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Advice You - Being Self-Employed - Is It All That It's Cracked Up To Be?
Ok, Here's the question. Is being self-employed all that it's cracked up to be? Ask anyone what they think about people
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
who are self employed and I will guarantee you that the first response will be that they are all "rich". Yup, it's true,
; 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
every self employed person is rich or suppose to be, baloney! Now, ask that same question of a dozen self-employed entre
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
reneurs and I bet you that you will hear twelve different responses.
Before working for the "man", I was self-employed o
Before working for the "man", I was self-employed o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the East Coast having owned 4 small businesses; not all at the same time, thank the Lord. Being self-employed has it's
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ros and cons, ups and downs, good days and bad days etc. I was responsible for making sure that my employees made an inc
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
me. I was responsible for my making and income and providing myself with Health Insurance and vacations. There was no o
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
e there when I was sick to answer the phone to tell them that I was taking a sick day as I had no sick days! I had no pa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d vacations as when I was lucky enough to take one, it was my own paid vacation and if i shut my business down to take th
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
vacation it was also a loss of income for that period. When days were good I was usually able to thank my employees but
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 had those bad days, I usually had no one to blame but myself as I was, the Captain of the ship!
My desk drawer h
My desk drawer h
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
ad bottles of tums, Tylenol for headache #325 (self-employed headache) and a lot of other stuff to ease the pain. There
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
as no such things as a 40hr work week and when police called at 2am to tell me that the business alarm was going off, th
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
re was no one else to call to have them get dressed, clear a snow path to the car to meet the police at the business door
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
I could go on and on and on, but you get the picture! There is so so much that one has to endure being self employed,
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
OWEVER, let me say this to you; that after working for the man for the past three years and putting up will all the every
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
ay garbage and having to bite my lip ten times a day in fear I might say something wrong and upset the "man", I would giv
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
it all up to be back self-employed again. So, if you are self-employed and you are experiencing all of the above, thank
.
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
yourself for the good days, thank yourself when you make accomplishments, thank yourself for having the type of employee
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
hat you would be and keep one thing in mind from one who has been there; the grass isn't always greener in the other yard
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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