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Q&A with Jon Hunt of Bardy Diagnostics

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Screen Shot 2017-03-23 at 2.56.06 PMJon Hunt is the President and CEO of Bardy Diagnostics ( Prior to Bardy, Jon spent 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation in 2012). He spent the 10 years prior with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Jon began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs; he subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East, and Africa. Jon has extensive experience providing key support to cardiac electrophysiologists around the world to ensure that they, and their patients, implement new technologies safely and effectively.

How did you and Dr. Gust Bardy, the founder of Bardy Diagnostics, initially connect?
Gust and I first worked together at Cameron Health, a medical device start-up company developing the world’s first totally subcutaneous implantable defibrillator (S-ICD®). Gust was the Founder of Cameron Health, Inc. and I was hired as the VP of Clinical and Regulatory Affairs in early 2002. Gust and I worked closely together on evaluating the clinical feasibility of the S-ICD and I was responsible for running the clinical trials to gain regulatory approvals in Europe in 2009 and the US in 2012. Cameron Health was acquired by Boston Scientific Corporation in 2012. Gust had been thinking about developing an ambulatory cardiac ECG monitor and shortly after the acquisition of Cameron Health asked me to join Bardy Diagnostics, Inc. once I exited Boston Scientific. I left Boston Scientific in September 2013 and became the CEO of Bardy Diagnostics in October 2013.

Explain how the CAM monitor works. What are its improvements on traditional ECG monitors?
The CAM is a single-lead, patch-based ambulatory cardiac ECG monitor that is approved for use in the US & Europe and fits within existing reimbursement codes in each region. Traditional Holter and Event Monitors are typically multi-lead systems that are connected to recording hardware that is worn on the patient’s belt or a lanyard, while the low-profile CAM is simply placed on the patient’s sternum. Traditional monitoring systems are cumbersome for the patient and result in poor patient compliance which is reflected by the low diagnostic yield (<10%) for these systems.

The CAM is the world’s smallest and lightest P-wave centric ambulatory cardiac monitor and arrhythmia detector. It is specifically designed to detect the P-wave, which defines the heart’s atrial electrical activity. Arrhythmias are defined by P-wave morphology and its relationship to the QRS. Detecting the P-wave and understanding its relationship to the QRS is critical to accurate rhythm diagnosis. Location of the atria and their low-amplitude signal make P-waves difficult to see. We designed the CAM sensing architecture with these factors in mind and the result is that the device’s functionality is built into the hardware and is not dependent on a software algorithm to see the P-wave. In addition, the CAM’s recorder has an extremely low noise floor to enable it to detect the low amplitude P-wave signals. The combination of these patented design elements allows the CAM to reliably see the P-wave and improve the prospects for clinically actionable arrhythmia diagnoses and timely interventions. The earlier intervention and proper treatment of arrhythmias has the potential to drastically reduce the long-term complications and costs.

Which patients benefit most from this technology?
The CAM technology is beneficial for all patients undergoing cardiac monitoring. Its design is female friendly and allows all patients to go about their normal daily activities, including exercising and showering, while being continuously monitored. Bardy provides the monitor directly to hospital systems, cardiology groups and electrophysiologists, so patients interested in the CAM should consult their physician to see if system is right for them.

What are your greatest challenges in the cardiac monitoring space?
Cardiac monitoring is a very high volume market, there are approximately 4-4.5 million cardiac monitors prescribed per year in the US. There has been very little innovation since the first Holter monitors were introduced in the 1960s. Current technologies are viewed as outdated and clinicians have low expectations because historically the diagnostic yields are low (<10%) and patient compliance is low, resulting in delayed, poor and missed diagnoses. Given the size of the market, the other big challenge we face is scaling the back-end infrastructure to accommodate data handling for centers around the world. We’ve developed the BDx web portal hosted on Microsft’s Azure Cloud to allow us to upload patient data, analyze it either locally at a hospital or clinic, or with a third-party ECG reading site, and provide patient ECG reports. The web portal allows us to host clinical data on the cloud in different geographic regions around the world to comply with patient information confidentiality legislation.

What is next on the horizon for Bardy?
We are in the process of scaling our US and European commercial operations. Our recent funding allowed us to hire a full direct sales team in the US to accelerate our US sales efforts. We have signed a distributor in the UK who is responsible for leading our sales efforts in Europe. We have developed a BDx web portal to allow customers to upload patient data, analyze the data, and access patient ECG reports. Our engineering resources are currently dedicated to supporting the BDx web portal development and to complete a multi-use recorder project for the CAM. The two-part design of the CAM allows us to provide a cost-effective solution for cardiac monitoring worldwide by providing a disposable patch (the Battrode) and a reusable recorder. This, in turn, allows us to launch the CAM globally, even in typically low-cost markets.

What occupies your time outside of the office?
My wife and I spend time at home with our two dogs, we entertain frequently and we are actively involved with several philanthropic endeavors in the Charlotte area. We enjoy traveling and take at least one trip a year to a location on our must do list.

Steve Lefar Interview

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Steve-PictureSteve Lefar is the CEO of Applied Pathways. Steve was formerly the President and CEO of Sg2, a market leader in providing analytics to providers which was acquired by MedAssets in 2015. Prior to Sg2, he was the President of MediRegs, a pioneer in SAAS applications and content for the healthcare compliance space that was acquired by WoltersKluwer. He currently is a Board Member of Enlitic and an Advisor to Evive Health. Steve also sits on the Board of the Juvenile Diabetes Foundation of Chicago, the Aptakisic-Tripp School District, and on the editorial board of the Society of Corporate Compliance and Ethics.

How has your long and illustrious career in HCIT framed your perspective on the opportunity for Applied Pathways?

For my entire 25 years in the industry, the challenge of exploding costs, mixed quality, and limited access for far too many people has been an issue.  Despite well-intentioned industry leaders, many massive investments in a variety of “disruptive and innovative” technologies have actually complicated workflow, solidified silos and not fixed the root causes of poor quality and cost – all tied to variance and a lack of use of evidence and outcomes based standards which will carry over to precision medicine.  My greatest concern is growing health disparities that are a threat to the stability and success of our country.

While we have made great strides, healthcare, in contrast to every other industry, has been resistant to viewing quality as at least partly driven by variance in process that drives sub-optimal outcomes and unnecessary costs. Healthcare leaders, particularly those in large integrated health systems and the payer community are now embracing it. It’s what we call “Putting Best Practice into Practice”

There is a great deal of attention being paid to the role of technology in improving healthcare delivery effectiveness. How is Applied Pathways contributing to this?

We need we need to shift our thinking and make sure as an industry we are not trying to automate flawed processes and approaches with “whiz bang” technology. To some extent, that is what Meaningful Use unintentionally enabled.  Applied Pathways’ technology tools and software solutions allow healthcare organizations to leverage the best available evidence, customize it for their own local or customer specific needs and standardize clinical and operational processes quickly and efficiently, without consuming costly and scarce engineering resources or multithreaded development cycles with analysts. They can use our tools to implement an expert or even machine learning-driven rules system that guides their clinical care process and allows them to achieve their desired results of better outcomes and lower costs.

I’m incredibly optimistic at the wave of innovation but am concerned, having been through the year 2000 bubble, that far too many health care venture capital “tourists,” CEOs and pundits are hyping the next “disruptive technology” that will fix everything in the next six months if only everyone would adopt it. Healthcare does adopt things slowly and, while painful at times for those of us running companies, there are some good reasons for it. The most important being that adopting new approaches that are half proven, or not at all proven, can kill people.  One of the reasons I love working with HEP is that they have been around healthcare for many decades and know what it takes to succeed in healthcare.

What is next on the horizon for Applied Pathways?

We have learned much from our clients like Mayo, AIM, American College of Cardiology and McKesson and will continue to focus on large scale commercialization of our software and tools. We are committed to moving the industry forward and even providing our authoring software to Qualified Provider Led Entities (under the new MACRA legislation) to support this effort.  While there is a lot of opportunity for Applied Pathways within all segments of healthcare – payers, providers, technology vendors (who can white label our software), pharma and health services organizations we are focused on supporting use cases in primary care access and care coordination, utilization and appropriate use management and advanced scheduling/referrals. As the shift toward value-based care intensifies and the volume of information available to inform clinical care explodes, organizations will increasingly need software tools like ours to manage complexity and reduce variance in their clinical care practices or they won’t be viable.

What do you do for fun outside of the office?

This is my third time working with founders to commercialize their vision and it is fun!  Building companies for me is like an artist working with his or her canvas. That said, being in nature for significant periods daily (no matter the weather) keeps me grounded and those around me a lot happier. My family and I love to hike, ski, bike and spend parts of the winter and summer seeking out those adventures.  Being amongst glaciers in British Columbia (what’s left of them) and vast nature is humbling and I do my best thinking in the woods. I also practice yoga several times a week.

Catapult Health Raises $10 Million in Series B Funding

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Catapult Health announced the completion of a $10M Series B financing which includes a significant investment by a new partner, UCHealth. Catapult Health’s existing investors also participated in the round, including founders Deborah and David Michel, Chief Technology Officer, Jeffrey O. Smith, Ph.D., and Series A investor Health Enterprise Partners. The company will use the funds to accelerate its rapid national customer growth and expand its team of board certified nurse practitioners who conduct Catapult’s onsite health evaluations. Read more.