Advice You - Business

1. Let people know what you expect. If people know what’s expected of them, that’s what they’ll do--if they don’t know what’s expected, they’ll do something else. Communicate clear and unambigu

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

ous performance expectations and hold people accountable for their achievement.

2. Be a systems thinker. Remind people of their interconnectedness and that something happening in one area affe

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

Examples of combination products may in

ts all other areas. If people know how what they do impacts on others, they’ll try harder to do it well.

3. Keep people informed. Don’t assume that others can read your mind. If there’s someth

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

ng going on, let them in on it. Without information people invent it and the human tendency is to think the worst. A well-timed word can prevent a lot of worry.

4. Let people “own” their jobs.

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

Remember your first car and how you felt about owning it and how hard you worked to keep it clean and in good running order? Well the same hold true for people’s jobs. If people feel ownership

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

Combination pro

f their job, the harder they will try to take care of it and do it well.

5. Establish a feedback culture. Things go wrong probably no more than five or ten percent of the time yet we spend nin

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

ty percent of our time belabouring those few things. We probably only spend ten percent of our energy talking about the ninety percent of things that are done well. Spending more time providing

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

feedback about the positive outcomes makes it easier to talk to people about those that are negative. Passing on a good word about someone or providing deserved praise or recognition doesn’t di

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

inish you in any way. It doesn’t take any light from your candle to light someone else’s. Feedback truly is the breakfast of champions and people who feel like champions act like champions.

6.

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

Share your power. Invariably when I ask people in my training sessions who has power in the room they point to me. To an extent that’s true. I do have power but only if the group gives it to me

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

When we’re given power, there is an expectation that we will use it responsibly. People who use power responsibly shun manipulation and intimidation and focus on what they can give to others r

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

Following aspects would a

ather than on what they can get. They share their power, giving others the opportunity to influence events and situations. And, like the biblical direction about “casting your bread upon the wa

dd to the challenges in developing combination products:

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

ers,” the return is a thousand fold. Those with whom the power is shared give it back in greater measure and the mutual ability to influence is enhanced. Simply put, power shared is power gaine

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

.

7. The coach, not the players get fired. When a sports team performs poorly, the coach is fired, not the players. And the players, not the general manager, fire the coach. How does all of th

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

s work? Quite simply, the coach fails to provide the conditions that motivate players to maximize their performance and, as a result, they play just hard enough to keep their jobs. “Spoiled ath

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

etes,” you might say. “The money they make should be enough to motivate them!” Which leads to eighth key:

8. Money only keeps them coming back. Take it away and they won’t come at all but more

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

Professional from academic institutions, pharmaceutical industries, health care indust

of it will do nothing to make them work or play harder.

9. Treat your people like volunteers. Have you ever noticed how hard volunteers’ work, how dedicated most of them are, how much time the

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

give to their volunteer organizations? Why is that? Well mostly because others recognize and appreciate their skills. Often volunteers are given important jobs that carry large responsibility.

.

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

Recognition and opportunity are what drive volunteers. Treat the people who work with you like volunteers and the results will amaze you.

10. And finally, remember that happens while you’re th

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

Companies that provide selfless information through particip

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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