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.