Will P4 Medicine Be The Killer Healthcare App?
Portland, OR – Dr. Leroy Hood of the Institute for Systems Biology (ISG) gave the keynote speech today at Supercomputing 09 conference on the emergence of P4 (predictive, personalized, preventive and participatory) medicine. Dr. Hood has serious street cred when it comes to making predictions about the future of healthcare, having co-founded some twenty startups including Amgen. He believes that medicine will become primarily an information science in ten years with the convergence of personal genomics, systems biology and grid computing. These tools will help create billions of physiological data points for each individual, enabling the creation of predictive and actionable models to explain emergent behavior.
How does this vision translate to primary care? According to Dr. Hood, you will first sequence your personal and family genomes and then show up at your doctor’s office every six months for a wellness assessment. Your physician will use a handheld blood assay device to profile 2500 blood proteins from a pinprick sample. The new assays will identify disease-related changes to organ-specific, blood protein fingerprints long before you become symptomatic. New therapies will stem from personal banking of stem cells and new drugs to “reengineer disease-perturbed networks.” “All the current business models will change,” says Dr. Hood. The time horizon for this vision becoming a reality? “Five to eight years.”
Given that the average timeline for a radical new technology to become ubiquitous in healthcare practice is seventeen years, I don’t know if I believe Dr. Hood’s timeline prediction. On the other hand, if he is right and the technology were available inexpensively today or in a few years time, wouldn’t you ask your physician for it? Your thoughts?
Can The Medical Device Industry Be Disrupted?
Perhaps it is an unfair question. Any industry can be re-invented or even disrupted. That is the history of industry. Maybe the better question is what sectors of the medical device industry have become static and how are they likely to be impacted, not only by changing how things are done, but also by the larger sea changes happening in healthcare. In some ways, the medical device industry today is similar to the mini-computer industry in the 1980s. In the 80’s, companies like Digital and Wang sold vertically integrated business computer systems, all based on proprietary hardware and software. Customers usually standardized on one vendor because systems from one mini-computer company were incompatible with systems from another. They couldn’t share data without a lot of custom development. Software was not portable between vendors and systems were expensive. Sound familiar?
In the mid-1980s IBM introduced the PC. Not only did it cost an order of magnitude less than a mini-computer, it had an open architecture with a published hardware/software specification. It was easy to modify and extend, write new software for and even replace hardware components. Design a better graphics card for it, write some custom CAD software and you could disrupt an industry like design automation, which was itself built on top of the old mini-computer silos. Digital and Wang and a host of other companies who depended on them never knew what hit them.
Hospitals today standardize on medical device vendors for some of the same reasons that people standardized on mini-computer vendors in the 1980s. Basically, they have few alternatives and plug-and-play between vendors doesn’t really exist yet except for HL7. ( When Welch Allyn recently came up with the Flexiport cuff to connect a single blood pressure cuff to devices from different vendors, this simple plug-and-play idea was a huge success. Nurses often waste time daily hunting through supplies looking for the right cuff to fit a particular device. ) Yet there is nothing preventing someone from developing a truly open PC-like architecture and toolset and radically lowering costs of both development and ownership. Commoditization is already a fact of life in segments like patient monitoring. Every year at Medica there are several new monitoring companies with lower-price products. However, commoditizing only deals with price/performance. It doesn’t really change the game. What happens when someone develops the equivalent of the IBM PC for the medical device industry? In some ways this is already happening bottom-up in patient monitoring with many high-level monitoring parameters available from multiple sources as off-the-shelf modules. One trend is clear, regardless of whether the full open-source, medical PC shows up: the software content of devices and their ability to synthesize multiple data streams into actionable information for a variety of user skill-levels is going to become a lot more important as hardware becomes cheaper, smaller, wireless and more re-targetable. (After all, the era of the disposable patient monitor isn’t far away. )
Better platforms and tools are only one part of the puzzle. Faster time to market is the other. Introducing Google’s concept of “fail faster to learn and succeed quicker” implies re-thinking the development process from the end stage backwards. Integrated design and test, much more sophisticated use of simulation, and re-thinking when and how to move under design controls are all elements of making the traditional development process more lightweight and Agile. Your thoughts?
Agile Development of Medical Devices
Developing medical devices is traditionally seen as a linear process with little formal feedback between stages. The FDA’s Quality System Regulation (QSR) even tends to enforce a linear, waterfall method of product development. Traditional waterfall development can contribute to long development cycles, costly late stage defect discovery and even missing the mark on market acceptance. However there is nothing in the QSR that precludes adopting a more iterative, Agile method of product development, even in a regulated industry. If you think about it, all product development is iterative anyway. It just gets more expensive to find and correct your design mistakes and latent defects in later stages, but you still have to loop back and correct them. Most medical device companies’ quality systems grew up in the gate-style product life cycle era. Smart companies are re-thinking their internal processes to allow more Agile development. It has been my experience that most engineers feel more empowered and productive using Agile methods, even if it means very tight tracking of tasks, daily stand-up meetings and higher accountability. Real teamwork and real results always feel better than slipping schedules and development death marches.
Moving to Agile does not mean having to throw out all the existing SOPs and starting over. Agile is a set of practices, but you don’t have to adopt them all. In the regulated world, it is still best to fully understand the requirements before you start design. The most useful techniques can be adapted to regulated industry style development and phased in, often under the existing SOPs. Even moving to daily scrums, project velocity tracking and enhanced collaboration tools can make a significant difference in schedule predictability. I’ll talk more about what this looks like in later posts. I’d appreciate any comments on other’s experiences using Agile methods in medical device development.
The Revolution in Healthcare Won’t Be Televised
San Diego, CA - The BIL:PIL conference this week was essentially an extension of TED:MED, with many speakers speaking at both. The keynoter, Joe Trippi (former Howard Dean campaign manager) says there are 200,000 people who work in biotech and their voices are not being heard in the current healthcare debate. He believes real change happens bottom-up and is starting iambiotech.org to give the biotech community a more visible public voice and forum.
The BIL:PIL talks seemed to center around three general themes: radical improvements in efficiency when moving from closed to open collaboration models for research and development, interesting new technologies emerging from the labs, and new companies leveraging mobile technology and social networking to improve care. If it wasn’t evident before, it surely was this week that the biggest potential disrupters to healthcare are in process changes rather than in new technologies. This aligns with the general understanding among innovation experts that reinventing the business model usually produces far greater ROI from innovation dollars than does a new product or product line. The most interesting talks were about changing how things are done — removing time, duplication and waste.
One of my favorite talks was by Scott Johnson of the Myelin foundation who spoke about his open research model. He is challenging the whole idea of private research, noting that there were 90 billion dollars spent on healthcare research in 2005 (40 in academia, 50 in biopharma) and yet new approvals remain flat. Johnson believes the current private research model is broken. “Biopharma is doing only development, academia is focused on publishing with 700k publications a year and declining quality. To do great science today you have to be very narrowly focused. The venture community is not investing significantly in biotech. You can’t get a grant to do validation work so most great ideas don’t get to market. It is almost impossible to get funds to build new tools to find new solutions. Brilliant scientists in today’s world have no way to brainstorm with a peer,” says Johnson.
Johnson’s foundation works from the endpoint backwards and overcomes roadblocks with the goal is of taking fifty to seventy percent of the time out of the process. He requires all funded research to be open and share data, process and results. “When we started people told us new commercial treatments for MS are 15 to 20 years away. We set a goal of doing it in five and so far we are tracking to that. You don’t have to throw a ton of money: it is about how you do things,” says Johnson.
Other highlights:
Andrew Hessel, fomerly of Amgen, wants to enable personalized, N=1 medicine by open-sourcing cancer drug development using an innovative coop model.
Jason Hwang, MD of the Innosite Institute used the example of the evolution of the computer industry to describe how centralized industries eventually decentralize, leading to greater accessibility, new markets and lower prices. Leaders of centralized industries (mini-computer companies, hospitals) almost never lead the revolution into decentralization and often don’t even survive. Hwang nicely framed three archetypes that define current healthcare business models and described how he believes each can be disrupted. He argues that hospitals are a mashup of three businesses: the full-service solution provider, the value-added processor and the faciliated exchange and in trying to be all things to all, they don’t do any one of these businesses well.
Microsoft and Healthcare
Redmond, WA -
Attending the 2009 Microsoft Healthcare User Group 2009 meeting September 2nd and 3rd in Redmond reminded me of why I like Seattle in the fall. Bright clear sunny days – at least some of the time – and lush green everywhere.
Microsoft has been working in the healthcare space for more than a decade. MSHUG was formed in 1996. For the time and effort and investment some companies might expect more of a presence by now, but I would not bet against Microsoft long term.
For pure technology, the demos of the Surfaces product were fun. Forty-eight input multi-touch, table-top computing. I could easily picture a family physician dragging and dropping images and teaching videos to help explain to a pediatric care issue to a family. The corporate video of their image of the future took this idea and spread it to every glass surface in an office: windows, walls, tables. In the Microsoft future, computer displays are part of the furniture.
Probably the most impactful presentation I saw was by Dr. Rajeev Chandry of the Mayo Clinic. He is in charge of Mayo’s platform for connected health. Dr. Chandry, who is a primary care physician, said that sixty percent of their clinician’s time is spent looking for information. EMRs and practice management systems do not handle the problems referring physicians encounter when data needs to travel with the patient. “Specialists typically deal with 229 referring docs, all with different systems,” said Chandry. Mayo cares for 140,000 patients. His solution was to deploy Microsoft Amalga. He claims it took only three IT staff to capture the data from Mayo’s different systems. Amalga allows him to set rules that indicate what type of follow-up a patient needs in a particular time frame.
Amalga enables Mayo to do things like get a list of all patients that need to be contacted in the next thirty days. Red, yellow, and green status lights indicate things like the level of diabetes control. Currently the secretaries and nurses are using the system, not the physicians. “This turns the nurses into care managers and takes the search burden off the physicians,” said Dr. Chandry. I’m sure the devil is in the details and there was some animated disagreement from the audience about Chandry’s claims of ease of importing data from disparate systems, normalizing the data, and pushing updates back out to the silos. I have some skepticism in this area also. But if Microsoft does anything well, it is to incite passion in it’s users.
Mayo’s next step is to connect Amalga to Microsoft HealthVault for help with chonic disease management. They are going to have to work to keep up with Google spinoff Keas in this regard.
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