Advice You - Business

I want to thank my teachers Cynthia Loy Darst, Faith Fuller, and Marita Fridjhon for their brilliant ideas on this topic. I owe them all.

Have you ever had a project where you succeeded? Sure you have. So

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

have I. Mine include starting a business, growing my business, staying fit, having a family, and buying a house.

Have you ever had a project where you didn’t succeed? Yes, I have, too. Mine include not

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

Examples of combination products may in

developing a solid business niche, not losing weight, not networking regularly, and not staying in touch with out-of-town friends.

Recently I have learned a new way of looking at why we succeed or fail at c

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

ertain goals or projects. The concept is called the Inside Team. We are heavily influenced by the voices we listen to from our Inside Team, that group of players who live inside our head and talk to us thro

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

ugh our inner dialogue. These voices variously cheer us on, bring us down or get in our way.

You know the dialogue. You’re thinking about changing something in your life, say, launching a new business devel

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

Combination pro

opment push, or finding new ways of helping your sales team surpass their goals. Then the Inside Team chatter begins:

Voice One: “Well, what if I tried this? Yeah, that sounds like a blast!” Voice Two:”Ho

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

ld on, you don’t have the time or energy for that.” Voice Three: ”I’ve got to try something – anything! ”Voice Four:” Maybe you should just give up. You’ll nev/er get around to it and you know it.” Back to

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

oice One:” Yes, I will, I just need to find the right approach.”

For every endeavour you wish to fulfill, for every issue with which you struggle, for every arena of your life, there is a corresponding Insi

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

de Team.

Here are a few members of my team who come to visit when I think of a new way to develop my business (with the appropriate names I have given them and their typical comments).

Faith, Not Fear: “I

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

t’ll work out. You’ve been around the block enough times to know that it will.”

Rottenella: “Why bother trying? You’re a loser and you won’t succeed.”

The Lone Ranger: “Take care of all the details your

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

self and do everything perfectly today.”

The Turtle: “Whoa…slow it down. Slow and steady wins the race.”

My job is to choose which voice to listen to, and when. By paying closer attention to the helpful

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

Following aspects would a

and encouraging voices, and toning down the critical and fearful ones (they’ll nev/er go away, and there is wisdom in each voice), I can clear the way to coming up with the best solution.

Here’s an exercise

dd to the challenges in developing combination products:

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

to try so you can start to identify some members of your own Inner Team and how they influence you. Think about a project you want to start or a goal you want to achieve. As you listen to your own thoughts

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

you’ll notice a dialogue beginning to form in your mind.

Take a moment to listen to the messages you’re hearing and the differing values that are fighting for attention. These are the voices of your Inside

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

Team as they debate about that project or goal.

What does this exercise have to do with managing/coaching sales people? If, as a sales coach, you can help your sales people identify their Inside Team playe

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

rs and access the wisdom of each voice, you help them make conscious choices about who they want to listen to, and who they want to send to the bench.

Here’s how to coach your salespeople using the Inside T

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

Professional from academic institutions, pharmaceutical industries, health care indust

eam concept:

Ask each team member to identify a project with which he or she is struggling.

Introduce the Inside Team concept.

Ask about the struggle, with an ear to hearing different Inside Team members.

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

Help each individual identify 5 – 7 different players. You may have to begin by sharing your insights about the players you hear, and checking whether you are interpreting correctly. The person may or may

.

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

not agree with your interpretation, and that’s fine. The point is to get the ball rolling.

During the discussion, here are some questions to ask each salesperson:
Who’s that talking?
What is sh

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

Companies that provide selfless information through particip

e or he saying?
What’s important to this player?
What is he concerned about?
What does she think you are going to forget?

Have fun with this. The results, I promise you, will be profound

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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