November 17, 2011 § Leave a comment
I’m old enough to have been on the leading edge of personal computing technology. At eighteen years old, I sold my beloved drum kit to buy one of the first IBM PC computers; no hard drive, just two floppy drives, one for the program and one for data. I was obsessed with specifications and design; reading every computer magazine I could find – comparing the Commodore 64 to the Kaypro II or maybe the TRS-80. These early machines had big differences and like the early days of the automobile, you had to be part engineer to know what you were looking at. For the next twenty plus years, while consolidation occurred and the PC, Windows platform dominated, hardware specifications was always a big factor when choosing a computer. Clock speed, chip type, drive capacity, cache, video card, etc, all became a part of the lexicon for computer shoppers. But this has changed in a big way the past few years; and good riddance. MG Siegler’s recent post on techcrunch, clearly articulates this change in the computer market. In reading this post, it brought me back to when I first adopted portable digital music technology, using MP3 and varying devices.
The iPod Experience
The iPod had been released, but I was still very much a PC guy and I just wanted to small player that fit in my pocket and cost no more than about $150. I bought a product from a company called Digital River which used Microsoft Media Player or some earlier version of it and had loads of problems. Often times songs didn’t sync or were lost. As a user, I found the method of ripping music, loading them to the player and managing my music very confusing and it simply did not work as I would expect. Ultimately, my user experience was poor and after several other attempts at using other Microsoft platform products, I eventually ended up with an iPod. Once I had that first iPod, it was clear to me that the platform worked well and my experience was dramatically improved. What Apple understood was how to take the product from the end user experience perspective and make it easy and pleasurable. The design work that went into the iPod was not only elegant and simple, the entire ecosystem that included iTunes was also a vast improvement over the alternatives. Quite simply, it worked. And it worked significantly better than anything out there.
Now, as I’m working with software technology within Life Sciences companies, I’m seeing similar trends in approach. No longer is it as important to focus on and flaunt the incremental improvements in specifications as it is to understand and address end-user experiences. Product design and specifications are not only about the specifications; but how end users respond to the product itself. Last week I spent time meeting with a medical device manufacturer, discussing my company’s software product, but we took a break at one point. Members of one of the product teams tested a product in our conference room and one of our team members was asked to test the product and provide feedback from the user perspective. He was able to give the product team advice on what he was experiencing and how it was working for him. Ultimately, the product’s success in the market will be determined more about how the user reacts to using the product – more so than the specifications that are listed on the label.
Mr. Daniel R. Matlis has again written an apropos article entitled, “Is That Car a Medical Device?”. Here, he interviews Robert B. McCray, President and CEO of the Wireless Life Sciences Alliance, WLSA. It’s a fascinating view into what is happening on the forefront of medical device development and how wireless technology is improving patient’s health management. The key development with these technologies is not just the capabilities these devices can deliver, but how the patient experiences the device’s use that will determine its success. Mr. Matlis notes, “A great example of the use of convergence [medical technology, connectivity and consumer devices] to support this challenge is Ford’s In-Car Health and Wellness Solutions. Researchers at Ford, in partnership with Medtronic and WellDoc, have developed a series of in-car health and wellness apps and services aimed at monitoring people with chronic illnesses or medical disorders so they can manage their condition while on the go.” Several major advancements are at work with these developments; increased speed of information to patients, improved monitoring of their conditions, decreased therapeutics and treatments for patients through lower need for diagnoses. Perhaps most importantly, patients will not require as many diagnoses and treatments with real-time monitoring. In turn, it’s the experience of patients that what will drive adoption for these technologies.
The Internet of Things
The expression, “The Internet of Things” sounds kind of goofy – a bit like the title of a children’s book. This phrase is commonly used to describe the connectivity of the wide variety of devices to the web. Whether through 3G, 4G, or Wi-Fi, varying appliances, medical devices, automobiles, you name it, are quickly coming online. They are sending status messages; in TIBCO terms, “events”, to the web. For example, I recently purchased an all electric vehicle, the Nissan Leaf. One of the features of the car is that it sends data wirelessly about the current state of the battery. Using an iPhone app, I can get full details on the battery’s charge status and I can opt to get text messages or email notifications when certain events or thresholds are crossed. This capability adds tremendous value to my experience as I feel in greater control over the state of battery life remaining which is the biggest concern when owning this type of car. Similarly, medical devices such as glucose monitors can be enabled to send data directly to the web and alerting patients via text, email or even having their car speak to them if and when specific conditions exist. Now, I’m not certain of the exact capabilities that WLSA, Ford or others will bring to market, but one thing is certain: the customer experience will determine how well the product is accepted and demanded in the marketplace.
Making it Work with all that data
When I wrote this title, I couldn’t help hearing the voice of Tim Gunn from the show “Project Runway” uttering his famous tag line. At the end of the day, organizations who are bringing products to market are seeing a massive opportunity coupled with a massive challenge. The convergence of medical devices, consumer devices, and ubiquitous connectivity brings enormous potential and with it the challenge of handling a tidal wave of event data that is frequently sent by a massive volume of devices. How should data be managed? Again, taking the customer perspective, the end user wants this data to be monitored and reported immediately for specific conditions. Especially, when we’re talking about medical devices that are monitoring critical patient physical conditions – the response must be fast. Patients cannot have the data sent to some massive data repository, stored and then queried periodically. This is the method of data storage and search that is quickly becoming antiquated.
21st Century Architecture
Capabilities exist with TIBCOs platform to perform what is referred to as pattern event matching or complex event processing (CEP). These capabilities allow organizations to look at patterns within sets of events that may indicate specific conditions. Within the Life Sciences sector, the movement towards creating greater value and usability with connected devices is growing. The software platform that supports these capabilities is critical toward realizing that value. In order for medical device companies to provide near real-time status to a patient, the system must utilize software that cannot only capture that data, but analyze it as it is received and trigger actions based on user-driven rules. For instance, using the glucose monitor example, every patient may have specific requirements that they want to personally set for when and how they are notified by the device. Providing a platform that allows the user to easily set those rules and modify them whenever they choose enables a positive user experience. For insurers, patients that are able to personally manage their condition will require less professional consultation and thus will reduce the overall care expense.
As Life Sciences and other sectors fully adopt 21st century information architecture, I see an evolving process management paradigm which in turn brings us new customer experiences. As any good Six Sigma expert would tell you, the customer experience drives the requirements for quality. Make it work for the customer experience and then you know you’re on to something.
November 7, 2011 § 2 Comments
On my white board sits a list of topics that are near and dear to my heart; topics that I think about often and want to espouse, pontificate and illuminate. Most often, I think I have original ideas on these subjects and while I don’t feel I have the time to get it all out at once, I keep this list with the intention of banging them out slowly – one by one. And almost without fail, in my regular reading or research, I’ll come upon an article or book on one of these topics and then suddenly, like a bolt of revelation, someone’s beaten me to the punch; made the key insights that I thought were my domain.
The Surety of Fools
One such happening this past weekend as I perused the New York Times Magazine, a gentleman by the name of Daniel Kahneman wrote an article entitled “The Surety of Fools”, an adaptation from his upcoming book entitled “Thinking, Fast and Slow”. He hit on a key observation that is at the core of what I’ve been writing about over these last few months; misperceptions of risk. I won’t rehash the whole article, but in essence, Mr. Kahneman points out how we often hypothesize based on logic, but when empirical evidence belies our theories, we simply don’t believe the facts. He calls this phenomenon the “illusion of validity.” I love this premise as I see it so often with investment managers, news reporters, mortgage brokers, sport team coaches, politicians, voters and prognosticators in general – they all create their own reality.
Creating Your Own Reality
We ALL do it to some degree. We watch the news channel that validates our set biases. We befriend people who support and validate our opinions and views. On the topic of investment risk, operational risk and risk in general, how does that phenomenon play out? Do we see the facts and are we able to evaluate data without bias? Mr. Kahneman illustrates the reality of investment bias with examples of studying investment managers and how their performance is measured. The vast majority of investment managers he studies do not perform better than a purely random pick of stocks. Yet, the illusion of validity causes the management of the largest investment firms to bonus and commission those managers as if they are keenly skilled; as if the fund managers have brought tremendous value to their client’s interests. They create their own reality – instead of accepting that the unbiased data shows no value in their management of investment assets.
Life Sciences’ High stakes
There are even greater risk examples. Life Sciences companies such as pharmaceuticals, biotechnology and medical device firms have huge investments and pressures to produce new products. Each development stage requires rigorous testing and massive volumes of data. While the FDA enforces regulations and these companies are regularly audited both internally and externally, the pressure to produce is high. Time is of the essence when it comes to bringing a new drug to market; both for the sake of patients as well as profits. How well is the data reviewed and scrutinized before passing each validity stage? Is there a bias that errs on the side of validation ahead of rejection? Absolutely. Kahneman’s Illusion of validity is at play and the consequences are immense.
The Supply Chain Fog
For Life Sciences companies the risks involve patient health as well as immense risks to the company including product recalls, regulatory findings, lawsuits, and ultimately, reputation damage. The organizations I’ve worked with over these last few years are extremely diligent in their processes and methods for R&D, trials, manufacturing as well as distribution. But other operational risks do exist. In a post last year by Daniel R. Matlis entitled, “Life Science Executives Concerned about Outsourcing and Globalization Unintended Consequences”, Mr. Matlis notes, “In the drive to lower costs, manufacturing and sourcing of ingredients and components in countries such as China and India are playing a more prominent role. Yet, according to the research, outsourcing to manufacturers in developing economies carries significant operational risks. Industry Executives surveyed for the research said that Raw Materials sourced outside the US represented the greatest risk to the Value Chain, with 94% of those who responded seeing it as a significant or moderate risk. When comparing the risk profile of US vs. foreign raw material Suppliers, United States Suppliers were classified as low risk nearly 10 times as often as foreign Suppliers.” Any Life Science company’s ability to define, monitor and track each and all of their third party providers adds a level of complexity and difficulty. This difficulty stems from what consultants at Nimbus have labeled the “fog of process accountability, control and oversight.”
To be certain, this fog exists to some degree everywhere and obviously with supply chain partners even more so, but how well an organization tries to create clarity of process definition and clarity of quality both from within and beyond the enterprise is critical when managing operational risk. Perhaps the biggest concern I have with the phenomena of “creating your own reality” is the fact that the “fog of accountability” provides a condition for pushing forward; an excuse for not accepting what the data is revealing; and a scenario wherein doubt can always be cast on outliers.
Focus on the Facts
I spent part of last week with a biotechnology firm’s scientific directors, their CIO and colleagues from TIBCO, briefing them on my company’s software technologies and how they apply to the wide variety of process areas they represent. The volume of data and the complexity of that data as it applies within their product trials is tremendous. Next week I’m with a medical device company who’s in the process of a major transformation and will need to address most every operational area as part of a corporate spinoff. These are just a couple of quick snapshots, but they epitomize the speed with which organizations change, adapt, and grow. Speed and volume is only increasing – further escalating the demands for validation of each initiative.
I can only hope that Mr. Kahneman’s “illusion of validity” is tempered when organizations manage operational risk and the key decisions that drive product development. The stakes are indeed high when it comes to Life Sciences, but every industry is predisposed to this condition. In short, we can never be to too sure. Let’s not fall too in love with our own marketing slogans. Let’s understand the complexity that we’re faced with, make our best, valid judgments and do the best with the facts we have. While there is never purity in our judgments, we can at least try to be aware of the propensity to fulfill objectives through maintaining a blindness to the facts.