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-Organize your team around specific goals.

You should organize your teams to achieve specific goals. Don’t just throw a team together without a clear purpose for the team. For

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

instance, you might want to have a cross-functional team at your site if your organization is large enough. A hospital site could well use a team of nurses from different departm

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

Examples of combination products may in

nts, as pediatrics and oncology, along with pharmacists and any employees who are involved in communications between nurses and pharmacists. Such a team could help eliminate the

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

any problems that often arise between them. If your site is not large enough for such specialized teams, you might want to have a team made up of representatives from various gro

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

ps at your site.

For instance, a doctor’s office might want a team made up of a representative from front office staff, back office staff, doctors, and the office manager. S

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

Combination pro

ch a team could address issues such as staff morale or eliminating waste in various office processes. You might even want to have a short term team just to solve billing erro

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

s, for instance.

-Pick a good leader.

Once you have organized a team at your site, you next need to pick a team leader. This is not necessarily a site leader—office or depart

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

ent manager, CEO, etc.—but it should be someone who has the respect of the staff and who has a good insight into the problem to be solved. This person should also be able to

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

eep the team on task and be able keep the morale of the team up. Ideally, you want someone who can develop synergy, the sixth habit of Steve Covey’s “The Seven Habits of High

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 Effective People.”

-Stages of team development.

Be aware too that teams go through stages of development. A newly organized team will probably not be as effective as one

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

hat has already achieved numerous successes. The team leader can help move a new group into a positive, supportive team. Some texts describe the steps in team development as

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

Following aspects would a

Forming, Storming, Norming, and Performing. The first stage we have already discussed. The second stage-norming-is when the individuals test the leadership and test to see

dd to the challenges in developing combination products:

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

f the goals can be changed to meet their own needs. The third is when individuals start to shift from their own personal agenda to the team’s agenda. Finally, the last stage

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

is when the synergy of the group appears.

-Positive, unintended consequences.

The power of teams can have many beneficial, unintended consequences. Recently, I heard a spee

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

h by a lawyer who specialized in helping Human Resource Departments with problem employees. In one part of his speech he described one defense used by disruptive employees. H

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

stated that such an employee claims that he was never told what his specific tasks were. This actually does happen. Thus such an employee has justification for his poor per

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

Professional from academic institutions, pharmaceutical industries, health care indust

ormance.

With good functioning groups, though, such excuses often can be eliminated. Often teams reinforce the responsibilities of individual team members and develop effici

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

nt processes in achieving tasks. Everyone should know what they are expected to contribute to the success of the organization. Writing a team mission statement can strengthe

.

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

the delivery of individual performance. Positive employee performance is just one consequence of good team organization.

If you have not used teams in your setting, I hope

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

Companies that provide selfless information through particip

hat you form one soon. I know it will have many good outcomes. If you regularly use teams, I hope that you continue and that my tips will help you achieve a state of synergy

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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