Advice You - Business

As clients meet with me to discuss leadership, inevitably the conversation turns to decision-making. Making decisions is one of the most taxing job responsibilities that leaders have. In my experience,

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

leaders suffer more than they should because they make too many decisions. Too often, they fail to ask, “Whose decision is it?” or “Who is the decider?”

When leaders take the burden of respons

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

Examples of combination products may in

bility too far, they either want to protect others from making tough decisions or they want to extend their power. The result is often poor decision-making because these leaders do not have sufficient i

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

formation. And the team members who should have made the decision do not gain valuable experience. Instead of adhering to the old Harry S. Truman adage, “The buck stops here,” these leaders should do a

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

etter job of clarifying job responsibilities, trusting their team members to make good decisions, and then holding them accountable.

Lord Carrington, whom I knew for a brief time, was minister

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

Combination pro

of the British Defense Department during the Falkland Islands war. The war was launched because of a mistake a radio operator made on one of the frigates out at sea. Lord Carrington was obligated via m

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

nisterial responsibility (the British version of “The buck stops here”) to resign. After all, if he was doing his job, all those under his command must be doing their jobs, too, no matter how far remove

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

—including the radio operator. This practice is outdated, in part, because it takes accountability away from the person who is directly responsible. And it results in leaders who are either too controll

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

ng or unjustly blamed for the bad decisions of others.

“Perhaps you can help me with a problem I’m having, Gary,” Todd, President of one of the largest financial services company on the east c

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

oast, said as we sat down to coffee. “I have this woman who works for me. She’s grown her department by thirty percent in the last year. But she hasn’t been showing up at the weekly executive meetings e

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

en when she’s in the office. Her boss thinks everything’s fine and keeps citing the thirty-percent figure, but the competition in that industry segment is scoring even higher. Plus, her department is th

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

Following aspects would a

doorway into my company for many customers.” I asked Todd what exactly the problem was. He said, “Her!”

I asked, “Are you sure?” He looked at me quizzically. “You’re saying the problem lies w

dd to the challenges in developing combination products:

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

th me?” I asked him whom she reported to. He said, “She reports to Dave.” I then asked, “So whose problem is it?” Begrudgingly, he said, “Dave’s.” We then investigated why he thought it was his problem

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

to begin with. This employee did not show up for Dave’s meeting, but since it was Todd’s company and he had heard complaints, he felt it reflected badly on him. Since I don’t have an emotional investmen

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

, it was easier for me to see who was the decider here than it was for Todd. And, since Dave is invested in this woman in many ways that Todd is not, Todd might be able to supply some perspective to Dav

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

that he is currently missing.

As a leader, Todd shouldn’t ignore the fact that he had heard complaints about this particular employee. Instead, he must hold Dave accountable for his people.

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

Professional from academic institutions, pharmaceutical industries, health care indust

nce Dave is alerted to the issue, it is no longer Todd’s issue. If Dave fails to act, however, then Todd must confront a new issue: Dave’s failure to manage his team members.

Since Todd is

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

impacted by the failure of the employee to attend his meeting, I suggested a strategy that helps set clear boundaries. I encouraged him to cancel the next meeting if one or more people did not attend. I

.

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

find it hard to employ shaming tactics, but, at the same time, they can be extremely effective. In this case, the message would be loud and clear: everyone’s participation is critical to the process. An

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

Companies that provide selfless information through particip

, based upon my experience, I doubt Dave would have to cancel more than one meeting.

Employee empowerment begins with leaders asking themselves four words over and over: “Whose decision is it?

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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