As Arena International’s OCT Medical Devices conference gets underway in Santa Clara, CA, this week, Clinical Trials Arena will be shining a spotlight on medical devices. Running throughout the week of June 26th, 2017, CTA will post articles uncovering the most pressing issues facing industry today.  

Be sure to visit CTA tomorrow when Abhijit Vaidya, Cipla Ltd., sheds light on the issues of running trials for human factors studies. On Wednesday, a leading industry expert talks to CTA editor Henry Kerali about the challenges of running a virtual medical device company. On Thursday, a GlobalData Expert Insight explores electronic alert systems, and on Friday, CTA will round off the week by looking at patient centricity in medical device trials.

In the meantime, catch up on some CTA’s most recent stories delving into the challenges of medical device trials… (click on the headline to finish reading).

A Tale of Three Medical Device Study Designs

The Question

Which study design is best for a Post-Market Device Efficacy Study – a prospective randomized clinical trial, a prospective cohort observational study, or a retrospective cohort observational study?

The Problem

510K approval and initial acceptance by a small group of interested physicians may only be the first step toward widespread use and for making the case for reimbursement, leading wider market acceptance. Oftentimes, device marketers hear physicians say, “I will only accept data from a Randomized Controlled Clinical study of this device.”This sentiment is largely based on a belief that an RCT is the gold standard and other study designs are inferior. An RCT can generate reliable, high quality data, but how much better are they compared to prospective or retrospective observational studies?

New EU Regulation for Medical Devices will enforce stricter requirements, but will that enhance Patient Safety?

On April 5, the European parliament voted in favor of tightening regulations for medical devices and diagnostics to ensure stricter post-market surveillance, and the addition of safety checks for devices deemed as ‘higher-risk.’ Traditionally, the tightening of regulations can spell disruption and confusion for the ensuing industries. However, this was not the case. For many in the med-device industry the regulation was welcomed as a much needed amendment to device development. The CEO of MedTech Europe, hailed the tightened regulations as necessary for the industry. GS1, the UK’s leading not-for-profit standards organization, which works with the Department of Health, NHS England, and the industry to help drive more efficient and compliant ways of working, is also in favor of the new regulations. The overwhelming support ties in, at least in part, with previous malpractice in the device industry.

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4 Keys to Constructing an Accurate Medical Device Study Budget

For the majority of medical device sponsors, conducting a clinical trial comes at a huge cost, consuming most of a typical company’s R&D budget. The importance of putting together a precise forecast of potential spend is essential as an inaccurate study budget could have damaging implications on the trial in question. What’s more, a failure to manage all costs would do little to enhance the credibility of an industry renowned for large expenditures on clinical research.

For the person responsible of developing that budget, they are tasked with an onerous challenge. To start with, there are many unknown variables, putting the gatekeeper at an automatic disadvantage as it becomes difficult to accurately estimate the final budget. Even with a draft trial design in place, there are many factors that make it difficult to determine the final forecast, such as rising inflation for a trial that will last over a number of years. So what are key things to consider when planning a budget? Here are four tips…