Healthcare

Five Trends Transforming the Medical Device Industry in 2015

For 2014, we predicted that longer life expectancies, emerging markets, increased regulatory scrutiny and health care reform would drive industry change. As we move into 2015, we see many of those trends continuing to evolve, and some exciting new trends emerging. Disruptive technologies like 3-D printing and mobile health applications are prompting regulators to re-examine their roles, leading to new regulatory frameworks and clarified rules. Consumers are demanding more transparency and convenience but are also concerned about the security of their medical information and devices. Investors and stakeholders are paying closer attention to reimbursement policy, which could limit innovation and access to life-saving products. A wired, patient-centric device market is taking shape, and the industry must learn to adapt—quickly. This white paper highlights five trends device manufacturers would be wise to follow closely this year.

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Healthcare

Hospitals & Health Networks

Hospitals & Health Networks chronicles the values and ideas that drive the new era in health care. H&HN is the place leaders turn for new insights and to recharge their imagination. H&HN stands for stewardship, creativity and results. It de…

Healthcare

HealthShareTV

HealthShareTV delivers to your inbox a summary of the best health care videos and facilitate a community for health care professionals and other interested parties to post, view, rate, comment and discuss videos regarding any business or clinical aspec…

Healthcare

Top 5 Trends in the Pharmaceutical Industry in 2015

If the surge in TV commercials for prescription drugs is an indicator of the economic health of drug companies, then the pharmaceutical industry is indeed going strong. The industry’s advertising spending rose from $3.5 billion in 2012 to $4.5 billion …

Healthcare

Reducing Human Error in the Operating Room

One of the best tools for achieving better communication in the clinical setting is Crew Resource Management (CRM). CRM increases patient safety and operational efficiency by empowering all team members to identify and communicate potential patient har…

Healthcare

Building and Sustaining a Blood Management Program

Implementing a standardized blood management program is one hospital initiative that addresses many of today’s challenges, including reduced funds, rising blood costs, and the desire for better clinical outcomes. Blood transfusions are one of the most …

Healthcare

How Effective Training Management Can Help You Prevent Quality Issues

It’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work. “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring,” said Hunter.

In a regulated environment, training is a means to minimize (if not avoid) human error, a common cause of deviations and nonconformances. It’s no wonder that various standards and regulations, such as the following, require training as an integral part of the quality management system.

  • FDA 21 CFR Part 211.25 for pharmaceutical companies
  • FDA 21 CFR Part 820.25 for medical device manufacturers
  • ISO 9000 2000 for general manufacturers and other businesses
  • ISO 13485 for medical device manufacturers

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