22Aug/06

The impact of IBM’s Acquisition of MRO Software on the Life-Sciences Market

On August 3, 2006 MRO Software announced that it has agreed to be acquired by IBM.

So, what the impact on Life-Sciences Customers? I think this is great news. The combination of MRO’s deep Enterprise and IT Asset Management knowledge and IBM’s strength in integration software and services allows the combined company to provide a complete Asset Management solution to the Life-Science Market. 

The Life-Sciences industry is facing an increased focus on asset utilization stemming from rising healthcare costs and unprecedented economic and socio-political pressures. As a result, companies are seeking ways to consolidate and streamline asset management, both operational and IT-related, to increase asset utilization. The industry is transitioning from a “Maintenance Management” to an “Asset Management” paradigm, including predictive maintenance, increased asset reliability, and condition based monitoring.  

“This is exciting news for MRO Software and for our customers: we can combine expertise, leverage our focus and offer an even more complete and global solution to our customers in the Life Sciences Industry. Technologies as RFID, integration of the different operational systems with an asset-and service management-centric approach fits very well with the Service Oriented Architecture capabilities IBM is offering. Combining industrial, operational and IT assets and related services in a regulated environment will increase efficiency and differentiate the combined offering” commented Eric Luyer, Industry & Solutions Marketing for Life Sciences & Healthcare markets of MRO Software.  

While vendors like ORACLE(IFS), SAP and Infor (DataStream) propose a monolithic approach to Asset Management, MRO Software continues to provide best in class Enterprise Asset Management solutions and leads the Gartner Magic Quadrant.The acquisition by IBM will propel MRO software to fully realize its “Rational Suite” approach the Asset Management while increasing integration capabilities with key Financial and Knowledge Management vendors though IBM’s Software and Services.   

As I mentioned in an earlier article, there is no one size fit’s all when it comes to software. But if you are serious about managing your Industrial and IT assets, Maximo is still your best choice. If you are still unsure, remember the saying, “no one gets fired for hiring IBM”.

02Aug/06

Can I make your pacemaker software run faster?

I recently read an article on the Free Software Foundation’s Website entitled “Regulatory compliance is no reason to lock up users” The author states that “Medical devices are (theoretically) programmed to a high standard of safety, and careless modification could cause great harm. Medical device manufacturers want to Tivo-ize their devices so that only they can upgrade the software on them. They claim that this is necessary for compliance with FDA regulations.”

The FDA gives manufacturers the freedom to choose what software to use in medical devices. But with this freedom comes responsibly. The Agency does not require or favor the use of commercial over free software in medical devices.  However, the Quality System Regulation (21CFR§820) does require that Medical Devices automated with computer software be subject to design controls.

FDA’s Guidance on Software Validation states that “where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) …the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.”

The difficulty with Free Software is that it falls into software quality limbo.  After all there is no vendor to audit, or documented evidence that a quality system exists and was followed in the design and testing of the Free Software.

I know that auditing Off the Shelf Software vendors can be hard enough (I tried to audit Microsoft once), but in general you can perform an audit of your software provider to assess the quality systems they have established and to ensure that they are following their quality system. Whom do you audit for your open source code?

Nevertheless, this does not purge the use of Free Software in devices. It does put the burden for proving and documenting that the software meets the intended squarely on the shoulders of the Device Manufacturer. The level of diligence required for Free Software is not unlike that of Custom Software. The cost of the Open source Software (free) may offset the cost of this additional compliance burden, but that is a business decision each manufacturer must make.

Free Software has a place in our industry. You want to run your HTTP server on Apache, go ahead (after you have assessed the impact on you compliance program), but I would not recommend using open source software in Medical Devices.

Device Software is one area where reliability and safety should always come before speed.

After all making a pacemaker run faster is not always a good thing.

13Jul/06

Doctors Don’t Treat Populations, They Treat Individual Patients

This week, Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration made an interesting speech before the 2006 Conference on Adaptive Trial Design in Washington, DC.Dr Gotlieb commented how today’s clinical trials are highly empirical. Drugs are tested on general populations for a response and a treatment effect that is statistically not likely to be a chance result. This approach is rigorous and focused, but inflexible. According to Dr. Gotlieb, “another problem with the empirical approach is that it yields statistical information about how large populations with the same or similar conditions are likely to respond to a treatment. But doctors don’t treat populations, they treat individual patients. Doctors need information about the characteristics that predict which patients are more likely to respond well, or suffer certain side effect. The empirical approach doesn’t tell doctors how to personalize their care to their individual patients.” This results in a highly empirical approach to the practice of medicine. Gone are the days of: Take two off these and call me in the morning. Gottlieb comments “Doctors prescribe treatments knowing full well that only a certain percentage of their patients will receive a benefit from any given medicine.” This approach is akin to: Take all of these and call me if you have a side-effect. 

But with the demands for personalized medicine and the advent of Pharmaco-genomics, there are potentially better alternatives. By enabling more trials to be adapted based on knowledge about gene and protein markers or patient characteristics, we can help predict whether patients will respond well to a new medicine. “These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments, and resulting in clinical trials that may not only be more efficient but are more attractive to patients and their physicians to enroll in.” said Gottlieb. This is only a first step in the process to develop more adaptive clinical trials. This process will lead to more targeted therapies and in turn, Ii is my hope, more personal and personalized medicine.

04Jul/06

"Medicine is for the People, not for the Profits."

During my senior year, I was lucky to have a few job offers to evaluate. The top two were from Johnson & Johnson and Exxon. As part of my research I looked at how each company handled adversity. For me it was an easy choice when I compared J&J’s handling of the Tylenol situation vs. Exxon’s Valdez.  I was drawn by the impact I could make in people’s lives and by the industry’s reputation in general and J&J’s in particular.

But in recent years, our industry has gone though some tough times. We’ve have seen record FDA fines, product recalls and withdrawals as well as the erosion of consumer confidence.  In my opinion executives at some Life-Science companies lost focus on the patient and began to concentrate on profits for Wall Street.

It is in times like these that we must reach for our roots and reflect on the legacy left by our industry’s founders.

In the August 1952 Time magazine interview, George W. Merck said “Medicine is for people, not for profits.” He went on “…if we remembered that, the profits have never failed to appear. The better we remembered, the larger they have been.”

In 1943 General Robert Wood Johnson wrote: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.” This Credo is still etched in stone at the J&J world Headquarters.
In 1899 Charles Pfizer said, “Our goal, has been and continues to be the same: to find a way to produce the highest-quality products and to perfect the most efficient way to accomplish this, in order to serve our customers. This company has built itself on its reputation and its dedication to these standards, and if we are to celebrate another 50 years, we must always be aware that quality is the keystone.”

In this post Sarbanes-Oxley era, I am heartened to see that our industry is once again putting patients first.

Let us remember to chase after the cures for human ailments, then and only then will fair profits follow.

29Jun/06

I Lost the Cure for the Common Cold!

By Daniel R. Matlis 

It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm is set for Beijing, not Philadelphia, and he is wide awake.So you get a cup of coffee, turn on your laptop and start to do some work. In a moment of inspiration, you discover the cure for the common cold. It’s all there on the screen right in front of your eyes and then your baby kicks, the coffee spills on your laptop and, just like that, the cure is gone. Who do you call?

Monday, at the Corporate Computing Show in NY, I met the people for the job. DriveSavers Data Recovery is a company that recovers data from crashed and damaged media. They have been doing this for over 20 years and when James Bond looses the data in his laptop he doesn’t call Q. Instead he deals with Kelly Chessen, Data Crisis Counselor DriveSavers (Yes, Sean Connery is a client).

With the prospect of irretrievable information loss, many of the callers with whom Chessen deals are as distraught. The emotional trauma associated with the loss of critical data can be disruptive both at work and at home.

Chessen came to DriveSavers with a background in psychology that serves her well in her dealings with often-frantic customers. She worked with a suicide prevention hotline for more than five years, including one year as the manager and trainer. This is exactly the kind of training I want the person on the other end of the line to have under these circumstances.

In addition to the soft skills, DriveSavers has technical skills and facilities to back them up. They have recovered data from drives that have been damaged, dropped, deleted, burnt, crushed and drowned in the Amazon River. The company has a success rate of over 90%, and recovers data in as little as 24 hours from all operating systems and storage media including hard drives, disk arrays, floppies, CD-ROM, DVD, removable cartridges and digital camera media. They have they own calls 100 clean room, and if they work on your drive, the manufacturer’s warranty is still good, although I’m not sure that a drive full of Amazon River water is covered.

So the next time your husband, wife, son, daughter, dog, cat or self spill a cup of coffee on your laptop containing the cure for the common cold, or the therapeutic area you are working on, don’t sweat it, lay on the couch and call the Data Shrink.