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Digg It - Are You Managing to Lead?
For many people, the terms "manager" and "leader" are synonymous. In the business world, they are often used interchangeably, i.e. "team leader", "team manager", "project manager" - you get the idea. And
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
why not? After all, leaders and managers do basically the same thing, right?
In some instances, there do seem to be commonalities between the two and management techniques are sometimes confused with
In some instances, there do seem to be commonalities between the two and management techniques are sometimes confused with
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
eadership traits. However, there are, I believe, some key distinctions to be made that radically separate the two.
Here then, are what I consider to be some key differences between a leader and a m
Here then, are what I consider to be some key differences between a leader and a m
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nager:
1. A manager administers. A leader innovates.
Managers take policies and procedures and ensure that they are carried out. Leaders are constantly challenging the "status q
1. A manager administers. A leader innovates.
Managers take policies and procedures and ensure that they are carried out. Leaders are constantly challenging the "status q
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
o" to achieve bigger and better things.
2. A manager maintains. A leader develops.
As long as things are running smoothly, the manager is typically happy. The leader is never sa
2. A manager maintains. A leader develops.
As long as things are running smoothly, the manager is typically happy. The leader is never sa
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
isfied with the "status quo" or "the way we've always done it". Leaders are constantly asking for more and bigger things - of themselves as well as those they lead.
3. Managers rely on control
3. Managers rely on control
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
Leaders inspire trust.
Managers can feel threatened by subordinates who don't seem to be "towing the line". In doing so, they create a co-dependency in the subordinates who, in turn, rely
Managers can feel threatened by subordinates who don't seem to be "towing the line". In doing so, they create a co-dependency in the subordinates who, in turn, rely
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
on the manager to dictate nearly every step of the process. Leaders know how to tap into the inherent strengths of those they lead and then foster those strengths to the benefit of the organization.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
RONG>4. A manager has his eye only on the "bottom line". A leader has his eye on the horizon as well.
In orienteering (using a map and compass) you must set your sights on a distant object
In orienteering (using a map and compass) you must set your sights on a distant object
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
o get an accurate bearing. If you take only short-range sightings, it is much more likely you will stray far off the right course. In the same way, "bottom lining" only without also "visioning" can result
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
in ending up at a destination you did not plan on.
5. The manager imitates. The leader originates.
While using "tried and true" methods isn't always a bad thing, someone else's met
5. The manager imitates. The leader originates.
While using "tried and true" methods isn't always a bad thing, someone else's met
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ods may not be exactly right for every organization. Leaders aren't afraid to try new, and even unorthodox, methods to achieve optimum results.
6. Managers focus on product. Leaders focus on
6. Managers focus on product. Leaders focus on
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rocess.
While still holding to the principles of quality, productivity and efficiency, the leader is able to recognize the effort as well as the "end-product".
7. Managers need lo
While still holding to the principles of quality, productivity and efficiency, the leader is able to recognize the effort as well as the "end-product".
7. Managers need lo
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
s of positive feedback. Leaders have an innate sense of their own self-worth.
Everyone likes a "pat on the back" for a job well done. However, managers rely heavily on things like "performanc
Everyone likes a "pat on the back" for a job well done. However, managers rely heavily on things like "performanc
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e reviews", "appraisals" and "kudos" from their supervisors and their subordinates to demonstrate a job well done. They also tend to rely heavily on those tools as motivators for their subordinates.
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
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
RONG>8. Managers need subordinates. Leaders strive to develop other leaders.
Leaders are always in the process of developing other leaders. Managers tend to feel very threatened when they pe
Leaders are always in the process of developing other leaders. Managers tend to feel very threatened when they pe
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ceive someone may be "passing them up".
9. Managers tell "what". Leaders share "why".
The manager is primarily concerned with simply giving the steps to achieve the desired result.
9. Managers tell "what". Leaders share "why".
The manager is primarily concerned with simply giving the steps to achieve the desired result.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
The leader also takes the time to explain why those steps are crucial to the desired result. In doing so, the leader is also imparting his "vision" to those that help make that vision a reality.
.
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
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
NG>10. Managers are more concerned with doing things right. Leaders are more concerned with doing the right thing.
Managers tend to be very "order" and "structure" oriented. Leaders have a ke
Managers tend to be very "order" and "structure" oriented. Leaders have a ke
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
n sense of the "spirit of the law" and aren't afraid to "bend" the rules if it will achieve a greater good for everyone.
Copyright © 2002, Monty J. Sharp
Copyright © 2002, Monty J. Sharp
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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