Posts Tagged iRhythm

Enabling Physician Adoption of new Medical Technologies


Dr. Akhil Saklecha, General Partner at Artiman Ventures talked about understanding the challenges of physician adoption of new technologies and discussed ways of overcoming resistance and enable adoption of new medical and heatlhcare technologies by physicians, at www.bio2devicegroup.org event. (See below, at the end of the article, more info on bio2devicegroup, EPPICon, TiEcon, & HTF conf.)

Entrepreneurs in the health technology sector, must first understand physicians, the environment they work in, and the nature of the work flow.  Physicians have to be patient advocates, they often control the purse strings and make decisions on allocation of scare resources, and there is a potential to impact their adoption of new technologies by exercising influence upon them.  Physicians generally have competitive, type A personalities and they do not want to lag behind in adoption of useful technologies, said Saklecha.

So what are drivers for adoption of new technologies?  Technologies that solve problems that drive doctors crazy, get their attention.  Entrepreneurs with “must have” technology, will find it easier to get it adopted.  Entrepreneurs must focus on solving their problems, said Saklecha.  In addition to understanding physician’s work challenges, it is also important to understand every single stakeholder, in the healthcare setting.  For instance, Saklecha said he has seen some GI tools that solve a smaller problem but take up additional time of the scrub technician, general nurse, and GI nurse.  All this would add to the expenses and if the technology does not offset the cost, it will be rejected.  In fact, there is an early shift towards disposable colonoscopy devices because it saves set up and clean up time.

When it comes to money, “ignore it at your own peril”, said Saklecha.  His advice was that entrepreneurs must map out the flow of money, very early on.  They should get an understanding of where the revenue is generated and who makes the money and who loses the money.  Given the tremendous pressure to save costs, it is extremely important that new technology does not add costs to the system, unless it is a huge value add in terms of quality of health.  Entrepreneurs must know the flow of the money, direct and indirect costs and savings and they should understand CPT codes and reimbursement rules.  Obtaining CPT code does not necessarily translate into reimbursement, warned Saklecha.

Entrepreneurs must focus on enhancing quality and patient safety, said Saklecha.  Quality drives revenues and safety keeps patients alive and providers’ revenues are increasingly tied to performance.  A thorough understanding of work flow and how it impacts all various service providers including nurses, physicians, clerks etc. is very important.

One of the valuable advice Saklecha gave was with regard to timing and specific point of insertion of new technology.  Find a point of least friction for insertion of new techology, said Saklecha.  With regards to timing, it is important to keep in mind that no benefits will be seen during the first month, and instead there may be adverse effects.  Most inefficiencies will dissipate in the following 3-6 months and only then will the benefits begin to appear.  So this may be a time to keenly observe and understand the impact and every little nuance of the new technology on the work flow.  In the past decade, electronic medical records or EMR has been all the rage.  However, data entry and management takes physicians’ time away from patient care.  This is a challenge that is not yet effectively tackled, said Saklecha.   Voice recognition and scribes are used but the both have challenges of cost and errors.

Saklecha gave examples of several medical technologies and how they overcame physician adoption challenge by solving their key pressure point.  For instance, iRhythm cardiac monitoring device allows for remote monitoring of minimally “at risk” patients and it enables ER doctors to read the data and generate revenues.  Insurance companies also like it because instead of sending the patients over for hospital stays, they can be sent home and patients enjoy the convenience.  Minimally invasive blood test offered by Cardio Dx replaces cardiac stress test and it was a great improvement in saving costs.  The company directly marketed it to primary care physicians.  However, they misjudged and found that these doctors were slow to adopt because they were looking for validation from the cardiologists.  That was an important lesson in physician adoption of new technologies.  Now the company has pivoted and changed their marketing strategy and they are finding traction.

Another example is GI Dynamics which has a medical device that targets obesity.  Bariatric surgery is complex and there is high morbidity population.  The company has a fairly simple procedure that was found to simultaneously solve issues around hypertension and diabetes, while treating obesity.  GI physicians loved the technology since it offered them a whole new class of patients.  Just like GI physicians, cardiologists are also a competitive and procedure driven specialty, and they are quickly adopting new technologies in cardiac stents and percutaneous valves.  The talk was highly interactive and generated lot of discussion.
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Please mark 3 great conferences focused on life science, medtech, & healthcare, in the next two months, in San Francisco Bay Area, on your calendar, & see info on life science networking group that meets every week.

www.eppicglobal.org EPPICon annual conference is on March, 29, at Westin, SF and it features a panel on “Neglected & Rare Diseases” http://bit.ly/1c1vvTR, on “Point of Care”, on “Innovations in Clinical Development of Novel Agents” and more. Excellent event to network with VCs, panelists, speakers & other professionals.

www.tiecon.org is on May 16 & 17 at Santa Clara Convention Center.  On day 2, May 17th, it will feature a Life Science track with keynote and a distinguished panel on “Disruptions in Healthcare”. Great to network with entrepreneurs working inside and on the boundaries of various disciplines.

www.healthtechnologyforum.com  annual conference is on May, 20 at Parc 55, Wyndham, SF and it has excellent lineup of speakers and panels with a broad focus on “pathways to sustainable health”. More specific panels will focus on patient engagement, medical ethics, IoT, health apps, building resilient communities and more. Excellent to network with physicians, non profits & other entrepreneurs.

www.bio2devicegroup.org meets every Tuesday & covers a broad range of topics pertaining to biotech, medical device and pharmaceutical industries. On Tuesday, March 22, at 8:30am Johannes Schweizer, Arbor Vita will talk on OncoE6™ Cervical Test that Predicts Development of Cervical Cancer www.bio2devicegroup.org – Free event, all are welcome. Become a member and network with diverse range of life science industry professionals.
Bio2Device Group          Home 2014 HTF Innovation Conference: Pathways to Sustainable...

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Ambulatory ECG Monitoring


David Bondietti, VP of Marketing and Business Development at BioMedical Systems, talked about ambulatory ECG monitoring systems, at www.bio2devicegroup.org event.  There are four broad categories of devices that can record an ambulatory electrocardiogram or the electrical activity of the heart, while an individual is doing usual activities.  Sometimes heart problems become noticeable during certain activities like exercise, eating or even sleeping and continuous monitoring can detect abnormal heartbeats.

Holter monitoring devices were among the first ambulatory devices and they can now record every beat for up to 24 to 72 hours and give very detailed reports, recording up to 100,000 heartbeats in 24 hours..  All ECG data is analyzed via holter analysis software, all findings are validated by 4 certified cardiac technicians and these devices remain the gold standard in cardiac care.  These devices require very little patient compliance and they record all data, not just sporadic data.  However, short recording duration is a major limitation and additional limitation is that it takes some time to get the results.  Continuous recorder can be implanted under the skin for up to a year of recording but iRhythm has latest holter technology.  It’s zio patch goes over a patient’s chest and allows up to 14 days of continuous ECG recording.  It can then be mailed back to iRhythm where the report is generated.

Post system event monitoring device is a newer credit card size “Heart Card” device that a patient carries and when they feel something, they can open the shirt and place the device on the chest.  The strength of this device is that the patient is not attached to a machine and is not required to wear electrodes.  However, a major limitation in this device is that it could miss the onset of abnormal rhythms that give a lot of insight into cardiac problems.  Alive Cor has a sleeve that fits over iPhone or Android phone and patient can place two thumbs on the sleeve and ECG data is recorded and via blue tooth transmitted to the provider.

Loop Cardiac event monitoring devices are preplaced but only record when activated. Patient can wear two electrodes for up to 30 days.  When a patient has symptoms, a patient needs to press a button and record the heart rhythm.  The limitation is that there is no quantification of abnormalities; it only gives qualitative information.  Additionally, it does not record the onset of symptoms.  Some next gen devices save a small amount of information about how the heart was beating when the button was pressed; allowing for some presymptom recording.  This feature is useful for people who may lose consciousness for instance, when they had heart problems and can press the button only after regaining consciousness.  Some newer devices have auto triggers with event monitoring and added algorithms.  They all require landline for transmission of data.  These are generally not for patients with serious, life threatening cardiac arrhythmias.  Medtronic’s implantable Reveal Plus Insertable Loop Recorder, can record ECG up to 3 years.  It is ideal for long term follow up for post-ablation AF patients.  The limitation is that it has to be implanted.  However, next gen device may be so tiny that instead of having to implant it, it might be possible to inject it.

Mobile Telemetry Wireless ECG devices, introduced in early 2000, require no patient interaction to transmit the data.  They have built-in algorithms to detect abnormality and record 2-3 channels of ECG, though a few allow up to 8 channels.    Bondietti’s company BioMedical System’s TruVue wireless ambulatory device is the first mobile system that can transmit ALL of a patient’s ECG during the monitoring period.  It comprises of a sophisticated arrhythmia analysis algorithm with automatic wireless data transimission to provide a comprehensive long term ECG monitoring.  Patient wear sensors around a neck, under a shirt that are connected by electrodes, attached to their chest.  The sensor continuously digitizes a two channel electrocardiogram and transmits it via wireless link technology to a handheld unit that a patient can carry.  Via the cellphone data plan, the handheld unit can transmit every beat of the two channel ECG to secure servers, located at the company’s 24 X 7 monitoring center, staffed by certified cardiac technicians.  A patient may be monitored with this system for a duration of up to 30 days.  This provides a comprehensive long term ECG monitoring solution for patients with ongoing cardiac arrhythmia.

The talk was followed by Q&A.

English: Example of holter ECG software screen...

English: Example of holter ECG software screen shot. (Photo credit: Wikipedia)

 

 

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Stanford Biodesign Project taking the Lead in High Impact Low Cost Innovation for Quality Healthcare


Dr. Paul Yock spoke at www.bio2devicegroup.org event, earmarking 10th anniversary celebration of the Bio2Device Group.

 

Dr. Yock is Professor of Medicine and Mechanical Engineering and Founding Co-Chair of Stanford’s new Department of Bioengineering.  He also holds a courtesy appointment on Operations, Information and Technology in the Stanford School of Business.  Dr. Yock is internationally recognized name in the field of medical devices.  His number of contributions to field of devices include, the Rapid Exchange balloon angioplasty system, which is now the primary system in use worldwide.  He also invented a Doppler-guided access system known as the Smart Needle and PD-Access.   The main focus of Dr. Yock’s research program has been in the field of intravascular ultrasound. He authored the fundamental patents for mechanical intravascular ultrasound imaging and helped conduct the initial clinical trials.  In 1986 he founded Cardiovascular Imaging Systems, which was acquired by Boston Scientific in 1994.  Dr. Yock has cofounded several other medical technology companies, and has authored over 300 peer-reviewed publications.

 

Dr. Yock talked about the changing world of medical technology innovation, where the developing world will increasingly play a major role.  Thus far, medical technology world has been dominated by US followed by Europe, followed by Japan.  Total market has been about $350 billion.  These developed countries dominated the industry because they were willing to spend large amounts of money.  But collective impact of three major issues brewing in the US, will dynamically shift this landscape.   Looming uncertainly with regard to FDA issues, reimbursement pressures, and dried out VC funding, will lead to declining rate of device approvals, with increasing pressure to contain costs.   Concurrently, there is an emergence of new generation of global medtech innovators, coming from countries like India, China, and Brazil.  They are coming with different cultural mindset and thinking about technology with a global focus.

 

Dr. Yock discussed the Stanford Biodesign Program that focuses on innovation and entrepreneurship, with 3 pronged foundation, identify, invent, and implement.  Innovation begins with a cross-cultural, multi disciplinary team of entrepreneurial students, working together to identify a need.  They practically live in the hospitals, until they come up with a list of about 200 needs.  Gradually, through rigorous process of need screening, that includes consideration of clinical impact, stakeholder impact, treatment options, and market characteristics, a few needs go forward, which further go through rigorous tests, and through the final process of elimination the team arrives at a handful of needs.  For each need, the team comes up with several concepts, which are taken through prototyping, and finally one concept is selected.

 

The Stanford Biodesign program is 12 years old.  During this period, 26 companies have emerged and have been funded, and so far over 150,000 patients have been treated by technologies, coming from the program.  Graduates of the program are working in top notch jobs, bringing the same rigor and discipline into their current careers.  Dr. Yock gave several examples.  Highly successful companies like iRhythm have emerged from this program.  He then talked about the changing world, with a rapidly growing middle class, in countries like India and China.  These upwardly mobile societies are demanding quality care, while at the same time, dealing with a rise in obesity, chronic heart disease, and diabetes.  Stanford Biodesign program’s mission is also to find and help train innovators in these countries.  These innovators come for short duration and work in multidisciplinary settings at Stanford.  After returning to their home countries, many of them have done some amazing things and have often come up with low cost, high impact, innovative technologies.  These innovations not only have an impact on quality and delivery of care in their home countries, but in a likely trend dubbed as “reverse innovation”, some of these low cost technologies may be adapted for use in the US, where increasing cost pressures continue to make a push for effective, low cost technologies.

 

The presentation generated enthusiastic response and an animated Q&A session.

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