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Advice You - DIVERSITY is a BIG word -- With A HUGE Business IMPACT
Second thought! Just in case. YOU or someone you personally
know may fit the following picture of success which may carry
too much risk for comfort.
You can sit back and simply enjoy the day. Let tomorrow take c
You can sit back and simply enjoy the day. Let tomorrow take c
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
are of itself. Can't you just hear it? I've got my
money "salted" away in a safe place. Getting great returns.
No risk! Where? I'm invested in the dot.com firms of
the future..... remember the bubble that
; 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
urst?
YOUR BUSINESS
Obviously, you get the point. There is little need to bash the dot.com failures. Our goal is YOUR business. Your future expansions for growth.
EXPERIENCE is an expensive teacher. There a
YOUR BUSINESS
Obviously, you get the point. There is little need to bash the dot.com failures. Our goal is YOUR business. Your future expansions for growth.
EXPERIENCE is an expensive teacher. There a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
re BETTER
resources. Some of us have learned in the School of Hard
Knocks. At least YOU can benefit by knowing some of our
mistakes which we freely expose for your perusal.
Yes, most of our mistakes were NOT sm
Yes, most of our mistakes were NOT sm
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rt. Could have
been easily corrected. Most 'goofs' are so obvious AFTER
the fact it's embarassing to tell anyone.
DIVERSITY Is KEY --
Is that just a nice "sounding" word? Only to those who FAIL to understand
DIVERSITY Is KEY --
Is that just a nice "sounding" word? Only to those who FAIL to understand
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it's HUGE impact. SUDDENLY! Almost
an Overnight kick.... your financial well being can be GONE.
Many of us have been there. All of our business LINKED to ONE account. Are you in that position now? I hear you
Many of us have been there. All of our business LINKED to ONE account. Are you in that position now? I hear 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
loud
and clear. You are saying, "I'm making good money and
business is great. Why should I change?"
If that is the case, YOU are NOT in control. Unless you have a service or product without equal or competition
If that is the case, YOU are NOT in control. Unless you have a service or product without equal or competition
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
, YOU
are at risk. Simply ask... if my ONE customer or my major
customer GOES AWAY tomorrow... what happens to my
business?
Are your equipment debts personally guaranteed? Is your home at risk? Do you have
Are your equipment debts personally guaranteed? Is your home at risk? Do you have
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
a long-term office/warehouse
lease? Bank loans?
OUR EXPERIENCE
Yes, I was fortunate and survived. At the time, I had several businesses not dependent on each other. Regardless,the impact and surprise income l
OUR EXPERIENCE
Yes, I was fortunate and survived. At the time, I had several businesses not dependent on each other. Regardless,the impact and surprise income l
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
oss was real.
For 10 years it was wonderful. Profits were basically guaranteed. A major Insurance company needed "outside" typists. Large companies do strange things. Head-count! Move staff (human resource)
For 10 years it was wonderful. Profits were basically guaranteed. A major Insurance company needed "outside" typists. Large companies do strange things. Head-count! Move staff (human resource)
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ost to "service" overhead expense.
Situations change! Buyers of services RETIRE. Management gets promoted to a new location. Offices consolidate. DOWNsize. UPsize. Go out of business! Bankrupt yet still ow
Situations change! Buyers of services RETIRE. Management gets promoted to a new location. Offices consolidate. DOWNsize. UPsize. Go out of business! Bankrupt yet still ow
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
ing you money that will never come.
Most of the above happened! Our "connection" moved. I had no idea the company was going to suddenly NO LONGER need our services.
It's happening around us every day. Technol
Most of the above happened! Our "connection" moved. I had no idea the company was going to suddenly NO LONGER need our services.
It's happening around us every day. Technol
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
ogy! Yesterday
is gone -- history. New ways of doing business. Automation.
Push-button society. Home based workers.
In a FLASH! ONE day! Our business (95%) was gone. We had NO warning at all before t
In a FLASH! ONE day! Our business (95%) was gone. We had NO warning at all before t
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
e doors shut in our face.
WHAT COULD HAVE HAPPENED?
To capsule, we were able to use the equipment in our other businesses. Our lease on the space had NOT been renewed. Our own staff was transferred within. We
WHAT COULD HAVE HAPPENED?
To capsule, we were able to use the equipment in our other businesses. Our lease on the space had NOT been renewed. Our own staff was transferred within. We
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
lucked out!!
However, I "shudder" to think of the consequences that could have forced most folks out of business.
Had we signed another 5-year lease, the cost would have exceeded our PROFIT for the prior 10 year
However, I "shudder" to think of the consequences that could have forced most folks out of business.
Had we signed another 5-year lease, the cost would have exceeded our PROFIT for the prior 10 year
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
.
Equipment leases would still hang over our heads. Staff? Their jobs would have been gone in a flash.
YOUR CHALLENGE
Step back and look carefully at your business risks. Don't assume anything. Your "good o
Equipment leases would still hang over our heads. Staff? Their jobs would have been gone in a flash.
YOUR CHALLENGE
Step back and look carefully at your business risks. Don't assume anything. Your "good o
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
ld" boy network has
NO guarantees.
Make DIVERSITY your #1 priority in 2005. Add new clients. Add new products. Quickly reduce your RISK away from any controlling entity. Seek to make 10% a TOP line maximum
Make DIVERSITY your #1 priority in 2005. Add new clients. Add new products. Quickly reduce your RISK away from any controlling entity. Seek to make 10% a TOP line maximum
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ependence on any one source of income.
Large buyers have been known to absorb ALL of a major manufacturer's production. As an astute business executive, YOU can see the END in sight. Don't let it happen.
Your cu
Large buyers have been known to absorb ALL of a major manufacturer's production. As an astute business executive, YOU can see the END in sight. Don't let it happen.
Your cu
.
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
stomer now CONTROLS your business. Profits are no
longer your decision. Expect the "squeeze" to intensify!
Too often, we can't see the forest for the trees. Same experience happens to a small service business,
Too often, we can't see the forest for the trees. Same experience happens to a small service business,
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
too.
ACTION TIP: Best advice is simple. DIVERSIFY! Never allow ONE client to OWN your business. 10% is a good MAXIMUM for any single buyer. Reduce YOUR risk. Add new clients or new products as quickly as possible
ACTION TIP: Best advice is simple. DIVERSIFY! Never allow ONE client to OWN your business. 10% is a good MAXIMUM for any single buyer. Reduce YOUR risk. Add new clients or new products as quickly as possible
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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