Publications
Here you can find a short list of publications of Mark Charny, managing director of Translucency. He is widely published in peer-reviewed medical literature and other journals. All these articles were published by Clinica and you may download one of them as a protected pdf file. If you want to read more of them or need a consultation feel free to contact Mark Charny.
WINDOW INTO HTA: Planning a resource-effective strategy
11 December 2015. Mark Charny discusses how medtech companies can plan their HTA strategy on a country-specific level and on a broader EU level.
REIMBURSEMENT UNRAVELLED: Cleaning up the ins and outs of acute renal dialysis
8 October 2015. Mark Charny, Robert Handschuh, Maria Pia pellegrina and Thomas Seeger discuss the different landscapes for acute renal dialysis reimbursement in four EU regions: England, France, Germany, and Italy.
REIMBURSEMENT CLINIC: Pitfalls of using medical records for reimbursement
18 August 2015. Dr Mark Charny reviews the pros and cons of using medical records for data to get reimbursement.
REIMBURSEMENT CLINIC: Healthcare’s holy trinity of decision-makers
15 July 2015. Dr Mark Charny examines how medtech manufacturers need to be fully aware of the holy trinity of decision-makers when carving a market for their products.
REIMBURSEMENT CLINIC: How validity is vital
11 June 2015. Dr Mark Charny advises on the best way to design your trial so that your data will apply to decision-makers’ reimbursement criteria.
REIMBURSEMENT CLINIC: Compared to what?
11 May 2015. Dr Mark Charny advises on what comparison evidence you need to best highlight the value proposition of your product.
REIMBURSEMENT CLINIC: Trial and error – getting the right evidence to win over payers
23 April 2015. Dr Mark Charny tackles the question of what type of trial data would get you the most favorable reimbursement outcomes and advises on how to make the best use of the data you already have.
REIMBURSEMENT UNRAVELLED: Italy’s new HTA system signals major change
13 February 2015. Italy is preparing to set up a national health technology assessment system and assess medical technologies centrally in coordination with the regions and local hospitals. The legislative framework has been completed and its implementation is ...
REIMBURSEMENT UNRAVELLED: EU challenges of drug/device combinations
23 January 2015. Manufacturers of drug/device combination products need to consider carefully their reimbursement position and be prepared to collect the data necessary to support reimbursement submissions. Where a price premium is sought compared to ...
REIMBURSEMENT CLINIC: Seven trends to watch
19 January 2015. Dr Mark Charny predicts the key changes that will reshape the reimbursement pathway for medical devices.
REIMBURSEMENT UNRAVELLED: How to get a paid companion
30 December 2014. Dr Mark Charny discusses the reimbursement landscape for companion diagnostics and outlines the various routes in the EU to get funding.
REIMBURSEMENT CLINIC: Different strokes for different folks
12 December 2014. Dr Mark Charny tackles the perennial question of why Europe has such a fragmented and complex reimbursement landscape. By understanding the unique needs of each market and how your product can address those needs, you could increase y...
REIMBURSEMENT UNRAVELLED: How are EU healthcare systems funding mHealth and eHealth?
10 December 2014. Dr Mark Charny gives an insight into the EU reimbursement situation for eHealth and mHealth technologies, and includes a special focus on Germany, France, UK and Italy.
REIMBURSEMENT CLINIC: Laying down your starting blocks
12 November 2014. With Europe presenting such a fragmented reimbursement market, it is difficult to know where to start. Dr Mark Charny advises on what factors to consider when planning your reimbursement strategy and explains how a better understanding o...
REIMBURSEMENT UNRAVELLED: Why blood glucose monitoring products are reimbursement anomalies
30 October 2014. In this article Dr Mark Charny explains that careful and detailed consideration of the reimbursement, prescribing and purchasing regulations in each market is required to develop a coherent marketing strategy for blood glucose meters an...
REIMBURSEMENT CLINIC: Understanding the NICEties of medical devices
16 October 2014. Dr Mark Charny explains the different types of guidelines UK’s NICE puts out on medical devices and their impact on buyer’s decisions.
REIMBURSEMENT CLINIC: Mystery of the vanishing code
5 September 2014. Dr Mark Charny explains why there is a disconnect between medtech companies’ and their customers’ expectations of reimbursement and what the possible barriers could be.
REIMBURSEMENT CLINIC: Killing two birds with one stone
8 August 2014. Dr Mark Charny discusses how careful strategizing can help companies fulfil evidential needs for both regulatory approval and reimbursement while avoiding costly mistakes.
REIMBURSEMENT UNRAVELLED: Convincing UK medtech buyers
29 July 2014. Dr Mark Charny throws more light at the volume and type of evidence that is needed to encourage the uptake of medical devices by buyers in the UK.
Packing a punch with the right value dossier
3 May 2013. Dr Mark Charny gives tips on building a strong value dossier that presents the most compelling proposition for your technology.
Value: the fourth hurdle
7 February 2013. Dr Mark Charny discusses why it is necessary to demonstrate value and its implications on market access, as well as how value is perceived between different stakeholders.
EU country variations in medtech value assessment and the key routes to market entry
8 January 2013. Reimbursement of medical technology is linked to the value offered by the product. Some of this value is intrinsic to the technology and is constant across all EU markets; some varies by market according to the country’s specific reimbursement rul...
Unravelling reimbursement and HTA issues for drug/device combinations and companion diagnostics
5 December 2012. How do payers respond to the reimbursement issues that arise with companion diagnostics and drug/device combinations, where two products that span two different reimbursement channels are used together? This is the challenging issue t...
Is HTA too challenging for medical devices?
13 November 2012. The health technology assessment approach to assessing evidence is increasingly used by decision-makers trying to manage pressures on health care budgets. It is often said that because medical devices are different from pharmaceuticals, t...
Is a pan-European approach the way forward for HTA ?
7 September 2012. Health technology assessment (HTA) and its increased influence on healthcare payers’ decisionmaking process has a potentially profound impact on medtech manufacturers. In this article, Dr Mark Charny examines the different components of ...
Will France’s tighter medtech reimbursement rules leave industry room to manoeuvre?
16 August 2012. France is using its reimbursement system to introduce more onerous requirements than for CE marking. In this article in Clinica’s series on EU reimbursement and HTA, Dr Mark Charny analyses the impact of the latest challenges to having pro...
Eu reimbursement and HTA policy: an overview of key issues and how they impact industry
7 August 2012. In this article Dr Mark Charny outlines the current issues and challenges medtech companies are facing when seeking to bring innovative products into the EU.