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Digg It - The Business Failed, But Did You?
Q: After years of dreaming about starting my own business, I finally took the plunge a little over a year ago. To say the least, my dream quickly became a nightmare. The business didn't do nearly as well as I had hoped. I ran out of money within six months and had to take out a s
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
econd mortgage on my house just to keep things going. I have now closed the business and am left with a pile of bills that will probably put me in personal bankruptcy. I don't mean to take it out on you, but instead of telling people how great having your own business is all the
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ime you should also warn them that starting a business is not easy and can be devastating when things go wrong.
-- Gene K.
A: Gene, I hope that I have never given anyone the impression that having your own business is a walk in the park. To the contrary, I'm like the proverbial
A: Gene, I hope that I have never given anyone the impression that having your own business is a walk in the park. To the contrary, I'm like the proverbial
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Chicken Little when it comes to warning readers of the obstacles and pitfalls that await those considering the entrepreneurial plunge.
To quote myself from a column I wrote earlier this year, "If it was easy, my friend, everybody would do it."
Just to make sure we're in agreeme
To quote myself from a column I wrote earlier this year, "If it was easy, my friend, everybody would do it."
Just to make sure we're in agreeme
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nt, let me reiterate the standard warnings once again. Starting a business is incredibly hard work. It takes long hours and deep pockets. It demands unbridled passion and unquestioned commitment. It requires that you give of yourself until you often feel there is nothing left to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ive. And sometimes, even after you've done all that you can do and given all that you can give, the business fails.
Period.
Blood, sweat, and tears can only carry you so far in the business world. Good intentions and grand ideas won't pay the office rent. You can not make payro
Period.
Blood, sweat, and tears can only carry you so far in the business world. Good intentions and grand ideas won't pay the office rent. You can not make payro
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
l with Monopoly money.
I certainly don't mean to make light of your situation. In fact, I know exactly how you feel. I failed so miserably my first time in business that I swore I would never think about working for myself again. All I wanted to do was to find a nice, secure 9-t
I certainly don't mean to make light of your situation. In fact, I know exactly how you feel. I failed so miserably my first time in business that I swore I would never think about working for myself again. All I wanted to do was to find a nice, secure 9-t
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
o-5 job that provided me with a nice steady paycheck. I yearned for the opportunity to grow fat and happy on someone else's payroll for a change.
I never again wanted to have to think about customers or employees or withholding taxes or accounts receivable or anything else even
I never again wanted to have to think about customers or employees or withholding taxes or accounts receivable or anything else even
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
emotely associated with being in business.
I just wanted to crawl in a hole and die because my business had failed, and in my All-American, macho male, "you are what you do" brain that meant that I was a failure, too.
Getting over the failure of a business can be extremely diff
I just wanted to crawl in a hole and die because my business had failed, and in my All-American, macho male, "you are what you do" brain that meant that I was a failure, too.
Getting over the failure of a business can be extremely diff
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
cult, especially if you are one of those entrepreneurs (like I was) who wrongly relates the success or failure of a business to the success or failure of you as a person.
The best way that I know of to get over the failure of a business (and the deep feelings of personal failure
The best way that I know of to get over the failure of a business (and the deep feelings of personal failure
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
that go along with it) is to do an autopsy of the business to help find out exactly what went wrong. Only by discovering our weakness can we build on our strengths (Yogi Berra eat your heart out).
It took a long time and an enormous amount of reflection to realize that the busin
It took a long time and an enormous amount of reflection to realize that the busin
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ess had failed for many reasons, not simply because I was a miserable excuse for an entrepreneur. I wasn't looking to shuck the blame so much as simply trying to understand what really went wrong. A few years later when I mustered the courage to take the plunge again, I did so wi
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
h the knowledge gained from my first failed business. I knew what I had done wrong and I knew what I'd done right. Lessons learned, put to good use. Knock wood, this time so far, so good.
Performing an autopsy on a failed business is a simple process, but one that can reveal a w
Performing an autopsy on a failed business is a simple process, but one that can reveal a w
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
alth of information that you can use should you ever decide to step out onto the business high wire again.
To do your business autopsy find a quiet place where you can sit and reflect on the life of your business. With pen and paper in hand (or laptop on lap) write down everythi
To do your business autopsy find a quiet place where you can sit and reflect on the life of your business. With pen and paper in hand (or laptop on lap) write down everythi
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ng that you can think of that went right with the business and alternatively, everything that went wrong. Your goal is to create a "Success" versus "Failure" spreadsheet that will help you better understand exactly why the business went south.
For the autopsy to be effective, it
For the autopsy to be effective, it
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
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
is imperative that you are completely honest with yourself. Shove your ego in a drawer and be completely realistic or the autopsy will just become an exercise in futility. You will end up looking for scapegoats instead of reasons.
If your lack of experience was a contributing fa
If your lack of experience was a contributing fa
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
tor to the failure of the business, write it down. If your brilliant negotiating skills allowed you to close a big deal and beat out a competitor, write it down. If you were undercapitalized or incorrectly estimated your share of the market, write it down. If you had a partner wh
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o didn't pull his weight or a product that didn't sell as well as you thought it would or your building was flattened by an earthquake, write it down. Write it all down.
Once you have all the facts in front of you, it's easy to see why the business really failed. You might be su
Once you have all the facts in front of you, it's easy to see why the business really failed. You might be su
.
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
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
prised to find out that the failure of the business wasn't completely your fault, after all.
Then again, you might discover that the business failure was your fault. If that turns out to be the case, don't beat yourself up for long. Not everyone is cut out to be an entrepreneur
Then again, you might discover that the business failure was your fault. If that turns out to be the case, don't beat yourself up for long. Not everyone is cut out to be an entrepreneur
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
nd that's OK.
The world would be a miserable place if everyone sat around whining about their lack of customers or complaining about their employees.
Next time we'll take a look at the primary reasons businesses fail and discuss how you might avoid them.
Here's to your success
The world would be a miserable place if everyone sat around whining about their lack of customers or complaining about their employees.
Next time we'll take a look at the primary reasons businesses fail and discuss how you might avoid them.
Here's to your success
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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