July 24, 2015
Okay, let's make this one simple...
Click HERE to answer a few brief questions about how your lab approaches instrument support.
All info is confidential We will publish results in an upcoming post.
Shortest darn blog all year...
June 3, 2013
Thought I would share a few articles and interviews that talk about Asset Management and Multi-Vendor Service support.
Next Generation Pharmaceutical-Outsourcing Asset Management, Bob Moore – GE Healthcare, interview
Lab Manager Magazine – The Evolving Service Model ; Good overview of service offerings from GE, Agilent, PE and Thermo Fisher.
BioScience Technology.com – Managing More Lab Assets
GEN – Lab-Asset Management Gets Smarter; older article (circa 2008) but shows that Asset Mgt within life sciences has been around for awhile.
March 26, 2013
As many of you know, systems can be very expensive so end-users are making critical decisions on behalf of their employers, both on how well their money is being spent and what are reasonable expectations as to when the system will begin to show a return on that investment. There is always concern about that ramp up time and the problems you may encounter along the way, so the question of warranty becomes very important to the lab manager or principal user of the system.
Most system integrators go through a very similar process regardless of who the end user is. It generally all starts with a customer needs assessment, whereby a sales manager (usually accompanied by an Application Scientist) asks a number of questions prior to generating a system concept proposal. While it may seem tedious to the end-user, (I know what I want, why can’t these people just give me their quote?) this is a critical step in ensuring long term success. I have been involved in a number of situations where a customer had budgeted hundreds of thousands of dollars but could not provide a single manual method they wanted to automate. Not good.
Weeks (more like months) after the system is designed/proposed and agreed upon/purchased by the customer, a date is usually scheduled for a FAT (factory acceptance test) whereby the customer visits the integrator and goes through a “buy-off” checklist prior to shipment. This buy-off is best done with the actual customer methods (minus real chemistry) to ensure that the system performs as agreed upon prior to shipment. Remember, shipment means breaking down the system and packaging so that it can be “re-integrated” yet again upon arrival at the customer site whereupon it goes through the SAT (site acceptance test) which is basically the same buy-off as the SAT, albeit with actual chemistry. Once completed, you get a handshake (maybe a hug if it goes really well) and “TA-DA !”you own the system.
Most integrated systems come with a one year warranty. This can mean different things to different integrators but in my experience, entails parts and labor only (travel is not included). It also does not include operator induced failures like crashing a robot into an instrument. In general, most systems include a fair number of third party instruments that the integrator does not manufacture and they don’t make a lot of money providing them. These instruments come with their own warranties (usually 1 yr) and the integrator almost always passes these on to the end-user, acting as the first point of contact if a failure occurs. Since the instruments can often reside at the integration firm for several weeks prior to FAT, it is important for end-users to understand their warranty…’what is covered?’, for how long?’ and ‘when does the clock start ticking (upon shipment, acceptance)?’.
As mentioned in prior posts, an extended warranty for an integrated system can often cost 10-15% of the purchase price of the system. Some integrators offer an incentive (discount) if you purchase such an extension with they system, or prior to expiration of the standard one year warranty. Should you choose that option?
In short, the answer is no and I will tell you why. Let’s assume we are talking about a $350K ELISA system that includes a robot mover, bar code reader, liquid handler, plate washer, ambient storage hotels and plate reader. Those majorcomponents probably account for less than 50% of the price of that system. The remainder is comprised of things that don’t wear or break (system tables, enclosures, scheduling software, PC and …labor). That last one is a biggie. Integration is hard work and proper design, build, programming and testing prior to SAT can include hundreds of person-hours. That is commonly referred to as NRE or non-recurring engineering. A warranty for such a system could cost upwards of $50K, or more (not including travel) but you really should only care about the instruments…not the other stuff.
So, if you are faced with a decision regarding extending the warranty of your integratedsystem…push back. It’s pretty easy to determine the list price for each instrument in a system and request a contract that is based on just those costs. You could also go directly to each manufacturer and request contract pricing on their product only. If that is too time consuming or a management hassle you don’t need, you may want to reach out to one of the major MVS (multi-vendor services) providers (Thermo, PE, Johnson Controls, Agilent, GE) or smaller ISO (independent services organizations) like The LabSquad.
Don’t be nervous about system support…be informed.
March 21, 2013
Is there an acronym for excessive use of acronyms? It seems every industry has a long list of abbreviated jargon to capture the essence of what is important to their needs…and the life sciences industry is no exception. Below are a just a few of the many acronyms that we encounter in our daily support of lab instruments and some brief definitions.
OEM – Original Equipment Manufacturer, generally the name of the company who sold the instrument. However…there have been numerous mergers, acquisitions and bankruptcies over the past decade or more so your BioRad thermal cycler might be sitting on the bench with an older model with an MJ Research logo, or your Zymark Twister robot could now say Caliper Life Sciences (which is now Perkin Elmer)…you get the idea.
MVS – Multi-Vendor Services, a generic term that describes a single services provider who works across multiple vendor brands and product lines. Giants include Unity Lab Services (Thermo), PE OneSource, Agilent, Johnson Controls and GE Healthcare.
ISO – Independent Service Organization, anyone other than the OEM. Typically a local provider who works directly with customers or acts as a sub-contractor to MVS’s.
PM – Preventive Maintenance, sometimes called Periodic Maintenance. A pro-active service performed prior to instrument failure designed to catch wear items before they escalate into more costly failures resulting in downtime.
MTBF – Mean Time Between Failure, a spec provided by some OEM’s that statistically predicts instrument reliability. Failures are generally defined as abnormal occurrences that cannot be easily remedied by an operator and render the instrument or system inoperable.
MTTR- Mean Time To Repair, the average time required to repair a failed instrument or system. Total number of failures / total time instrument/system is unavailable for intended operation.
IQ – Installation Qualification, documents that the correct instrument was received and installed properly. IQ can be performed by the user or the vendor (typically both during the site acceptance of a device or system).
OQ – Operational Qualification, tests that the instrument meets specifications in the user environment. OQ can be performed by the user or the vendor. Some instrument include simple diagnostic routines that can be run by users, however a number of such tools are password protected or visible only to service personnel.
PQ – Performance Qualification, tests that the system performs the selected application correctly. PQ must be performed by the user, or in the case of some GxP or CLIA labs, a third party that provides hard data.
CV – Coefficient Of Variation (not your curriculum vitae, or resume), a normalized measure of dispersion of a probability distribution. Insofar as labs are concerned, this is generally a reference to unexpected errors across a microplate. The resulting errors or outliers may often be traced back to liquid handling or pipetting performance.
GLP 0r GMP – Good Laboratory/Manufacturing Practices, a set of standard operating procedures (SOP’s) to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests. Insofar as automation of assays is concerned, these SOP’s may contain periodic OQ & PQtesting of individual instruments, using NIST traceable tools and including analytical date (where applicable) . Techs working in such labs may be required to show tool certificates prior to beginning work and produce validation results.
CLIA – Clinical Laboratory Improvement Amendments, any facility which performslaboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment, and for the assessment of health. As with GxP above, CLIA labs follow stringent SOP’s regarding instrument support or verification, often requiring certified documentation (audit trails).
Did I forget any? Don’t be shy, let me know. TTFN!
January 25, 2013
Ever walk through a research lab and wonder ‘how do they keep all this stuff running?’ Well, I do and I make it a point to ask. From the many labs I have spoken with, the definitive answer is…’depends.’ Not to be too snarky but the answers vary widely depending upon the type and size of the organization, however there appear to be three main approaches;
- Internal (users/tinkerers or more organized support groups),
- Equipment manufacturers (OEM) (service contracts or break/fix)
- Third Party Providers or ISO’s (Independent Service Organization)
Usually, the smaller the entity, the more more likely they are to self maintain. Service contracts from OEMs are expensive and everyone’s budgets are limited these days. Because of this, many end-users also double as the resident experts on the instruments in their lab. Although it is getting rarer, many larger biotech and pharmas have the luxury of dedicated internal support teams that provide support.
Mid size and large biotech and pharma have also relied heavily upon large multi-vendor service (MVS) organizations to provide coverage of all their assets. Well known names such as Thermo Fisher Scientific, Perkin Elmer, Agilent, Johnson Controls and GE Healthcare all provide whole site support for hundreds, if not thousands of instruments.
Each of the aforementioned have their pros and cons. Just bear in mind that no one will ever know as much about an instrument as the company that made it. They will have the design knowledge, replacement parts, procedures and tools to remedy just about anything that can go wrong. But (you knew there would be a but), it isn’t cheap. Typical service contracts are priced out at 10-15% of the purchase price of an instrument. If you have to self maintain don’t despair. Often the best approach is to try to keep up with the basic PM schedule that the manufacturer recommends. Kinda like changing the oil and filters in your car. This is the approach many of the MVS companies use and for good reason. Basic PM’s are the most affordable and least invasive procedures to keep instruments ‘research-ready.’ In fact, the first thing most OEMs do when they begin a service contract is to perform a PM as they know it can often head off major repairs that can erode profit margins. Finally, ‘Break/Fix’ is more prevalent than you would think but be forewarned…the cost of repairs can be astronomical,
Truth be told, there is no perfect solution.
So what is the right strategy for your lab? Well, that depends…
Tell us how your keep your lab up and running.