All posts by Administrator

19Jun/17
Web

Focusing on Post-Discharge Communication and Connected Care to Reduce Readmission Rates

By: Chuck Hayes, Vice President of Product Management for TeleVox Solutions at West Corporation

Driving Better Patient Outcomes

High readmission rates have resulted in steep financial penalties for hospitals and intensified the need for health system providers to become more actively involved in post-discharge care. As the healthcare industry continues to embrace value-based payment models, hospitals are being held accountable for the long-term health of their patients, and they are facing pressure to keep patients engaged, in compliance with care plans, and out of the hospital. With Medicare penalties for hospitals surpassing $520 million this year alone, hospitals are looking to implement strategies that put a greater emphasis on two critical areas: follow-up communication and patient engagement.

Results from a recent West survey revealed that half of acute care professionals feel insufficient follow-up by hospital teams is a leading factor that contributes to readmissions. Another 32 percent of those surveyed suggested that a lack of communication on the part of providers also leads to readmissions. In order to reduce readmissions, hospital and health system providers need to work to keep communication lines open, while also providing meaningful interactions and intra-visit support to those patients that have left the hospital. And all of this must be done in a cost-effective manner.

The idea that providers need to offer more post-discharge support is a sentiment echoed by patients who want to see hospital teams expand long-term support efforts. Medicare’s HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) surveys show that patients often feel disconnected from their medical team after discharge. In fact, recent HCAHPS data reveals that half of surveyed patients reported feeling confused or uncertain about how to comply with care instructions after being discharged from the hospital.

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16Jun/17
FDANews150x150

10 FDA Answers on ‘Driving a Culture of Quality for Devicemakers’

By: Daniel R. Matlis, President

The Case for Quality: Why Does It Matter?

Last month, I had the privilege to moderate a discussion with Capt. Sean Boyd, deputy director for regulatory affairs in CDRH’s Office of Compliance, and Francisco (Cisco) Vicenty, acting program manager of Case for Quality in CDRH’s Office of Compliance.

During the webinar hosted by FDAnews, we discussed topics including:

  • The Case for Quality – Why does it matter?
  • Are we playing regulatory whack-a-mole?
  • How is the role of FDA evolving to encourage a culture of quality for device makers?
  • Have “Compliance First” regulatory approaches slowed innovation?
  • Who benefits from a focus on quality?
  • Are there appropriate substitutes for routine FDA inspections or pre-approval inspections?
  • What are the quality outcomes metrics FDA will collect and monitor?
  • How will FDA operate as we shift from documents to data/metrics as a result of using quality tools?

In addition, Capt. Boyd and Mr. Vicenty addressed the following audience questions:

Q1: How is the CfQ program different than Quality by Design?

A1: Quality by Design (QbD) is the systematic approach used in the pharmaceutical space for development that focuses on risk management and predefined objectives for product and process control. QbD is more analogous to Design Controls in Quality System Regulation. Case for Quality is an effort to work together with a community of stakeholders to incentivize performance and product quality. This collaboration will allow for faster and better data to drive purchasing decisions and FDA activity.

Fore more Q&A, read the article in its entirety in FDANews Device Daily Bulletin.

01Jun/17
webinar pic

Webinar Announced: How Connected Devices Improve Patient Outcomes

Designing and Manufacturing Devices that Excel in an Internet of Medical Things (IoMT) World

register

Daniel Matlis, President of Axendia and Jordan Reynolds, Senior Manager, Kalypso, will discuss how innovative companies should navigate the perilous intersection of FDA approval, quality manufacturing and support for superior patient outcomes during a live webinar at 1:30pm Eastern on June 20, 2017.

The device industry is changing rapidly — and with change you have winners and losers. Today’s winners are embracing connectivity and the quickly emerging internet of medical things (IoMT) movement.  They understand that the future is continuous glucose monitoring systems that connect to handheld meters, sensor-embedded hospital beds that proactively alert providers to problems, wearable mHealth devices which can send information to caregivers or a multitude of other remote patient monitoring technologies.

Getting these new products approved by the FDA is hard enough, making sure they connect properly with patients, physicians and healthcare centers is even harder.

Register today to learn how smart, connected devices are changing the device ecosystem in support of patient outcomes.

03May/17
Insanity Image

White Paper: Is Innovation Without Transformation Insanity?

By: Ellyn McMullin, Research Asssociate and Daniel R. Matlis, President

Are You Transforming Your Business or Merely Digitizing Process?

To fast-track the transformation of ideas into innovative products, pharma and biotech companies need to be open to new ideas and aware of new systems and technologies. Simply digitizing existing processes is accelerated insanity!

The costs of bringing a new drug to market is high, especially when you factor in the many candidates that do not make it. In this white paper, Axendia suggests an approach that will consistently create and deliver high quality products to market while reducing cost and improving ROI in today’s competitive marketplace.

Today’s challenge is not the availability of the technology but the rather the need for vision and leadership, knowhow and discipline to drive transformation.

Download this free white paper to learn now.

25Apr/17
Supply-Chain-Squares (3)

Quality Management Across Your Global Supply Chain

By: Sandra K. Rodriguez, Market Analyst

Learn How to Take Back Control of Quality – On Demand Webinar

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017.  Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments.  Topics of discussion included:

  • Globalization and Outsourcing Trends in Life-Sciences
  • Regulatory Expectations for Outsourcing
  • Quality Metrics and Data Integrity
  • The Paradigm Shift in Quality Management
  • How to Source Quality Data and Benefits of a Cloud QMS
  • Modernizing Quality Management
  • Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike.  Read More.

The webinar is also available on demand.