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“If you have a job without aggravation, you don’t have a job.” Malcolm Forbes

Teams need to have reasons for taking responsibility. They also need to be given the authority to act on the responsibilities handed down to them. And they need to have c

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

onsequences if those goals are not met. It would be nice to think everyone is motivated to be an exceptional employee strictly out of personal integrity. And in many instances that is the case, but not always.

Are you sure everyone on the team unde

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

Examples of combination products may in

rstands their individual roles, goals and objectives? In my team building seminars, team members often confide to me they don't know exactly what their job responsibilities are, or even the main goals of their organization. Has it been clearly exp

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

lained to them what their job responsibilities are, and where that fits in with the organization’s big picture objectives? Has each team member participated in leadership and team building seminars? Do they walk away with action plans for accountabi

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

lity? Is this information specific, measurable and in writing?

By having quantifiable goals in writing, it makes it harder for the underperformer to be able to say, “Well, you’re just picking on me.” No, you’re not picking on them. Not if you’ve ma

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

Combination pro

e their responsibilities clear, measurable, and in writing. And not if they’ve been properly trained and given authority to take initiatives and responsibilities. Good managers and team leaders understand the importance of explaining the mission/pur

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

pose of their organization, and where each individual fits in.

So what are the reasons teams don’t want to take responsibility? In conducting team building seminars worldwide over the past decade, I pose this question every day to team leaders and

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

managers, as well as team members. Here are the 12 most common reasons (not in any particular order) I hear over and over for why teams won’t take responsibility.

1. Weak leadership.

2. Not being specific with each team member’s responsibilities.

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

No clear goals or objectives in writing.

3. Lack of skill or possessing a negative attitude on the part of a team member. Sometimes that person won’t even admit it.

4. Too many people with similar leadership styles. For example, too many “drivers”

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

who each want total control. Or, too many “relaters,” those who are very people oriented, or who are not task oriented enough.

5. Fear of failure.

6. The “I don’t get paid enough to worry about that” type of mentality.

7. They don’t get along a

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

a team.

8. Some just don’t want the responsibility. They simply don’t want to do the work.

9. Attendance problems or team members who aren’t dependable. For example, a team member who doesn’t show up, and may not even call in sick right away.

10

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

Following aspects would a

. Loss of focus, lack of direction.

11. The excuse, “I’m in a union and it’s not in my job description.”

12. Lack of training. Both training in the area of hard skills as well as conflict resolution/communication, and team building seminars.

Look

dd to the challenges in developing combination products:

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

closely at number one. It says “weak leadership.” The number one reason I hear from my participants in team building seminars for why teams won’t take responsibility is “weak leadership.” And this answer FREQUENTLY comes from team leaders themselv

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

es in evaluating their own managers! Many of these managers serve as team members and report to leaders of their own. They tell me the number one trait they want to see to willingly WANT to follow their leader is honesty. Someone who does what they

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

say they’re going to do. The leaders and managers they dislike most are those with the “do as I say not as I do” mentality. Do people willingly want to follow you as their leader? The key word here is “willingly.”

If you are the team leader or mana

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

er, are you an effective communicator? Has everyone been properly trained in “hard skills,” as well as in communication and conflict resolution? Is everyone clear in knowing that they are held accountable for performing their tasks effectively? Have

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

Professional from academic institutions, pharmaceutical industries, health care indust

they been coached to think of themselves as a team in that they perceive team welfare as a priority?

Teams need to have reasons, measurable goals, and clear deadlines for doing something. And teams need rewards for exemplary performance. They also

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

need consequences for failing to accept responsibility. Make certain they have yearly performance reviews, or reviews every six months. What gets measured gets done.

In my team building seminars, I notice more organizations conducting performance

.

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

reviews every six months instead of yearly. The benefit to managers as well as team members is more face-to-face contact regarding the objectives on a more frequent basis. And, if you have union employees and must disregard any record of underperfor

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

Companies that provide selfless information through particip

mance after a year or so, consider writing this information into their performance review. Performance reviews follow an employee.

“Like begets like, honesty begets honesty; trust, trust, and so on.” James F. Bell

Copyright 2006 Colleen Kettenhofe

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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