Main Subject - Business

Note: This article is an excerpt from my Entrepreneur's Survival Reference E-Book Self-Help Manual titled "25 Avoidable Mistakes No One Will Warn You About In Starting Your Own Business"(in which "Failing To Prepare A Backup/Alternative Action" is one of the 25 mistakes discussed). As a result, you will find that illustrations used are more relevant to persons starting up their businesse

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

s. Having said that, the ideas proferred here can be easily adapted for use in any other business situation.

Do You Have Backup/Alternative Action Plans For When Your Business Suffers Unexpected Setbacks?

“One way to succeed is to work hard at not failing by always anticipating problems before they occur” – Peter Drucker

Certain successful entrepreneurs are reputed to be uncomf

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

Examples of combination products may in

ortable with "good times" i.e. when everything appears to be going "smoothly". According to one book I have read, these individuals formed this habit as a result of past experiences, when such "good times" in their businesses were followed by a string of unexpected setbacks. Their experiences apparently "trained them" to be sensitive to unseen but possibly impending problems or "danger". During

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

"good times" therefore, instead of relaxing and celebrating, they quickly develop/implement strategies aimed at addressing the problems they anticipate or fears they have.

Having Back Up Plans Can Help You Reduce Your Frequency Of Failure

Having back up plans will not guarantee you absence of failure. But it can ensure that you reduce the frequency of your failures, and/or don’t recor

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

d avoidable failures. In addition, the back up plans will enable you bounce back quickly from your setbacks. And that is of utmost importance. As most of us must have heard at one time or the other, it’s not falling down that matters. But being able to get up and keep going every time you fall down is what really matters. Backup plans will enable you do this much more easily, effectively and fr

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

Combination pro

quently.

Developing back up plans will help you prepare to deal with any suggestions of delays, disappointments or failures that might occur. It will make it easier for you to keep a positive outlook when things appear not to be going well – because you will be confident in the knowledge that you have an alternative plan(s) already in place.

How To Develop A Backup Plan

So how do 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

draw up your plan? Simple really. Just ask yourself questions. Imagine you are not you. (It’s easier than you think, I assure you). Just try and imagine that you’re one of those “nay-sayers” or unbelieving people who question your sanity, possibly because they do not understand your business idea. Then proceed to generate the kinds of questions(or reasons/arguments) you think they would come up

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

with, to prove that what you want to do cannot be done.

It might not be a bad idea to actually approach these individuals with the objective of deliberately getting them to discuss their thoughts about your ideas with you. Be smart about it. Make it look natural – start a conversation and gradually steer it to the subject you want them to comment upon.

Very often I have found people like thi

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

s especially eager, and they relish the opportunity to tell you why they are right and you are wrong to try doing it the way you intend. Never mind all that, just "record" all you can and then withdraw to generate action plans that will help you effectively ensure that those reasons they’ve given/questions they’ve raised, can be effectively addressed through the action plan you will develop.

N

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

ext, decide on the order in which you will implement items in the action plan you have come up with. Then commence doing so. As things progress, depending on your judgment of whether or not the plan you are working is doing well, you can then initiate implementation of other plans. You will find that some of your plans will require you to seek assistance of certain individuals at short notice.

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

f possible plan ahead and hint them that you might need them. Members of your mastermind alliance(especially those who do NOT take setbacks or problems too seriously) could prove useful in these circumstances.

How Having A Backup Plan Helped Me Win A Speaking Invitation

When I first started out in business in early 2002, I had just finished writing my latest management research paper t

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

Following aspects would a

itled “Self-Development As A Tool For Achieving Career Advancement(A Practical Guide Based On Experience)”. I recall vividly that after reading through my work on that paper, I repeatedly told my wife, brother, friends – and all who cared to listen – that I believed it was my best work so far. I also told them I was convinced I could win the next Nigerian Institute of Management’s (NIM’s) Young

dd to the challenges in developing combination products:

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

Manager’s competition (I had placed fifth in the National Finals on my debut in 1997).

So I began making enquiries about the competition, but was told the programme was not yet out. Something however began pushing me to make alternative plans to get my paper in front of the leaders of thought in management who I believed would be able to give me useful feedback. One evening I sat down and beg

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

an writing down the names of organisations/individuals who I felt would be able to give me authentic and useful criticisms. People like Dr. J. Y Maiyaki, Director General of Center for Management Development, and many others.

I prepared letters to each of these people, and hand delivered them with a copy of the neatly spiral bound paper to their offices. My objective was to use that paper to d

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

raw attention to myself with respect to my work on Self-Development Education. That was between January and late February 2002.

Some months later it became obvious that the NIM competition would not hold, so I was glad I had implemented my other plans. But not as glad as I was when in August 2002, I got a visit from the Training Manager of the Center for Management Development (CMD) who wanted

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

to know if I could meet with them for a discussion, towards leading their September 2002 staff seminar by delivering my paper on Self-Development Education at their main auditorium.

After about 3 meetings, agreements on honorarium to be paid, event date and time, etc were reached, and on Wednesday 25th September 2002, I successfully delivered a one-hour talk to an audience of over 100 persons

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

Professional from academic institutions, pharmaceutical industries, health care indust

including directors and other staff, in the CMD’s main auditorium.

(Read my article titled "I Flopped Badly At The National Finals!(A True Story About How NOT To Prepare For/Deliver An Important Presentation)" to learn more how I used learnings from a botched presentation during the 1997 NIM national competition - that took place 5 years BEFORE - to successfully deliver my presentation at the

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

CMD's Staff Seminar in 2002 without a hitch, despite a potentially destabilizing power failure occurrence).

Summary

Aside from positive verbal and written feebdack(I got back over 80 of the speaker evaluation forms I circulated to the audience, with an average rating of 4 - on a scale of 1[poor] to 5[excellent]) the CMD also sent me a letter of appreciation some weeks later. I actively

.

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

used this successful CMD outing to gain credibilty before other decision makers including: a Management Consultant who would later invite me as a paid External Speaker to deliver a paper I titled "Interpersonal Effectiveness(A Real-World Relevant Approach") - based on my experiences in paid employment - to management trainees just recruited into a leading fast foods company located in Lagos.

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

Companies that provide selfless information through particip

Did I achieve my objective of getting myself and my work noticed/acknowledged by leaders of thought in my niche or area? Yes I did. But I had to pro-actively develop(based on actively observing trends of events, and considering their possible implications) and implement an alternative plan in place of the one I had originally started out with. Be prepared to do that when(NOT if) the need arises

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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Dumping takes place when a company sells goods at a lower price in the foreign market then the price it charges in its domestic market. This is an unfair trade practice which can have a distorted effect on international trade.

Attracting and keeping long-term clients is a prevailing approach for your growing business. Long-term clients who are pleased with consistent on-going good service, are likely to refer others to your business, and are more likely to buy further services from you.

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