Posts Tagged Medtronic
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.
Disclaimer – Below is my best attempt to capture highlights from company presentations. Please check details against more authentic sources, before making any financial decisions.
The overview of the conference can be found at this link – http://bit.ly/UY1Cpk . In the next few links, I will share some highlights from presentations of big pharmaceutical companies. The recent global recession with challenges pertaining to price/volume issues, healthcare reforms, more restrictive regulatory environment, medical device taxes, medical reimbursement cuts, and extreme pressure to contain costs have put a lot of pressure on the device industry. Big Pharma is slightly different. Historically the industry has enjoyed growth rates in double digits and 20% operating margins with growing demand and big profits. But times are also changing for big pharma. Many firms responded to initial challenges by investing heavily in next-generation drugs, often based on biotechnology. Though promise of biotech has not panned out as expected, there is more fat in big pharma than in device industry. Below are highlights from some medical device companies.
Medtronic – Looking at returning 50% of capital back to shareholders over next several years
President & CEO, Omar Ishrak talked about the efforts undertaken during the last 18 months to operate more effectively in the changing healthcare environment. There is tight alignment and the company has made changes in business teams, making them accountable for growth. Three major US markets, ICDs, Core Spine, and Pacing, have started to stabilize. Additionally, Medtronic is focusing on multiple high growth platforms, including advanced energy, afib, glucose monitoring, deep brain stimulation and so on. As opposed to 10% return in 2012, for several coming years, Medtronic is looking at 20% revenue growth, for several years to come, said Ishrak. Medtronic is expecting to recoup $25B, in next 5 years, mostly from outside the US and is expecting to continue 50% rate of return to the shareholders, that is, $12.5B return to shareholders, over next 5 years.
Medtronic will also focus on generating more cash in the US, through increasing demand, visibility of supply chain, minimizing idle inventory, optimizing supply chain, reducing operating expenses, and finally repatriating cash from outside the US, if the tax policy becomes fair, said Ishrak. With increasing globalization, there will be continued focus on premium segments in emerging markets, particularly India and China. Additionally, Medtronic will also focus on value segment and underserved segments through creating infrastructure capability and then aim to bring the innovation back and disrupt developed markets. Medtronic is quickly adapting to the changing healthcare landscape, and moving from old fee for service model to new pay for value model, said Ishrak.
Stryker – Continued focus on M&A, share buy backs, and cash flow generation
Stryker CEO, Kevin Lobo said the company is focused on innovation, has a robust balance sheet and will continue strong cash flow generation. In 2012, the total revenue was $8.7B, up 4% from previous year and adjusted earnings per share increased 9%. Stryker has a very diversified market focus, with no single market representing more than 16%, said Lobo. US represents 2/3rd of total Stryker sales or 65% of the business. 29% is in Europe and the rest 6% is in emerging markets and Stryker aims to grow in these markets. Although 2012 was a quieter year from acquisition standpoint, Stryker will continue to focus on M&A and will continue to buy back shares and is looking at strong steady cash flow generation, said Lobo.
Hansen Medical – Maintains Leadership in Intravascular Robotics with Launch of New Products
CEO, Bruce Barclay asserted that Hansen continues to be a global leader in intravascular robotics and sees it as a platform technology in EP (electrophysiology) and vascular space. Hansen also has a strong pipeline and is developing a full suite of catheters to go with its technology. Hansen catheters and other flexible robotics have largely known to be used in catheter based interventional medical procedures, particularly for treatment of irregular heart arrhythmias.
In 2012, Hansen launched Magellan (TM) Robotic System in the US that allows Hansen to enter much larger vascular market, on account of greater precision and predictability of the distal tip control. Hansen has also launched some new products in the EP space. Artisan Extend catheter was approved in the US, last year and just got approval in the Europe. Improved procedure predictability of Hansen products offers an opportunity to hospitals for lowering cost and incremental patient turnaround. Additionally, it is vastly helpful to the physician, who can sit comfortably at a console, does not have to wear lead coat, is away from the radiation field, and has lower risk of orthopedic injuries. Therefore, this is a good ROI model.
Hansen has had five consecutive quarters of procedure growth on the robotic side and is now approaching 10,000 cases. Hansen had 14 new patents issued in 2012 and new transaction with Intuitive Surgical added $30M to the balance sheet. Hansen focuses on early adopters of new technology and on training them well, in this $2B+ medical robotics market, said Barclay.
St. Jude – Poised to deal with challenges and deliver long term growth
Daniel Starks, President, Chairman and CEO of St. Jude reported that preliminary sales for Q4, 2012 were as expected, at approximately $ 1.372 billion. The company initiated $1B share repurchase program, at the end of 2012, and expects a favorable impact from this in 2013.
Globally ICD market declined 3%, in 2012. St. Jude’s ICD market share has been stable, with some decline offset by CRT-D and replacement segments. Most recent data also allays previous market concern about reliability and safety of Durata line of (HV) high voltage leads. Durata lead survival at 5 years is shown to be 98.7% and compares favorably with MDT line of HV leads. FDA inspection of SymarCA facility generated form 483. None of the observations were pertaining to performance of Durata HV leads and all will be remedied with urgency, assured Starks. HV lead revenue comprises of less than 4% of STJ global sales.
Various cost saving initiatives have generated more than $100 million in cost reductions in 2012 and are expected to generate more than $100 million in additional cost savings in 2013. These cost savings plus $1B share repurchase will enable STJ to fund incremental R&D investments, expand market share development activities, and absorb the US medical device excise tax. While sales growth is expected to remain challenging due to macro-economic factors, STJ is well position to deal with the headwinds and deliver long term growth. Some of the growth drivers in 2013 will be, MediGuide non-fluoroscopic catheter tracking technology with STJ AF platform, LAA and PFO closure to reduce risk of stroke, STJ’s FFR and OCT product lines, STJ next generation EnligHTN renal denervation technology, TAVR and Trifecta tissue valve product lines, and the recovery of STJ neuromodulation franchise, said Starks.
Glaukos – Private Opthalmic Medical Device Company for management of Glaucoma
Glaukos is a private opthalmic medical device company. Thomas Burns, CEO and President of the company shared about Glaukos for management of glaucoma. Glaucoma is a long lasting, permanent condition that does not cause immediate blindness but causes dark patches or areas of blindness. High pressure caused by excessive fluid produced by the eye, can damage the optic nerve and lead to glaucoma. Glaukos technology is primarily an infinitesimal titanium stent, iStent, that can be implanted in the eye to drain fluid and thus reduce the pressure that leads to glaucoma. The iStent is the smallest medical device ever approved the FDA and is placed in the eye during cataract surgery. It is small enough that the patient will not see or feel it after surgery and post surgery, it continues to work to help reduce eye pressure. The 2nd generation G2 device is smaller than the first generation device, and can be loaded into a needle and injected at a predictable rate. Glaukos suprachoroidal stent model G3 device is currently in phase 3 trials.
All products are CE marked and there is great progress in reimbursement, said Burns. The current number of about 70 million patients in the US is expected to reach 80 M by 2020. CPT codes are established and currently 4100 stents are implanted to date.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech, Pharma & Medical Device News, Diversity & Inclusion for Effective Global Business Practice on November 14, 2012
Women in Biotech
EPPIC is an organization that promotes networking, entrepreneurship and mentoring for life science professionals, and is dedicated to creating US-India life science synergy and partnering opportunities. EPPIC annual meeting will be on January 6, 2013 and to register, please go to www.eppicglobal.org .
Recently EPPIC held an interesting event “women in biotech” to hear the perspectives of the prominent women leaders from the industry. As a Diversity and Inclusion Trainer, I found this event very enlightening. Anula Jayasuriya, Managing Director with Evolvence India Life Science Fund and Invascent Advisory moderated the event. Jayasuriya shared some interesting stats. For instance, do you know that 7.1% of successful companies have women executives versus 3.1% of unsuccessful companies? Jayasuriya asked some pointed questions of the panelists and the responses were equally insightful.
All the panelists talked about the importance of some really good mentors, in their career progression. Their mentors helped them see their true potential early on in their careers, and guided them during key phases in their careers. When asked, if they felt excluded from existing networks, the panelists seemed to agree that they frequently experienced being excluded, during early stages in their careers. Debra Riesenthel, Consultant and Former CEO of Novasys Medical, shared that while men frequently had activities like golf that they shared, during company events, their wives went on shopping trips, and she was often mistaken for an admin. While “men get promoted on potential, women often get promoted on performance”, said Reisenthel. Karen Drexler, Founder & Chair of the Board at Cellscape, agreed and said, women often feel they have to be better than men to be recognized”. According to Sara Kenkara-Mitra, Vice President of Development Sciences at Genentech, there is a subtle bonding and camaraderie that exists among men because of their ongoing banter and playful competitiveness, whereas women do not do well, in that area. She advised, women find their voice and get comfortable in speaking up. Janet (Jian) Xiao, Partner with Life Science Group at Morrison & Forester, Palo Alto (host for the evening event), said, often when men say something it looks real but when women say something it has to be real. According to Daria Mochly-Rosen, Senior Associate Dean and George D. Smith Professor of Translational Medicine at Stanford University School of Medicine, women often cannot afford the time to hang around and engage in small talk. However, this also gives an advantage to women, she said. Women have to disengage and switch off to focus on other priorities like picking up children, thinking about meal preparation and that often gives them an ability to approach the task with renewed perspective and sharper focus. Kenkara-Mitra observed that while exclusion can be a barrier, things are changing rapidly and women should not consider it a major barrier.
The panelists discussed issues like differences between male versus female bosses in terms of how they relate to their bosses and the bosses’ perceptions of them. They also shared the role of their life partners or spouses, in their career. It seemed, almost all of the panelists had a strong and steadfast spouse who strongly supported them in their careers in various ways, including handling meals, childcare, and at times, even taking a back seat in their own careers. The panel ended with panelists sharing their observations on how diversity of perspectives and styles enriches the workplace and makes the workplace better for everyone. The panelists shared advise and tips on how women can progress in their careers. These included, seeking guidance from a mentor to becoming a good listener to finding a voice and speaking up to being a keen observer.
For more information and to register for EPPIC annual conference, go to www.eppicglobal.org . For information in “Diversity & Inclusion Training for Effective Global Business Practice”. please contact me at wd_darshana@ hotmail dot com and please click the link below for other similar article on diversity and inclusion in medical device company, Medtronic — http://alturl.com/qkxy7 .
Emerging markets already represent huge growth opportunities for pharmaceutical companies. In may countries, lifespan has increased and as people live longer, they are more in need of traditional health enhancing drugs for common ailments like diabetes and cardiovascular diseases; in many countries such as India and China, as diet and lifestyle changes, there is also and increase of such diseases; and there is a huge and growing middle class that is able to spend the money, and is more conscious of health. One would presume that these same factors will also open growth opportunities for medical device companies. For instance, Medtronic expects India sales to grow 25% for the next five years and is considering setting up R&D and Manufacturing facility in India (I saw firsthand that emerging markets is a big priority for Medtronic, when I facilitated leadership and inclusion training for Medtronic team in India in 2010 – http://darshanavnadkarni.wordpress.com/category/musings/). At TiEcon 2012 (www.tiecon.org), a panel that includes Katie Szyman, President at Medtronic Diabetes, Tom Fogarty, Serial Entrepreneur, Renee Compton Ryan from J&J, and Dana Mead from Kleiner Perkins, will address trends, challenges, and opportunities presented by emerging markets, in this $350B industry. I am also looking forward to hear more about “reverse innovation”, a term coined by GE’s Jeffrey Immelt, where the innovation in new products and services is driven by cost conscious emerging markets, and is then reintroduced into the Western markets.
Mobile health panel, at TiEcon, will discuss entrepreneurial opportunities in the fast growing field of Mobile Health. Increasing reach and easy access of mobile communication devices like mobile phones,Tablets, patient monitors etc. is making monitoring of health, dissemination of health information to patient and care providers, and providing healthcare in a timely and real-time manner, possible. A panel of experts including Aza Raskin from Massive Health, Ron Gutman, CEO of HealthTap, Jack Young from Qualcomm, and Alex De Winter from Mohr Davidow will share success stories and discuss the pitfalls to avoid, in the mobile health market. This is a fast growing market which has yet many unanswered questions like, who would own the data, what would be the regulatory impact, and more.
Panelists Randall Spratt from McKesson, John Mattison from Kaiser, Adrian Rawlinson from Brown & Toland Physicians, and Jim Murray from UC Irvine Health Information Services will discuss investment trends in health IT including demographic trends, technological enablers, cost pressures, regulatory mandates and where the VCs are looking to invest, given all the challenges.
With mHealth, cross-functional collaboration, and emerging markets as the drivers of innovation, the boundaries are increasingly more flexible and TiEcon is focusing on Life Sciences, and addressing the enormous entrepreneurship and innovation that will take place by those playing with the boundaries, rather than within them. Register at http://www.tiecon.org.