Technology Integration and Industry Convergence: Bioinformatics, Patient-Empowered Point of Care, and Beyond

In this session from Medical Technologies 2014: A Frost & Sullivan Executive MindXchange, panelists discussed value-driven healthcare and how to use big data, providing insights on the challenges and opportunities posed by the evolution of healthcare, focusing on emerging markets, handling mass amounts of data, and funding innovative R&D.





MODERATED BY
Amir Jafri, Principal Partner, Executive Vice President, Netspective Communications

PANELISTS
-Joseph Boystak, Co-Chairman, Bessor-Brightwaters Pharma, Chief Executive Officer, Brightwaters Capital
-Robin Farmanfarmaian, Vice President, Strategic Relations, Singularity University
-Sanjay Shrivastava, Director, Global Marketing, Covidien
-Barbara Sosnowski, Vice President, External R&D Inflammation, ERDI Lead WRD External Partnerships, Pfizer
-Richie Etwaru, Group Vice President, Digital Innovation, Cegedim

TAKE-AWAY

The major challenge facing big data in the medical technology world revolves around the question of what to do with the data. The information is there, but it’s important to build a model that can verify and validate the data for actionable use in medicine.

BEST PRACTICES

Technology needs to create analytic systems that can properly interpret data given through information avenues, and companies must develop ways to apply it and use it.

ACTION ITEM(S) TO IMPLEMENT

Medical technology companies must focus on devices that enable patient engagement, rather than just those used for record-keeping. Success in the changing world of healthcare will require developing products that can disseminate information provided by patients and make the information actionable. The goal must be to engage patients to participate in their own care.

TAKE-AWAY

Like they are in other fields, strategies and business models in the medical world are moving toward a more data-centric focus, with the goal of conducting healthcare in a more efficient and precise manner. The medical device industry must examine what its role is in that major paradigm shift, the panelists said.

BEST PRACTICES

Companies should look to develop new technologies to compile and acquire actionable data in order to allow healthcare industries to do what they do in a more proficient and nimble manner.

Medical device companies should begin to look into emerging markets and areas that serve countries such as India and China. Focus on these markets, which have a potential to be as vast as the domestic market.

ACTION ITEM(S) TO IMPLEMENT

Companies should begin to actively engage with the worldwide medical community in emerging markets like India and China. Open dialogue with physicians in those countries can show how they are looking to do things and what technology they need so they can provide better care for their patients.

TAKE-AWAY

Of course, new products require new capital. That’s why there must be collaboration with investors and others to determine the exact cost of developing new products throughout the world.

Only about 10% of the 3 billion people who live in China and India can afford the healthcare that Americans can. That means there are opportunities to find innovative and cost-effective solutions and increase access for people around the world.

BEST PRACTICES

Accumulating data should be the first step in this process, according to the panelists. Look for solutions to treat, manage, and prevent diseases where there currently aren’t any solutions.

Opportunities for research exist in:

• The decentralization of medicine
• Value-based healthcare
• Remote monitoring and wireless applications
• Individualized health and therapeutics
• Actionable data
• The notion of competency and educational aspects
• Patient compliance and engagement

Companies should take the data, partner with different groups, and work toward analyzing and interpreting the data.

Money can be brought in through partnerships and investments, with patient advocacy as a driver. Companies should look for partners in non-medical sectors, such as telecommunications.

ACTION ITEM(S) TO IMPLEMENT

Companies can launch ventures to acquire funding for new medical technology devices to bring big data to the healthcare system. Those tools must have the ability to analyze information and make it useful for physicians and patients.

Corporate innovation exchange programs with Fortune 500 companies allow small businesses to learn from large corporations and vice versa.

FINAL THOUGHT

For big data and new technology to thrive in the evolving medical world, technology companies must find ways to make data actionable and prove the benefits for the cost and quality of care.

For more valuable information, download Frost & Sullivan's Executive MindXchange Chronicles: Medical Technologies 2014, a unique collection of all the key take-aways and best practices discussed at the event

New Growth Momentum for Private Hospitals in China?

By Ngan Yin Lai
Industry Analyst, Malaysia
Frost & Sullivan

The recent price deregulation for private hospitals in China is anticipated to stimulate new growth momentum for the sector. Post the deregulation, private hospitals have been allowed to set prices for medical services based on the principle of fair and free market competition. In addition, qualified private hospitals will be included in public health insurance schemes, similar to public hospitals. This write-up analyses the extent to which these new measures will facilitate the growth of private hospitals in China.

The Current State of China's Private Hospitals

Since 2008, China's private hospital sector has been experiencing strong growth. The number of private hospitals has increased from 5,403 in 2008 to 11,432 in 2014 (as of February), accounting for 46% of the total hospitals in the country. Outpatient volumes grew at a compound annual growth rate (CAGR) of 15%, and inpatient volumes grew at 20%, from 2008 to 2013. Although private hospitals experienced double-digit growth in patient volumes, the sector contributed only 10% of total patient volumes in 2013. Further, most private hospitals are small in size (98% of the hospitals have a bed size that is less than 500). In 2012, the number of beds for private hospitals was 582,177 (15% of the total hospital beds), and this number reached 677,000 (estimate) in 2013.

Chart 1: Hospital Outpatient Volume, China, 2008 & 2013 and Hospital Inpatient Volume, China, 2008 & 2013

Under the 12th Healthcare Reform Plan, the government aims to increase the role of private hospitals in the provision of healthcare service - private hospitals will account for 20% of total hospital beds and patient volumes by 2015.

Based on a 7.6% CAGR, the number of hospital beds will reach 5,184,000 by 2015. Based on a 7.7% CAGR for total outpatient volume and a 11.7% CAGR for total inpatient volume, total outpatient and inpatient volumes will reach 3,223 million and 178.96 million, respectively, by 2015. In 2 years, private hospitals will need to increase the number of beds to 359,800, and aim for 355 million outpatient volumes and 18.3 million inpatient volumes, to achieve the target.

The Path to Privatization Opens Up Investment Opportunities

Initiatives to open up the hospital sector for private capital were introduced in 1997. The Chinese Ministry of Health (MOH) stated that the government intended to relax rules for private investment in healthcare. 3 years later, the government permitted joint ventures between Chinese businesses and foreign investors in healthcare facilities; however, foreign equity was limited to 70%.

The healthcare reform agenda 2009-2020 reveals the firm stance of the government to encourage private investment in healthcare. Reforms have been put in place in the past few years - (i) allowing 100% foreign equity by removing the foreign investment in healthcare services under the restricted category of the Catalogue of Industries for Foreign Investment, effective 2012 and (ii) business tax exemptions.

The most recent measure to draw private capital into the hospital sector is to allow private hospitals to set their own prices for medical services and to enroll qualified private hospitals into public health insurance schemes.

This will make investing in the hospital sector more attractive as it will enable private hospitals to earn higher margins for the specialized services they offer. Many private hospitals are specialty hospitals, as the entry barrier is lower than that of general hospitals. Tapping on their strength to provide high-quality medical services and advanced technologies, private specialty hospitals cater to the healthcare needs of the burgeoning upper middle class who can afford the high prices. More than 75% of the urban population will reach an income level of $9,000 - $34,000 by 2022*. This huge potential purchasing power will create high demand for the specialized care offered by private hospitals.

The measure for enrolling private hospitals into public health insurance schemes will work as a double-edge sword for private hospitals. Being entitled to the coverage of public health insurance will encourage the general public to utilize healthcare services at public hospitals. On the other hand, private hospitals will need to conform to the prices for medical services, drugs, and medical examinations that are set by the National Development and Reform Commission once they are entitled to the reimbursement of public health insurance schemes. This will lower the profit margins of private hospitals.

The public health insurance authority will have to relax some of the requirements for private hospitals to qualify for reimbursement. For private hospitals to be included in public health insurance schemes, a minimum of 50% of their services must comprise basic medical care, as listed in the reimbursement schemes. Many private hospitals will not be able to meet the requirement because they are specialty hospitals and many of the services offered are not covered by the reimbursement schemes.

Challenges for Investing in Private Healthcare

While the prospect of investing in the hospital sector is encouraging, private capital investments in the sector will face 2 major challenges. Private hospitals have not been able to recruit experienced and skilled doctors. Most doctors prefer to work at public hospitals that provide better benefits, career advancements, and reputation. The absence of a policy that allows doctors to practice at multiple locations prevents doctors at public hospitals from working part-time at private hospitals.

The scarcity of land in big cities is another major challenge for private investors. The current land use policy provides land at low cost to public hospitals only. Private hospitals will have to absorb huge (and rising) costs for land lease, which will lead to escalating operating costs.

The latest wave of measures signifies a step forward in encouraging private investments in the hospital sector. Private companies interested in investing in the hospital sector should carefully study the intricacies of the market - policies play out differently across provinces in China due to differences in provincial politics and implementation. Investors should come up with strategies that fully utilize their strengths and core values.

Note: * McKinsey Quarterly (June 2013). Mapping China's Middle Class

Emerging Markets: Narayana Health’s Growth and Technological Innovation

An interview with
Dr. Ashutosh Raghuvanshi
Vice Chairman, Managing Director &
Group Chief Executive Officer
Narayana Health

By Sam Narisi




Over the past several years, India’s Narayana Health has experienced tremendous growth. After beginning in 2001 as a 225-bed hospital in Bangalore, Narayana became a two-hospital system in 2007 and since that time has grown to include 27 facilities in 16 different cities.

Even more growth is on the horizon, as Narayana aims to continue feeling India’s need for affordable high-quality healthcare. “There is a big gap between the supply and demand for high-quality care in India,” said Dr. Ashutosh Raghuvanshi, Narayana’s Vice Chairman, Managing Director & Group Chief Executive Officer.

Technology has played a big role in Narayana’s growth, helping the organization both reduce costs and expand its patient reach. Moving IT systems to the cloud has made an especially big impact, according to Raghuvanshi. Using cloud-based IT services allows Narayana to pay based how much is used, which has allowed for significant cost reductions.

Remote consultations

In addition, the move to the cloud has allowed Narayana to integrate and consolidate patient data from across the entire system. That’s made it possible to treat patients remotely, and with fewer specialists on staff. For instance, a patient can have imaging done in one hospital, and the results can be viewed by a specialist in a different facility. “We don’t have to have a specialist in every location,” Raghuvanshi said. “We can treat many patients effectively without have a large number of these specialists.”

Narayana is also offering more telehealth services, which is critical in giving access to high-quality, low-cost care to as many people as possible despite economic and geographic boundaries. In addition to its hospitals, the organization now runs a number of e-health clinics patients can also visit.

Those clinics are staffed by a paramedical workforce, so Narayana doesn’t necessary need physicians on site. Patients can have some diagnostics done at one of those locations and then visit a main hospital if necessary.

Again, this allows Narayana to treat more patients with a limited staff of specialists. Despite employing the largest number of doctors in India, the organization still faces an overall shortage of medical professionals in the country. In addition to expanding the reach through technology, Narayana has also invested in a teaching hospital to develop more skilled clinicians.

Narayana also uses those e-health clinics to track disease patterns and help improve overall population health. With all patient data collected in electronic health records, the organization is able to analyze that information to discover trends and detect outbreaks and other incidents.

Technology is key

Moving forward, Narayana will continue adopting new technology to help fulfill its missing of providing affordable high-quality care. “Technology is the only tool that can help keep the costs in the range that people in these areas can afford,” Raghuvanshi said.

This includes expansion into biotechnology, as well as greater use of clinical decision support, particularly for the hospitals’ nursing staff. By using those tools, Raghuvanshi said, nurses will be aware of available treatment options without having to do too much analysis on their own. That will help to standardize treatments, as well as increase accountability and the quality of care.

While there are some challenges that come from operating a healthcare organization in a country like India, Raghuvanshi said, those conditions also lead to some great opportunities, especially when it comes to technological advancement and innovation.

The environment in India and other emerging markets is typically less restrictive compared to other places. “The regulations and restrictive environment that exist in other places is not there,” Raghuvanshi said. “That is an advantage to help us innovate on the technology front.”

Also, in the US for example, the system is very payer-focused. So a lot of energy is spent developing technology that can help with better billing for hospitals, rather than with creating newer and better systems to improve the quality of care.

“Changing those legacies can be very difficult,” Raghuvanshi said. “We’re starting from a clean slate, and we are more focused on evidence-based care and emerging technology”

Healthcare IT in Latin America: A Conversation with Industry Leaders

Interviewed by Federico Baguear, Industry Analyst, Healthcare – Latin America


Introduction

An analysis of the Latin American Hospital Information System (HIS) market is showing some interesting and promising results. In 2012, the Latin American market reached $550 million and is expected to reach $1100 million in 2018 with a compound annual rate of 14.9%, as the region is now in a growth phase for health IT.

Federico Baguear, industry analyst with Frost & Sullivan, interviewed CSC, everis and NoemaLife as part of the healthcare IT market trends analysis in Latin America.

Guillermo Ramas is industry general manager for Southern Europe & Latin America within the Healthcare division of CSC. Ramas has been part of the management in companies such as Lawson, Agresso Spain, Agfa Healthcare IT and Shared Medical Systems. In 2008, he became iSoft's healthcare director for South Europe and Latin America, a position he still holds in CSC Healthcare after the fusion of the companies in August 2011.

Mario Chao is healthcare partner and global director with everis, based in Mexico D.F. He has more than 20 years of consulting experience and 10 years in healthcare and government.

Cristián Power has been general manager with NoemaLife Chile and Peru since 2011. He has 15 years of experience in IT. After obtaining a MSc in Image Processing at the University of Paris, Power returned to Chile to develop several projects related to RIS, PACS, LIS and EMR.


This Movers & Shakers interview focuses on five points centric to the current situation in Latin America: healthcare IT growth, challenges presented in system adoption, the public sector role, market needs, and strategies each company is applying to access the market.

Frost & Sullivan is honored to feature Ramas, Chao, and Power as part of its Movers & Shakers series, and thanks them for sharing their views and perspectives on the Latin American HC IT market.

Federico Baguear: There is a global trend toward the use of healthcare IT (HC IT) systems to improve healthcare administration and patient treatment. Which trends are you seeing in Latin America? What are the main benefits of HC IT solution adoption?

Guillermo Ramas: There is a big interest in using technology information systems in healthcare in Latin America. Mexico is seen as a reference standard in the region because it represents one of the most advanced countries in terms of specific regulations and regional projects. Other countries like Ecuador, Panama and Honduras are facing ambitious technology projects in which one of the main objectives is to implement electronic medical records (EMR).

The use of information and communication technologies (ICT) systems offers numerous benefits to the healthcare system. Organizations and healthcare delivery institutions increase management effectiveness and efficiency in both financial and clinical areas. This allows healthcare professionals to focus on providing better-quality patient care. EMR enables professionals to have information whenever it is needed, leading to major process control and better diagnosis.

In the long term, these solutions allow optimization of resources by increasing productivity, thereby helping healthcare institutions to be more competitive and provide better services to their patients.

Mario Chao: The informatization of the healthcare sector warrants process efficiency and decision support by providing access to the right information at the right time.

The use of EMR provides an opportunity to improve healthcare, more comprehensive control of population health, better patient safety, reduced waiting times for information, and increased precision of diagnosis. This comes about through multidisciplinary information-sharing at the same time, and ability to precisely control and manage expenses and costs. That is the reason EMR is the cornerstone of healthcare industry transformation. The EMR provides the basic platform that allows building an ecosystem based on registers and events because it records all the transactional health movements.

Click here to read more.

Collaborating to Meet Global Regulatory Challenges

An interview with
Elisabeth George
Vice President of Global Government Affairs, Regulations and Standards
Philips Healthcare

Interviewed by Sam Narisi

Medical technology companies often struggle to balance the need to bring new products and innovations to market quickly with the ever changing   regulations and standards. That is an especially big challenge for companies working globally due to the difference in the laws of different countries.

In her role at Philips Healthcare, Elisabeth George is responsible for both helping shape healthcare regulations around the world, as well as making sure her company can strategically adapt to the shifting rules. Frost & Sullivan recent spoke with Elisabeth about some of the strategies companies can use to navigate the complex global regulatory environment.

Describe your role with Philips Healthcare.

I’m responsible, from a global perspective, for interface with government affairs, regulations and standards. I’m working from a strategic perspective toward future regulations and standards. When a regulator starts developing a guidance document or a new regulation, I’m a focal point for our company. I work with our different businesses within our company as well as interact with the different stakeholders  to evaluate those proposals and represent the company back to the regulatory authority, explaining either why I disagree or agree with what they’ve defined.

Then once a new regulation or guidance document comes out, my team puts together the training and deploys it across the company. We also participate around the world  in a number of standards organizations as well as industry organizations including as a board member or a chairperson of committees.

What are some of the trends you see developing in the regulatory landscape?

There a couple of things. First off, every country that has a regulation seems to be changing them, and every country that doesn’t have a regulation seems to be defining and implementing one. So that’s a big challenge. Another change that is somewhat on the positive side is that a number of the larger regulatory regions –  US, Japan, China, Russia, Brazil, and Europe – are all working together toward some aspect of convergence on regulations through IMDRF (the International Medical Device Regulators Forum). They are realizing that the world is getting smaller and if they all have different ways of doing things it impacts time to market, availability to patients, and potentially patient care.

Another new area is anything having to do with the use of IT, including medical apps on phones and the use of software in the clinical environment. Everything that used to be mechanical is becoming much more electronic and software-based. There’s also the whole Big Data aspect, where there’s a desire to collect information and for people to use that information in all sorts of decisions including financial, clinical and environmental. There are questions around who owns the data and how they’re allowed to use it, as well as concerns regarding privacy and the accuracy of the data. With all of health IT, there is also the challenge of cyber security.

One big challenge in medicine is that the regulations typically don’t evolve as fast as the technology changes. What are some things companies can do about that?

That’s a problem everywhere in the world. Some of the emerging countries that are just starting to implement regulations have very slow burdensome processes that require very significant testing, even for products that have been used in the US for several years. So that’s a challenge, and I think one of the ways to work on that is to spend a lot of time with the regulators to help them understand what regulations are in place elsewhere. Try to get those regulators talking to regulators from the other countries. Offer to educate them, and if possible, instead of sending the product to them to test it, offer to have regulators come and see the product in use in a hospital or bring them into the factories.

When dealing with regulations in the US, again the way to help overcome these challenges is to work with the regulators. The FDA has people involved in the standards process so they can partner with industry on standards development. It’s important not to be afraid of regulators and to work with them either directly or indirectly by joining an industry group.  The FDA has an Experiential Learning Program (ELP) that industry should reach out to the FDA to engage them in learning about new technology.

Companies can also reach out to consultants, and make use of opportunities like Frost & Sullivan events to network and find out what other people are doing. Don’t assume that there’s only one way. It’s a moving target, so never assume that if you analyzed something yesterday that it will have exactly the same answer today. There are a lot of inputs that regulators are getting every day, from competitors of your company, from post-market complaints and failures, and from patients. Regulators realize they have to change, and agencies are willing to have open door discussions, and they’re willing to take risks with us as well.  Companies must use the Benefit Risk thought process when making decisions.

Given how constantly things are changing, what advice do you have for staying current, especially when dealing with regulations globally?

One way is what I call “feet on the street,” which is having people physically in the region that communicate with regulators and stay on top of local regulations. There are also different organizations that publish updates to regulations and offer pointers. Again, it helps also to be a part of a local industry organization, such as AdvaMed  or MITA in the US. Even if you can’t actively participate in all of the committees they have, you can be on their email list so you get updates to see what’s changing. It’s also important is spend time surfing the web for information. And again, whenever you can, network.

None of these are perfect, and to be honest we do all of them and don’t always find out about every change. But when we’re caught off guard, we try to find out why we were caught off guard. The good news is most of time it’s one of those weird regulations or requirements that’s maybe only applicable to one small slice of our product line. We’re not usually caught off guard when it’s a major change.

What are some of the differences in introducing products in emerging markets such as India or Latin America, for example, compared to the US or Europe?

If I look at India specifically, fortunately for us, most of our products are not on their medical list that requires those products to go through an extra-burdensome process. What they require is that the country of origin regulatory submission has been done. They do happen to have more  burdensome radiation requirements, so for our imaging products, we took some of our radiation specialists there and scheduled meetings with the people who work on those regulations. We went through some general training and shared the practices we go through to ensure safety and effective performance and all of that. That allowed us to integrate what the regulators needed into our design process so it added next to no effort on our part. We also helped introduce them to people in the radiation area of the FDA, so they understood what they were doing in the US. Those relationships are very valuable.

Another example I’ll use is Brazil. A number of years ago, Brazil had no regulations. One thing we did early on before they started to develop regulations was to visit them with the US State Department and try to educate them on the many different regulatory schemes that were already out there. I was part of that group, but it wasn’t just me. It was part of an industry group effort. Let’s say you don’t know what’s going on in that country and you’re not really sure how to find out. You can find the medical device industry group in that area, and the other medical device manufacturers in that area. Even if they’re only doing band-aids and you’re doing an MRI machine, at least you can talk to them and find out about the oversight process, what’s expected, and who you can talk to.

Especially if you’re a small company and you don’t know what to do, find some local networking opportunities. Regulatory people aren’t like the R&D people and design engineers who don’t want to share general perspectives information with competitors because it may be proprietary. I’m not going to share the dirty details of my regulatory submission with other companies, but I can tell them who they may be able to call for help, or I can  reach out and ask a question to one of my contacts.

Handling the Regulatory Challenges of Bringing New Innovative Technology to Market

In our ever changing world, innovation is an imperative for medical industries. We must have effective, safe solutions that are available quickly. Incremental changes used to be enough, but now with the increased needs and through the use of wireless communication, the Internet, and social media, it’s imperative that we find creative ways to get our ideas and solutions to market quickly. In this panel discussion from Medical Technologies 2014: A Frost & Sullivan Executive MindXchange, participants discussed challenges being faced and how companies might overcome them.

MODERATED BY
Elisabeth George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare

PANELISTS

- Laetitia Cousin, Vice President, Clinical Affairs & Quality Assurance, Nuvasive

- Frederick (Rick) A. Curro, Clinical Professor & Director, PEARL Practice Based Translational Network

- Vinu Gurukar, Information Technology Leader, Product Development, Edwards Life Sciences

- Michelle McMurry-Heath, Associate Director of Science, Office of the Center Director (OCD) at the Center for Devices and Radiological Health (CDRH), FDA

- Robert Newman, Vice President, Regulatory Affairs, Apical Instruments

TAKE-AWAY

All sides agree that patients need access to innovative medical technologies sooner. In today’s highly globalized medical world, the amount of regulations around technology and products has slowed down the release of potentially life-changing technology. Medical tech companies, along with pharmacology and healthcare organizations, are trying to find the best ways to meet those guidelines without delaying new products.

BEST PRACTICES

One key to success for medical technology is to keep up to date with regulations and be heavily involved in learning those requirements.

Speed will be important for products’ success. Companies need to think about how to have devices accepted by the FDA and CMS simultaneously.

That will require thinking about the regulatory process as products are designed. Developers must measure what is beneficial to patients versus which risks are tolerable. It’s also critical to maintain the ability to put in local flexibilities for other markets where the rules may be different.

ACTION ITEM(S) TO IMPLEMENT

For every aspect of development, all people involved need to be highly educated and informed on changes in regulations and laws, both nationally and globally. Employees must be trained on those regulations, so when products are moved into the regulatory phase, the process is as quick and efficient as possible.
Education is paramount. Companies must make sure they diversify their knowledge about the different levels of regulation so that people know exactly what needs to be done to meet the needs of the FDA and other agencies.

As advanced healthcare technology becomes accessible across the world, a global standard for approval and quality assurance needs to be set, panelists argued. However, in the meantime, it’s critical to make sure the company is knowledgeable about the regulations in all applicable areas.

TAKE-AWAY

Medical technology companies should also work to open communication pathways with regulators and innovators in order to increase the expediency of the regulation process. That will help pull ideas for projects and allow new medical technologies to make it through the FDA regulatory process at a much faster rate.

BEST PRACTICES

Consortiums and partnerships should be established to foster dialogue and breed ideas on solid solutions that will make it through the regulatory hurdles.

ACTION ITEM(S) TO IMPLEMENT

Panelists offered some of the steps medical technology companies can take to stay on the cutting edge of the regulatory environment and avoid delay in bringing new products to market:

• Offer training and classes on regulatory issues to all employees involved in developing new products
• Network and foster relationships with the FDA, as well as other agencies and political figures. That will make sure the company understands the best ways to get approval as well as offer opportunities to educate regulators on the value of the products.
• Maintain those relationships so the company always has up-to-date information.

TAKE-AWAY

One of the three top priorities for the FDA over the next few years will be to shift the balance of pre-market and post-market regulatory requirements. The goal is to make sure that only what is essential is required for pre-market data and allow for additional data to be collected post-market.

BEST PRACTICES

In that new environment, panelists encouraged companies to open lines of communication with regulators early on in the process. Pre-submission work will expedite the approval process by allowing companies to engage with review teams and get early feedback.

ACTION ITEM(S) TO IMPLEMENT

Companies should be in communication with the FDA and other agencies during the pre-submission phase and engage early on with review teams. Educate the agency on the existing property and which vendors will use the product. Present the product to different reviewers and educate them on the importance of the device.

Fortunately for medical technology companies, the FDA is working to expand its pre-submission base so that more companies can come to the FDA early on for a consultation.

FINAL THOUGHT

The FDA has developed a tracking system for applications in order to increase transparency. This system allows applicants to monitor the status of their application as it moves through the approval process. There are also new quality assurance measures in place, including more education and training for all new reviewers to make sure they are knowledgeable.

Though the agency is working to streamline processes, there are still major hurdles in making potentially lifesaving technologies available quickly. Technology companies need to find the best ways to navigate the bureaucracy so they can deliver their products quickly to healthcare systems around the world.
It’s important for any business to educate itself on the changing regulation landscape within the United States and internationally. There is also a very important need to maintain and foster relationships with regulators around the world.

Information should be gathered quickly and efficiently when new products are developed in order to pass the information along to reviewers in a timely manner. Partnerships can also help in the expedition of approval for new devices.

For more valuable information, download Frost & Sullivan's Executive MindXchange Chronicles: Medical Technologies 2014, a unique collection of all the key take-aways and best practices discussed at the event.

4 Business Strategy Lessons Learned from SWAT Training

By Robert Wood PE
Vice President, World Wide Manufacturing
Varian Medical Systems









I had the honor of spending an entire day training with a local SWAT team as a result of a charity auction. I had no idea of what to expect and as soon as we began our day, instantly, I was in testosterone heaven and I soon learned some valuable lessons that could be immediately applied to the business world. Because of my life-long familiarity with firearms, I was allowed to participate in all of their drills. One of the drills was door entry and room egress. Being a total novice, it bothered me that the SWAT team was required to knock and announce themselves to the bad guy in the building, giving him plenty of time to prepare an ambush for the team that would soon enter through the door. In the drill, the door is breached, and then a line of SWAT members file through the door very quickly, but controlled, with the goal of dominating the space they entered.

I noticed that they alternated left or right as they entered and thus filling every blind spot and space in the room. I asked the leader of the team if there was a strategy for which direction the first guy goes, either left or right. The leader told me that in shooting situations, it’s usually the second guy through the door that gets shot, not the first. I had two thoughts; first, I never wanted to be the second guy through the door, and second, the direction the first guy goes, either left or right, could determine the fate of the second guy and the rest of the team. I asked the leader if they decide prior to the entry which direction the first guy goes and the leader said something truly amazing and this strategy has direct implications to us in the business world. Looking me directly in the eyes, he told me, “It’s our strategy that whatever direction the first guy goes, it is the right direction. We never second guess that decision and we commit fully all the way through the exercise based on that decision."

In the little I know about the inner workings of the SWAT, I do know that they critique everything they do. They review every movement, every eye movement, and every decision- except this one decision which is the initial direction the first guy goes on a door entry. The other important thing is that once they begin to execute the plan, they commit 100% to the strategy until the very end.

In business, I find that in many cases, we lack the discipline and sometimes courage to follow a strategy completely to the end. In many cases, after meeting upon meeting, a strategy is hammered out, except that more than one on the team really hasn’t actually bought into the plan. They may have agreed to the strategy, but their heart is not in it and then during the execution portion of the plan, they find excuses why the strategy was flawed and they withdraw support. In other cases, as soon as the first bump in the project occurs, there is a call to abandon the plan and start the grinding planning process all over again. This would never be allowed in the SWAT world. Many times, I’ve been told, the team enters a room full of chaos – dogs barking, people screaming and crying, unplanned obstacles which trip team members, and walls standing where they are not supposed to be. Likewise, even in the best plan, we in business get hit with all kinds of obstacles and unplanned roadblocks. I think the impressive attribute of the SWAT that we should do more of in business is to stay committed to the plan, pull together as a team, and stick to the strategy. How many of our plans would have been successful if we just executed with the focus and spirit of the SWAT? Naturally, there may be a time to change the strategy based on market or business dynamics, but only after a fully committed and focused attempt has been made.

In the world of the SWAT Team, the Team is everything. Flawless execution of the strategy insures that the innocent are saved, the team member go home to their families, and the bad guy meets justice. I think we in the business world can learn a few lessons about strategy, commitment, and execution from these brave and loyal public servants. So here are my take-aways:

• Have open and honest dialog during the planning portion of developing a business strategy. Here is where we, as leaders, should and must speak into the process. Our arguments must be data-based and factual. The SWAT team does the same before entering a house. They look at the risk, the situation, getting input from the team, and then they make a plan and they never have all the information they need.

• Once a decision is made, stick to the plan. Here is where leadership comes in. When the going gets rough, how many times have you seen team members start second guessing the strategy? Many times, the lack of total commitment is the reason the plan fails; it becomes a self-fulfilling prophecy. The SWAT team upon entering a hostile space faces many obstacles and it’s their commitment to follow the plan that gets them through most of the time.

• Even if you originally dislike the strategy, once it’s approved, you must become an advocate and full supporter of the plan. This might be the toughest attribute of leadership; even if you opposed the plan, now you must execute the strategy and be the champion. Everybody watches leaders and those who behave in this manner always set the best example for the organization. I’m sure that there are plenty of number 2 guys in the SWAT team egress team that wish that they would get the call on which way the first guy goes, but regardless of their feelings, they go with the team and risk their necks based on the strategy. How many of us in the business world risks our lives based on plan or strategy? It is critical that even if you opposed the plan originally, that once its approved, you act as if it was your plan from the beginning.

• Once the plan has been executed, openly critique the execution with the goal of getting better and smarter. This SWAT team I visited has “open kimono” meetings where they review every little detail of an operation. No one is spared criticism or rebuke, but once the meeting is over, they put the past behind them and reaffirm and pull together as a team. Likewise, we need to do more post-activity critiquing with the goal of fixing what went wrong and developing better processes to insure better results in the future. Never in this critique are the words, “I told you so”.

So there you have it. Sound business practices from guys who risk everything to protect the innocent. My hat’s off to these brave public servants!

This post was originally posted by Robert Wood on LinkedIn. For more, read part two and part three of the series.

The Doctor Is (Always) In

By Denise Fletcher
Chief Innovation Officer
Healthcare Payer and Pharma Group
Xerox








Within five years, accessing medicine is going to be very similar to the online shopping experience, which is both convenient and personal. There was a time when doctors would make house calls, showing up with a little black bag to check your vital signs. Today, we‘re headed back to that model – but the doctor will appear on your computer instead of knocking at the door.

Just as Amazon changed the way we access goods, telemedicine is revolutionizing the way we access healthcare. Today, for example, you can use a smart phone to take a picture of a mole and have it analyzed for signs of skin melanoma. Below are some scenarios that I see coming within the next five years:

Goodbye stuffy waiting rooms

Often for the elderly, the sick or the parents of newborns, life feels like a string of doctor appointments. These visits typically involve monitoring vital signs, taking measurements and ensuring the course of treatment is working. But very soon, the idea of trudging through a snowy parking lot or carrying a newborn into a stuffy waiting room to see the doctor will be a distant memory. Patients will be able to communicate face to face with doctors via their smartphone, television or computer screen.

Sayonara to the mammogram

“Smart” homes will not only monitor room temperature and electricity, your “smart” home will also track your health. Sensors embedded in homes (and perhaps in the buttons and fabric of shirts) will keep an eye on us 24/7 without the need for wires or pin pricks. Wouldn’t it be great if a camera could conduct a simple test, and tell you every day that you are cancer free? Or alert your doctor if irregular heartbeats are detected or that you are at high risk for stroke? Today, Xerox researchers are working on ways to use video cameras for contactless health monitoring that would make some of these automated systems possible and eventually used in a “smart” home.

The doctor is (always) in

Some doctors will work primarily in the physical world, others will concentrate on telemedicine and some will work as hybrids – seeing patients in their offices but also visiting them using telemedicine technology. Doctors might pull up test results on a screen and set up a video chat to walk a patient through a prognosis. Geography will no longer restrict access to specialists. The world’s leading neurosurgeon could oversee an operation in Morelia, Mexico — in real time — while sitting in a Paris office. Think of how this could help patients in rural areas or emerging countries.
While there are aspects of medicine that online visits and sensors can’t replace, many medical experts believe doctors have the skills to know when in-person visits are needed. Meanwhile, telemedicine can help reduce the costs of services and make it easier to get help when you need it the most.

This post was first published on the Xerox blog, Simplify Work.

About the Author

Denise Fletcher is responsible for leading healthcare innovation through Xerox’s research and development pipeline in order to serve customer and industry needs. As Chief Innovation Officer for the Xerox Healthcare Payer and Pharma group, Denise spends a lot of time engaging with customers and connecting research and emerging technology to their business processes. She has six pending U.S. patents in healthcare, and recently was recognized by Front End Innovation as one of the top 40 women in Innovation.

The 5 Biggest Trends Shaping the Future of Healthcare

By Reenita Das
Partner and Senior Vice President
Healthcare and Life Sciences
Frost & Sullivan





As the healthcare industry is transforming and becoming more consumer driven, the “5 Ps” are becoming the hub of the industry: prevention, personalization, prediction, preemption and personal responsibility. As a result, there is a rush of new stakeholders who are entering the game and changing many of the rules. Who are these new breed of companies and what are they bringing to this industry? How are they transforming the way healthcare is practiced?

Social Media, IT Co.’s & Telecom: Shifting the Balance of Power

The foundation driving change in regard to how providers and patients interact and how medicine is practiced is "information technology." We have witnessed a whole generation of content providers and social media companies – from Google, Facebook and Twitter, to Web MD and zillions more – that are playing the role of democratizing this data and taking it a step further by building consumer participation and responsibility into the mix.

Healthcare is a largely untapped market for specialized telecommunications systems with a strong immediate potential; therefore, it presents a handsome alternative revenue stream for this group. Telecommunication companies – or “telecoms” – are striving to customize their traditional offerings to meet the unique requirements and regulatory standards of the healthcare industry. These range from providing connectivity for enterprise mobility, asset management and exchange of health data in various formats; platforms for healthcare IT tools; mobile apps for physicians and healthcare professionals; all the way to patient engagement solutions. At a more consumer level, the telecommunications industry is targeting the increasingly health-conscious consumer with mobile apps that support education, health and wellness, patient monitoring as well as mobile communication. On a larger scale, telecoms will eventually look toward creating a connected community or a smart city of which healthcare will be one component.

We are also waiting with bated breath to see if media companies will seriously enter this space for the long haul. Time Warner Cable recently announced the “Virtual Visit” program, implemented via Cleveland Clinic's Center for Connected Care, whereby patients will be able to interact with their doctors via an encrypted two-way video without leaving their home. This product will be offered as a bundled service consisting of connectivity installation, customer premises equipment (modems and video conferencing equipment), and technical support in patients’ homes. There are other cable companies in addition to Time Warner Cable that are entering this space such as Cox Communications and Comcast who are doing similar pilots and seeking additional revenue streams from healthcare. War has already begun with AT&T’s recent announcement to acquire DirecTV, leading to more consolidation among internet and TV providers. Should we now expect Google who, recently, has been making moves to acquire gaming companies, to gear toward healthcare tech companies? Google has been trying to reinvent themselves and move outwards laterally for a while now.

Digitization of Health Draws Sensor/RFID Co.’s & Consumer Electronics into the Foreground

As healthcare moves toward a model of constant monitoring and feedback based on “on-demand, anytime, anywhere” concepts, sensor technology will drive the revolution of mobile health to the next frontier as it becomes more available, visible and usable to people everywhere. Readings from sensors can be used in many facets of healthcare and disease prevention. Apart from regular monitoring, we can use sensors to track the emergence of disease, detect exposure to harmful environmental elements, or even predict the likelihood of developing health problems based on patient medical records, family health history and public health data.

Nokia held a competition in 2013 and again in 2014 called the Nokia Sensing XCHALLENGE. It is a $2.25 million global competition to accelerate the availability of hardware sensors and software sensing technology that individuals use to access, understand and improve their health and well-being. The 2013 winner was Nanobiosym Health RADAR with its device that enables diagnostic testing in the palm of your hand. A drop of blood or saliva is placed on a nanochip and inserted into a mobile device. The user selects a particular disease strain from the software interface and then pushes the start button to begin. The device detects the presence (or absence) of that disease's pathogen in real-time with gold standard accuracy. These mobile diagnostic technologies are taking the laboratory to the patient – quite the reverse of where diagnostic testing has been so far. The tremendous advances in health sensing are truly game changing and will transform how doctors interact with their patients to address and solve health challenges. More importantly, it puts patients at the center of the care process and provides personalization.

As the line between health and fitness devices is blurring, every consumer electronics company – from LG to Samsung to Sony – is getting into the game. Thus begins a whole generation of wellness app companies that are now moving from the regular "step counting" outfits to more sophisticated platforms that includes building connectivity across all the stakeholders and connected to the cloud. Apple’s newest foray into setting up a medical technology division and focusing on building a healthcare playbook, as well as its recent discussions with FDA, shows how serious they are about the healthcare space. However, on the acquisition front, Apple is definitely a slow mover, more resistant and less aggressive than Google, so it will be interesting to watch their technology acquisition strategy in regards to healthcare.

Direct-to-Consumer Testing Brings a Potpourri of Others

I believe the age of "direct-to-consumer testing" has already begun with devices such as the electrocardiogram monitor that can be carried in your pocket or the ability to take a hearing aid or eye test at home. This has heralded the advent of retail grocery and drug stores offering a “one stop shop” for diagnostic testing, monitoring and coaching. Global giants like the Walmarts and Walgreens of the world are clamoring to take control of the consumer as quickly as possible and provide a full service solution that can be personalized on demand. These consumer-facing testing devices are becoming the gateway to personalized medicine as they can aggregate data in a continuous contextual fashion. It then can be connected through the cloud to a supercomputer like IBM’s Watson to provide insights into not just your health but also your personal potential. In the future, we will have personal avatars that will help us reach our potential by way of coaching and motivation.

The Supply Chain is Growing More Complex

Outside of the coterie of healthcare products and service-type companies, we are also witnessing a complex supply chain emerging regarding logistics companies building their muscle and strategy for healthcare. Many of these companies like FedEx and DHL Express are already partnering with healthcare providers along the continuum of care and looking at extending their service offering beyond just distribution and logistics to build more value, consolidate cost and increase outcomes to this large diverse audience group. This implies these new entrants could start controlling more of the chain and eventually start competing with traditional pharmaceutical and medical device companies.

What do Healthcare and Hospitality Have in Common?

On a last note - healthcare and hospitality have much in common. For one, both have the same etymology. The word “hospital” comes from the Latin word “hospes,” or host, which is the root for English words such as “hotel,” “hostel” and “hospitality.” Imagine if we are treated as a guest in hospitals compared to being treated as patients. What implications does this have for healthcare providers? What does "guest-focused care" really mean?

In fact, as healthcare is becoming a consumer service industry, there are many lessons that healthcare can learn from the hospitality industry. In the future, it is expected that the hospitality industry will extend beyond recreation, leisure and wellness to healthcare services providing an end-to-end customer experience. The irony is we are already witnessing some of this by way of medical tourism. I expect this will be a natural transition for the hotel chains of the world to enter into healthcare soon enough. Alternatively, it may be time for healthcare suppliers to push themselves out of their comfort zone and look at partners outside their traditional ecosystem rather than waiting for more intruders to attack.

For more, view Frost & Sullivan's infographic about the changing healthcare environment.

Submit Your Nomination for the 2015 CIO !mpact Awards

All industries are changing fast, and no business can survive without serious digital innovation. As a result, CIOs and other IT leaders have never been more integral to their organizations’ success than they are now.

At the 2015 CIO !mpact Award & Gala, Frost & Sullivan will honor those IT leaders who are true game-changers and have stepped up to help their companies innovate, overcome challenges, and capitalize on new opportunities. To make sure your organization or others are considered, submit your nomination today. Nominations are open to companies and their IT teams from around the world. For each nomination submitted, nominees are required to identify a senior project sponsor at the VP level or above.

Held annually during CoNEXTions: A Frost & Sullivan Executive MindXchange, The CIO !mpact Awards honor enterprise teams and individuals that are enabling breakthrough new business models and strategies through the innovative use of transformative technologies.

The CIO !mpact Awards recognize top performers in the following categories:

• Enterprise Social Networking
• Advanced Software Development
• Advanced Analytics and Big Data
• Enterprise Architecture
• Mobility
• Cloud Computing
• Unified Communications and Collaboration
• Data and Network Resilience

In addition those award categories, the CIO !mpact Awards will honor two CIO Innovators of the Year from among all of the project award winners. These winners are CIOs whose teams had the most positive impact on their enterprises’ strategic innovation and who delivered a significant competitive advantage.

Winners of the CIO !mpact Awards will be presented with their award at the gala on the final day of the event, February 10, 2015, in San Francisco, and will be recognized in front of their peers as global IT leaders.

Act Now to Reserve Your Company’s Spot at Our Next IT Think Tank

Never before have CIOs and IT team been so critical to the company's growth strategy, and never has it been so important to showcase IT's impact on the business. While there are definitely challenges ahead, this is a time of significant and electrifying change for IT executives. New industries, business models, and products will emerge, organizational roles and relationships will be redefined, and IT will be at the epicenter of it all.

Frost & Sullivan is pleased to announce the 3rdAnnual ConNEXTions 2015: A Frost & Sullivan Executive MindXchange, featuring a unique format designed specifically to help CIOs and other IT professionals navigate this new environment and plan for the future. In an effort to maximize the value of this think tank and its interactive discussions, Frost & Sullivan has invited a selection of cross-vertical IT leaders. Most of the content will be PowerPoint-free, relying instead on interactive discussions to engage peers in small groups to facilitate candid discussions and cross-industry leaning. The date and location have been confirmed for February 8-10, 2015, in San Francisco.

For this year’s event, Frost & Sullivan has invited representatives from sectors such as:

• Information and Communication Technology (eBay, Expedia, Yahoo!, Xerox, Honeywell)
• Financial Services (The Blackstone Group, Charles Schwab, JP Morgan Chase, Wells Fargo)
• Government Administration (U.S. Department of Energy, U.S. Department of Commerce, City of Palo Alto, California Department of Public Health, Office of Management and Budget)
• Healthcare and Medical Devices (Abbott Laboratories, Cardinal Health, CVS Caremark, United Health Group, Quest Diagnostics)

Building close relationships with peers in other organizations and industries will be critical for IT leaders to develop the innovative ideas and best practices needed to help their companies succeed in the future. Past participants agree the unique format of a Frost & Sullivan Executive MindXchange offers the best opportunities to network, build relationships, and share best practices with peers.

To make sure your company is represented in this innovative information technology think tank, be sure to take advantage of Frost & Sullivan’s new Colleagues and Clients referral program. If you refer a colleague, you’ll receive a $100 discount on your next Frost & Sullivan event. And If the person you refer registers for ConNEXTions, that discount will increase to $250.

To maximize your savings, let your company’s IT leadership know about the 3rd Annual ConNEXTions 2015: A Frost & SullivanExecutive MindXchange today.

5 Technologies Shaping the Future of Medicine

By Robin Farmanfarmaian
Vice President, Strategic Relations
Singularity University

In a classic “Star Trek” episode, Captain Kirk and Spock lean over the battered body of Dr. McCoy. Spock waves a shiny device over the doctor’s chest.

He glances at it, “Severe heart damage. Signs of congestion in both lungs. Evidence of massive circulatory collapse.”

Spock may be smart, but he's no physician. However, his casual civilian access to medical data might be a reality very soon. As technology advances, care will increasingly shift into the hands of patients who have access to high-tech devices and state-of-the-art resources.

Current research reveals exciting possibilities as technology and healthcare continue to advance. Here’s a look at five ways technology is revolutionizing the medical field:

• 3-D Printing: California-based research company Organovo has printed human liver tissue to test drug toxicity on specific sections of the liver. Although printing organs for transplants may still be far off, this technology could be used in the near future with individual patients to test their toxicity reactions to specific drugs.

• Artificial Intelligence: IBM’s Watson is just the first step of using artificial intelligence in medicine. The supercomputer, which defeated two human champions in Jeopardy two years ago, is now being used to diagnose and manage lung cancer treatment. Imagine a computer that could evaluate and analyze your entire genome, biometric data, and environmental and personal data including your diet and activity level. The quantity of information is too much for a person to analyze efficiently, so adding an artificial intelligence component could help us get to a new level of understanding.

• BCI and BBIs: As Brain-Computer Interfaces become more advanced, healthcare will incorporate more complex human-computer connections. The uses range from helping people manage pain to controlling robotic limbs and more. Harvard University researchers recently created the first brain-to-brain interface that allowed a human to control a rat’s tail and another human’s movements with his mind.

• Robotics: Robotics are quickly advancing medical treatment. Ekso Bionics has already launched the first version of its eksoskeleton, which enables paraplegics to stand and walk independently. Emotionally and physically revolutionary, the technology allows a person who has spent 20 years in a wheelchair to stand on her own. This holds huge promise for the next generation of robotics.

• Electronic diagnoses: Technology promises to put the burden of care and diagnosis directly in the hands of patients. The XPRIZE Tricorder Challenge is sponsoring a $10 million race to develop a hand-held, non-invasive electronic device that can diagnose patients better than a panel of doctors. This could revolutionize how we see diagnostics. You will no longer have to go into a doctor’s office or hospital. Instead, a device in your home will analyze your data, diagnose the problem, and send your information to a doctor who can treat you remotely. Such a device could make healthcare more accessible in rural areas and developing nations. One of the devices up for the challenge is being developed by Scanadu, which also has an electronic urinanalysis stick similar to a pregnancy test that performs up to 12 different tests and sends the results through the cloud to your physician, eliminating the need for routine lab visits.

Changing patient experiences

Advances in technology are already making healthcare better, easier, more accurate, and more efficient for physicians, patients, hospital staff, and administrators.

These changes will no doubt affect the role of hospitals and emergency rooms. As continuous monitoring of biometric data becomes the norm, I see the ER being used as a dispatch center, with patients’ information reaching the hospital before they do. This will eliminate wait times and decrease the risk of disease transmission, especially important when immunocompromised patients face hours in the ER.

Patient-physician interactions will also be affected by changing technology. In a typical doctor visit, which lasts just 15 minutes, the provider must evaluate electronic and paper records, check vitals, diagnose, and communicate with a patient, and then provide effective treatment. Advancing technology means the first three of those tasks could be done automatically, giving the doctor more time to spend interacting with the patient and providing more accurate treatment. Patients will soon be monitoring their own vital signs. MC10 is prototyping a temporary tattoo (epidermal electronics) that remains for two weeks and effortlessly and continuously captures biometric data.

All of these advances translate into one main objective — improving patient outcomes. With access to more powerful tools that are cheaper, faster, and better than their predecessors, people will become increasingly responsible for their own health. This will lead to more effective care as people can detect problems much earlier in the process. Patients will no longer delay physician appointments for years because personal health will be ever-present. This will reduce healthcare costs on several levels and change the type of medical professionals the industry needs most. 

I can’t even begin to anticipate much of what will come after all of this, but the possibilities for technology and healthcare really are endless. Now, if we could just get a transporter.

Robin Farmanfarmaian, a major driving force behind building the successful medical conference at Singularity University, has spent most of her career focused on making a positive impact on medicine and healthcare.  Robin is the Founding Executive Producer of FutureMed and the Vice President of Strategic Relations for Singularity University.  Connect with Robin on Twitter and LinkedIn.