
Journal of Diabetes Science and Technology | Year: 2015

Manufacturers launching next-generation or innovative medical devices in Europe face a very heterogeneous reimbursement landscape, with each country having its own pathways, timing, requirements and success factors. We selected 2 markets for a deeper look into the reimbursement landscape: France, representing a country with central decision making with defined processes, and Italy, which delegates reimbursement decisions to the regional level, resulting in a less transparent approach to reimbursement. Based on our experience in working on various new product launches and analyzing recent reimbursement decisions, we found that payers in both countries do not reward improved next-generation products with incremental reimbursement. Looking at innovations, we observe that manufacturers face a challenging and lengthy process to obtain reimbursement. In addition, requirements and key success factors differ by country: In France, comparative clinical evidence and budget impact very much drive reimbursement decisions in terms of pricing and restrictions, whereas in Italy, regional key opinion leader (KOL) support and additional local observational data are key. ©. 2014 Diabetes Technology Society.

Schafer E.,InsuLine Medical GmbH | Schnell G.,Simon Kucher and Partners | Bobakova T.,Simon Kucher and Partners
Journal of Diabetes Science and Technology | Year: 2013

The reimbursement landscape for new and innovative diabetes devices in Europe is very heterogeneous and nontransparent, with each country employing different mechanisms, pathways, and requirements. This article provides an overview of how diabetes device reimbursement works in the outpatient setting in the five major European Union markets (France, Germany, Italy, Spain, and the United Kingdom; the EU-5). It will be of particular interest to manufacturers of innovative devices. Markets are first categorized as either a centralized or a regionalized reimbursement decision-making system, and implications for device reimbursement are explored. In the second part, specific requirements and success factors for wide reimbursement in the EU-5 are analyzed in detail. Gaining early acceptance by the main influencers (key opinion leaders and payers) is the first step. Equally important is the provision of convincing evidence, be this clinical, health-economic (cost-efectiveness), or a demonstration of cost savings (budget impact). In some countries, local usage data may be a requirement as well. Lastly, as payers' willingness to pay stems directly from their perceived value of a device, a key success factor and a necessary precondition for manufacturers is to set the right price. © Diabetes Technology Society.

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