Nonsense. One of the many functions of a VP in R&D is ensure that products are developed in accordance with FDA regulation and that appropriate technical reviews are conducted as various stages of product development. A VP may consult with the RA department, but the buck stops with the R&D VP. All regulations are published and easily available for anyone to read and understand. Despite the myth, most regulations are actually written in understandable English and are not terribly difficult to understand. AN R&D VP doesn't develop products by himself or herself. But they have the responsibility to make sure that those under them are developing products that meet market needs as developed by the marketing department. The VP is an interface to marketing who presents tradeoffs in time and cost vs. various product specifications. Thus, the VP is responsible to lead his entire operation.

Trying to blame a failure of an R&D VP on regulatory affairs or marketing or anything else is simply passing the buck.

Sorry, but no sale here.

Firing people during times of crisis, such as a warning letter from the FDA is a common practice. It is often a knee-jerk response to a situation. Siemens should be focusing on fixing the problem first and, once that is done, conducting an internal review to determine who, if anyone in partiulcar, was at fault. The only reason to fire an R&D VP is this kind of siutation is if there is clear evidence that the VP is incapable of fixing the problem or leading the solution. More often, however, the sacrificial lamb is the same individual who brought success to the company in the first place. I'm not certain I would put RD is this category although he certainly has a list of many contributions to developing methods for Bayer and Siemens. It is hardly a good sign that we see signs of retribution for poor performance much sooner than we see a resolution to Siemens' issues with the FDA.

Sad truth is RD is paying for other's mistakes. RD was right it's always R&D's fault. Like Regulatory dept and others who advise R&D have no stake in this FDA letter. They got rid of the wrong person. It's ashame. Wrong direction for the dept and company.

VP of R&D in ttn dismissed today

"Someone should put up red warning signs around diagnostics companies that warn potential buyers that DX is a unique business and that they best stay away".
Wish there had been such a notice round Amerlite before Kodak bought it.
Marketing and product planners at Rochester knew dick about IDX yet imposed a boondoggle of a new DX system (ECi) on the new company.
Getting it to work was like having sex standing up in a hammock. There was a much better way but Rochester wouldn't listen. Only thing it wanted was random-access, multi-assay fully automated.
Nor did common sense prevail when J&J bought it in near-bankrupt Kodak's firesale.
Decisions made on the golf course rarely make technical sense.

At the 2012 AACC meeting in LA you can count on two things.
1) Siemens will have largest booth
2) Booth will be filled with old Diagnostic platforms no one once anymore.
Just goes to show you that having money doesn't mean you have brains.
To date, Imaging, is the only shining star in Siemens Healthcare.

"If you don't think the culture fits your company, then PLEASE, for EVERYONE'S SAKE, DON'T BUY IT!!!!"
END QUOTE

Exactly. Anyone who had worked for DPC would tell you the company culture and employee's would never fit into the Siemens mold.
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.
It's my understanding the remaining 10% are just waiting for a final shutdown and a crappy package.
What I do know for sure is those I still stay in contact with in LA could care less about Siemens.
It's just one bad joke after another.
I have no doubt both Bayer and Dade employee's have similar
stories.
I'm based on east coast now (thankfully not Siemens!)and haven't heard anything about a new Siemens Platform. So if they're working on one it would still be "years" before it's on the market.
Big winners of the acquistion of Bayer, Dade and DPC were companies like Roche.

It's interesting that the same thing happened to Dade people during the Bain Capital years and the same thing happened in Tarrytown after Bayer bought Technicon. In both cases, Dade and Bayer walked away with a profit, but it wasn't a pretty picture for the employees, the customers, or the people who depend on getting decent medical care. I think the message is simple:

Stick to the knitting; stick with what you know.

Someone should put up red warning signs around diagnostics companies that warn potential buyers that DX is a unique business and that they best stay away.

I find all these Siemens DX threads so sad and such a missed opportunity. Literally, NO ONE won in all this - except maybe the former owners of Dade, DPC and Bayer-Scherring for "selling out". Customers, employees, management, Siemens, shareholders and humankind in general all lost something that could have made a difference in so many ways. Until large corporations understand that Mergers and Acquisitions are all about INTEGRATING THE CULTURES, we'll see more of this. If you don't think the culture fits your company, then PLEASE, for EVERYONE'S SAKE, DON'T BUY IT!!!!

The original Siemens strategy was sound, but incredibly poorly managed. It sounds like Siemens is working on a new system that will become the flagship of a new line of Siemens DX products. If development really goes well, and customer evaluations, early on, go well with little service interruptions, and the system gets a thumbs up, it can turn things around for Siemens and the long list of problems with shutting LA down to the FDA will seem like small bumps in the road. If, on the other hand, development goes poorly, things take alot longer than planned, reliability of the system becomes an issue, etc., then look for Siemens to try to sell DX off either piece by piece or all at once. In the latter case, they will have to be prepared to take a big loss since they will have no system for the future and very little in the way of high value employees.

It will be interesting to see which path will be the one for Siemens.

True, things have not gone well for DX the past 6 years. Wow, 6 years already. Going from #1 to #4 isn't exactly the great accomplishment Germany was shooting for.
I think the sad part is that nothing new has really materialized with DX. The same Centaur, Vista and Immulite. Actually I'd count out Immulite. It's basically already dead and Siemens sales-reps don't push it.
Centaur was supposedly the golden child but now with FDA problems it could really put a crimp in sales.
Walpole is a state of the art manufacturing facility so what in blazes happened?
Vista is a whole different beast. It's huge!
The cost of maintaining all these very different instruments basically negates any profit margin.
At our last Town Hall we were told up front we're losing customers and Siemens doesn't expect to get them back.
What a waste of money buying these companies.

First up, Siemens is not shutting down DX. Just a foolish notion.
Yes, Tarrytown, Glasgow, LA, etc. never needed Siemens. But, nontheless, Siemens bought them and has the right to do whatever they want to do with them.
So bad Senior Management, an ignorant middle management and uninformed/trashed employee's are the consequences of a company which has "no" experience in running a Diagnostic Branch.
Was it all for nothing? It would seem so. Just ask those who've already been let go.
What's on the horizon? So far nothing to speak of. Same old platforms.
What to expect? Customers will continue to leave.
The 2013 Agenda will be the big joke in 2014.
Siemens will eventually start selling off pieces of DX long before that happens.

The feeling is mutual. You say that Siemens doesn't need DX and I can assure you that LA, Glasgow, Tarrytown, etc., never needed or wanted Siemens. The fact that you seem to believe that Siemens can just write off their DX losses is completely offensive.

"What's the worst case about this whole FDA drama? Say Siemens would be forced to shut down entire DX operations and pay penalty. It's like your investment portfolio worth billions of dollars and less than 1% of it is Facebook stock. Unload FB may be not looking good, but it wouldn't not hurt you either. So to all the Siemens haters, just shut up and sleep tight."

This is typical Siemens arrogance....

Yes but if you are in THAT 1% of Siemens - you do care!

What's the worst case about this whole FDA drama? Say Siemens would be forced to shut down entire DX operations and pay penalty. It's like your investment portfolio worth billions of dollars and less than 1% of it is Facebook stock. Unload FB may be not looking good, but it wouldn't not hurt you either. So to all the Siemens haters, just shut up and sleep tight.

Was the NID thing about meeting product claims or development process and manufacturing change control?

Back in '06, NID was shut down and its parent company fined $300M over troubles with their iPTH assay on the Advantage. Some of those same NID people got hired by Siemens and now they are in trouble over the same thing.

Coincidence?

Yes, a letter was sent out to all employees from the CEO but it was long after everyone knew about it.
In genenral, employee's get better and quicker information from the the Mill than the Management.

Well, someone here has to be wrong. One poster says its been a while now with no company response. Another poster says that a company-wide email about the FDA letter went out to all employees.

You can't both be right. Once again, there is a difference between a response (any response) and the response you, as an individual, would like to hear.

"Of course it was on the net first. Like it or not, it takes a bit of time to assess a situation and decide how to present it to your employees and customers. If the memo went out before the letter became public you might be happier, but you'd be dealing with a knee-jerk reaction which generally isn't the best response in a crisis. Any mature management in any company takes time to evaluate first and speak later. If you don't like Siemens' response, that is a different issue."

It's been a while now...and no responses from the company.

Get real. Management knew of the issues within the letter. There is time to to assess and respond. Never ever should an employee hear of this kind of news from any source other than their leaders. That shows me a sign of poor management.

Of course it was on the net first. Like it or not, it takes a bit of time to assess a situation and decide how to present it to your employees and customers. If the memo went out before the letter became public you might be happier, but you'd be dealing with a knee-jerk reaction which generally isn't the best response in a crisis. Any mature management in any company takes time to evaluate first and speak later. If you don't like Siemens' response, that is a different issue.

When the info went out is the key here, and it was on this post before it went to employees.
Get a grip junior.

Siemens would rather send in reps that know nothing about this and get smacked in the head by on the ball customers than showing a little bit of transparency and let the reps know what's going on.

Well then they need to check their emails. The information went out to EVERYONE in the organization by the leadership team. Maybe too busy playing golf

SK is an a**hole.

Who is TA?

Pure speculation. You may be right, but there is zero concrete evidence to support your guess. Should I guess which competitor you are?

Yeah, the whistleblower, who spends his time and energy bashing all the companies.

SK? What about TA? Thay guy would be lucky to get a job and be able to say 'do you want fries with that?'

Perhaps their Vitamin D assay will save them?

The whole TTN is filled with arrogant, self serving bosses. SK is one of the worst VPs I have seen in ages.

I am not a competitor, in fact I used to work for siemens. When I read that letter I see it the same way.
When I first saw the letter last week I sent it to a few of my ex-colleagues and they knew nothing about it.
Siemens would rather send in reps that know nothing about this and get smacked in the head by on the ball customers than showing a little bit of transparency and let the reps know what's going on.
Quite a group of incompetents you have there!

"To me, that sounds like Siemens made a modification to the assay without adequate notification and validations to the FDA....To me, that sounds like Siemens made a modification to the assay without adequate notification and validations to the FDA...."

Pure speculation. You may be right, but there is zero concrete evidence to support your guess. Should I guess which competitor you are?

I wonder if the FDA will expand their warning to other assays, such as Troponin. I remember when they launched their new ultra-sensitive troponin for the Centaur and there were massive reports of false positives due to heterophile interferences and within two months, there was a reformulation to remove the heterophile cross-reactivity. To me, that sounds like Siemens made a modification to the assay without adequate notification and validations to the FDA....

uh-oh!

be scared and like the last poster said-run.
You have to be able to get a better job with a
better company.

run!

I am going for a Job interview to Siemens Dx, Walpole next week. All this about Siemens Dx scares me. Any advice?

don't worry, Mary Lou will fix

You may be right that the findings are worse than the letter indictes. MR can make decisions about how to deal with the FDA. Unfortunately, between Siemens and Bayer, the talent required to pull this new project together (the FDA project) were all laid off or left out of frustration. Some may even be employees of yours now. Siemens will need the kind of people who know how to organize an effort like this, quickly grasp what the FDA wants to see happen, and then actually make it happen and do it well in a crisis mode. Tarrytown had many people like that in the 'old days'; I doubt they have any at all now.

We can speculate on much of this for weeks. The devil, as usual, is in the details and whatever is transpiring now in talks between Siemens and the FDA. But from an outsiders point of view, it's just fun to watch another bunch of arrogant executives who thought that running a diagnostics operation would be easy and the money would just come rolling on in, now having to squirm and not even have a clue as to who to turn to in order to get them out of this mess and get them moving forward again. Whoever they call, the first number they enter on their phones should be a nine.

Under normal circumstances I would agree with you.
But this isn't one of them.
It's well known the FDA was at Tarrytown and Walpole for several months before coming out with the letter. In this industry everyone knows everyone.
Manufacturing inconsistencies, incomplete paper trails and QC issues are just the beginning of a long, dragged out FDA search process. Admittedly, I don't know all the findings but this is no slap on the wrist.
MR can be as forthcoming as he likes but, truth is, he knows nothing of this business, these sites and the can of worms he's now in the middle of. Several ex-Siemens middle management are working in my lab now.
Heads will roll on this one. Customers lost and R&D projects shutdown will also cost DX months, if not years, of potential growth. This is a no-win scenerio. DX employee's thought things couldn't get any worse a year ago.
How long do you think Siemens will put up with the ongoing financial loss and horrific reputation generated by DX?
The DX venture will continue to be one of the largest financial losses in Siemens long history.
My lab has already replaced both Centaur and Immulite platforms and moved on with companies we have greater faith in.
The employee's who came from Siemens often tell me how happy they left when they did.

Here is a possible scenario:

The FDA letter actually does turn out to affect a number of different methods. All of the issues continue to be about documentation and following FDA development and manufacturing rules. Siemens comes back to the FDA with a plan to provide all the information the FDA requires and to implement whatever changes are necessary in their internal processes. They also provide a schedule by which date various parts of the plan will be completed. Since there does not appear to be an issue with manufacturing a product that meets the product labeling claims (at least for now), Siemens will be allowed to continue to market these products as long as they continue to make satisfactory progress in correcting their deficiencies. As long as the actual product coming out of Walpole is a) meeting claims, and b) substantially equivalent to competitive products, this is one possible outcome. The key will be for Siemens to maintain an attitude of cooperation and humility (basically, thank you, FDA, for pointing out our problems and helping us to correct them and be a better company, yadda yadda yadda) and the actually act on correcting things.

When Abbott was caught with problems years back, they were not only uncooperative, they were downright feisty in their attitude and more or less told the FDA that they were irrelevant. With Beckman, the problem was that they were unable to manufacture the product that would meet its claims. As I recall, that FDA letter arose out of a series of customer complaints about defective product. The situation with Siemens is altogether different and they should be able to negotiate a reasonable settlement with the FDA, perhaps, worst case, have to pull a couple of assays until they can supply the data to obtain clearance to market them again. The big impact will be with ongoing projects in R&D, and maybe some overtime at Walpole to get these additional things done. It is definitely not fatal.

Very much like the IRS, the FDA will be quite accomodating if you simple show a willingness to cooperate and do what is required. With the IRA, simply telling an investigator that you a very willing to pay whatever amount you really owe, will generally avoid any penalties (unless fraud is involved). With the FDA, punative action generally does happen with cooperative and humble companies.

Another big decision for MR. Humble or arrogant? Straightforward or Town Hall evasive and spin?

Did Management announce which Centaur kits will be affected?
If the FDA calls for more data on existing released kits this could be a very long process.

You're absolutely correct regarding R&D being gone. Maybe a handful on east coast. Nothing left in LA (despite the silliness of one "demoted" Department Head telling everyone "we are the experts". My goodness. My contact there told me they nearly all vomited when he said it at a town Hall. Some people never learn.
Tarrytown and Walpole have their handsful getting out of this mess.
As someone else mentioned, the ripple effect will hit all of DX on both coasts.
I fully believe expected sales will continue in the double digit negative for the foreseeable future.
The FDA bows to no one.
This is a good time to get your resume updated.

I'm not sure what remains of the R&D group from Dade that helped make them a leader in clinical chemistry. The Syva component of Dade, the group that invented and developed LOCI is basically gone. DPC R&D no longer exists. Whatever talent existed in Tarrytown was laid off during the Bayer years as revenge for the failure of Advia IMS. The Massachusetts R&D group that developed acs-180 and its successor, Centaur, is gone as well. Only a few of them stayed on after the Bayer acquisition.

Are you surprised that R&D doens't have a clue?

What surprises me is that DH is getting criticized for this. As I recall, DH was a marketing/sales guy from the UK, and was pretty good in that position. Whoever had the brilliant idea to involve him in R&D, which is just not his cup of tea, should get the blame. When a fish out of water dies, do you blame the fish or the person who drained the fish tank?

Siemens obviously doesn't care about this business unit. They drove off the competent leaders and installed Mikey.
All the management from the region managers on up are a kissers that haven't a clue how to manage sales.
Now we find out that the R & D is as clueless as everyone else and they throw up Dave Hickey to spout some of his nonsense.
As I've said, now that I'm on the outside this is all very entertaining.
It's kind of like watching the Titanic sink. Sad, but interesting nonetheless.

Are those responsible for this letter malicious towards Siemens DX and trying to get the FDA to stick their nose in its business? And are things so bad at DX that this tactic was actually the morally correct thing to do? It's like waving a red cape in front of a charging bull. I simply can't believe anyone in Quality and Regulatory could be that incompetent to pull such a stunt - it was either done for malicious purposes or for a morally higher purpose...

So true. My jaw dropped as well. In my company, a warning letter alone would get people fired. Incompetence in responding late or inappropriately would get the whole dept fired. This is inexcusable. Don't believe they understand the gravity of these actions.

"Town Halls"

Sounds like they hired the same damage control firm as Beckman did.

Becmank then implemented the WIG system to covertly keep people "on message" in front of customers.

ugh, shutup about politics!@#$

"Remember the old saying: Everybody can be bought, it's just matter of price." END QUOTE

Don't be silly. The FDA will not be bought by Siemens.
But Siemens will be losing additional business added on to the loss already generated for the quarter.
That much is a given.
Maybe a few heads will roll but, sorry to say, not MR's.
They eventually will have to start selling off pieces of
DX "if" they can find a buyer.
Just too many relatively old platforms to maintain.
The next few weeks should be very interesting.
Damage Control and Town Halls are already scheduled.

"At DX, we have an unwavering commitment to upholding the highest quality standards and are working diligently to address the FDA's concerns. Quality is not just about the absence of defects or mistakes—it’s about recognizing and solving problems. It’s about improving our products and services to best meet the needs of our customers and the patients they serve. "
MR

AHHHHH HA HA HA HA HA HA HA
AHHHHHH HA HA HA HA HA

Glad you mention Scooter Libby, who was disbarred and convicted of a felony of leaking covert identity of a CIA officer, and that's the consequence I'm talking about.

Read the news (from left or right), some people from the president's inner circle will be indicted too.