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The dictionary defines power as “control and influence exercised over others”. With positions of management, and leadership, comes power and it seems to sit more comfortably with some than others. It is increasingly recognised that organisations need good leaders if they are to go forward successfully. Their people wi

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

ll feel motivated, empowered and want to contribute. Leaders who are not using their power positively and abusing will act in a way which will be coercive and, in extremes, could be bullying. This latter situation is one which appears to be on the increase and is creating further problems in the workplace such as stress. Thi

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

Examples of combination products may in

s article will look at what is “power” and how it can be used productively. We want to consider how leaders can become more confident in their positions and with their power and explore the benefits for all parties when they do.

Power tends to corrupt, and absolute power corrupts absolutely. Lord Acton

There are two

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

elements of power in an organisational context – “position power” and “personal power”. The leader has “position power” given from the organisation. This comes from the authority which the job role has to do things or make things happen. The “personal power” is about the degree of influence the individual has and is given by

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

the followers. The two are interlinked to an extent. People will look to the leader’s “position power” and give them a degree of “personal power” based on how they perceive the leader might influence them. Equally, when organisations are looking to promote someone, the more aware ones will look to see how well individuals c

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

Combination pro

an seem to influence others around them – and give them some “position power”.

Problems arise when people are put into roles where they have considerable “position power” but feel out of their depth and under-confident. What starts to happen is that they feel a need to cover their discomfort and they begin to do this by abusi

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

ng the power they hold. Over my years of working with organisations, I have heard and seen so many examples of poor or inappropriate behaviour from various levels of management and leadership. This is despite the amount of training which many of these people have participated in! I wonder how many times you have been on the

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

receiving end of such behaviour? More to the point, how many of you have been guilty of using them? Sometimes, these abuses of power are obvious:

shouting, screaming even, at staff;

threats being used;

unreasonable demands;

intimidating body language;

being a time-stealer to

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

staff;
setting unreasonable levels of expectation, etc.

The list can go on beyond this – and could expand to include some less obvious behaviours. Why is it that so many previously reasonable people can start to behave so unreasonably? Experience suggests that one factor is that they are often merel

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

y carrying on a trend from their bosses! If there are not good role models, it can be difficult to behave correctly. However, this is something of an excuse. What is really going to be achieved with abuse of power? The daily reports of problems with bullying in the workplace, increasing stress-related problems in the workp

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

lace are clear indicators of that this is an on-going issue.

The consequences for the organisation, and the leaders, can be significant. There are probably issues with productivity and effectiveness, absenteeism (or just presenteeism!), and possibly staff retention is also a problem? If these things are happening, there as a

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

Following aspects would a

potential for a vicious spiral – the manager feels under more pressure and passes this on with even more inappropriate use of their “position power”.

The flip-side is to consider what can happen when the leader is able to use their power in a constructive manner. Why are they able to do this? Partly it is because they are c

dd to the challenges in developing combination products:

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

omfortable with their “personal power” and adjust to the additional “position power”. Maybe they have the right role models, or suitable training. They do recognise that they can get more from their people by supporting and encouraging rather than coercing!

Power does not corrupt. Fear corrupts... perhaps the fear of a lo

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

ss of power. John Steinbeck

For me, this quotation says a great deal about the two types of leader – the abusers of power are frequently out of their depth in their role. They fear losing their position and the likely loss of face, status and money. They do not feel that they can ask for help or support to improve the w

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

ay they operate. Possibly, they believe it will be seen as a sign of weakness and so they aim to compensate with what they think is a show of strength.

Leaders have a right to ask things of their followers. There are many different ways they can go about this and there is no, one right way. At times a leader may need to be

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

more directive and authoritative – at others more inclusive and supportive. Whatever the situation, the leader still operates from “position power” – and the good one, remains aware of their own “personal power”.

When you are in a position of leadership, stop and think about how you behave with those you are leading. You wil

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

Professional from academic institutions, pharmaceutical industries, health care indust

l gain far more “personal power” by treating people with respect – and earn it in return. Accept that with your position comes responsibility. Regardless of how your bosses may treat you, or colleagues treat their people, it is no excuse for you to abuse your power. Remember, the most effective way to engage people and to ge

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

t them to work with and for you is to treat them as they want to be treated!! Pay attention to your behaviours and notice if you have any tendencies to make unreasonable demands or revert to authority to get things done. How difficult is it to think about the other person first and then ask for what you want in the most appro

.

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

priate way?

As a leader, you have a choice about whether you abuse or use the power you are given. Many who are abusing their power do not always realise that they are doing it, or why. The reason is usually that they are struggling in their role. If you find yourself slipping towards this, do something about it! Think abo

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

Companies that provide selfless information through particip

ut what is making you feel like this and identify what areas you want to improve or develop. Now go and find out how you can get the support or training you want and go and ask for it. Learn to be comfortable with your power, both “position” and “personal” and you will be pleasantly surprised what you can achieve as a leader!

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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