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Advice Pool - A Small Business Consultant Can Help in Many Ways... But One Thing He Can't Provide
A consultant must remember that the business belongs to the client. There is always a danger that the consultant will take a dominant position to the detriment of both of them.
Let me tell you a story of when this was for
Let me tell you a story of when this was for
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
gotten…
It’s not often a small business consultant will admit to a failure in a small business but my first adventure into small business consulting was a failure. I closed the business within two years.
In 1980 I had pl
It’s not often a small business consultant will admit to a failure in a small business but my first adventure into small business consulting was a failure. I closed the business within two years.
In 1980 I had pl
; 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
nned to offer Mom-and-Pop sized businesses cheap but effective small business help. I saw many who badly needed something to pull their businesses out of the doldrums. But consultants were asking minimum fees of $3,000 whi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
h they could not afford.
My thinking was that if I computerized and systemized my services I could offer a low-cost service which would rejuvenated their enterprises. They, of course, would be so thrilled that they would
My thinking was that if I computerized and systemized my services I could offer a low-cost service which would rejuvenated their enterprises. They, of course, would be so thrilled that they would
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
etain my firm to do their general tax and accounting work.
Like the curate’s egg I was partly right. Kelvyn Peters CPA and Associates still retain clients from that era who still think I’m wonderful (but expensive). My sm
Like the curate’s egg I was partly right. Kelvyn Peters CPA and Associates still retain clients from that era who still think I’m wonderful (but expensive). My sm
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ll success blinded me for a while to where my plan was doomed to fail.
The first trap was that the ‘oomph’ for the business had to be supplied by the client. It did no matter how passionate and excited I was in improving
The first trap was that the ‘oomph’ for the business had to be supplied by the client. It did no matter how passionate and excited I was in improving
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
sick business if the client had no excitement. The punch and the drive to run a business have to come from the owner. The consultant can only steer that drive in the right direction.
The second pitfall was in not realiz
The second pitfall was in not realiz
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
ng that small businesses are sometimes run by ‘small’ people. Nice people; generous and kind people who you’d be glad to have as friends…but people with low horizons who are comfortable where they are. They know they shoul
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
be concerned about their business. Everybody tells them so.
But in their hearts they are not.
When these people engaged my services it was because they felt they had to. The bank or a creditor had advised it. Sometimes
But in their hearts they are not.
When these people engaged my services it was because they felt they had to. The bank or a creditor had advised it. Sometimes
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
well-meaning son or daughter had said, ”Pop you’ve gotta get some help! You’re killing yourself here!”
However, what had to be done made them so uncomfortable that they just did not do anything and fell by the wayside. (
However, what had to be done made them so uncomfortable that they just did not do anything and fell by the wayside. (
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
robably blaming the consultant).
If they retained our services they became high-maintenance clients phoning us (no e-mails then) before they made almost every new decision. Sending out a mailbox drop? Please design and pr
If they retained our services they became high-maintenance clients phoning us (no e-mails then) before they made almost every new decision. Sending out a mailbox drop? Please design and pr
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
oduce it for me. A monthly newsletter? Could you do it for me because you are so good at it.
This normally would have been great except in this case they could not pay for the service and felt it should be included in the
This normally would have been great except in this case they could not pay for the service and felt it should be included in the
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
initial fee. We lost heaps of money providing these extra services without charge.
My staff said I was too good-hearted. I do not agree. Here were people really needed our service and they couldn’t pay for it. How could w
My staff said I was too good-hearted. I do not agree. Here were people really needed our service and they couldn’t pay for it. How could 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
let them sink alone.
We could not continue and had to close the service…and the world continued. ‘Mom-and-Pop’ businesses still need help but now we know how to interact with them so that neither of us is burned.
The th
We could not continue and had to close the service…and the world continued. ‘Mom-and-Pop’ businesses still need help but now we know how to interact with them so that neither of us is burned.
The th
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
rd problem is one I discovered only yesterday from a book called Success Engineering by Phil Gosling.
In the book he tells of clients who on the face of it believe in what he tells them. They seem eager to follow his sugg
In the book he tells of clients who on the face of it believe in what he tells them. They seem eager to follow his sugg
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
stions. and seem eager to do what he tells them. They attempt to do every thing he suggests, but things just don’t work for them. They work for everyone else but not for them. I experienced the same thing.
I felt that the
I felt that the
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
were psychologically sabotaging themselves because of their fear of the unknown. Phil has a completely different explanation which he explains in his book.
So now our number one criteria for accepting a new client is tha
So now our number one criteria for accepting a new client is tha
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
they should have the passion and persistence to see it through. An ailing business shows signs of improvement week by week but sometimes it will be two years before vigilance can be relaxed. Those two years are too hard t
.
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
deal with for some people. They would rather surrender.
Previously, I have said that to me accounting wasn’t boring or dull. I am passionate about being an accountant. I have an excitement about helping people because I
Previously, I have said that to me accounting wasn’t boring or dull. I am passionate about being an accountant. I have an excitement about helping people because I
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
an make a difference to their lives.
If my experience and knowledge is added to the excitement and drive of a business owner we, together, can really make things happen. Dreams really will come true.
Keep the dream alive
If my experience and knowledge is added to the excitement and drive of a business owner we, together, can really make things happen. Dreams really will come true.
Keep the dream alive
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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