26Jul/17
New Idea

#newidea or #throwbackthursday?

By: Giselle C. Matlis, Research Assistant

Outcome based Medicine

On Monday June 26th 2017, Medtronic announced that they will be using a “new outcomes-based [payment] agreement with Aetna (NYSE:AET) for type 1 and type 2 diabetes patients”. Hooman Hakami, president of the Diabetes Group at Medtronic stated that “this agreement reinforces our shift towards value-based healthcare. We know technology alone isn’t enough and ultimately improved outcomes are what matter…Our goal is to continue to lead by driving innovation that demonstrably improves patient outcomes, elevates patient experience and lowers the total cost of care”.

This sounds like a great new idea.

Ironically, Axendia President, Daniel Matlis, predicted this ten years ago!

In a June 4, 2007 blog post on Axendia.com, Mr. Matlis noted that Sear’s Craftsman line of tools had a lifetime guarantee. This was a business decision by Sears to gamble that the high quality of their tools would minimize warranty costs. He then suggested that a similar approach could work in the healthcare industry and projected that out-come based billing would be the next big thing for the pharmaceutical world. He stated that this approach could, “enable a new health care paradigm, where all involved have the proverbial ‘skin in the game’. Patients get access to drugs that are nearly certain to be effective. Health care payers can ‘afford’ to make new, and let’s face it, expensive, treatments available to patients since they are provided a degree of confidence of treatment effectiveness, and limited downside through a refund”.

So, you decide: #newidea or #throwbackthursday?

06Jul/17
Mind-Boggling-Change

Thriving in the Age of Mind Boggling Change

By: Daniel R. Matlis, President Axendia, Inc.

Thriving in the Age of Mind Boggling Change

“Change is the Only Constant” said Heraclitus of Ephesus two and a half millennia ago.  While change has been the constant throughout human history, the rate of change seems to be accelerating exponentially.

Change, and the need to adapt to “Mind Boggling Change” was a key theme at QAD Explore 2017 in Detroit last month.  “Adapting to this rapid change is an imperative,” said Pam Lopker President of QAD. Ray Kurzweil, inventor, futurist and Director of Engineering at Google explained that while the human brain operates linearly, the rate of change growing is exponential. In information technology, this is represented by Moore’s law. Correspondingly, the rate of information processing is growing exponentially.

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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.