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A tight knit team is a group of competent individuals who care deeply about each other and are fiercely committed to their mission. The members are highly motivated to combing their energy and expertise to achieve a common objective. From our observation and studies on team development

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

, we have found three primary conditions that have to be met in order to attain higher levels of team performance and member satisfaction.

Resources and Commitment
Ownership and Heart
Learning

These three conditions are the heart and soul of team development and

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

Examples of combination products may in

yet these conditions are not blueprints. Each developing team is unique, and its needs and details of teamwork have to be worked out separately. Let’s look closer at condition number three - Learning. CONDITION NO. 3 – LEARNING

In order to harvest the enormous power

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

of teamwork, one’s knowledge, skills and abilities have to be sharpened. This is required to support the values describe in “Condition No. 2 – Ownership.” (This is because values with skills will result in good intentions. But without the skills and behavior the values alone can not p

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

roduce results. Likewise, nifty skills and techniques without the heart and soul of values will likely be perceived as manipulative and just another management ploy to trick people into giving more to the organization at the expense of its members.

How does a team learn best about team

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

Combination pro

work? How to take back responsibility? What exactly is there to learn from experiences in teamwork? We have found that the principles of teamwork can best be explored by adult learning modules where people try out their team development skills on actual tasks and activities. We usual

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

ly select tasks that are uncommon so that participants have a level experience field. Once a task is completed, we carefully lead the learners back through their experience and encourage them to discuss the positives and negatives of the team’s effort. We look for common threads of tho

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

ught and weave together, with their experiences, the key concepts of principles of sound team development. Learners are then asked to plan and transfer their experiences back to the work place and develop plans to turn their learning into productive ideas or strategies. This approach t

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

o learning is fun and exciting. It usually leaves a lasting impact and memorable reference points for the future. Groups really acquire the language and the concepts of teamwork.

The insights about teamwork are broad and deep. The following is basically an unaltered flip chart session

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

of lessons and insights from a team located in the Midwest that produces heavy equipment. IN OUR TEAM DEVELOPMENT WE LEARNED THAT…

We typically underestimate the importance of the role of the leader.
Cross training really enhances the strength of the team

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

Careful management and control of the team’s resources is crucial.

You can’t wait for perfect conditions before you start a task.

You really haven’t failed until the team stops trying.

We have to view mistakes as opportunities to learn and grow for the long run.

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

Following aspects would a

>The team has to ensure that all of its members are informed and enrolled.

Your ideas won’t be heard unless you speak up

Feedback is essential for process improvement.

Open minds are essential for synergy to occur.

Our biggest barriers and fears are all perceptions th

dd to the challenges in developing combination products:

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

at can be overcome.

Leaders have to lead and guide the processes; they can’t be expected to produce the technical breakthroughs.

High performance teams must develop even their weakest or newest members.

We should not limit others by presupposing their limitations.

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

t is important to celebrate the success along the journey to the ultimate result.

Patience fosters empowerment.

You can’t “push” a rope and you can’t “push” people in the direction you want.

We need to share knowledge and develop people through effective coaching.

Whe

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

n you find yourself in a hole, quit digging!

With a little trust you can move remarkably fast through a situation.

Stretch goals yield stretch results.

It is OK for adults to request and accept help.

Mature adults are willing to admit that they have fears.

The pi

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

tfall of holding back on a good idea is bigger than the pitfall of spending some time to hear the ideas.

If you can visualize the process and the goal, we are in a better position to achieve it.

No one of us is as smart as all of us.

Our limitations are driven primarily by

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

Professional from academic institutions, pharmaceutical industries, health care indust

our fears.

We can’t afford the cost of uncaring criticism.

True leaders will encourage input from everyone.

Showing emotion is OK.

Teamwork “ain’t” easy, and it “isn’t” automatic. You have to work at it.

Teamwork means that you have to understand the paradoxes

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

and manage them well.

You have to bring people together if you are to build enthusiasm and spirit.

Collaboration means a lot more than agreeing to stay out of each other’s way.

The actual list was longer and took nearly two hours to share and report. Frankly, we have not

.

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

seen any other type of team development process where so many insights occur in a relatively brief period of time. Since we have had the opportunity to work with this group over an extended period of time, we can report that this team was noticeably closer according to reports from oth

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

Companies that provide selfless information through particip

er members of the organization as well. After all, what is good for the goose is good for the gander. And if we see the members of the organization as the goose who lays the golden eggs then we need to make a real investment in terms of time and money to keep the goose healthy and well

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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One of the most common medical billing problems is forms printing. In this installment, we cover the most common problems and how to fix them.

People wear nametags more often than you think. The majority of retail establishments, stores and other social gatherings require nametags for several purposes. Sometimes it’s for security. Other nametags are solely for identification. But simply stated; people wear nametags for one reason: so other people can use their names for friendlier, more personable service and conversation.

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