Archive for the 'Wireless Medical Devices' Category

Wireless Health – Product Development Cycle?

I had an opportunity the other day to have a great conversation with someone very involved in the wireless health industry to talk about my goal of establishing a seed acceleration program focused on wireless health products. We talked about a number of things like what I expected could be done in 90 days, is this really an incubator, how is this different from some other local initiatives? I like being tested and challenged especially from people considered experts in the field. I get feedback about how well I know what I am doing and how good I am at expressing myself on the subject. It is also a great learning experience and, quite honestly, I have a lot to learn.

Every so often, someone says something that doesn’t immediately resonate with me, but later comes back into my thoughts when I have some time to think about. During our conversation, I mentioned that the goal of the accelerator was to shorten the learning curve that all early stage entrepreneurs go through, which I feel is somewhere between 18 and 24 months. I think that much of this time is wasted by looking for the right information, contacts, processes, investors, etc. I have always believed that there are different types of capital needed by early stage entrepreneurs with two of them being Time and Money. Both are critical and precious resources and need to be monitored as much as possible.

At one point he said, and I am paraphrasing, you might be able to shorten the learning curve, but I’m not sure you will be able to shorten the 7 to 9 years it takes to get a wireless medical device developed and into the market. Although I did hear the 7 to 9 year piece, I did not immediately focus on it. Later, it hit me, why 7 to 9 years? I can understand it might take that long to get a new drug approved where the FDA needs to make sure that the drug reacts the way the manufacturer says it will and that it doesn’t cause any harm. I am also aware that some products that have stored medicine in the device, like insulin, don’t lose potency while sitting on a shelf; so you must have it some for some number of years. But a non-invasive, medical device that combines cellular/wireless capabilities with it, 7 to 9 years and 10s of millions of dollars? It makes no sense.

During my corporate career, I was always involved with products, and worked through maybe 6 different product management processes. The differences were generally how you compartmentalized the various steps and how you organized your R&D, Product Development, or Life Cycle Management tasks. One of our goals was to continually monitor and evaluate our processes and look for ways to make them more efficient. Our longest cycles were 36 months for large PBX and Central Office systems.

I have heard quite a lot about the FDA 510(k) process as being a big part of the problem, but have also heard the FDA say that entrepreneurs share the blame by not following procedures, or not taking advantage of pre-meetings or making changes they have requested. If the 510(k) process was put in place to facilitate getting devices into the market quicker and it is still taking anywhere north of 36 months on an exception basis, then the process is very broken.

So, I would really like to understand what the process is to get a product from concept to patient or consumer along with the timing. Can anyone share or point me to a description of the processes being used?

I look at the types of products under development in this industry and feel they are just too important to languish in development for extended time frames while there are patients or consumers who will benefit greatly by having access to them. There are some very innovative devices and applications under development. If great innovation collides head on with process, rules and policies that make it incredibly expensive and too time consuming to get into the market, entrepreneurs will turn their attention somewhere else. Whether it is to another country or industry, it is just wrong!

So, I would really appreciate it if someone can point me in the right direction. Maybe we can test some new ideas within the accelerator.

Happy Independence Day.

Jim

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Wireless Health – Seed Accelerator 2

My next big set of issues were around what it would take to put a program together. Issues to consider included: a place to run the program, finding and signing mentors, getting the word out about it, figuring out how to fund this (and how much would be needed), finding sponsors, and a myriad of other details.

I watched Brad Feld at the Startup America unveiling, and listened to his announcement of TechStars Network. So, a natural place for me to start was to find out about TechStars Network and see if there was a format to follow. I exchanged a couple of emails with Brad and his partner in this organization, David Cohen, and discovered that they were in the process of putting a program together and gave me the contact information for the new Director of the Network, Jenny Boyd.

One of the things I really like about the people involved in this startup space is how open and sharing they are. I was able to read a lot about the program before I had a call with Jenny, but she spent 30 minutes filling in what details were in place and it sounded like just the program that fit what I wan planning. When I mentioned that I was talking to a number of organizations that were looking a creating programs, she offered to talk with anyone that wanted to know more about the Network.  I now had a list of things I needed to put in place in order to apply to TechStars Network.

The first was to find a space. Late last year, my partner and I attended a meeting of the Escondido City Council, in support of  Gary Knight, the CEO of the San Diego North Economic Development Council (SDNEDC). This was Gary’s final step in the process where he was looking for approval of the SDNEDC’s plan to rehab a vacant public building in Downtown Escondido and create a Business Innovation Accelerator (a new name for a Business Incubator). Gary walked out with a 3 year lease with a 2 year extension. I had previously agreed to support his efforts and be a business mentor for his program.

This is a big space and having a seed acceleration program seemed like a natural fit; Gary agreed and I was able to check off two big program milestones. I had the space but I also had a supporting organization for the program, which TechStars wants to see as part of a proposal. Additionally, there was a natural evolution for the companies in the program. If they decided to stay in the area, they could move to another part of the building and take up residence in the Innovation Accelerator. As they grow and need more space or different support services, they can move a couple of blocks to the new Technology Business Center that the city is building. This creates a natural pool of mentors for subsequent programs and, hopefully, a technology hotspot for wireless health product development. I realize that this may take a number of years to evolve, but as Brad Feld has stated many times, you must have a long view for these types of programs and not expect or promise big short-term gains.

In my next post, I will continue describing my experience focusing on defining and engaging possible mentors.

In the meantime, any thoughts, comments or suggestions are, as always, welcomed.

VC’s Go to Washington to Talk About Medical Device Approval Process

I ran across this post on the Wall Street Journal’s Venture Capital Dispatch blog. A group of Venture Capitalists that invest in medical devices went to Washington to talk about the issues associated with getting medical devices cleared through the FDA. Main point was they were focusing on making the process consistent, predictable and transparent. They also talked about how the current process is driving more entrepreneurs overseas along with all their innovations.

It seems they got to speak their minds, but doesn’t sound like they got commitments to resolve the problems. Now that’s not good.

Wireless Health – Seed Accelerator

At first, the idea of me putting together a seed accelerator program based on wireless health products was daunting. After all, I am not in that field and certainly have little knowledge of the science involved in developing medical devices. As for wireless, I do have a communications background from my career at Bell Labs, AT&T and Lucent Technologies although not necessarily cellular. Then I realized that a seed accelerator is actually focused on positively affecting the “process” of startups not the technologies and products of the startups. I can deal with that!

I began looking at the current process being used. Not necessarily a pretty picture. The length of time it takes to get from idea to market is extremely long if you are developing a medical device. I understand that a lot of this time is to ensure that the product does what is says it will do while not harming the patient. That responsibility falls onto the Food and Drug Administration (FDA), which has a long and involved process for bringing new drugs to market that takes 10 years to get through.

They were reasonable about devices to conclude that maybe there should be a shorter process for devices without risking harm to patients, and developed the 510 (k) process where some devices can be approved in a matter of months versus years; a big breakthrough. They did make provisions that result in longer approvals by requesting more tests (clinical trials) whose complexity can add years and millions of dollars to the product development cycle. The good news is that the Center for Devices and Radiological Health (CDRH) who is responsible for approving medical devices has been studying ways to make the program more effective and be better prepared for new technologies like wireless being added to new devices. You can read about their plans here.

I have no intention of trying to become involved in the changes at CDRH or their 510 (k) process. Since I am looking at the process itself, I started to look at the process and see if there are things that startups, especially first time entrepreneurs, can do to get closer to the Months to Approval that I mentioned above versus the Years and Millions of Dollars alternative. So, I talked to entrepreneurs who have been in the medical device space and have successfully navigated the approval process along with others who seemed trapped in it. I also talked with lawyers who have helped clients with their applications and listened to people who have years of experience with the FDA. I learned that there are a number of things that entrepreneurs can do that will help them through the process many of which can be included in a seed acceleration 90 day program.

Personal Health devices like the Nike iPod Touch application or the Fitbit product require no FDA approval and can get to market much quicker. With an increased interest on personal health, there will be many new wireless personal health products introduced over the next few years. Obviously, there are lots of things you can accomplish during a seed accelerator program to assist companies startup process.

Once a medical device is approved by the FDA, it can be brought into the market. The next important step is for the product to be reviewed by the Center for Medicare and Medicaid (CMS) who determines if and how much they will allow patients to be reimbursed when they have the devices prescribed for them. There are currently some problems with wireless medical devices within the current CMS policies, but, as with the FDA 510 (k) process, these have been identified and CMS is working on resolving the issues. In the meantime, there are things that entrepreneurs can do to facilitate the CMS process that can be covered in the seed acceleration 90 day program.

My next big question was “Can I develop a program that addresses the main issues that I described above and includes other relevant information that will accelerate companies working in this sector in 90 days?” Again, I talked to a lot of people currently operating in this space along with the service providers who support them, and created a set of program milestones. I got great feedback especially in relation to the milestones. There is a significant learning curve with first time entrepreneurs that can be positively impacted in a seed acceleration program. As an side, if you put an entrepreneur who has developed medical devices together with an entrepreneur who has developed wireless devices the result is a set of first time entrepreneurs who will have a learning curve.

So, I’ll end here for now. In my next post in the series, I’ll begin to discuss the process of putting the program together. One last point, as I have been working through the process, I originally used Wireless Medical and Personal Health as the title.  As I move along, I get input and adjust accordingly. One recent recommendation was to shorten the title to Wireless Health. The rationale was that the title was too long and this shorter version includes both the medical device and personal health device spaces.  It also reduces the number of keystrokes, which may not seem like much, but over time will be significant. So, I have adopted that recommendation.

As I said above, I look for input and I believe this will be a program that will get better based on continuous process improvement. So, if you have any thoughts or suggestions, please send them along in the comments.

Wireless Health: Development Pitfalls

As any entrepreneur knows, getting started with a new company is fraught problems that can turn a great idea into a big mistake. There are just so many decisions that, if the wrong one is made, can kill or cripple the company. Worse though are the startups that haven’t encountered the big “Oh Crap” as yet and there’s a glimmer of hope that entrepreneur latches onto.  These startups are under the impression that they are really close to big sales/financing/strategic partnership.  Encountering your first big speed bump can be a slow and painful experience.

Many companies entering the wireless medical device space get stuck in this last category. However, their being stuck and not able to move forward may be less about something they did or did not do and more about the pitfalls along the path of taking a medical device to market.

For example, wireless devices startups may get snared in government processes that were put in place to insure that medical products are safe before allowing them into the market (by our friends the Food & Drug Administration, FDA). Once they are found to be safe, then another government organization gets involved to decide how much Medicare and Medicaid will pay for the product (Center for Medicare and Medicaid, a.k.a., CMS).

Now if you include working with the Patent and Trademark organization on intellectual property applications and issues, that’s a total of three government organizations involved in the product realization process. And, as we know, government organizations are not the fastest groups to deal with. Not only is this two-pronged FDA-CMS process time consuming, it is very costly, and every entrepreneur in this space has to make sure that he/she has planned on having sufficient financing and investors who understand what’s required to get through the FDA and CMS.

I am sure that this is one important reason why many investors avoid life sciences deals including medical device space altogether. After all, an entrepreneur can start an consumer Internet company for a few thousand dollars, a couple of great programmers, a good understanding of the demographics of the prospective customers and someone who understands the elements of SEO and Conversion. Consumer Internet startups can begin generating money in a matter of months. Contrast this to medical devices requiring large initial cash outlays over an extended period of time; in many cases years.

I find it interesting that, when there is talk about fixing the issues in the FDA, e.g., around the long timeframe for a wireless medical device company to get its products through the FDA’s 510 (k) process, there are always many comments about making sure that the primary goal of safety isn’t overlooked. I’m clearly not a proponent of having the pendulum swing all the over and weaken the process so that unsafe products get to market faster, but who can argue that the US economy and consumers both can benefit from an overhaul to the 35-year old 510 (k) process?

On a positive note, in January of this year, the FDA announced a plan consisting of 25 proposals targeted at overhauling the approval program and is targeting to implement some changes in 2011. Their list includes streamlining the review process for lower-risk devices, clarifying when companies should submit clinical data for a 510 (k) application and creating a new council of senior FDA experts (“Center Science Council”).

As for the insurance reimbursement process shepherded by CMS, a number of major stumbling blocks are under review. For example, the current process allows reimbursement for a medical device or associated devices only if the patient is at a medical facility when using the device. Now, given the nature of wireless medical devices, this just doesn’t make sense. Why should we mandate that an elderly or ill patient, having a wireless device that collects information and sends it along to a health care professional, leave their home and travel to some medical facility to use a product that works perfectly well in their home?  Especially for a device that’s merely sending data—readings of blood pressure, etc. along to the physician. This is one that we all hope is resolved soon.

I assume that it will take some time for both the FDA and CMS to make changes and integrate the improvements into their overall processes. In the meantime, what can we do to facilitate getting wireless medical devices to market faster and have them reimbursable?

Here are my suggestions:

•    What can entrepreneurs learn about the language they should use on an application for a specific device that would both position it correctly with the FDA reviewer and ensure that it is not incorrectly categorized into a class that all but ensures a lengthy approval?
•    A medical device will have both a “patent” which needs to be innovative and not intuitively obvious while the goal of a 510 (k) application is to describe the device as very much like something that has already been approved. What is the best strategy for an entrepreneur to follow given the diametrically opposed requirements of these two required organizations? There are knowledgeable people who know these organizations and have dealt with them and can provoke great suggestions to entrepreneurs.
•    So how do we get the knowledge where it is needed? This is, in fact, one of the goals of a startup acceleration program and one that we will be attempting to resolve as we move forward with an accelerator in our region.

As we put our program together, I am constantly looking for ideas and contacts that can help with this. Any suggestions or recommendations are always welcomed.

Seed Acceleration Program for Wireless Medical/Personal Health Devices

Over the last five years I have blogged and ranted about a number of topics, but never focused on a specific topic for an extended period of time. Well, over the last year, I have gotten interested in a specific area and thought it was time to focus on the subject so that I can get my thoughts down and, hopefully, get input from others. There area is Wireless Medical and Personal Health devices.

There are a number of things got me interested in this space. The first was an email from a friend back in early 2010 with a link to a YouTube video from TEDMED09 conference that was held in San Diego in October 2010. The presenter, Dr. Eric Topol, was showing off some devices that were a combination of an iPhone, some apps and some additional hardware connectors that turned the iPhone into devices that provided information about a persons health that is usually only available in a medical facility using equipment that costs hundreds of thousands of dollars.

For example, Eric has a blue, wing shaped object that he attaches to his chest and can send EKG info to a cellphone and can then be forwarded to a physician or other medical professional. Another device, attached to a phone can produce sonograms, while another can track sleep patterns. This 17 minute video just knocked me over. These types of devices can improve personal health by providing patients and doctors valuable information at reduced costs. The patient no longer has to travel to a medical facility, where tests of done using equipment that costs tens, if not hundreds of thousands of dollars.

Additionally, these are not future products, that are hidden in the depths of R&D facilities, but already exist. More importantly, these are just the beginning. A year later, this industry is still in its infancy but quickly picking up steam. And for me, what is nice is that the focal point for this industry is San Diego!

So this got me excited. Throughout my career I seemed to gravitate towards cutting edge products and services that were possibly the next new new thing.

I was in telecommunications when computers and telecom converged. It was an interesting time and lots of changes occurred. New industries evolved and some, including very large ones, went by the wayside. The world is radically different in the way we communicate than it was in the 80’s and 90’s. Entire industries were turned upside down with very big players disinter-mediated.

While some players went away, others sprang to the top and benefitted from the this new industry like Cisco, Skype, Vonage and other VoIP solutions. Lets of different devices including voice communications through our personal/home computers. Lots of startups, lots of new entrepreneurs, lots of job creation, lots of wealth creation.

So, I am thinking that medical devices and wireless/cellular are colliding markets on track to converge and create the same kind of impact on our lifestyles, economy and there will be big winners along with big losers along the way.

With this in mind, I decided to write a series of posts on the industry, what is happening, some obstacles, and some ideas about how we can facilitate the development of new companies and help them get over the valley of death.

To accomplish this and attempt to get as much information and feedback as I can, I will be publishing these posts on the three sites I have: www.resonnect.com, www.socalbuzz.com and www.startupcoast.com. If you have opinions, comments, ideas you would like to share about this space, please comment. I still have a lot to learn.

Wireless Medical Devices for the Home, the Next Big Thing?

About a year ago, I started to see more and more about a new line of medical devices that utilize smart phone platforms and add software and/or a physical attachment that turns the phone into a powerful medical device. If this is hard to visualize or understand, watch the video by Eric Topol at last years TedMed conference and be prepared to be amazed. Many of the large, heavy diagnostic devices in a doctor’s office can now be carried in a brief case. In fact, multiple devices will fit and still leave plenty of room for other things a doctor might carry along.

Part of the amazing aspect of Eric’s presentation is that the devices he shows already exist! They are not prototypes that will be available sometime around 2020.

Another amazing thing is that Southern California, especially San Diego, is considered “Ground Zero” for this emerging class of technologies and products. It certainly makes sense since San Diego was “Ground Zero” in the development of the cell phone industry and quite a few Life Sciences companies began life here. Combine this with the small town atmosphere where people and businesses seem to know each other and it doesn’t take long for engineers from both areas to talk and share ideas. One result that Eric mentions is that there were 100 companies working on wireless medical products last October. In talking with a friend who is a lawyer back in DC and works with the FDA a lot, he mentioned that there were 300 patents issued in this space this year and 180 were issued to San Diego companies!

As I mentioned when I started this post, I first began looking at this area about a year ago, but decided to learn a lot more a few months ago. Any time a hot new industry begins to emerge, lots of opportunities develop for entrepreneurs, service providers, and investors especially those who take the time to follow the developments and discover the true opportunities from the rat holes that you can get caught up in that burn considerable time and dollar resources.

Over the next couple of weeks, I will put up some posts of things I have discovered and some pitfalls that you can avoid if you decide to get on this roller coaster as the industry develops. I am also interested in understanding what others have encountered as they have gotten involved in this industry and the recommendations they will share with this developing community.

So, my answer to the question I posed in the title is ABSOLUTELY, this is the next big thing and how big it gets will depend on how well the community around this industry develops. If history repeats itself, San Diego will have an active community and stay in the forefront as this industry develops.


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