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What happens to a business or life when you change the measure of success?

When I was establishing my business, I struck upon targets that defined success for me. This was not a simple t

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

ask and required a fair amount of soul-searching. I set goals for 6 months, 12 months and 36 months. The timeline was a bit loose, but I knew that I would be able to achieve the 6 month t

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

Examples of combination products may in

rget; I figured that I would be able to achieve the 12 month target; and I had no idea how I would achieve the 36 month target, but it would come. I was not wedded to the timeline; in fac

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

, I was not at all sure that the targets were achievable in those timeframes. Nonetheless, I wrote down the targets; I shared them with people central to the business. I was on my way.

T

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

e targets were defined in terms of business revenue – money. Yet, whether I talked with people about what I was doing, I frequently commented that the money was not that important. More

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

Combination pro

han one close friend challenged me, “is money why you’re doing this?” The answer was no, but the money represented a level of achievement; and so, I continued on my merry way; noticing th

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

t as the money did not flow, I was feeling disappointment and dissatisfaction, rather than relishing the success I was achieving.

One of the advantages of having a coach is that they do n

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

t let inconsistencies pass, at least not for long. My coach challenged me to consider whether there were other possible measures of success that better aligned with why I am in this busin

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

ss. As all good coaching questions are, this was thought provoking. If I attest to having defined why I am here – my purpose in life – and it does not have any emphasis on money, why is

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

hat the measure of success for my business?

Looking at what I gain from this business besides revenue, it is the satisfaction and joy of helping people; of being a part of people improvin

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

their lives. It was easy then to restate the goals around the number of people I can help through my coaching.

Which leads us back to the question, “what happens to a business or life w

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

Following aspects would a

en you change the measure of success?” In this case, the focus shifted from an uncontrollable outcome (the revenue) to controllable events. The focus shifts from the outcome to the proces

dd to the challenges in developing combination products:

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

(and the former statistician in me says “duh!”). Let us get more concrete. A trial session may not result in immediate or any revenue, but it does help someone if I have done my job wel

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

. The trial session that does not convert to a paying client is a small part of my success; rather than a $0 income failure. And that session may lead to a coaching agreement in the futu

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

e. The blogs and newsletter do not generate any revenue, but they do, I hope, help someone.

Ah, but the businessperson says, that is fine, but you need to make money; it is an important

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

measure. Well, like the manufacturing or quality engineer, perhaps what I need to do is to trust in the process. The process says that I need to establish a fair price for my work. The

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

Professional from academic institutions, pharmaceutical industries, health care indust

rocess says that I need to develop credibility and a base level of clients that can lead to subsequent referrals. The process says I need to have a structure for getting, conducting and f

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

llowing up from trial sessions. The process says I need to have structures around the coaching practice. If I succeed in the processes, can I trust the outcome (eventually money) will fo

.

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

low?

Only time will tell. In the meantime, it is much more fulfilling to look at every step as a success; to evaluate the business building in terms of helping people improve lives, rath

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

Companies that provide selfless information through particip

r than how much money I made today.

Do you have any examples where changes in your measures of success had an impact in the conduct of your business or life?

Copyright 2007 Sherry L. Rea

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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