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As a conscientious leader, you will learn to:

• Build a high performance team

• Value your team members

• Bring out the best in each of the members of the

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

team

Don’t risk losing your people…

Enhancing performance will not work unless employees / team members actually become a part of the team. This will happen

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

Examples of combination products may in

when they feel included in plans for the future and when they feel rewarded for achieving goals. Everyone wants to be part of the team, part of the company,

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

part of the big picture.

Being included doesn’t mean being consulted or being asked for approval. It does mean taking those employees into consideration and

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

eeping them informed of the ‘plan’ and the ‘progress’.

Feeling rewarded for achieving goals doesn’t have to include money or awards but in fact could be just

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

Combination pro

high 5’s and back patting as steps are achieved along the way. Show them that you understand that the actually helper achieve that goal. Timing is important

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

The word rewarded, conjures up thoughts of money or gifts that are considered expenses or costs. Rewards can of course range anywhere from a thanks, you did

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

a good job… to Cash bonuses and everywhere in between.

Rewards can be the success of the company and the continuance of operation or even expansion which co

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

ld lead to promotions and long term employment.

Actual rewards should be considered as investments.

Plan rewards

Set criteria for awards program, Present

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

lasting, personalized awards

Standard, classy timeless awards stand the test of time

A personalized award will be kept and treasured

A functional gift wil

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

l be used and discarded.

Trendy and gimmicky gifts are fun for a while

When your company name is on an award, you are in fact advertising your company while

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

Following aspects would a

rewarding or acknowledging someone. Everyone who sees it will have that same image of your company.

Set clear objectives for your company

Philosophies

Man

dd to the challenges in developing combination products:

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

gement & Shareholder needs

Company Vision and Mission Statements

Products

Main or Key products

Ancilliary products

Possible new products

Timeline

Short

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

term goal, 1 year goal, 5 year goals, beyond

Year end

Expansion/merger/takeover plans

Set clear goals for month, year and future

Product Volume

Dollar V

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

alue

Dates

Measureability

Progress tracking

Who is on your team.

• Yourself
• Employees
• Staff
• Suppliers
• Customers
• Commun

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

ity

10 steps to achieving max performance –through recognition

1. Timing, Timing, Timing. (Not Location, Location, Location)

2. Quality (not cheap, doe

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

Professional from academic institutions, pharmaceutical industries, health care indust

the trick)

3. Appropriateness (choose the award to match the event)

4. First Impression, Last Impression

5. Corporate Image

6. Achievability of contests

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

or programs

7. Image building. Communicate/advertise the program, the winners

8. Reciprocation creates obligation payoff – repayment

9. Consistency ex

.

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

udes reliability

10. Focus on your

- Business

- Product

- Customers

- Suppliers

- Employees.

You can focus on each one, one at a time.

Is it all about

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

Companies that provide selfless information through particip

Recognition, Promotional Products, Awards Program and Incentives?

NO!! There's more to come in the next ezine. I'll talk about Human Resources & Motivatio

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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