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E-Folder - Strategic Planning- Document or Tool?
One credit union I worked with on strategic planning was so proud of the previous year's plan, it
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
was bound, had a fancy cover and was a document they were eager to show everyone.
Once I starte
Once I starte
; 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
d breaking it down, I soon realized how this fancy document was essentially hollow and with even
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
further exploration found barely any of the goals and objectives had even been attempted. The exe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cutive team and board were much more focused on creating a document than in creating a tool. We h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ad plenty of work to do to really get a strategic focus that went beyond the creation of a fancy
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
notebook.
A strategic plan as a tool is focused on taking a realistic vision and mapping out the
A strategic plan as a tool is focused on taking a realistic vision and mapping out the
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
steps to accomplishing that vision. Those steps should have a specific intent, an action or tact
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ical plan complete with due dates, accountabilities, and a person, (a champion) in charge to driv
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
e this plan toward completion. Each area should also have a form of measurement to ensure everyth
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ing is on target, is progressing well and most importantly; to identify when success is happening
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
!
Simplified strategic planning is less about a fancy document, or a convoluted plan only someon
Simplified strategic planning is less about a fancy document, or a convoluted plan only someon
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
e with a doctorate in finance could understand. It's more about creating a simple, functional too
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
l that everyone can understand, support, and dive into to make your vision a successful reality.
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
The strategic planning process is exactly that; a process. Not a retreat. Not a document. A livi
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
ng document that is the foundation of every positive step an organization makes. Test your daily
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
activities by asking: Does this support or advance the plan? If not, what's the purpose of doing
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
that action? If it is, how can you make it have greater impact.
Once the plan is being used as a
Once the plan is being used as a
.
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
tool by all employees, the synergy of working together takes on great momentum because finally p
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
eople are actually working in concert to achieve a common end -- the vision set forth in the plan
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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