Hill-Rom Acquires Voalte: Analysis
Hill-Rom announced March 12, 2019 that it was in the process of acquiring Voalte for $180 million. An additional $15 million earn out was also disclosed. With annual revenue approaching $40M, the enterprise-value to revenue multiple for Voalte is a over 4.5. The acquisition is expected to close during Hill-Rom's third quarter of 2019, which ends June 30th 2019.
Voalte was rumored to be for sale since Q4 of 2018.
Voalte Profile
Founded by Trey Lauderdale in 2008, Voalte is located in Sarasota, Florida and currently has about 140 employees. Voalte sells perpetual software licenses, services and resells ...
Source: Medical Connectivity Consulting - March 19, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Strategy & Planning Source Type: blogs
Hill-Rom Acquires Voalte: Analysis
Hill-Rom announced March 12, 2019 that it was in the process of acquiring Voalte for $180 million. An additional $15 million earn out was also disclosed. With annual revenue approaching $40M, the enterprise-value to revenue multiple for Voalte is a over 4.5. The acquisition is expected to close during Hill-Rom's third quarter of 2019, which ends June 30th 2019.
Voalte was rumored to be for sale since Q4 of 2018.
Voalte Profile
Founded by Trey Lauderdale in 2008, Voalte is located in Sarasota, Florida and currently has about 140 employees. Voalte sells perpetual software licenses, services and resells ...
Source: Medical Connectivity Consulting - March 19, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Strategy & Planning Source Type: blogs
ONC Finds Possible Merit in FDA Pre-Cert
We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several occasions. The basic premise of Pre-Cert is that reasonable assurance of low to moderate risk SaMD safety and effectiveness can be achieved by looking at the processes of the vendor/developer rather than looking primarily at the product itself.
The Office of the National Coordinator for Health Information Technology (ONC) is part of the Department of Health and Human Services. While Health IT might sound rather expansive, in the ONC context it means record keeping software that receives, sends, and stores health information. This...
Source: Medical Connectivity Consulting - February 25, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
Medical Device & IoT Summit
New Dates, Same Venue!
Join us in Boston on February 25-26 April 23-24 to dig deep into medical devices and the Internet of medical things.
In this post-EMR world, medical device data is increasingly valuable and continues to evolve. Use cases have moved beyond clinical documentation into the EMR to include near real-time remote surveillance, and the collection of high fidelity medical device data for clinical decision support and training artificial intelligence algorithms.
As use cases have evolved, suppliers of all sorts and their related technology have likewise changed considerably over the years. Miniaturization, the...
Source: Medical Connectivity Consulting - January 24, 2019 Category: Information Technology Authors: Tim Gee Tags: Events Source Type: blogs
Medical Device & IoT Summit
Join us in Boston on February 25-26 to dig deep into medical devices and the Internet of medical things.
In this post-EMR world, medical device data is increasingly valuable and continues to evolve. Use cases have moved beyond clinical documentation into the EMR to include near real-time remote surveillance, and the collection of high fidelity medical device data for clinical decision support and training artificial intelligence algorithms.
As use cases have evolved, suppliers of all sorts and their related technology have likewise changed considerably over the years. Miniaturization, the consolidation of technologies into...
Source: Medical Connectivity Consulting - January 24, 2019 Category: Information Technology Authors: Tim Gee Tags: Events Source Type: blogs
Another Update to the FDA ’s Pre-Certification Model
The FDA has released a January 2019 update to its working model of the precertification program (Pre-Cert) for software that is a medical device (SaMD). As we have previously addressed (here, here, and here) the idea of the Pre-Cert approach is that a reasonable level of safety can be assured by looking at the developer’s quality system for product development rather than by looking primarily at the product itself. This “look” involves determining a level of excellence for the developer and matching this level to the risk level of the software. Where appropriate, a streamlined review process would then be ...
Source: Medical Connectivity Consulting - January 19, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
FDA on Software That Isn ’t a Medical Device
The 21st Century Cures Act of 2016 (Cures) had many provisions including defining what kinds of software are medical devices, and some specific kinds of software that are not, and which therefore weren’t subject to FDA regulation. Cures then directed the FDA to look into those that are not and report if they presented a public health problem. The FDA has now released such a report.
Curiously the report is based only on information published after the passage of Cures through July 31, 2018 so that what was known before passage or after the given date is not considered. I would not suggest to any student that they follow...
Source: Medical Connectivity Consulting - January 2, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
FDA to Divide Cybersecurity Risk Into Two Tiers
Medical devices that contain software, or are software, are subject to the well-known medical device classifications of I, II, III, listed in increasing level of risk and correspondingly increasing degree of FDA scrutiny before marketing. In addition to classification, for Software as Medical Device (SaMD) the FDA has suggested, via a Guidance Document (as discussed here), that there are four categories depending on the state of the healthcare situation or condition, and the significance of the information provided by such software to a healthcare decision.
In addition to this ranking of the importance of the device, the F...
Source: Medical Connectivity Consulting - November 20, 2018 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
What You Really Need to Know about Digital Health
You Won't Find This Information in Publications or Vendor Blogs
Just where does one draw the boundaries around "digital health?"
This will be a discussion unlike those you see in publications or hear at trade shows. We’ll cut through the noise and conventional thinking to key issues regarding what’s needed and what to avoid, in order to be successful in the digital health market.
Register Here
Join me for a 1-hour conversation with Bridget Moorman about digital health.
What does the term digital health mean to us?
How have the different levels of technology adoption between the US and EU shaped digital health initiati...
Source: Medical Connectivity Consulting - November 16, 2018 Category: Information Technology Authors: Tim Gee Tags: Events Resources Source Type: blogs
Managing Digital Health Regulatory Uncertainty
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and other international regulatory bodies. For this discussion we'll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing - or going to do - about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let's start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many...
Source: Medical Connectivity Consulting - October 24, 2018 Category: Information Technology Authors: Tim Gee Tags: Regulatory Bibliography Standards & Regulatory Source Type: blogs
FDA ’s Guidance Plans for Software in FY 2019
The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019. There are A and B lists for each category in terms of FDA's priority for action. On the A list there are 11 current drafts scheduled for finalization. The drafts of seven of these are from late 2017 with the remainder from 2018. There are 5 drafts on the B list. For new topics for which the FDA is considering developing a draft (as opposed to committed to developing one) the A and B lists have 10 and 2 items respectively, but the B lists have no items directly related to our domain.
Of the 11 current drafts on the A list that are...
Source: Medical Connectivity Consulting - October 16, 2018 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
HHS OIG on Cybersecurity and the FDA
The Office of the Inspector General (OIG) of Health and Human Services (HHS) recently released a 25 page report on the FDA's regulatory function in the medical device cybersecurity is domain. The report opens with a rehashing of real and imagined cyber risks, including those reported on by self appointed "white hat" hackers and other vulnerabilities that have not been identified to having actually caused any harm.
The FDA's current cybersecurity review process is briefly addressed, which is noted to be based at least in part on its 2014 Guidance on Content of Premarket Submissions for Management of Cybersecurity in Med...
Source: Medical Connectivity Consulting - September 22, 2018 Category: Information Technology Authors: William Hyman Tags: Data Security Standards & Regulatory Uncategorized Source Type: blogs
What ’ s So Different About the Health Care Market?
Things your health care product strategy must consider to be successful
If you’ve been in health care for any length of time, you know that it is a “different” kind of market, when it comes to health care product strategy. Strategies, tactics and value propositions that would work in any other market tend to stumble in health care — often for unforeseen reasons.
We’ve put together a 5-part email series that details why we keep running into these health care market obstacles. Our goal is to provide you with actionable information to better navigate the murky waters of product development and innovation for healt...
Source: Medical Connectivity Consulting - September 4, 2018 Category: Information Technology Authors: Tim Gee Tags: Resource email series strategy Source Type: blogs
The IoMT Value Hierarchy Webinar
I think it's time that we have this conversation.
If data from your medical device ends up in the EMR, then automating that clinical documentation process is now part of the minimal viable product.
Sure, innovators and early adopters (less than 20% of the market) may buy without connectivity, but mainstream buyers won't.
Luckily, there’s more than one way to accomplish this, and there are additional features and benefits you can deliver with connectivity for competitive advantage. The challenge is figuring out where you fit on the connectivity value hierarchy.
Join me on Tuesday, August 14 at 10am Pacific| 1pm Eastern f...
Source: Medical Connectivity Consulting - July 27, 2018 Category: Information Technology Authors: Tim Gee Tags: Events Source Type: blogs
