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Digg It - Are You At The Mercy Of Computer Geeks?
Many business owners are sabotaging their business without even realizing it. They are completely out of the loop when it comes to all technology aspects of their operation such as websites, computers an
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
d software. They become completely dependent on their technical people and naively believe that things are "being taken care of".
This "head in the sand" approach is very dangerous. Here are just a few
This "head in the sand" approach is very dangerous. Here are just a few
; 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
scenarios of what can happen:
- Your webmaster is the only person who knows the username, password and other improtant settings for your website. If the webmaster suddenly stops responding to yo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ur phone calls or e-mails (which I've seen happen many times), you would have no idea how to hand off the website updates to another person.
Your programmer no longer wishes to work with you. When y
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
u hire a replacement, it turns out that there is no documentation for the program, the code is unreadable, and it will be cheaper for you to buy a new program than salvage this "sinking ship".
The so
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tware that was developed for your business theoretically does all that was required, but there is one big problem: it is sitting idle because it is so confusing that nobody wants to use it.
The web
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
server crashes and your website files get erased. Then it turns out that nobody has a backup copy
Your technical person realized how dependent you've become, and starts acting like a "primadonna", a
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
d even blackmails you into shelling out more cash, "or else"!
So how do you protect yourself?
If you are now thinking that you need to become a computer geek yourself so you don't have to depend
So how do you protect yourself?
If you are now thinking that you need to become a computer geek yourself so you don't have to depend
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n anyone else - that could not be further from the truth. If you spend all your time digging through computer books, writing code and working on the technical details, there will be no time for you to ru
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
n your business.
Doing it all yourself is not the answer. Everyone should concentrate on doing what they do best. What you need to do is just take some measures to protect yourself. Just knowing and a
Doing it all yourself is not the answer. Everyone should concentrate on doing what they do best. What you need to do is just take some measures to protect yourself. Just knowing and a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
plying these few basic things that I'm about to describe will put you a giant leap ahead of most other business owners.
Here are the things you should do:
Here are the things you should do:
- Require documentation on all technica
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
projects. Every technology aspect of your business should be documented in such a way that you can hand off this document to a new technical person and they'll understand exactly how the system works an
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
d what to do with it.
Let me warn you: you will encounter a lot of resistance from the technical people when you make them document things. However, you need to be firm and require documentation as part
Let me warn you: you will encounter a lot of resistance from the technical people when you make them document things. However, you need to be firm and require documentation as part
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
f the project before you release the final payment.
When asking someone to develop a website or software, communicate exactly what you want and how you want it to work. Don't assume that people can
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
ead your mind.
Communicate all your requirements upfront. If you don't tell programmers or designers exactly what you want, they'll put together a project according to their own vision, which often does
Communicate all your requirements upfront. If you don't tell programmers or designers exactly what you want, they'll put together a project according to their own vision, which often does
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
not correspond to yours.
Most problems with technical projects occur because of miscommunication.
Make sure you have copies of all files and do regular backups. Don't put it off until tomorrow, be
Most problems with technical projects occur because of miscommunication.
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
ause tomorrow might be too late. Losing data can be absolutely devastating.
The easiest thing to do to protect your data is to write those files to a CD on a regular basis. Also, don't forget to store
The easiest thing to do to protect your data is to write those files to a CD on a regular basis. Also, don't forget to store
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
hose CDs in a secure location.
Keep track of all technical projects and know what's going on. Being "clueless" should not be acceptable.
Many business owners have such fear of technology that they
Many business owners have such fear of technology that they
.
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
just don't want to understand the projects and hope that others will simply take care of everything. While you don't need to get involved in all the little technical details, you still need to understand
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
the process and "the big picture".
Practice these simple strategies, and you'll find yourself having more control, more piece of mind and more money in your bank account.
Melanie Mendelson (c)200
Practice these simple strategies, and you'll find yourself having more control, more piece of mind and more money in your bank account.
Melanie Mendelson (c)200
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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