FOR IMMEDIATE RELEASE: ClearRoadmap® announces a new service offering for hospitals to reduce risk and improve the cyber security monitoring of medical device.

Ashburn, VA – March 30, 2017. ClearRoadmap® , a cloud based platform that enables hospitals to track issues with the medical devices they use announces, a new cyber-security service offering for hospitals to reduce risk and improve the cyber security monitoring of medical devices.

“We are on a mission to provide mHealth and Medical Device users  with a ClearRoadmap® that reduces time and costs spent accessing data for decision making.  This includes recalls and field reports of digital security problems with Medical Devices” said Vizma Carver, Founder and CEO.

According to CNBC “As Cyberthreats Multiply, Hackers now Target Medical Devices”[1] "There is no [impervious] device," Kevin Fu told CNBC's "On the Money" in an interview”.

Wired Magazine’s Article “Medical Devices Are The Next Security Nightmare” [2] documents that there are millions of existing medical devices with potential security vulnerabilities.

By leveraging Natural Language Processing (NLP)  with its proprietary integration of FDA’s 510k, PMA, DeNovo, TPLC, Recalls, MAUDE, and other datasets with clinical and efficacy trials information, ClearRoadmap®  is able to provide the medical device industry with custom, integrated alerting functions that include digital security issues.

This enables hospitals and medical system administrators to receive customized security alerts for the medical devices in use in their systems, right in their inbox, thereby reducing the time and staffing required to identify and react to these security risks.

ClearRoadmap® – is a product of Carver Global Health Group LLC, a privately owned company of seasoned executives with proven track-records pioneering life sciences, healthcare, health information technology, mobile technology, and enterprise information systems.

Contact:
ClearRoadmap Team
ClearRoadmap_info@cg-hg.com
703-943-0894
www.clearroadmap.com

[1] http://www.cnbc.com/2016/10/15/as-cyberthreats-multiply-hackers-now-target-medical-devices.html

[1] https://www.wired.com/2017/03/medical-devices-next-security-nightmare/

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FOR IMMEDIATE RELEASE: ClearRoadmap announces Gold Sponsorship of Medical Device Cyber Security Seminar

Ashburn, VA – March  29, 2017. ClearRoadmap® , a cloud based platform thatenables innovators, researchers and industry experts to accelerate product development is proud to announce its sponsorship of Inside Job "Securing Medical Devices and Health Records" Medical Device Security Conference.

 “We are on a mission to provide mHealth and Medical Device innovators with a ClearRoadmap® that reduces time and costs spent accessing data for decision making.  This includes recalls and field reports of digital security problems with Medical Devices” said Vizma Carver, Founder and CEO.

By leveraging Natural Language Processing (NLP) with its proprietary integration of FDA’s 510k, PMA, DeNovo, TPLC, Recalls, MAUDE, and other datasets with clinical and efficacy trials information, ClearRoadmapR  is able to provide the medical device industry with custom, integrated alerting functions that include digital security issues.

ClearRoadmap® – is a product of Carver Global Health Group LLC, a privately owned company of seasoned executives with proven track-records pioneering life sciences, healthcare, health information technology, mobile technology, and enterprise information systems.

Contact:
ClearRoadmap Team
ClearRoadmap_info@cg-hg.com
703-943-0894
www.clearroadmap.com

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Source: https://ghgpresents-insidejob.swoogo.com/_...

Sorry to be gone so long. While we were away we improved ClearRoadmap medical device data and helped MDIC and FDA realize the value of quality

As you can see from our websites new face, we have been a bit busy!

If you have not already looked at how ClearRoadmap data can support cyber security risk management, then visit our home page for a quick diagram.

This is possible with the ClearRoadmap API.  You can now connect your favorite business intelligence tool and run the analytics on ClearRoadmap data.  Since ClearRoadmap has extracted out of the FDA medical device and biotechnology Summary of Safety and Efficacy PDF documents, and correlated with each devices Clinical Trials.gov data, you can run your own analytics.

Many of you also asked for the MAUDE data.  We heard you and added the MAUDE Adverse Events to the ClearRoadmap database.  The data is currentlyaccessible with the API, and soon to have a web interface.  With the MAUDE Adverse Events module we added the MAUDE data to the comprehensive device data.  This means you have the ability to search using keywords or free text in the MAUDE data, or add other context, such as Indication of Use and Adverse Effects.  Yes, we have linked  the MAUDE data with the devices known Adverse Effects and Indication of Use.  So go to town and do your research!

The complexity of the ClearRoadmap database require process to maintain quality.  It is in the right processes and their sequences that enables us to deliver data in efficient and effective manner.

The concept of the right processes and their sequences as a framework for quality is nothing new.

This past fall I had the privilege to co-lead the team that evaluated CMMI (Capability Maturity Model Integration) as a maturity model that FDA CDRH and industry can embrace. The future looks promising!  In the future blogs I will discuss my experience with CMMI.

Vizma Carver
Founder and CEO

 

Is your HIT or medical device company mature enough for the market demands?

How do you determine the quality of a company and product?  Is it based on just the bells and whistles of the product, or their employee's experience and the corporate brand's reputation?  Or, is it the list of prominent clients, catchy commercials, or regulatory hurdles?

All of those have value, but those are typically reactive, most often subjective and have the ability to bounce back from major setbacks, such as how Martha Stewart's brand which posted higher revenue post-incarceration. 

Not all industries are equal, and even in the highly regulated industry of medical devices, FDA leadership has publically noted that meeting regulatory requirements is not a guarantee of a quality product.    

We have all seen this play out when an HIT or medical device fails, and the health care provider, or medical specialty deem a product unsafe or unreliable.  The ability to rebound is expensive and can be detrimental to a brand.  From the Metal-On-Metal (MOM) hip replacement recalls leading J&J- Depuy brand todiscontinue manufacturing the $300+ million MOM business, and Fitbit's stocks declining since the sleep tracker lawsuit filing, the cost of low quality can be catastrophic.

Professionals in the healthcare industry can be a major contributing factor to this. Fom primary care physicians, to specialists and surgeons, they have been trained based on applying critical thinking to scientific evidence.  Their careers are under the scrutiny of peer-review journal publication status and outcomes based performance. So in this industry, more-so than other industries, the cost of brand management has a higher premium. 

This means that the infrastrucure to create a corporate culture of quality becomes an asset with whch to lead, while regulatory enforcement follows behind to bring non-conforming products into regulatory alignment.  Relying on regulatory enforcement alone will always leave your brand playing catch-up in the quality department.

So what is at the core of quality? Companies will tout their skilled people and their processes to meet what Deming coined the "plan-do-check-act" continuous-improvement loop. Yet the nut to crack is - how to measure the people and processes at a wholistic while preventing an infrastructure that stifles that which is at the core – the continuous-improvement loop.  It is not from a shortage of quality process organizations: SixSigma, the FDA's QSR, ISO QMS, to IEEE and CMMi.  Each spearheading the challenge of creating an infrastucture that is mature enough to prevent poor quality, yet not too ridgid to prevent continuous process improvement.

While Six Sigma has gained in popularity and Jack Welch brought name recognition to the process improvement methodology, the underlying assumption to Six Sigma is that it has a product with a locked down design, so that the focus can remain on the manufacturing process cycle times, allowing a reduction of waste and cost, so that there is an increase in profits and customer satisfaction.  However, HIT and many medical devices iterate, so that the incremental changes require an agile approach.  FDA QSR is actually a very comprehensive methodology, but because of the combination of the audits creates a "checklist" culture, and the myopic view of the FDA requirements, the process exists in a vacuum dictated by the FDA on to a company.  ISO 9000 - Quality management is also very valuable, yet focused on the seven principals: 1) QMP 1 – Customer focus QMP 2 – Leadership QMP 3 – Engagement of people QMP 4 – Process approach QMP 5 – Improvement QMP 6 – Evidence-based decision making QMP 7 – Relationship management. All of the principles have value, yet in implementation ISO 9000 is overly focused on inspections and audits.  While the arguments between the proponents can lead to passionate debates, Smith (2007) assessed ISO certification in 2005 and found that Chinese companies lead the world in ISO 9000 certifications, while Bristow's 2007 study found that Chinese companies frequently made headlines due to dangerous from product manufacturing (pet food, lead-based paint on children's toys, poisoned toothpaste, and tainted cough syrup).  While new ISO 9001:2015 is hopefully going to helps customers get more consistent, good quality products and services, we still need to see how that will play out.  While software industry embraces IEEE 730 Software Quality Assurance Processes, it is very focused on the software aspects of the product manufacturing.  Having used Six Sigma, ISO QSM and IEE-730, they each have their value. Yet in their own way they are each very ridgid to a subset of methods, or lead to a culture of checklist implementation.

While we all know we want quality, and in many ways we know quality when we see quality, what is required to implement and measure for an organization to encourage behaviors that consistently produce quality is no easy task. 

I have found CMMi to be the strongest of the methodologies, because of two primary focus points.  First,  the process of focusing on implementation, rather than creating a check list.  Througout my career it was fairly easy to identify what was needed for an ISO inspection or IEEE, as the list was straightforward and required only sufficient resources and effort.  However my first CMMi conversation felt more like nailing jello on the wall.  Most of my questions were answered with "it depends on how you are doing it".  Looking back with the advantage of hindsight, the CMMi secret ingredient is in the lanuguage.  The methodology focuses on Goals and Practices.  From General Goals and Specific Goals, to General Practices and Specific Practices.  CMMi speaks language similar to that of a world class athelete.  One that has to set goals and then establish the practices necessary to attain the goals.  Each of the Goals and Practices are set in 22 Practice Areas. Which is something most technical, management and scientific minds can relate to, such as: requirements, configuration management and measurement and analysis.  But a great CMMi consultant will not let you gravitate to those from the onset of your CMMi journey in the traditional sense, which is to map into familar checklists.  If anything at Level 1 they will force you to step back and first thoroughly question "who is my client" and at Level 5 expect that your communication is so well established between all of your clients, that the artifacts and evidence demonstrate that which is at the core of quality – thinking about your products, caring enough to do the right thing and monitoring with discipline that at any time you know what is going on with your product.

And this is why CMMi is so ideal for HIT and medical devices.  The origin of HIT and medical devices has the same ingredient as CMMi – people dedicated serving clients by improving the quality of life of fellow citizens.  Though all industries involve serving clients, the healthcare industry ultimately serves all of us, as we all need good health and healthcare.  The second reason it matches so well is about the process.  Just as healthcare is a practice of medicine, which evolves with time and experience, so do the goals and practices of an orgnization that embraces the CMMi methodology.

he next installments of this series will walk you through my personal expereince bringing CMMi into numerous companies, from small health IT companies starting their journey achieveing Level 2 and Level 3, to my programs that were able to obtain Northorp Grumman's Health Division CMMi Level 5, using Agile software development.

-- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™

vizma.carver@cg-hg.com
www.clearroadmap.com  

The risk to mHealth and Medical IT innovation from FBI's Apple lawsuit

The FBI's demand for Apple to build a custom operating system and push it on to the work iPhone of the San Bernadino terrorists has been in the news not just locally but internationally.  There are some serious implications here for Medical Devices, particularly mHealth and other "connected" devices. 

It is important to understand that the issue is not just the FBI vs Apple – though this has direct implications on solutions like AliveCor's Heart Monitor For IPhone product.  Depending on the government's broader agenda, this might have implications for all HIPAA based software implementations.

On the surface the FBI is simply demanding that Apple provide them with a custom OS that can be "force pushed" onto the iPhone, that in turn disables the "autowipe" feature that erases the contents of the phone after 10 incorrect tries.  Apple could potentially do this via the same mechanism that allows them to force an update to the OS.   However this still would require that Apple build a custom version of the OS and to set up a specialized secure lab within which this update could be forced. This has both policy and technical implications.

The policy implications could be much more significant for the mHealth, Medical Device, TeleMedicine, and HealthIT industries.  The FBI and other Government Agencies may be working on a broader legislative strategy – even perhaps hoping to lose in court against Apple, as it already has in NY Federal District Court. This strategy would be "lose in court" and then in this election year go to Congress and ask for an updated Communications Assistance for Law Enforcement Act (CALEA) that requires ALL US corporations engaging in data and communications encryption to provide the FBI (or some other government agency) with a set of "golden keys"/backdoors with which to unlock the encryption.

Much has been written about why "backdoors" for encryption are technically a bad idea.  For the mHealth, Medical Device, Telemedicine and HealthIT industries this is doubly a bad idea.   First of all, the security implications of such "backdoors" make the systems inherently more vulnerable to "bad actors" – thus adding costs to securing such systems.   But there is a second and tertiary aspect of this.  

mHealth solutions that monitor a patients heart, are life critical and rely on data being secured by encryption, as we discussed in an earlier blog about Authentication vs. Repudiation . mHealth app developers will suddenly not be able to rely on their platforms to provide security.  Even an "authorized"/legal intrusion into the data could potentially disrupt/alter the data in ways that have adverse effects on the patient due to inadvertent modifications of the data.   Thus innovators would have to implement data backup and redundancy protocols that have adverse cost, performance and complexity affects.

Similarly it is unclear what the implications are on HIPAA data privacy requirements for "Protected Health Information" (PIH) that this might have.  While under HIPAA a "Covered Entity" (someone holdingPIH data) is required to cooperate with Law Enforcement,  a "backdoor key" would allow government users to access this information without warrants and without evidence of intrusion.  Does this create a HIPAA violation for Covered Entities?   Arguably yes.  And that in turn would require that additional auditing and intrusion monitoring procedures get added.  This potentially hits Telemedicine the hardest.

All of this drives up costs of innovation, operation, and development and stifles the sort of innovation.

The mHealth, Medical Device, Telemedicine and HealthIT industries need to look hard at this and be prepared for the potential impacts of this fight between Apple and the FBI.

By Karl Schulmeisters, CTO

 

Lessons Learned from the Medical Device Industry

For those that missed our series on leverging Lessons Learned from the Medical Device Industry and wish to see read up on it:

Part I Quality is all about the User Experience

How small changes can help your wearable achieve the success it needs.

Part II Tools to Learn From Others

How to access existing data to incorporate into design and development to learn from past mistakes.

Part III Labeling Description

How to sequence the information and the order of the subsections, so that users better understand the device and therefore increase the adoption of the device.

Part IV Labeling Operation and Troubleshooting

How to leverage existing information

Part V Learning and Education

What details to provide, so users have the ability to learn and educate themselves on the supporting information.

-- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™

vizma.carver@cg-hg.com
www.clearroadmap.com  

Come hear former FDA CDRH Entrepreneur In Residence speak on Building Virtual Patient Models at CRT 2016!

ClearRoadmap and Carver Global Health Group are proud to announce that Ms. Carver will be presenting at the annual Cardiovascular Research Technologies meeting February 20-23.  http://bit.ly/1Ql1vzx 

She will be speaking on the subject of “How to Innovate and Reduce Pre-Clinical and Clinical Trials by Comparing Data and Building Virtual Patient Models”.    Ms. Carver has 25+ years of industry experience including her role as Entrepreneur in Residence at FDA CDRH.  She currently is the CEO of Carver Global Health Group who’s https://ClearRoadmap.com product is a component of building and creating Virtual Patient Models.

Lessons Learned from the Medical Device Industry: Part V Learning and Education

ast blog we talked about the sequence of the Operation and Troubleshooting section of your devices Label, and how to leverage existing information.

Finally, we come to our last category, Additional information.  Such as the details that are provided, so users have the ability to learn and educate themselves on the supporting information. Such as, clinical trial studies associated with the device and competitive devices, any educational self-care on health and wellness, list of adverse events and warranty, especially during travel.

While the extensiveness of using the regulatory device user labeling for wellness products may seem like an overkill, the benefits of a well-built product that users know how to function becomes both an investment into adoption and lays the foundation for wellness devices that can expand into medical devices.  Though regulatory hurdles are costly, the value of having the Government validate the product does have value as a gold stamp of approval, and opens up the potential for new clients.  After all, the difference between a wellness application and a regulated mobile medical device is a fine line; tracking clinical data for monitoring wellness and tracking clinical data to diagnose the progression of a disease in real-time, may use the same clinical data such as the A1c levels.  A study by Freedman's team showed rising disability levels among those nearing retirement age (ages 55 to 64) and flat trends for those ages 65 to 84, which means making decisions in real-time can help reduce diseases from advancing to more severe stages.  ClearRoadmap™ Pathways provides step-by-step through regulatory and reimbursement processes, so you can build your wellness app to expand into the larger market of clients that need your help.

  • -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™

vizma.carver@cg-hg.com
www.clearroadmap.com

Lessons Learned from the Medical Device Industry: Part IV Labeling Operation and Troubleshooting

arlier in the month we talked about the Description section of your devices Label, and how to sequence the information and the order of the subsections, so that users better understand the device and therefore increase the adoption of the device.

As we listed the categories in Part II Tools to learn from others, the second category of the user Label is the Operation. Knowing how to operate a device is critical for adoption.  As we all know, technology features are rarely used to their fullest, and to rely on only the principle to "build with intuitive use" in mind can become short sighted, if not validated with the target client.  Regulated technologies have over the years increased the scrutiny on the user technology literacy.  ClearRoadmap mHealth Pathways goes into an extensive tutorial on assessing your target audiences' technology literacy, as it is one of the larger barriers to product adoption.  Healthcare apps are a bit of a different breed from other business technologies.  As healthcare providers have known for years, taking one vital is just one data point, it rarely gives clear direction on the patients' health.  Similarly wellness apps that under-collect their users information will face additional challenges to show value to the user and scale adoption. Thus building with a clear understanding of the target population and their technology literacy will play a critical role in adoption, and ultimately the viability of your business.

Once you have your target audience's technology literacy well understood, including the understanding and use of icons and images, then the following sequence has been found to be most useful for Operations:

  • Set up (including calibration and other preparation)
  • Instructions for operation
  • Maintenance/storage
  • Other applicable topics associated with operating the device

It may seem obvious to use certain icons, such as a yellow triangle or a red exclamation mark for attention, but the development of icons and images that have meaning across user age, culture, gender is a process and requires evaluation with target users.  This is a place where wellness technologies can learn a lot from the regulated devices.  FDA Labeling Reviewers leverage the QSR requirements process to assess the extent at which medical device companies have validated their instructions with users, including the images.  ClearRoadmap™ can help you quickly learn about the QSR Pathways and find images that have been through review processes. The Comparison module lets you search on products of similar Indication of Use and then select up to 10 medical technologies to your custom Report.  The Report includes the latest approved PMA device labeling information with their approved images.  Of all of the underlying documents, the Labeling documents are updated by industry, with field production lessons learned. Thus, you can learn from the industry on methods that have been evaluated, reviewed, and withstood the test of time in a cost effective manner. 

 

Keep in mind as you learn from the regulated devices, that Troubleshooting should be called out as a separate section in the instructions, to be most effective.  Ideally Troubleshooting should follow the Set up and Operations sections, and before Maintenance and Other sections, so users can easily access as they set up and learn to use the technology. One of the critical outcomes of successful troubleshooting, is for the user to quickly determine if the trouble is with their application, or if there is a health concern that requires physicians' expertise.  The order of the potential issues a user may encounter should be grouped in categories (e.g. alarm, data entry), with each group highlighted and ordered from the most critical patient health impact, to the least critical.  Logically thinking, if the trouble is potentially harmful to the patient, you don't want the patient to have to dig for the information.

This is the fourth part in a five part series, next month will be the final of the five part series, with the last section of the Label and tools to help traverse the regulatory processes.

  • -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™

vizma.carver@cg-hg.com
www.clearroadmap.com  

FOR IMMEDIATE RELEASE: ClearRoadmap selected as StartUp Health: Entrepreneurs Transforming Healthcare Preferred Provider.

shburn, VA – January 21, 2016. ClearRoadmapTM, a new cloud based platform enables innovators, to accelerate product development by applying automation and data analytics to the current highly manual data search process – reducing time and cost from hours and days to seconds and minutes.

StartUp Health is on a mission to help 1,000 health startups to reimagine and transform healthcare over the next decade. We believe entrepreneurs have the collective power to build the future of healthcare and we enable them to develop the leadership, relationships and industry intelligence to succeed.

ClearRoadmapTM users can plan their Idea to Market using step-by-step Pathways which consolidates state legislations, federal regulations, reimbursement policies, technical standards, and business strategy with Best Practices and Helpful Hints.  Planning for the complete Go-To-Market enables innovators to avoid pitfalls, unplanned requirements and costly re-organization.

 ClearRoadmapTM leverages Natural Language Processing, Cloud based platforms and contextual based search that sets a new standard for this industry.  The NLP engine uniquely enables users to search across 15+ context categories within the underlying unstructured documents from over 10 databases. It enables broad as well as detailed searches across FDA medical device regulatory, NIH Clinical Trials and CMS reimbursement.  It has never been this easy to learn from industries mistakes.  Instantaneously find devices made of the same biomaterial as your device, and have had recalls, to understand what can go wrong and prevent costly and known errors.

The single Search interface across all datasets is accessible globally on tablets, laptops and desktops.  The detailed product information is displayed in a side-by-side Comparison, for market evaluation. Details can be downloaded into Reports with the search criteria documented, and hyperlinks to original document sources. Users can save customized searches as an Alert to receive notifications when changes or new information becomes available. 

"We are on a mission to provide mHealth and Medical Device innovators with a ClearRoadmapTM that reduces time and costs spent accessing data for decision making." said Vizma Carver, Founder and CEO.                          

ClearRoadmap – is a product of Carver Global Health Group LLC, a privately owned company of seasoned executives with proven track-records pioneering life sciences, healthcare, health information technology, mobile technology, and enterprise information systems.

Contact:
ClearRoadmap Team
ClearRoadmap_info@cg-hg.com
703-943-0894
www.clearroadmap.com

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