Lab Soft News

The "Early Health Model" as an Example of Disruptive Innovation

I am pleased to announce that Dr.Jason Hwang has agreed to deliver a lecture at the next Lab InfoTech Summit that will take place in Las Vegas on March 16-18, 2009. He is a co-author with Clayton Christensen of a book (The Innovator's Prescription: A Disruptive Solution for Health Care) that discuses disruptive innovation as it relates to the healthcare industry entitled. You are going to have to wait for it to be published -- it won't be available until October 23, 2008. However, we will be distributing complimentary copies of this book to the first 100 conference registrants. Details about this offer to follow.

To launch this discussion about disruptive innovation, here are two brief quotes from the Wikipedia defining the term with boldface emphasis mine:

A disruptive technology or disruptive innovation is a term describing a technological innovation, product, or service that uses a "disruptive" strategy, rather than a "revolutionary" or "sustaining" strategy, to overturn the existing dominant technologies or status quo products in a market....Christensen replaced disruptive technology with the term disruptive innovation because he recognized that few technologies are intrinsically disruptive or sustaining in character. It is the strategy or business model that the technology enables that creates the disruptive impact.

"New market disruption" occurs when a product fits a new or emerging market segment that is not being served by existing incumbents in the industry.

I have posted a number of previous notes about the early health model (EHM), defined as pre-clinical, pre-symptomatic diagnosis of disease, which I believe is an example of disruptive innovation. I put the question to Jason about the extent to which the that the EHM is disruptive for the various major participants in our healthcare system. Here is his answer:

One of the key tests of whether something is disruptive is to ask if it serves the interests of the industry’s most favored customers and, conversely, if it serves a market that was previously disenfranchised or altogether ignored. Obviously, healthcare is bit more complex, because [the term] “customers” is not so clearly defined. However, here’s my take on the early health model:

• [The early health model] is almost certainly disruptive to MDs and hospitals, because they have little to gain (and almost certainly will lose income) when they diagnose diseases pre-symptomatically. More importantly, if the early health model implies that someone with less skill and training, especially the patient herself, can do some of the diagnostic workup, then it is clearly disruptive.
• The answer is not so simple with insurers. I think all of them would say they would prefer to pay for pre-symptomatic and preventive care, so it’s difficult to say they would be disrupted. I’m also not convinced that their business model necessarily prevents them from paying for such a model of care, other than the fact that they could potentially alienate their existing network of providers. My best prediction is that it will take a new insurer that primarily promotes early health through the use of health savings accounts, combined with a more traditional provider for acute and complex care, paid through the use of catastrophic insurance.
• Pharma and other suppliers would indeed object, because this naturally squeezes their opportunities for downstream care, much like it does for the providers. Profit margins would also be predictably lower at the preventive end of care, so it would be difficult for their business model to adapt. Needless to say, they could be the ones being disrupted.
• Finally, the new markets that would open up would primarily benefit patients and purchasers. However, the first customer segments would be those who have the right incentives to seek out early care, such as patients paying out-of-pocket, self-insured employers, or proactive/educated patients. From their perspective, I’d agree this is a new-market disruption, since they have no real alternative otherwise.

Joel Saltz Appointed as Emory Healthcare’s Chief Medical Information Officer

In a previous note, I reported Fred Sanfilippo's departure from Ohio State (see: Fred Sanfilippo, Noted Pathologist, Moves to Emory). Joel Saltz, a leader in pathology informatics, is now making a similar move to Atlanta (see: Bioinformatics Pioneer Will Lead New Initiatives at Emory University). He currently serves as professor and chair of the Department of Biomedical Informatics and professor in the Department of Computer Science and Engineering at The Ohio State University, Davis Endowed Chair of Cancer at OSU, and a senior fellow of the Ohio Supercomputer Center. Below is an excerpt from the article:

Joel H. Saltz, MD, PhD, a pioneer in the fields of high-performance computing and biomedical informatics, will join Emory University’s Woodruff Health Sciences Center in September as director of the Center for Comprehensive Informatics and as Emory Healthcare’s Chief Medical Information Officer. The announcement was made by Fred Sanfilippo, MD, PhD, Emory executive vice president for health affairs, CEO of the Woodruff Health Sciences Center and chairman of Emory Healthcare....As chief medical information officer for Emory Healthcare, Saltz will direct strategic planning and implementation of the comprehensive Emory Medical Information Enterprise. He will guide recruitment, research and resource allocation for informatics programs across academic departments. Additionally, he will lead the further development of Emory’s external partnerships in bioinformatics, including those with the Georgia Institute of Technology, Children’s Healthcare of Atlanta, Morehouse School of Medicine, the Atlanta Veterans Affairs Medical Center, the Georgia Research Alliance and the Georgia Cancer Coalition.

Epic Flexes Its Political Muscle in Wisconsin with Boycott

Some of my recent notes have focused on the corporate culture of Epic Systems (see: Epic Systems and Its Corporate Culture; More on the Epic Culture: Is This a Cult or a Company?). This activity has brought to my attention a political tempest that has been brewing around Epic in its own back yard in Wisconsin (see: Epic Systems Should be WMC's Biggest Fan). Epic recently announced that it will no longer do business with companies associated with Wisconsin Manufacturers & Commerce (WMC), a Wisconsin trade and lobbying organization.  The reason for this boycott is Epic's opposition to WMC's involvement in the election of Michael Gableman to the State Supreme Court. This same article makes the following comment about Judy Faulkner, the CEO and founder of Epic (boldface emphasis mine):

Epic has always marched to its own beat.  Founded and led by Judy Faulkner, the company has blossomed into one of the top five providers of automated medical record systems in the nation....She likes telling people that the company is growing 30% annually and has zero debt.... While on paper she has a number of advisory groups, no company decision of any consequence is made without her....[She refuses to] advertise or market [and shuns] traditional business planning....But she can do that because it is her company. She has no board of directors to answer to, no proxy votes to worry about and no annual shareholder meetings where she has to explain herself.  In fact, the reclusive Ms. Faulkner feels little need to explain herself about anything.

Forbes.com had the following to say in a recent article about this same issue (see: Madison area company targets lobbying group):

[WMC's] participation in the recent state Supreme Court race won by ... Judge Michael Gableman has drawn the ire of Epic Systems, a medical records company in Verona that doesn't belong to the group. Epic said in a statement it was upset that WMC spent an estimated $1.8 million on that race and may pull business from local vendors who support the group. Those vendors included...J.P. Cullen & Sons, the contractor for Epic's more than $200 million campus expansion. CEO David Cullen resigned from WMC's board of directors on June 9 and his company dropped its membership....Epic's threat not to work with another company based on an election campaign appears to be the first of its kind nationwide, said Howard Schweber, a professor of law and political science at the University of Wisconsin-Madison. Its action is perilously close to a type of illegal boycott that typically arises in labor disputes, Schweber said. "We should be uncomfortable when private businesses have enough power to coerce businesses or other organizations to change their political views or affiliations or keep them secret," Schweber said.

Here's more about Epic's actions from Professor Schweber (see: Howard Schweber: Epic's power should not be used to silence others). He himself is very critical of WMC but makes some very interesting points about primary versus secondary boycotts and this is the basis for his criticism of Epic. In the case of a secondary boycott, an attack is mounted on the supporters of the primary target.

What I find the most interesting about this controversy is that large health systems such as Kaiser are willing to spend hundreds of millions of dollars for mission-critical clinical software supplied by a privately-held company like Epic that is so tightly controlled by its executive office and founder. This same issue may occasionally arise during the purchase of an LIS but the stakes are never as high.

More on the Epic Culture: Is This a Cult or a Company?

My recent blog note about Epic Systems (see: Epic Systems and Its Corporate Culture) seems to have stirred great interest and is currently the most popular individual entry page for Lab Soft News. Interestingly enough, many of the visitors have come from the Epic IP address. Perhaps I should label Lab Soft News as "not safe for work." Because of its strong corporate culture, Epic is not infrequently referred to as a cult. I am not the first to consider this idea -- a Google search for Epic Systems and cult yielded 779 hits.

Cult members are followers of an exclusive system of religious beliefs and practices. Describing a company such as Epic as a cult can perhaps be interpreted as an overzealous attempt by its competitors to cast it in a negative light and perhaps hinder its new employee recruiting efforts. On the other hand and drawing ideas from my original note, certain aspects of its culture may appear to be cult-like. Take the following Epic strategy, for example:

Rather than seeking experienced healthcare IT professionals, Epic relies on hiring a large corps of the brightest young, just-out-of-college IT professionals for its programming and implementation positions.

The Marine Corps has followed a similar strategy of attracting young recruits and then inculcating in them the culture of the organization. Everyone understands that young minds are generally more malleable and trainable. However, there is one major threat to establishing a cultish HIT company. After an initial training and indoctrination program, the newly minted acolytes are sent into the field to mingle with the unenlightened, otherwise know as employees of client hospitals. In such environments, there is the risk that the Epic doctrine can be questioned by more experienced hospital IT personnel. In order to avoid such confusion, it is necessary to establish a high degree of client-control. Evidence about how this is achieved can be found in three other elements of the Epic set of beliefs, copied from my original blog note with boldface emphasis mine:

Epic does retain salespeople, but they make no commissions on sales, and act more like advisers and consultants than traditional salespeople.

Epic turns away potential business. Indeed, prospective customers meeting with Epic representatives find they are being evaluated as much as they are evaluating.

Epic executives have evolved a very specific implementation process over time, one that involves intensive pre-implementation analysis and planning, but then focuses very strongly on meeting go-live dates.

Epic seems to choose its customers -- they do not choose it. Presumably this selection process is based on the willingness of the client to accept rules and processes set by the company. The company personnel function as advisers and consultants and not as a vendor at the beck and call of its customers. Finally, the specific implementation process, which is obviously enforced by the terms of the contract, imposes discipline on the client hospitals which presumably results in a successful go-live of the Epic software products in most cases. Cult of not, this is not the modus operandi of any other healthcare IT company.

For what's it's worth, here's  the opinion of Viktorcello abut Epic:

They are the devil! People get sucked into there and become totally arrogant and they change! And they really eff with you throughout the interview process, which takes like three months. And they make you work overtime all the time.

Radiofrequency Ablation of Lung Cancer Found Effective

I came across a recent article that discusses a non-surgical means for ablating malignant lesions of the lung for patients who cannot tolerate surgery or other therapeutic approaches (see: Non-Surgical Approach Can Treat Lung Cancers). It's called radiofrequency ablation (RFA), Below is an excerpt from the article with boldface emphasis mine:

A minimally invasive procedure normally used to treat liver cancer also holds promise for lung cancer patients, according to a new study. In the study..., 88 percent of lung cancer patients responded well to treatment with percutaneous image-guided radiofrequency ablation (RFA). RFA is performed in less than an hour and is a non-surgical procedure that targets large tumors with no harm to surrounding healthy tissue. After one year, 70 percent of patients survived at least one year with few side effects; none that impaired lung function, the researchers report....Lung cancer is the leading cause of cancer death in both men and women. Surgery is the standard treatment for early-stage, non-small-cell lung cancer (NSCLC), which constitutes about 80 percent of most malignant lung tumors. Unfortunately not all patients are eligible due to other health reasons. The alternatives, radiotherapy or chemotherapy, do not have good survival rates. The study...involved 106 patients with malignant lung tumors that were smaller than 5 cm in diameter. Thirty-three patients had NSCLC; 53, metastatic lung cancer from the colon; and 20, metastatic lung cancer from other sites in the body. All the patients had been turned down for surgery, radiotherapy or chemotherapy. The major post-RFA complications were pneumothorax (27 instances) and pleural effusion (4 instances) which needed drainage.

Here is a more detailed description of RFA from RadiologyInfo:

In radiofrequency ablation, imaging techniques such as ultrasound and computed tomography (CT) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, creating heat that destroys the abnormal cells.

Basically, this technique is analogous to "cooking" the primary or metastatic lung lesions in a microwave oven. This approach would seem to bypass both the thoracic surgeons and pathologists unless fine needle aspiration (FNA) is used to diagnose the NSCLC lung lesions. In the case of those patients with metastatic disease, biopsies may have been obtained previously to diagnose the primary lesions. This seems to be an excellent approach for patients who are not candidates for other therapies. It also effectively demonstrates the expanding scope of practice of interventional radiology.

The Future of the Personal Health Record (PHR)

I have posted a number of previous notes about personal health records (PHRs). John Moore over at the Chilmark Research blog recently posted on the web one of his lectures about PHRs: Evolving PHR Market: Analysis and Trends. John has been providing some of the most perceptive comments I have seen on the evolution of the PHR. Below is a short list of some of his ideas contained in this specific lecture that caught my attention:

• The PHR market has moved to a B2B model with an employer-provided PHR (35%), provider provided (25%), and health plan-provided (15%).(Slide #5)
• First generation PHRs: isolated. The target was the end consumer and most third party PHRs remain stuck here.(Slide #8)
• Second generation PHRs: Online with some data. One of the major goals was to promote healthy behavior.(Slide #9)
• Third generation PHRs: Highly networked utility. Richer data and a richer experience.(Slide #10)

John is right on target with his remarks. Much of the PHR news recently has been about Google or Microsoft cutting some deal with a large health system or major health insurance company regarding their PHRs. This is a reflection of the increasing importance of the B2B model to which John refers above. John's idea about the third generation PHR as a highly networked utility is pitch-perfect. PHRs will only provide very high value for consumers when they are populated with important medical information. Hospitals, physician clinics, health plans, and health insurance companies control most such information. Therefore, the networked utilities that John describes will serve to connect consumers to providers to payors.

A number of conclusions can be drawn about the networked medical record architecture that John suggests. First of all, the goal of practical untethered PHRs (i.e., the non-networked PHR) that I have supported (see: Implications of the Kaiser-Microsoft PHR Deal) was probably a pipe dream. Secondly, the notion of consumer-space versus provider-space on these networked healthcare utilities is going to get a little fuzzy. I think that this blending and ambiguity will be helpful in the long run. For example, a health care consumer's observations about his or her own health status can be an important component of a health record whereas they are generally not considered to have great value. In addition and starting now, we need to set up standards such that the origin and authors of all data contained in a networked health record can be clearly delineated.

Epic Systems and Its Corporate Culture

Anyone deeply involved in lab computing needs to understand the companies supplying  LISs and EMRs to this market. Part of this understanding involves the "culture" of these companies. The term corporate culture is complex and incorporates a number of variables. As one measure of the complexity of the term, a Google search for it yields 4,450,000 hits. As only one example, some HIT companies are technology-driven whereas others are more marketing-driven. Probably no company is as interesting culture-wise as Epic Systems, currently the market leader in the EMR market. A recent article (see: Behind the Curtain) discusses the company in great detail. For me, the most interesting part of the article was the list of the differences between Epic and its competitors. Below is that portion of the article:

• Epic almost never advertises, and relies almost entirely on word-of-mouth recommendations to market itself.
• Epic does retain salespeople, but they make no commissions on sales, and act more like advisers and consultants than traditional salespeople.
• Epic turns away potential business. Indeed, prospective customers meeting with Epic representatives find they are being evaluated as much as they are evaluating.
• Epic executives have evolved a very specific implementation process over time, one that involves intensive pre-implementation analysis and planning, but then focuses very strongly on meeting go-live dates.
• Rather than seeking experienced healthcare IT professionals, Epic relies on hiring a large corps of the brightest young, just-out-of-college IT professionals for its programming and implementation positions.
• Epic never grows through acquisition, but rather relies on internal development, in extreme contrast to all its competitors among the largest clinical IS vendors.
• Most of all, Epic has a very unusual corporate culture, one that intrigues and sometimes puzzles those who encounter it or hear about it....That culture emanates to an extraordinary degree from the personality of the company's visionary, media-averse founder and CEO.

The true test of the value of any corporate culture is the success of that company in the competitive market. There are clearly no rigid rules. And by this test, the Epic culture has been, and continues to be, a successful one. My guess is that its competitors may  review this list and then probably decide that their own cultures will triumph in the end.

The Evolution of Integrated Diagnostics into Integrated Diagnostic Centers

In a recent post (see: A Call for the Development of Integrated Diagnostic Centers), I posted an abstract of a lecture that I will be delivering at the 42nd annual Congress of the Brazilian Society of Clinical Pathology (Sociedade Brasileira de Patologia Clínica; SBPC) on July 3, 2008, in Sao Paulo, Brazil. In it I emphasize the idea that pathologists, lab medicine specialists, and radiologists should collaborate to develop physical or virtual integrated diagnostic centers (IDCs) to which patients can be referred with early symptoms of disease or for wellness/preventive medicine consultations. In these centers, diagnostic specialists would use the most advanced imaging modalities and in-vitro laboratory testing to quickly arrive at the correct diagnosis. These patients would then be referred to clinicians for treatment. This idea is the logical outgrowth of the concept of integrated diagnostics (see: Siemens' Pursuit of an Integrated Diagnostics Portfolio) and the early health model, both of which have been addressed extensively in Lab Soft News. It is also closely related to the merger/conversion of pathology, radiology, and lab medicine into the new specialty of diagnostic medicine. I am now posting the entire lecture here (see: Integrated Diagnostics Emerges as Key Element in Healthcare) and would welcome any comments from readers about any of the ideas contained in it.

Some New Insights into "Bypass Brain"

The cognitive and behavioral aspects of bypass brain are now in the news as a result of the presidential political campaign and Bill Clinton's behavior. Read more about this in a recent blog note (see: 'Bypass Brain': How Surgery May Affect Mental Acuity). Below is an excerpt from the story with boldface emphasis mine:

Aides to Bill Clinton last week vehemently denied speculation that the former president's intemperate remarks on the campaign trail were due to mild cognitive damage from his quadruple-bypass surgery in 2004....But the condition dubbed "pump head" or "bypass brain" has long been recognized by doctors, even if they seldom warn patients about it....Symptoms include short-term memory loss, slowed responses, trouble concentrating and emotional instability....[R]esearchers at Duke University Medical Center tested 261 patients before and after bypass surgery and found that 53% of them had significant cognitive decline when they were discharged -- and 42% still suffered from it five years later....One explanation is that when a patient's blood is pumped through a heart-lung machine during bypass, tiny air bubbles, fat globules and other particles may enter the bloodstream. The pump can also damage platelets, which form clumps, and clamping the aorta loosens bits of plaque. That debris can travel to the brain and clog tiny capillaries, forming microscopic strokes....There's little dispute that heart surgery does cause short-term cognitive problems -- anesthesia alone can do that, particularly in older patients. But recent studies suggest that the cognitive decline years later may be due more to the underlying artery disease than to the effects of surgery.

I don't think that it's fair that the cardiac surgeons need to bear the brunt of Clinton's off-the-cuff remarks on the campaign trail. I also understand that more research is needed to further delineate the true nature of bypass brain. Nevertheless, I suspect that all of us have grown far too complacent about the inherent risks of any surgical procedure and general anesthesia. Here's some food for thought from the U.K. (see: 'Care flawed' in many bypass ops):

Coronary artery bypass graft operations, the focus of their latest project, has approximately a 2% death rate, and over the three year period checked, there were 1,198 deaths reported....There were problems found in every step of the process, from delays after referral, to the way tests were carried out, doctors communicated with each other, and the way patients were cared for after their operations. Overall, they concluded that in two-thirds of cases which ended in the death of a patient, some aspect of care was flawed, due to poor organisation, communication or teamwork.

If the time comes, I guess that I will opt to have a cardiologist snake a catheter into my heart, steer the tip into the ostium of one of my coronary arteries, and drop off a small spring-like device to keep the vessel open. This seems to be the safest course of action.

Sometimes Consultants Surprise You with Their Reports

Reports from healthcare consultants can sometimes be warmed-over pap or merely external validation of decisions already made by hospital executives. On occasion, however, reports from consultants can surprise you. This was obviously the situation described in the following article with boldface emphasis mine (see: WVU dumps its consultant):

West Virginia University officials fired a $75,000-a-month consulting firm Friday, saying the consultants' scathing report about WVU's health science division and affiliated hospitals was full of errors and misunderstandings. The nine-page report, by R&V Associates of Pittsburgh, alleged that "serious," "intolerable" and "alarming" problems at WVU hospitals put patients' lives at risk.  The consultants cited the unexpected deaths of two children and an adult. They also criticized WVU for serious shortages of general surgeons, anesthesiologists and heart surgeons that forced hospitals to send patients to facilities in Columbus, Ohio, and Pittsburgh. WVU said R&V reached false conclusions, in some cases, and the university already was working to fix other problems brought up in the report....[The interim vice president of health sciences] said the university plans to hire another outside consultant that "has experience with academic medical centers." R&V Associates, which has been paid $321,789, plus expenses, for its work since March, has said the report is accurate.

What in the world is going on here? A consulting firm accuses the hospital that engages it of putting "patients' lives at risk." It then adds insult to injury by inserting this claim in only a nine-page report. However, the interim vice president of health sciences at WVU hospitals seems to be heading in the right direction when he says that the organization is now seeking another consultant with "experience with academic medical centers." The web site of R&V Associates describes the discharged firm as specializing in "business consulting and crisis management." It's not clear from the article whether the officials at WVU hospitals anticipated that the consulting firm that they first engaged would precipitate the crisis that now apparently needs to be managed by yet another set of consultants.