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Spirit in the work place?

Absurd, you say? After all why should it be there? We’re here to work and earn our daily wage.

On the weekends and in the evening many of us watch some amazing sporting feats. Some of us may even participate in some great events. What spirit those athletes have! How they

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

throw everything they have to gain an extra yard, drive an extra foot or shave off an extra millisecond.

Then there’s Monday morning. What happens? People come to work and shuffle paper, see prospects, perhaps they make a sale, deal with customer complaints, speak to suppliers, arrange meetings, ho

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

Examples of combination products may in

ld meetings, read e-mail, mail, send mail, e-mail. Are they challenged? Do they really want to be there? What would they be doing if they weren’t there?

You as manager or owner wonder why the quarterly results aren’t what you predicted. Even with a good spin they still suck like a bad dream. So wh

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

t’s the problem? Motivation? You sent the sales guys to Zig Ziglar last year and that didn’t help. Sales training is not going to help the finance department get with the program. They don’t take any ownership of the results because they merely pulled them from the system.

So what could it take to

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

have your team or your business working like a Pro sports team?

Involvement, accountability, understanding of the vision, learning more about the business, learning more about the function they perform and even about their team.

Now ole Fred Taylor really killed spirit when he decided to break wor

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

Combination pro

k down into its constituent parts. In the Taylorist days no one had ownership of the end product. People were not doing their best and nobody really cared. Mediocrity ruled the day. They clocked their hours and were paid. They did what was asked of them and nothing more, mere factors of production,

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

hat’s it. They didn’t care for their labors and hence quality products were a dream. Consultants leaped on this and found ways of improving quality, reducing waste, saving time, working smarter not harder. Still, however the worker was not really engaged, just worked harder in the name of productivi

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

ty.

Total Quality Management (TQM), however, in a weird way actually brings spirit back into the place of work! Things slowly began to change. The Japanese approach where anybody can shut down a line at any time brings ownership of the final product back to the workers. The workers thus had a retur

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

n of their integrity; they could have a mission in life, a value, a purpose. Amazing, they could swear they had made the best gosh darn car there was. And mean it!

So could it be that by not doing your best and saying that you were is a lie? We know how we hate liars! Just ask a recent ex US Presid

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

nt! They say lying corrupts the soul; it sure has corrupted our business world. From poor quality products to ENRON scale corruption. Can we turn over a new leaf? Can we take pride in our activities? Youbetcha!

Now if TQM’s philosophy is about getting things right the first time and doing better to

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

morrow than you did today. It could be seen as pretty close to a religious tenant. In this day and age where we are seeing the return of religious morals back to the work place, TQM and its resulting focus on excellence is a way in which we are doing it. Perhaps not striving for excellence could be

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

Following aspects would a

contrived as heresy. If Monty Python were a manager he’d have his staff stoned, with rocks not pot!

What does this mean for us as CEO’s, managers or even supervisors?

We have to focus on what we are being and let our staff or our teams be the best they can be. It’s about ‘being’, not doing. We’re

dd to the challenges in developing combination products:

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

uman beings, after all. We need to be.

We make small changes in the way we do things. Kaizen is an example of that. Six Sigma and Lean Manufacturing and the resulting process improvement are all about how we do things. Doing things in an improved manner leads to incremental changes not to huge chan

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

ges, just marginal change. Which for many industries and business is good enough. It affects what, and how, we are doing our jobs and producing results.

If an industry is in transformation making process changes isn't going to do much. It's like Nero fiddling while Rome burnt to the ground. If we w

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

ant to make huge transformations in our business we'll have to focus on what we are 'being', in order to achieve the results we are focused on. In order to counter the threat of Apple IBM had to transform it's business model. It had to be in the PC market. While it was in the Computer market general

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

y it wasn't at that point in the PC market. It had to cahnge the way it operated to counter Apple's strategy and success. Or go away like many older businesses that could not transform themselves. No small changes there! IBM did and it survived to compete, and it's still in the game growing stronger

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

Professional from academic institutions, pharmaceutical industries, health care indust

every day. COuld your organization do the same?

We as managers, business owners and staff, need to create something that is not possible in our current reality. This means we have to be involved in developing our strategies for going forward. The we have to ensure they are implemented. Implementat

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

ion and execution of the strategies is of paramount importance. Stepping boldly where we have not stepped before. Who really believed man would walk on the moon less than ten years after JFK made his promise? So who believes your business can be something it currently isn’t? Can we strive for 100 pe

.

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

cent improvement, as opposed to 10 percent? Why not? What’s holding you back? What’s not feasible? Or is that only true because you don’t know that there is a new technology that will change everything, overnight? What are you going to 'be'all o when you grow up?

Let the spirit return to the workpl

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

Companies that provide selfless information through particip

ace. No, I am not talking about having a religious session in the lunchroom. Let people be all of what they are capable of. Let your business transform. Not a slow change or death, but an amazing transformation. Let it fly and your team along with it!

As the US army says – Be all you can be.

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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