Main Subject - Business

More and more I hear and read about a looming crisis of leadership at the middle management level and the inevitable resulting increase in, poor performance, accidents and production mistakes and hence declining pro

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

fits.

I’m afraid to say these observations are not just rumours. In my own work as a management consultant I’ve noticed a distinct increase in negative behaviours in many middle managers in all sorts of companies.

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

Examples of combination products may in

In this short article I’ll explain what I mean by “negative behaviours” offer suggestions on what senior managers can do about it.

Over the past four years I’ve noticed the following kinds of behaviours from many 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.

ddle managers:

· Increasingly using harsh, abrupt language: “Don’t be so stupid”. “I don’t care what the problem is just get it fixed”

· Becoming more dictatorial (unwilling to listen) “Yes, I know all that now 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

it this way”

· Putting time pressure on people by continually asking when jobs will be completed and why things are taking so long

· Losing tempers and insulting others when things go wrong

· Unwilling to take th

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

Combination pro

time to read, seek advice and think things out carefully

· Creating a them and us culture: “We decide and direct and you do”.

· Using more of the fear factor: “Perform or you’re out”.

If you’re a senior managers

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

reading you’ll be disappointed and even shocked. The tragedy is that the middle managers I meet are excellent people – they are not behaving like this on purpose. When you point out the danger and destructiveness of

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

these behaviours they acknowledge it and change for a few days. However, in a few weeks they forget and go back to unhelpful behaviours. Why?

In a nutshell, middle managers are under more pressure to perform than

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

have seen in a long time. For example, · In the past five years, levels of management have been stripped out resulting in middle managers doing more and more. · The constant downsizing, having to apply “for your

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

wn job” and frequent relocation have numbed many people. Some just don’t care anymore. · Many middle managers are now forced to be contractors and work in a culture where “you are only as good as your last job” and

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

loyalty and long-term thinking is not seen to be valued.

Middle management is now overstretched to breaking point both physically and mentally, hence the behaviours listed above. This is having an adverse effect on

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

Following aspects would a

the supervisors they manage and in turn on al their people. Another tragedy is that most middle managers won’t own up that they are under this pressure. So senior managers don’t know about it.

For me it’s the effec

dd to the challenges in developing combination products:

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

ive leadership of senior managers that will prevent the coming crisis. Here are just six straightforward steps senior managers should take now.

1. Initiate a short, anonymous survey to measure the extent of pressur

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

on middle managers.

2. Take even more time to discuss in detail the workload and targets of direct reports. Probe to see if people are accepting unreasonable workloads just to please you as the boss. Make sure you

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

r direct reports do this with their people too.

3. Deliberately create situations where you as a senior manager can admit that you can’t cope and need help. People will not own up if you don’t do it first.

4. Find

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

ways to show middle managers that you value them as people not just a resource. Especially when they are non-core staff. Yes, short-term contracting as a mode of employment is increasing but that doesn’t mean we sho

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

Professional from academic institutions, pharmaceutical industries, health care indust

ld treat managers who are contractors as less valuable than full time staff.

5. Provide the time for management training.

6. Here’s the toughest of all. When the Board trims the budget for a project and you’ve str

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

ggled to find ways to do more with less and you realise you can’t, you should tell them. This is the ultimate source of unreasonable pressure. Don’t allow it to flow down hill.

Yes, we need a leaner business model

.

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

or the modern competitive and fast-paced economy. Yes, we must keep pushing for better performance from everyone. But does lean have to be mean – do we have to lose the human touch? Indeed, doesn’t success in this e

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

Companies that provide selfless information through particip

a require senior managers to be even more human?

Copyright (c) 2004 Dr William Robb. Electronic distribution to ezines, friends and colleagues permitted but publication in print prohibited without written permissio

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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