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Pride. Envy. Gluttony. Lust. Anger. Greed. Sloth. You either recognize these as the seven deadly sins or as themes for prime-time television. Nonetheless, you were probably taught as a child that these are bad and you shouldn't do them. For purposes of this article, do as you were taught and think

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

bad when you commit these similar sins in the workplace.

As leaders, we are continually being introduced to new techniques and theories. Hammer & Champy's Business Process Re-engineering Model, McKinsey's 7-S Framework, and Kenichi Ohmae's 3C's Strategic Triangle are all examples of strategic mode

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

Examples of combination products may in

ls designed to help leaders think about their business in different and innovative ways. What sits on top of all of the models and frameworks, though, are a series of foundational attributes that every leader should possess if he or she is going to have demonstrated, sustained success as a leader.

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

In my career as a leader, I've been fortunate enough to experience a broad array of leadership situations where sometimes I enjoyed fantastic success, and at other times experienced dismal failure. In looking back at my failures, many of them had nothing to do with a theory, framework, or technolo

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

gy that was utilized. The failures had to do with cracks in my own foundational attributes which left me vulnerable as a leader. I've boiled these down to seven key sins which this article will focus on to help you become a more effective leader.

Sin #1 - Arrogance

Ever known a manager that consi

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

Combination pro

stently claimed to know more than the rest of the team? How about one that was unwilling to listen to opposing views? Isn't this just a sign of confidence? What's wrong with that?

Confidence as a manager is crucial as people will look to you, particularly when things get tough. When it runs amok a

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

nd turns to arrogance, the manager disrespects the team. Show respect and have confidence and you'll do fine. Subtract out respect and you're just an arrogant doofus.

Sin #2 - Indecisiveness

So you have a meeting on Monday and the management agrees on a course of action. On Tuesday, the manager d

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

ecides to take a completely different course of action. Thursday the manager goes back to Monday's course of action. The following Monday you're back re-hashing through the same problem from last Monday. Blech.

Decisiveness means the manager listens to those around him or her and then makes the be

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

st decision for the project that the rest of the team can understand, and sticks to it. While team members may not agree with the decision, they should be able to see the rationale. Decisions without rationale or without listening will ultimately frustrate the team and put a target on your back.

S

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

in #3 - Disorganization

We've all known the manager that asks for the same information multiple times, keeps the plan in their head versus writing things down, or is so frantic that they're on the verge of spontaneously combusting. Their disorganization creates unneeded stress and frustration 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 project team.

The manager needs to have a clear pathway paved for the staff to get from start to completion, and make sure the ball moves forward every day of the project. Disorganization leads to frustration, which leads to either empathy or anarchy.

Sin #4 - Stubbornness

On one of my early

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

Following aspects would a

project management jobs I was a month behind schedule on a three-month project. I refused to alter the project schedule insisting that I could "make up schedule" by cutting corners and eliminating tasks. Despite the entire project team telling me we were in deep yogurt, I stubbornly forged ahead.

dd to the challenges in developing combination products:

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

I ended up never seeing the end of the project because my stubbornness got me removed as the project manager. Talk about your 2x4 across the head.

The manager may believe his or her view of reality is the right way to go, but it's imperative that he or she balances their own perspective with that

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

of the rest of the project team. Decisiveness without listening to the team leads to stubbornness.

Sin #5 - Negativism

Years back, one of my peer managers, in their zeal to "manage expectations" would consistently discuss the project in a negative light. Either the focus was on what work didn't g

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

et done, what the new issue of the week was, who wasn't doing their job. Their negative attitude about the work, people, and purpose of the project sapped the energy, enthusiasm, and passion out of the work. It was a self-fulfilling prophecy; the project failed because the project manager willed it

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

to fail.

This one's simple; a glass-is-half-empty project manager is going to be a horrible motivator and will sap the energy from a team. This doesn't mean that you have to be a shiny-happy person all the time; but that the project manager has to truly believe in what he or she is doing and need

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

Professional from academic institutions, pharmaceutical industries, health care indust

s to positively motivate the team to get there.

Sin #6 - Cowardice

Imagine this: the manager who, when pressed on a budget or schedule over-run, will blame team members, stakeholders, or anyone else that could possibly have contributed to their non-performance. Much easier to play the blame game

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

and implicate others because everything didn't go perfectly as planned. What a weenie.

It's perfectly OK to be self-critical and aware of your own weaknesses and mistakes. For a leader to truly continue to grow in their leadership capabilities they need to be the first to admit their mistakes and

.

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

learn from them as opposed to being the last one to admit their mistakes.

Sin #7 - Untrustworthiness

Simply put, managers that don't display necessary skills, show wisdom in their decisions, or demonstrate integrity aren't going to be trusted. For the team to truly have trust in their leader, the

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

Companies that provide selfless information through particip

y need to believe that the manager has the skills to manage the project, the wisdom to make sound business decisions, and the integrity to put the team's interests ahead of their own. Take any one of these attributes away, and it's just a matter of time before the manager gets voted off the island.

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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