According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
AN>
Recently I had a long discussion with a friend of mine about Managers and managing. She is a former HR Manager for several major companies and was bemoaning the fact that training for managers has been cut back so significantly in recent years and tha
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
managers no longer receive the type of help, guidance and assistance that they received just a few short years ago. My background has been in retail and telecom. Hers was neither. Yet the same problems and issues seem to rise in every industry. Of course, this is exactly the reason that I got into coa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hing.
Coaching allows those managers who want to improve a very personalized venue to do just that.
We went on to agree that the common pattern these days seemed to be here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
">
for the department star performer to be promoted from contributor, to team leader, to manager in seemingly record time. We agreed that new managers have difficulty moving from the contributor to the manager role because no one is willing to spend the time and energy to coach them through the various hurdles that new managers and leaders face.d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
mso-spacerun: yes"> We agreed that this lack of training never seemed to lower the expectations of the manager, just the performance.
Then we disagreed, strongly. What caused the di
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
agreement?
The
concept was micro-management. My friend explained to me that she has "coached" many employees recently and that many of them complained about one particular manager who was m
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
icro-managing them.
She told me that she helps the employees understand and come to grips with "their problem".
"You're not going to be able to change that manager, she explained to me, "so you've got to change the employees".
She explains to them that if they are being micro-
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mso-fareast-font-family: 'MS Mincho'">managed, there's probably a reason for it. They are probably doing something wrong. If they just identify that problem and improve, their manager will stop the micro-management. "The employees need to improve themselves.and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
cerun: yes"> It's as simple as that."
I wish my life was as simple as that.
She acknowledges that with that m
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ny employees complaining that
it's likely the manager is the problem. But changing the manager is too much trouble, she says, so let's tell the employees it's their fault.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
GIN: 0in 0in 0pt">
While it is true that it is sometimes necessary to micro-manage
people, her explanation makes little sense to me. You might micro-manage
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
an employee if their performance is lacking.
Or because the project they are working on is very high visibility and any chance of error must be minimized.
But when a number of employees are complaining about the same manager micro-managing them it implies one of two things.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
0in 0pt">
Either this manager:
1. Has a lot of problem employees and needs to start weeding tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ncho'">
them out, or
2. This manager does not know how to let go and properly
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
'">
delegate to their staff.
Excessive micro-management is not the sign of a healthy manager.
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
">When someone is constantly micro-managing their staff it's generally their problem, not the employees.
If you are micro-managing your staff, refusing to delegate routine, and not so routine tasks to them for completion, then you are setting yourself up for trouble.y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
AN style="mso-spacerun: yes"> Have you ever heard yourself say, "I would delegate this to someone else, but it's just as easy to do it myself"?
Or maybe you say, "This task is too complicated to delegate.
I have to make sure it's done right."
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
o-fareast-font-family: 'MS Mincho'">If so, I hope you like your job. Because you aren't going anyplace higher. Delegation can be difficult to learn because it looks like a huge risk and a huge leap of faith. But it doesn't have to be that way. <
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
SPAN>There are techniques that you can learn that will help you delegate and get you out of the detail. And you have to get out of the detail if you really want to be an executive.
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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