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Main Subject - Leveraging Promotional Software Techniques
In recent consulting work for a number of large corporations, I conducted an experiment using software to distinguish the level and value of my services to the co
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
mpanies I worked with on a number of assignments. The objective was to test the response, continued use, and perceived value of the services provided to my custo
; 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
mers. As part of each assignment, the companies requested that I provide procedural information to document my positions in a way that would orient their own per
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sonnel, or subsequent contractors to the resources, information, and procedures used to accomplish various tasks involved with the work. What they did not specif
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
y was the means I was expected to use in accomplishing this task.
Since I had already developed a number of tools for increasing individual productivity, I decid
Since I had already developed a number of tools for increasing individual productivity, I decid
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ed to use the licensed software from my own company to accomplish the assignments. For all the tasks, I packaged the information in a software bundle that includ
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
ed connections to web sites, documents, personal notations, graphics, program start ups, and other media within the context of a single focused application, then
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
dded information about licensing, my business contact information, and web site location for purposes of supporting the presentations. In anticipation of the cli
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ents’ requests, I had built each package from the beginning of each assignment, so by the time my work was completed, I had detailed information regarding how the
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
assignments had evolved, contacts, procedures used, and tools employed in accomplishing the work.
As the assignments drew to a close, the companies anticipated
As the assignments drew to a close, the companies anticipated
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
they would need me to spend a week or two with subsequent personnel to orient and train them in my work. When I showed them the information I had already package
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
d for them, and demonstrated how it was accessed, they were very surprised to see how thoroughly the task had been completed, and accepted the work immediately.
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
Rather than spending weeks in orienting new people to the tasks, I simply turned over the software information package, and made myself available for questions af
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
ter briefly orienting my replacements to how the software worked. The subsequent “training” required no more than two days worth of being available for what few
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
uestions were raised. Though I did allow the customers the ability to change the contents of documents and certain information gathered by the tool, the licensin
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
g and functions of the software package itself did not allow users to alter what was included, or how the software itself worked. I also incorporated each compan
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
y’s logo information into the displays of the packages, so they appeared to be managed by the companies themselves.
The techniques resulted in subsequent calls f
The techniques resulted in subsequent calls f
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rom the clients asking for me by name to return for more consulting work, and led to calls from others within the company to my business over a year later, asking
.
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
questions related to my expertise on the content of their information. This experience proved helpful in establishing techniques and practices in leveraging sof
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
tware for business promotional purposes, and providing outstanding tools for distinguishing my services from those competitors who are not using similar practices
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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