Frustration - New to the Medical Device field, I come from generic pharmaceuticals

A

Achemd

#1
I am new to the Medical Device field, I come from generic pharmaceuticals. I am not sure how to phrase this, but where I am there appears to be mass chaos. There is no understanding of GMPs and wow there is even a very well educated Analytical Chemist that does not understand rounding to significant figures. I guess my question is, do I stay in the medical device field or will I just get thourougly frustrated becasue of my pharmaceutical background? Looking for some insight as I cleary can not stay where I presently am and I do not want to repeat this mistake if I stay in this field.

Please advise.
 
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GStough

Staff member
Super Moderator
#2
Re: New to the Medical Device field, I come from generic pharmaceuticals

I can empathize. My background is in class I and class II medical devices (spent 13 yrs there), and everyone was fairly well-versed in GMPs and such. My present location is a class I medical device manufacturer, but this medical device is only one product family of the hundreds of other product families we manufacture that are NOT medical devices.

The culture shock was significant, :mg: but after a couple years here now, I've adjusted by just getting my head wrapped around the notion that the product (here) is not used in as critical an application as what I had been accustomed to in the previous life. And because for so long the people here had not dealt with medical devices before (this product is relatively new to this facility), it's basically been a learning process for everyone.

Give it some time and talk to people and see how it goes. Would be interested in an update in a future thread. :bigwave:

Good luck!
 
Q

qualeety

#3
Re: New to the Medical Device field, I come from generic pharmaceuticals

I am new to the Medical Device field, I come from generic pharmaceuticals. I am not sure how to phrase this, but where I am there appears to be mass chaos. There is no understanding of GMPs and wow there is even a very well educated Analytical Chemist that does not understand rounding to significant figures. I guess my question is, do I stay in the medical device field or will I just get thourougly frustrated becasue of my pharmaceutical background? Looking for some insight as I cleary can not stay where I presently am and I do not want to repeat this mistake if I stay in this field.

Please advise.
Few questions...if you don't mind

1. you are frustrated because of incompentency of your surroundings? or because of your inability to accept things as is and unable to make changes?

2. you cannot stay with current company...elaborate why you cannnot stay.

3. why did you move to the medical device field?...what made you move from generic pharmaceuticals?
 

SteelMaiden

Super Moderator
Super Moderator
#4
Re: Frustration

Can you help to make things better?
Do you like, or could you like what you are doing?
Is the company ripe for change, and do they want to change?
Do you like the people you are working with?
Are you willing to change?
Did you have any idea what you were getting into when you took the job?

If the answers are yes, then you will probably adjust.

If the answers are no, you will proabably be miserable until you quit or are fired.

Sorry, that sounded harsh. good luck.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Re: Frustration

Why is the Analytical Chemist expected to round to significant figures?

It probably seems like a silly question, but I get the sense this company's QMS is in an early development stage, or at least some people are insulated within it. Which do you think is true?

There are lots of "young" QMS systems out there. I've been in one, and I share your sense of exasperation. (I only lasted four years there) I would not assume the troubles are industry related, though I do expect there are a good number of them with little undersanding or appreciation of quality management needs. Just look how long it's been taking to manage quality problems in medical delivery--the discussion is still on dealing with handwriting prescriptions. :mg:

The problem is, of course, that it can be hard to tell just what the situation is until you're in there. So every new job is a roll of the dice.
 
A

Achemd

#6
Re: Frustration

Few questions...if you don't mind

1. you are frustrated because of incompentency of your surroundings? or because of your inability to accept things as is and unable to make changes?

1 - I think both. I believe that for class 1 non exampt and class II products there should be a basic level or GMP. The company is small and so many people doing numerous jobs and they are a new devision spun off from commercial/industrial side with that mentality.

2. you cannot stay with current company...elaborate why you cannnot stay.

2- covering Reg Affairs, and quality on medical side. Found out I have to cover quality on the industrial side and there is no one here for GMP training and auditing so as quality I will have to cover that and document control. Trust me, I do not mind the work but spread so thin each job will be sub standard and I don't know if I can accept that from myself.

3. why did you move to the medical device field?...what made you move from generic pharmaceuticals?
3 - Had to relocate with significant other and stupidly took first job offer
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Re: Frustration - New to the Medical Device field, I come from generic pharmaceutical

So, you have plopped yourself in chaos. What to do?

If you like to be surrounded by order and don't want to wear the spurs to establish it--if you don't want to try to build a robust system there, then seek other placement.

If you don't believe the people there are serious and want a system that works--if they will want YOU to be the system, then seek other placement.

If you are willing to take the wide-angle look at this situation and build a functioning, though not perfect, system, then take a deep breath and make a project plan. I don't know what else is on your resume, but establishing a QMS is pretty good stuff in there. If that's what you want, and for the right reasons. It's not just a job, and the result is not just a resume. It's the people you leave behind with your work when you go. Our best assets are our intellect, empathy, self esteem and reputation. If you look at this thing hard and see it for the people and then decide to stay (that's why so many teachers stay in education) you could pull it off.

The forces may work against you. It's not all about your strength of will. If upper management does not desire and support your efforts then there is no reason to make them.

So, think about it awhile; look at your options, make your move and don't look back. :2cents:
 

BradM

Staff member
Admin
#8
Re: Frustration - New to the Medical Device field, I come from generic pharmaceutical

Aside from the excellent advice already offered, I'll pitch in just a bit.

Things like GMP and procedures on how to round are generally found in regulated environments. People follow them because they have to.

The company you are in now are not following them because they don't have to, or don't know they have to.

Did you happen to see the movie Shawshank Redemption? Morgan Freeman's character had been in prison for so long, that he did not know how to operate in the Outside World when he was free. He had wanted his freedom for so long, that once he got it, he could not handle it.

It could be possible that you have been trained so stringely in a set of requirements that you may feel that is the way things are done. Your new company may be OK not doing those things.

Do some research and find out if your present organization must be following GMP or GLP. If so, you may need to pitch that to the managers. If not, free yourself from that previous life, and open your mind to a new and possibly interesting way of doing things.

:2cents:
 

Statistical Steven

Statistician
Staff member
Super Moderator
#9
Re: Frustration - New to the Medical Device field, I come from generic pharmaceutical

As a consultant in all 3 GMP regulated industries (medical device, pharmaceutical and biotechnology), I can tell you that there are MAJOR cultural differences in the industries. The medical device industry is a risk based management system for quality with its own QMS based on ISO13485. Ironically, I have found that most people who go from medical device to pharma have a tougher time being as detailed oriented as needed. No need to get frustrated by the chaos at a medical device company, I would just become as familiar with ISO standards 13485 and 14971. Hope that helps.
 
G

Gert Sorensen

#10
Re: Frustration - New to the Medical Device field, I come from generic pharmaceutical

Now, I've been in the Medical Device field for a few years now, and, BOY do I know how you feel. To put it bluntly: If you don't like frustrations, find other employment. A lot of companies in this field has been started in someones garage, and the general feeling is that what was good enough some 20 years ago is still good enough today - and all this paperwork that "you call a QMS" is just a waste of time.

Sadly, that's my experience, but for the time being I fight the battle - with a high degree of stress, i.e. high bloodpressure, sleeplessnes, burning sensations in the chest etc......

Anybody want to trade jobs?
 
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