Advice You - Business

Have you ever noticed when you are in traffic and in a hurry to get somewhere, it is almost impossible not to creep up closer to the person in front?

It is as if there is a force field around the front bumper of your

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

vehicle and that by creeping up to the car in front it is possible to push their car faster so that we can get where we want to go quicker.

But have you ever thought what happens when someone starts to creep up too

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

lose behind your own car. Do you accelerate away smartly leaving them to catch up? Or do you slow down?

The fact is we are all human beings and the human reaction to being pushed in one direction is to resist or t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

push back in the opposite direction. (Remember what happens when a teenager is told to clean their room?)

If someone is trying to make us hurry up by driving too close we will almost invariably resist by slowing do

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

wn. Even when we know this, we ourselves will still drive too close to the person in front when we want them to go faster and as a result we become even more frustrated when they slow down.

Our own behaviour is cre

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ting the conditions for our failure.

Fifty Years ago there was an American Business Guru called Douglas McGregor. Douglas McGregor was in the van of a growing band of enlightened management savants who appreciated t

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

is aspect of our behaviour and realised that most of the problems to do with lack of morale and performance at work are directly created by the way that managers behave towards their workforces.

To explain how this w

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

orks McGregor coined the two terms, “Theory X” and “Theory Y”

“Theory X” being the model that describes the management behaviour that creates problems and “Theory Y”, the model that, recognising the problems created

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

y the directive “Theory X” manager, creates the environment for the workforce that allows them the space they need to work as well as they can.

To explain these models briefly, “Theory X” management assumes that the

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

orkforce is lazy and ignorant and would rather do anything except work. The job of the “Theory X” manager therefore is to drive the workforce to do their work, to create an environment in which it is so difficult for

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

the workforce to avoid work that they have no option but to work. This is seen as the traditional role of the manager by both the manager and the workforce.

“Theory Y” on the other hand assumes that the workforce is

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

skilled and experienced, is willing to share that experience and take pride in what they do. The job of the “Theory Y” manager is therefore no longer to tell the workforce what he thinks they ought to be doing. The “

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

heory Y” manager’s job is to create the environment at work that will allow the workforce to take pride in what they do and to give them the support that they need.

The difference between the two models is the huge d

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

fference it makes to the way the workforce feels about what they do, and therefore their ability to do their jobs.

The problems occur when a creative and motivated workforce, is treated as if they are lazy and ignora

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

nt by a “Theory X” type of manager.

Predominant management behaviour, learned from our peers or from schools, is all about what managers can do to drive the workforce to perform better. The “Theory X” management stra

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

egy.

What Douglas McGregor shows us is that “Driving” performance is actually the management behaviour that causes poor performance and bad attitude.

The lesson from Douglas McGregor and “Theory Y” is, if you want t

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

get there quicker, if you want to increase the performance of your own organisation, stop pushing the people who actually control your organisations ability to perform, the workforce.

If you want to go faster, Slow

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

down!

Try the “Theory Y” approach next time you are stuck in traffic.

The more space you give to the people in front the quicker they will go. When we slow down we give the driver of the car front more space. He wi

.

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

l stop feeling as if he is being pushed and will therefore speed up, By allowing the driver in front to feel that he is not being pushed we will get where we want to go quicker.

At work it is the same. The less di

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ection and control the manager imposes on the workforce, the better they will perform.

Give people the space they need to do their jobs. You will be amazed at what happens.

Peter A Hunter Author Breaking the Mould

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/20406/adviceyou-How-To-Get-Where-You-Want-To-Go--Quicker--By--Going-Slower.html">How To Get Where You Want To Go - Quicker - By Going Slower!</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/20406/adviceyou-How-To-Get-Where-You-Want-To-Go--Quicker--By--Going-Slower.html]How To Get Where You Want To Go - Quicker - By Going Slower![/url]

Most small business owners don't really know what business systems are. They think they are expensive computer hardware and software. Expert author Michael Clark share what they really are and how they are absolutely essential for small business success.

Virtually every organization encounters customer complaints from time to time. Sometimes it is easy to get caught up in the complaints and to lose track of how many satisfied customers say nothing at all. Even worse, sometimes it is hard to remember just how valuable a customer complaint can be to the organization. Contrary to how it may feel to be the recipient of a customer complaint, it is a wonderful opportunity if embraced with commitment and integrity. You can turn customer complaints into valuable assets.

It takes courage to examine what we are doing and where we are going. But if we honestly stop and think about it and then pull out of those non-productive activities and rectify those poor decisions we have made in the past, we will never look back.

Tags

Links

Advice You - How To Get Where You Want To Go - Quicker - By Going Slower!

Related Articles: