Main Subject - Business

Years ago I used to focus on the worst members of the audience. The ones who crossed their arms and legs, never smiled, hardly said a word or took a

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

single note throughout the day. I felt the need to ‘win them over’ to prove my ability as a speaker and a trainer.

I’ve learned something over the

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

Examples of combination products may in

years: Some people do not want to be won over – and that’s OK.

Now I focus on the audience members who do respond with smiling, nodding, taking not

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

s, asking questions and laughing along with my stories. This gives me a lot more energy when I work, and also makes those participants feel apprecia

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

ed.

And guess what? By the end of my presentations, most of the tough nuts have cracked themselves. Even tough nuts sometimes want to join the part

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

Combination pro

– but they don’t want someone else to do the cracking.

This can be equally true with members of your staff or service team. Some people inside you

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

r organization can be real tough nuts, sticks-in-the-mud, fuddy duddies, old-timers, or even new-timers who don’t want to support a change, improvem

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

nt or new program.

What should you do? Should you work extra hard to win them over? I suggest otherwise.

Instead of focusing on the few who don’t

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

ant to support new ideas, focus on those who are enthusiastic, helpful, optimistic about change and generally inclined to make new things work.

Thi

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

k about it: Every ounce of energy you put into the enthusiastic members of your team comes back to you in support, ideas, action, initiative and pos

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

tive effort. Every ounce of energy you put into the ‘tough nuts’ gets you what? A worn-out nutcracker.

Here’s one example: A prestigious hospital a

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

Following aspects would a

sked me to help improve the morale among the nurses in the operating theaters. There were 86 nurses on the team, but senior managers were most conce

dd to the challenges in developing combination products:

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

ned with four long-serving staff who had become negative and reluctant.

I studied the situation carefully and recommended they ignore those unwilli

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

g or uninterested in change. Instead, we focused every ounce of effort on working with those nurses who wanted to work toward a better culture.

Wit

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

in months, three of the tough nuts loosened up and started contributing good ideas. They were welcomed with appreciation for their wisdom and the qu

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

lity of their contributions.

The other tough nut never cracked; she left the hospital and went to work elsewhere. Funny thing, within a few months,

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

Professional from academic institutions, pharmaceutical industries, health care indust

no one missed her.

Key Learning Point

In life, with staff, customers and everyone else on this planet, some will be keen and helpful and eager to

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

see you win – and others will not. Be careful where you focus.

Action Steps

Identify which of your staff are most constructive and helpful in brin

.

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

ing new plans to light. Tell them how much you appreciate their efforts and support. You will find you get even more. Don’t ignore the tough nuts, j

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

Companies that provide selfless information through particip

st don’t give them any more attention than they require. In time they will join the successful crowd, or they will leave. In which case, let them go

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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After identifying the sources of manpower from college, the next step is to stimulate them in applying for jobs in an organization. Then comes the step of selecting the right student from the college. The guiding policy in general is the intention to choose the best-qualified and suitable candidate for each unfilled spot and to avoid commitments to those who will not work well. The objective of the selection decision is to choose the individual who can most successfully perform the job from the pool of qualified candidates.

Congratulations! The hard work you have put into your job search has paid off. You now have a job offer on the table and are excited about the opportunities that this position presents. There is just one thing that is troubling you: the offered salary.

Your customer has a complaint or problem with your company's service or product? What should you do about it?

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