How serious you want Siemens to become? Are there any Fortune 100 companies went bankruptcy due to FDA? Even the worst happens to Siemens this time, the entire DX group can be written off or sold at loss over night (figuratively, of course).

If Siemens is a Costco pizza, DX would be a couple of pepperoni circles. Those think Siemens executives would have nightmares because a few warning letters from a US agency, either too naive or ignorant.

"You're right it's not doomsday. Just shows they are no different than the rest of them".

This poster is an idiot, must be a Siemens troll, trying to say that everybody does it, only difference is we got caught. Not true, other companies have learned their lessons (some the hard way). The FDA has teeth and they will use them. If you get a warning letter, (or two now in last 60 days), Siemens should take it seriously. Siemens strategy of 'pay no attention to the man behind the curtain' doesn't work with the FDA.

Might not be doomsday, but they got another letter June 29th... When the FDA deems that you should have recalled product and did not, then it seems the issues are getting worse. Especially when it involves cardiacs.

You're right it's not doomsday. Just shows they are no different than the rest of them.

This is not news. This thread was started over a month ago. Some people look at this as a doomsday scenario and others say that Siemens can still the their act together, although they will have to further delay their new systems as resources are used to bring their processes up to FDA standards.

Siemens Healthcare Diagnostics, part of Siemens (NYSE:SI), has received a warning letter from the U.S. Food and Drug Administration over allegedly changing without following proper protocol the design of an immunoassay device used to test blood and other biological liquids.

The letter, addressed to its Tarrytown, New York office dated May 29, said the company violated good manufacturing practices over changes made to its AD VIA Centaur iPTH immunoassay. The regulator faulted the company on alleged procedural violations to ensure the design fit the requirements for the device’s intended use. The company was missing documents to demonstrate that formal documented reviews of the design were being conducted at the appropriate stages.

Although Siemens’ premarket notification review was made in September 2009, followed by a regulatory assessment and then a validation report nine months later, the letter said the changes made to the device were not reflected in the paperwork.

“The effect of the device changes on performance was not documented until these reports were completed, but your firm’s assessment claims that there was no change in performance requiring a premarket submission,” the letter said.

The regulator also took the device manufacturer to task over what it said was its failure to adequately review and evaluate complaints over the device to determine whether an investigation was necessary.
The letter warned that the FDA could take regulatory action if it did not receive a response from Siemens addressing the points raised in the letter.

Not sure who this idiot is talking about the Vitros 1500... that product doesn't exist. If you mean the Vitros 5600, you are correct in that this instrument is a piece of shit too. Poor Quality... SLOW turn around times, and you will be feeding the slides non stop all day. Good luck connecting OCD to automation, and please don't ask for a LEAN presentation... those arrogant a-holes will tell you that you don't need pre-analytics every time!!! just because they know if automation is on the table... it's game over!!!

Supporting documentation? LOL! We try not to talk about that when potential customers ask... try to change the subject... Deals are over when we have to put MTBF in writing...

Truth is the Vista menu will never be complete... too dependent on Centaur to help fill the gaps, and these systems (especially the 1500) are down more than they are up.

These recent FDA warnings are just the beginning... I'm working on my resume right now!

MTBF rate is that low? Wow. Any supporting documentation? That would help a lot.

Regarding the Vitros 1500 MTBF rate. Yes, it is high along with the Siemens VISTA. It is a shame with JNJ's assumption of the Kodak products that the reliability has dropped significantly. However, I feel as though the sales reps have oversold the capability of the Vitros 1500, by placing them in laboratories that place too much demand on them in terms of volume/throughput. Integrating an IA module and having some wet chemistries on the instrument slowed the system down significantly. I've always felt that the IA design of the ECI would never have the reliability compared to the dry slide V950's. The V1500 would probably do very well in the medium to lower volume labs.

Not sure about the VISTA....I've just heard the horror stories about its poor performance in higher volume laboratories....again, probably the same issue of these instruments not being properly designed for high volume use.

Vista 1500 Mean Time to Failure of 12.3 days - I wonder if that will get a FDA letter too? The few hospitals that have these are really regretting that decision!

I read this a bit differently. Much of the specifics concern how products are made, tested and released, and about the casual use of the 'replace upon complaint' option. It appears that this last issue is being addressed by Siemens although it sounds like they are still trying to all of the paperwork together. It also sounds like Siemens already has a system of reviews, but it needs to be tightened up. Conducting a review of their entire control system, as the FDA suggests is a complex and lengthy process and Siemens will have to work through that in planning it out (another FDA request).

From the way I read the FDA response and it's tone, it sounds like Siemens has simply been slow in responding. There was nothing in the letter to suggest that Siemens is refusing to comply; but only that their response, to date, has been quite incomplete. It does sound like whoever from Siemens' RA is dealing with this doesn't know how to deal with the FDA in this kind of situation. The FDA comments almost suggest an amateurish quality to Siemens' response. A good RA person would know to explain why responses are incomplete, what Siemens is doing about it, and when they expect to have it completed and not have to wait for a second letter.

I saw nothing really fatal in either the FDA letter or the specifics of the various methods affected. Everything I read seems easily corrected from a technical perspective. The big effort for Siemens will come in reviewing their control system, modifying it as necessary to comply with FDA regs and then, the most difficult, to actually follow the compying system.

It's bad news all around, I guess. Competitors aren't going to see Siemens go away soon, and Siemens will have to divert alot of energy from their new system to fixing their internal processes. The silver lining for Siemens is that if they do put in a good system which includes development, they might actually turn out a good product with their first all-Siemens system and not rush it through to meet some predetermined time schedule. One of the main purposes for control systems during development is to prevent just such things from happening which leads to products like Advia IMS, Gen-a-Mess, and even Vista to some extent. The lack of an adequate control system is probably the main reason that Llanberis had so much trouble acquiring some of the methods from LA.

You have a big job ahead of you Siemens, but you will be rewarded for the effort in the long run.

What part of this response were you surprised by?
They didn't learn a lesson from abbott and beckman.
I guess the rocket scientists at siemens aren't the
brightest bulbs in the closet. Where did those Ph.D.s
come from?

While I will admit the issues cited were handled incorrectly, I'm not sure there is a diagnostic manufacturer big or small that will meet the 'letter of the law' when it comes to the new FDA. It is foolish to believe that these issues were not readily apparent during past FDA inspections. It appears that it is now Siemens turn to deal with the FDA for a couple years and then off to the next big fish, be it BD, Roche, Abbot....

I was working for Beckman during their FDA investigations and the mitigations implemented to 'fix' the issues. Again it is apparent that only a 'fresh coat of paint' was applied and the core issues have still not been resolved. However I will bet you dollars to doughnuts that contrary to many posters hopes on this site the FDA is effectively done with Beckman barring a monumental pooch screw that the FDA can not ignore.

I no longer work for Beckman and have no dog in this fight, but I have worked for several diagnostic manufacturers and all have similar issues. It is the nature of a regulated industry.

If anyone thinks the FDA is any better at understanding and controlling the myriad of regulations you are fooling yourself. The awful truth is all products fail and no matter how much we try to reduce the risks, there will be times when a product becomes harmful to the operator or end users. Once this fact is accepted then and only then can the entire industry begin to look at it's products in a meaningful way to the customer.

Which makes more sense to attack?

A) A product performing with out issue in the field that does not have a decision recorded for changing acceptance criteria during a design validation review.

Or

B) A well documented product that was developed with a lack of understanding of how to approach a reagent characterization leaving the possibility open that a failure is likely with just a simple vendor switch of a raw material not deemed critical to the process and is thus not measured.

Until both the FDA and the industry can answer this question fairly, both sides will continue to just check boxes and go through the motions

Looks like Siemens received another warning letter on June 29th:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm31057...

I think the FDA is probably realizing that Siemens has systematic issues.

Good luck to Siemens! Time to put a sock in their arrogant attitude.

MLMP should have listened to Sheldon

FDA is not done with BC

We hear that Glasgow received one also

The fact that Siemens sent their response to the FDA incorrectly is noteworthy, but not necessarily important. Sending it to the wrong place is evidence of stupidity. The important thing is what was actually in the response and its tone. The FDA can easily forgive the ignorance in how or where to file a response. If the response says 'mea cupla' and we will fix things to your satisfaction, that is one thing. If the response says that Siemens disagrees with the findings and is challenging the FDA's power or finding, then they are doomed to be punished heavily. It's like the old saying: you catch more flies with honey than with vinegar (for those who like to catch flies).

It is also far better for Siemens (or any company) to keep their FDA discussions as private as possible and not air this issue in public until a resolution is achieved. For those of you who don't see the importance of discretion, I refer you to the Bible which explains why Moses was allowed to lead his people to the promised land, but not to enter it himself. (A prize will be awarded to those who know Moses why was punished in this manner).

From the Director of The Biblical University of Diagnostics (aka, BUD).

Your thinking of Apple not Facebook, $1000 for a $200 phone made in a slave camp - and we love it!

I guess the company that Siemens and all others should look up to is Facebook, which can legally rob the public in bright daylight, and then still have millions of followers. Bribery becomes so amateur now.

Once Siemens had it fundamental business tool taken away (bribery!) it has nothing left to try to deal with the FDA with!

Damn you Enron... look what you did!

Sounds a lot like what FDA did to Abbott and Beckman. Suspect FDA now that they have finished with those 2,have there sights on Siemens. Once FDA has you in their sights, it is downhill all the way!

I'm wodering if Siemens had a holier than thou attitude towards the FDA, similar to Abbott's attitude toward the FDA right before they were slapped with a consent decree.

I have to say that RA is very relaxed about the whole thing and treating it like FDA is out of line. This is not a great attitude to have. They can't even admit they screwed up royally on so many counts. Hey, FDA speaks and you jump! You don't question them or assume they are wrong. That attitude is counter productive. I've been with other companies where more than 3 observations was a killer-let alone multiple warning letters. Many companies would NEVER let it come to that. Scary.

If you've read the warning letter...Siemens' response to the FDA was a bit arrogant because they did not mail their responses to the FDA and required the FDA to log into a secure Siemens server to download the documents. The FDA sauid, "we don't do that"! Not a great way to start off your dance with the FDA!

I'm wodering if Siemens had a holier than thou attitude towards the FDA, similar to Abbott's attitude toward the FDA right before they were slapped with a consent decree.

My guess is that if the iPTH wasn't properly validated, the FDA may provide them with a reasonable amount of time to complete and send in a new application and allow them to temporarily continue selling the reagent pending FDA submission and approval. I hope Siemsns doesn't use the "were too big to fail" excuse....

All true.
They are in a lot more trouble than the siemens heads will admit.
If I'm a competitor I'm jumping on this puppy, just like the siemens heads did when beckman had their problems.
Stop pulling the 'holier than thou' crap.

"The complaint is about paperwork and documentation when changes were made. As long as Bayer provides assurance to the FDA, Siemens should do fine."

"It seems that Siemens' competitors are trying to make more of this than the FDA letter indicates such as statements that perhaps 10-12 methods are affected and may have to be withdrawn."
------------------------

This is just what happened to Beckman. Their troponin was withdrawn after unreported changes. Now they have to start all over and re-prove their claims. FDA is out to take heads.

can MLMP

The complaint is about paperwork and documentation and whether necessary reviews were carried out during development or when changes were made to manufacturing procedures. It does not appear that the FDA is citing Siemens for putting out a bad product or one that does not meet product claims which is an entirely different situation. As long as Bayer says 'yes sir, yes sir' and provide the appropriate information and, perhaps, hold the appropriate reviews and, then, provide assurance to the FDA that a system has been implemented to ensure that these deficiencies won't occur again, Siemens should do fine. The may have to pay a fine for past omissions, but that should be it. Siemens just has to make sure that the FDA does not start to think they are stalling and delaying.

It seems that Siemens' competitors are trying to make more of this than the FDA letter indicates such as statements that perhaps 10-12 methods are affected and may have to be withdrawn. I see no evidence of this in the actual FDA letter. There is little need for these attacks by the competition though. Siemens is doing a more than adequate job of destroying the businesses they bought all by themselves and don't really need any help from the likes of Beckman/Danaher, Roche, Abbott, etc.

Then why did they not inform the FDA and investigate the complaints? They figured the hard part out.....

I saw a follow-up article on this and the allegations are that the proper documentation, proper manufactoring procedures and something to do with complaint follow-ups were sited. It sounds kinda scary...

"Since we are all scientists, Let us switch gear towards the science part of it. The reason Siemens had to change their original Intact PTH assay format (launched around 2001) was because of substantial biotin interference in this Streptavidin (magnetic particle)-Biotin antibody based assay. Biotin now as a common ingredient in muti-vitamin supplement, they were forced to get away from Streptavidin-Biotin system and reformat the new Intact PTH assay (which culminated all these issues)."

The way to solve that problem is to incubate the particle with the biotin Ab, then wash, the add sample plus Acr Ab. What's so hard about that?

FDA’s New England District Director Mutahar Shamsi alleges the company’s Walpole, Massachusetts facility is not conforming to current good manufacturing practices (CGMPs). As a result of the alleged deficiencies at the facility, all in vitro diagnostic devices manufactured at the facility are, as far as FDA is concerned, adulterated.
The roots of Siemens’ manufacturing problems go deep, explained FDA, and cover the facility and at least two products manufactured at the facility. FDA identified eight facility-related deficiencies:
 Failure to establish, maintain, and consistently meet device validation specifications
 Failure to verify device design and address device failures
 Failure to verify production processes
 Failure to implement or document corrective and preventive action (CAPA) procedures in multiple instances
 Failure to investigate medical device failures
 Failure to evaluate more than 1,250 complaints received regarding the firm’s iPTH device
 Failure to provide adequate instructions for end users with distributed medical devices
 Failure to maintain an adequate device history record, including the quantity manufactured
Siemens was also cited for purportedly failing to submit more than 15 reports to FDA regarding potential adverse events occurring as the result of a device malfunctions. Such reports are due to FDA within 30 days of the company being made aware of the malfunction.
“The information in the complaint files … reasonably suggests that the device malfunctioned and that the device or a similar device marketed by your firm would be likely to cause or contribute to a death or serious injury if the malfunction were to recur,” FDA wrote. Additional reports related to information known to the company about interference with a device were similarly not reported to FDA in a timely manner, the agency said.
FDA also expressed its opinion that Siemen’s iPTH devices are misbranded as the result of repeated instances in which the company withheld safety and market removal information from FDA, and subsequently failed to justify its actions when FDA learned of the infractions.

Ya gotta wait for them to tell you to leave and then you get the package.
After that, take it from me, there are great jobs out there where you will feel wanted, and make more money.
Wait it out!!

I just wanted to remind anyone considering joining Siemens DX, it sucks, it really does! if there were any such jobs available for something menial and I could get it, being overqualified some, I would take it and tell Siemens to stick it up their ass, except they are SOOOO anally retentive you couldn't get anything thicker than vit.D molecule up there. (not that anything we sell would know what a vit.D molecule looked like anyway LOL)

Thank you Sheldon Cooper

Since we are all scientists, Let us switch gear towards the science part of it. The reason Siemens had to change their original Intact PTH assay format (launched around 2001) was because of substantial biotin interference in this Streptavidin (magnetic particle)-Biotin antibody based assay. Biotin now as a common ingredient in muti-vitamin supplement, they were forced to get away from Streptavidin-Biotin system and reformat the new Intact PTH assay (which culminated all these issues).

Question is, if IVD companies are now shying away from Streptavidin-Biotin assay format? That would be real pity since Streptavidin-Biotin is one of the strongest binding affinity pair in biological system.

Quote "I don't know when Siemens began negotiating to buy DPC, but they were in negotiation with Bayer for several years before they actually made the purchase. From what I hear, the same is true about their purchase of Dade. Based on this, it appears that Siemens was pursuing three different companies simultaneously, not serially as you suggest. There were several possible reasons to buy DPC. One is my oft suggested cash cow theory. Another, as you said, was to obtain certain intellectual property and a few assays to move from Immulite to Centaur. A third reason would be to gain access to customers that DPC had who were in a different market niche than Bayer occupied with Centaur and to use this access as a means to convert customers to Centaur as part of an instrument consolidation. Siemens, like many, if not most, large companies simply look at things as a business and do not consider people. They care about dollars (or Deutchmarks), but not people. Siemens turned over the management of their new organization to Bayer people (prior to the Dade acquisition), but it is not that clear whether the poor treatment that LA got was because of some vindictive attitude on the part of ex-Bayer people or whether the Bayerites were simply following orders from Siemens in Germany.

One thing seems fairly clear though. Each of the three companies that Siemens acquired had an attitude that they were the best and the others were worthless and just bringing the business down. This 'we are the best' attitude contributed nothing positive to the equation and only hurt Siemens DX and the people who worked for the new organization. From everything that has been posted here as well as other public information about the three companies, each had its share of problems. Bayer had thrown millions into Advia IMS which turned out to be a stillborn product. Dade was trying to get Vista off of life support. DPC had just received a strong warning letter from the FDA and they had a very good, but old technology with Immulite and were seriously discussing a big change from beads to another solid support which would have taken a large, expensive effort to qualify all their assays with the new technology. Apparently, Siemens did not catch most of these problems during their due diligence, a failure upon which I have commented repeatedly.

Bottom line is that almost everyone in this epic dramedy turns out to be a loser and, it appears, that, to some extent, almost everyone contributed to the mess that Siemens finds itself in today. Pointing fingers won't help the situation even if it makes the finger pointers feel good and vindicated. If Siemens is to turn things around and make something positive out of DX, those remaining have to forget the past and move on in harmony to work towards a common goal (assuming that Siemens can set goals that are realistic).

Its been many years now and it's about time for a kumbaya moment. If not, there will be many more people joining the misery that LA has suffered through no fault of their own."

That's it in a nutshell. Great summary.

You know how it goes in the scifi films? the big alien spaceship turns up and the eternal optimists go to the roof of the Trump towers and sing Kumbaya up to the sky. Then the belly of the ship opens up, there is a bright blue light and then..... Bang!

Kumbaya time has been and gone my friends. The only strategy I can see going on in Siemens is middle management climbing over each other to get as high up the rope as possible against an ever rising flood water.

Those of us in the lower levels are already resigned to the end and are laying back in the icy water, chilling out and wondering if we will still be concious long enough to see the propeller end stuck in the air before the Titanic finally slides under.

I don't know when Siemens began negotiating to buy DPC, but they were in negotiation with Bayer for several years before they actually made the purchase. From what I hear, the same is true about their purchase of Dade. Based on this, it appears that Siemens was pursuing three different companies simultaneously, not serially as you suggest. There were several possible reasons to buy DPC. One is my oft suggested cash cow theory. Another, as you said, was to obtain certain intellectual property and a few assays to move from Immulite to Centaur. A third reason would be to gain access to customers that DPC had who were in a different market niche than Bayer occupied with Centaur and to use this access as a means to convert customers to Centaur as part of an instrument consolidation. Siemens, like many, if not most, large companies simply look at things as a business and do not consider people. They care about dollars (or Deutchmarks), but not people. Siemens turned over the management of their new organization to Bayer people (prior to the Dade acquisition), but it is not that clear whether the poor treatment that LA got was because of some vindictive attitude on the part of ex-Bayer people or whether the Bayerites were simply following orders from Siemens in Germany.

One thing seems fairly clear though. Each of the three companies that Siemens acquired had an attitude that they were the best and the others were worthless and just bringing the business down. This 'we are the best' attitude contributed nothing positive to the equation and only hurt Siemens DX and the people who worked for the new organization. From everything that has been posted here as well as other public information about the three companies, each had its share of problems. Bayer had thrown millions into Advia IMS which turned out to be a stillborn product. Dade was trying to get Vista off of life support. DPC had just received a strong warning letter from the FDA and they had a very good, but old technology with Immulite and were seriously discussing a big change from beads to another solid support which would have taken a large, expensive effort to qualify all their assays with the new technology. Apparently, Siemens did not catch most of these problems during their due diligence, a failure upon which I have commented repeatedly.

Bottom line is that almost everyone in this epic dramedy turns out to be a loser and, it appears, that, to some extent, almost everyone contributed to the mess that Siemens finds itself in today. Pointing fingers won't help the situation even if it makes the finger pointers feel good and vindicated. If Siemens is to turn things around and make something positive out of DX, those remaining have to forget the past and move on in harmony to work towards a common goal (assuming that Siemens can set goals that are realistic).

Its been many years now and it's about time for a kumbaya moment. If not, there will be many more people joining the misery that LA has suffered through no fault of their own.

Siemens bought DPC well before the others as it was a great opportunity to dip a toe in the business. DPC was lean, profitable and with full in house technical and chemistry capabilities. It worked well for a while but then the opportunity came up to buy Bayer and it all went pear shaped. Bayer raped DPC and in revenge for beating them by winning the customer in the first place forced customers into Centaurs even if it wasn't the best system for them. To this day they treat DPC poorly. Siemens were too dozy to see what they had and let Bayer take control and spread their train crash ways. Dade then joined the party but it was too late. Siemens now had DPC version 0.5, Bayer version 0.7 and Dade version 0.2!

Siemens investment (we were promised it by Siemens "we don't do old product, Siemens always aggressively brings out new products on short cycles") should have gone into taking the fight to Roche and Abbott with competitive automation and instruments before it was too late. Instead Siemens kept the taps turned off for fear of it all being lost from the Bayer holey bucket. It is too late now and Siemens DX is the scraps that fall off the table dog.

Hopefully some of us can hang on the derailment long enough to get a few more bucks in the pension.

Wasn't the original purpose for Siemens to acquire DPC was primarily for their intellectual property rights and specialized assays they could migrate to the Centaur in order to increase is test menu? It does sound a little crazy to maintain several lines of competing assays and instruments.

However, you are right about the Siemens' management, they have shoddy business practices and treat people poorly. We consistently would see a new sales rep every two years....probably because they could not meet high quota expectations. It did not allow for them to develop a professional relationship with each facility. For those other sales reps who did stay, I couldn't trust them because they would spread lies about the competition.

As a follow up, my agenda, if you must insist that I have one, was never to criticize the people who worked at DPC or what they accomplished during the real DPC years (pre-Siemens). My goal was simply to look at whatever facts I could get my hands on, analyze them, and then offer an (not the) explanation of why DPC was probably sold in the first place and why Siemens did what it did with DPC. The basic response that my interpretation has received is that I am somehow hostile to DPC or that Siemens should not have done what they did. I understand that many, if not most, DPC people agree that Siemens treated them poorly, to say the least, but I am trying to look at things from a possible perspective of the last DPC owners and Siemens; what they did and why. I am more than happy to humbly accept that it has been my failure to communicate that has caused this reaction, but an attack on DPC employees was never my goal.

That being said, I will reiterate that it is fine to remember fondly the days of yore, but that reasonable people should be prepared to move on, even in the face of what they consider to be unfair. SZ was a perfect example of moving on with his life after the life of far greater unfairness and evil he endured as a young person. He didn't spend the rest of his life complaining about the injustices of his youth; he went out and made something of the rest of his life. Perhaps his example of success after disaster should be a lesson to us all.

Yes DPC does have unique people. Spend all their lives on one project.
All they do in DPC is whine about everything. They are a bunch of kids. We all know how great Informatics, run by former DPC guys, is going. Their engineering head ,RB ,has no leadership skills.Their software dude DV is nuts.I can go on and on. Do they have some good people? Sure. but so does ex-Bayer and ex-Dade. DPC guys are not special

I can't understand why you can't accept someone agreeing with you. Where did I ever say there wasn't magic at some point? Where did I say that DPC was not a special company that achieved alot more than most companies in the business. I merely stated what you acknowledge as well: that those days no longer exist and ceased to exist when DPC was sold. I have no ax to grind with DPC and, in many ways, I admired the original Z's. The only thing I've said over the past few years is that DPC's era was over under Siemens and that people there needed to eventually accept that as a reality, mourn a bit, and then prepare to move on with their lives. Whatever obsession you see in me is simply my weariness with hearing the same old story about the good old days or the taunts at Siemens for their utter incompetance in managing the situation in LA. I am a far bigger fan of what DPC once was than I could ever be of Siemens. So I really can't figure out how you conclude that I am bitter about something or have hostility to DPC itself. We are really saying the same thing if you put aside your bias and read what I've written here.

"It just seems to me that people with the kind of creative minds that made DPC what it was would choose the latter. Those who choose to be stuck in the past will only find that their minds and lives atropy......"

This has got to be the same guy with the obsessive need to bag on the feelings that the original DPC'ers had over their experience with the company. I'm starting to wonder why the obsession. It may actually be a current or former DPC employee who had a falling out with the company and harbors incessant anger towards the company and just has made it his lifelong purpose to finally bury the hatchet on the ghost that is still there. He just doesn't get it.
We are not trying to revive the company or keep our jobs there; many of us are no longer there. I'll even say this.....even if SES, DR.Z, SA, etc. could come back from the dead or wherever they are and buy back the company (and lets even say the industry environent was still like it was 30 years ago), they still could not turn DPC around in less than, say, a 20+ year period of time, and maybe not at all.
Why? It took them that long to get the company and the select crew that they eventually had, because they used their very efficient, no nonsense management style for that long a period of time before the company was so well stocked with unique people, that they out competed everyone in the industry. I would guess that they would have great difficulty to assemble such a crew one more time. A rather few, very talented individuls in each department was not easy to assemble, and was perhaps a lot of good fortune or perhaps luck.......dare I call that "Magic?".....better not or our friend might blow a fuse. We talk continually about DPC's management style not because we hope to be back somehow in the "glory days", thats nonsense......the company very likely could not be regenerated again by the same people, in the same environment, with out a bit of the "Magic" (oops, I forgot) that occured during the 1970-2000 period. What we are trying to do is figure out what Siemens is doing, and looking back to DPC brings a lot of focus as to what was different about the two management styles. The fact that Siemens is failing so miserably only fuels the fire. We abhor the waste of a very unique company, and wonder if other companies will ever follow DPC's path to success.........well, we ex-DPC'ers may wonder for a second or two, but I think you know what we are thinking. As for the angry dude, we do not want our old jobs back because the company ceased to exist the way we liked it, many, many years ago so get off of that theme.....I don't know how many times I have to say this.

It is all well and good to talk about the good old days under the Z's and the magic that was DPC back then. It's like talking about the good old days of Richie Cunningham and the Fonz. People grow up and so to industries. The time period to which you refer represented the early days of immunochemistry, when it was young and new and exciting. Have you seen Ron Howard or Henry Winkler (doing ads for reverse mortgages) recently? Have you been paying attention to what has been happening in diagnostics recently? The days of rapidly increasing menus, new analytes, etc. are over, my friend. It's a commodity business today. There will always be new analytes to be added to the menus of existing instruments (both clinical chemistry and immuno), but nowadays that will happen at a much slower rate. Some of the novelty will come from small companies whose methods will be sold or licensed to the big boys. I know it's hard to admit that Immulite, as it existed at the end of the DPC era, was at the end of it's lifetime. Beads needed to be replaced by another solid support which is alot of grunt work with a poor return. The Z's saw that even if you didn't and got out while the getting was good. At the end, they didn't care any more about their employees that Siemens does today. Siemens has only done what was easily predicted: 1) transfer certain (unique) methods from Immulite to Centaur, 2) use Immulite as a cash cow, and 3) do their best to convert Immulite users to Centaur so they can eventually shut down all of the former DPC. Yeah, it's not very nice, but it's the way business operates today. It happened to the auto industry in the 50s and 60s when companies like Packard, Hudson, Studebaker, and American Motors were either absorbed by others or simply went out of business.

So former DPC people and those who are still there have a number of choices. They can continue to whine and vent here and remember the good old days and remain stuck in their former glory. They can try to fight the trend, an exercise in futility. Or, they can say, hey, we had a great run and an unique experience during our good times at DPC and move on to their future. It just seems to me that people with the kind of creative minds that made DPC what it was would choose the latter. Those who choose to be stuck in the past will only find that their minds and lives atropy, not to mention how the whining destroys whatever sympathy anyone (other than DPC people) have for your fate at the hands of big business Siemens. Living in the past can only hurt those who do.

It's a brave new world, baby ... deal with it!

"The success of DPC for 35 years was its out of the box thinking.
Siemens solution: Buy the company and then lay off 90% of it's employee's. It has to be one of biggest mistakes in any of Siemens acquisitions"

I don't know if you worked at DPC, but I suspect you did because you nailed it buddy! The place was run in a way that would have scared the pants off of any staight laced Diagnostic company. It could not have been run more differently than virtually every other company. It was so different that just walking through the place would have been an eye opener for most; the place was filled with the oldest, ugliest, strangest, sometimes scariest cast off's in the world. Some didn't even have all their body parts! Many were such characters that they would most likely be bypassed by other company's leery of having such stange characters running around in their company's halls. Many were socially awkward or just plain mean. But I must admit they all (at least the ones that survived for long) were fiercely dedicated to their jobs and were good at whatever they did. The management would hire loads of PHD's and those with impressive resume's and give them a shot........if they so much as stumbled twice they were chastized. A few more non-productive months and they got rid of them. They did this for decades and ended up with a staff that conformed to their own ideals of what a great employee should be. Their definitions certainly didn't agree with the industry standards, buy it is impossible to argue that they were wrong about the choices they made.........their staff out produced every other independant Diagnostic firm in the marketplace. I think Siemens looked around, didn't like what they saw, and concluded that replacing the entire DPC staff would improve the productivity immediately and very easily...........I'm pretty sure they realize they just butchered the best asset they had acquired from the three companies they purchased. The other divisions employees were more like the industry standard; group thinking, presentable people who could talk a good game and play the politics game.........while contributing very little original input. I think Siemens is only beginning to understand the tragedy of it all.

The letter is not just about the PTH but failure to investigate customer complaints and is not all inclusive. Please do be aware FDA does monitor these sites too.

looks like the whiner who was let go from Ortho is back

the person never understood that random access was the correct way to go as that was was labs were asking for

the UK position was 'we know better'

Rochester would not listen because Rochester had to fix what was given to them