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Useful Advices - Technology Is Not a Substitute for Organization
Technology is changing business for everyone -- from small home- based businesses to mega multi-national corporations. Whether you are inspired or threatened by those changes, they are here to stay, or more accurately, to continue changing. You cannot only survive these changes, but turn them into exciting opportunities by applying some basic organizing princi
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
ples.
Not many years ago, getting organized was an option. Today technology has made it a necessity for three reasons: Today we have more to organize than ever before. Not only did the computer not give us the paperless age, it created more. In addition, we now have to organize the technology itself. Computers, fax machines, cellular phones, and on-line se
Not many years ago, getting organized was an option. Today technology has made it a necessity for three reasons: Today we have more to organize than ever before. Not only did the computer not give us the paperless age, it created more. In addition, we now have to organize the technology itself. Computers, fax machines, cellular phones, and on-line se
; 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
vices enable us to do more -- and require us to do more. The speed of the microchip doubles every 18 months -- with no end in sight.
Secondly, as a result of the economy, and fueled by the capabilities of technology, companies are downsizing. All managers used to have an assistant, and it was the job of that assistant to keep them organized. We fired the ass
Secondly, as a result of the economy, and fueled by the capabilities of technology, companies are downsizing. All managers used to have an assistant, and it was the job of that assistant to keep them organized. We fired the ass
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
stants, and are now faced with organizing ourselves.
And finally, there is a greater sense of urgency than ever before. If I can fax you a question in 20 seconds, why can’t you fax me the answer? There is a constant demand for decreasing costs while continuing to improve quality of products and services with fewer people. The price of failure is staggering.
And finally, there is a greater sense of urgency than ever before. If I can fax you a question in 20 seconds, why can’t you fax me the answer? There is a constant demand for decreasing costs while continuing to improve quality of products and services with fewer people. The price of failure is staggering.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
You may be reluctant to get organized, as many people are. But often it is because they have been misled about what it means to be organized. My definition of organization is very simple: Does it work? and Do you like it?” And if what you are organizing -- or not organizing! -- affects others, there is a third question: “Does it work for others?”
Tom Landry,
Tom Landry,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
former coach of the Dallas Cowboys once said, “My job is to make the guys do what they don’t want to do, so they can be who they’ve always wanted to be.” Often that’s my job as an organizing consultant! Successful people make a habit of doing what failures don’t like to do -- and that frequently includes getting organized!
If your answer to any of the questi
If your answer to any of the questi
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
ns above is “No,” try these suggestions to help you get started on the road to organization and make the most of your technology:
1. Continually practice the Art of Wastebasketry?. Research shows we use only 20% of what we keep. For each piece of information you receive, whether in hard copy or on the computer screen, ask these questions: Does this require
1. Continually practice the Art of Wastebasketry?. Research shows we use only 20% of what we keep. For each piece of information you receive, whether in hard copy or on the computer screen, ask these questions: Does this require
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
ction? Can I identify a specific use? Would it be difficult to get again? Is it recent enough to be useful? If the answer to all those questions is “No,” ask one final question: "What's the worst thing that could happen if I don't have this piece of paper?" If you can live with your answer -- toss or recycle it! Take a look around your office. Do you se
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
unused equipment, books you’ll never use again, drawers full of unidentified paper, or outdated inventory? If so, you’ll experience a new sense of energy if you get rid of it.
2. Learn to choose technology effectively. Most of us are trying to do more with less, and working harder is not always the answer. The real question is "Does anyone really need to d
2. Learn to choose technology effectively. Most of us are trying to do more with less, and working harder is not always the answer. The real question is "Does anyone really need to d
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
o this?" Just because technology allows you to accomplish a specific task doesn’t mean it’s the best way for you to use your resources. Just because an upgrade is available doesn’t mean you need to use it. Make sure that the results will be worth your investment of financial and human resources.
3. Implement a system for keeping track of names and telephon
3. Implement a system for keeping track of names and telephon
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
numbers. Most of my clients agree that their best source of business is networking, but piles of unidentified business cards will not do the trick. Deciding which system to use is far less important that using it consistently. For some people, technology is the perfect answer, while others accomplish their needs with a Rolodex.
My own system combines four
My own system combines four
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
ethods:
(1) Contact management software program for all past, present, and potential clients.
(2) Rolodex to enter business cards for all services such as computer repair, graphics, etc., most frequent clients (for easy access), and my colleagues.
(3) Address book for family and friends.
(4) Pocket address book to carry in my briefcase with m
(1) Contact management software program for all past, present, and potential clients.
(2) Rolodex to enter business cards for all services such as computer repair, graphics, etc., most frequent clients (for easy access), and my colleagues.
(3) Address book for family and friends.
(4) Pocket address book to carry in my briefcase with m
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
st frequently used numbers -- business and personal.
4. Create a paper filing system that works -- easily and consistently! In spite of the computer-age promises of a paperless office, most of us are faced with more paper than ever before. If you find that your filing system is not working and most of it you never use, clean out your most accessible file dr
4. Create a paper filing system that works -- easily and consistently! In spite of the computer-age promises of a paperless office, most of us are faced with more paper than ever before. If you find that your filing system is not working and most of it you never use, clean out your most accessible file dr
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
awer and start over! Begin filing new information by asking “If I need this information again, what word will I think of first?” The answer is your new file title. Alphabetize the file titles, and keep a list of them -- a file index. Before you make a new file, check the existing list to avoid creating a file for "Car" when you already have "Auto." Keep a c
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
py near the filing cabinets and at the desk of everyone who uses the files.
5. Create a computer filing system that works -- easily and consistently! Remember that a computer’s value is that it allows you to use a file again. If you do not intend to use the document again, there is no value in storing it in a computer.
The key to effectively organizing your
5. Create a computer filing system that works -- easily and consistently! Remember that a computer’s value is that it allows you to use a file again. If you do not intend to use the document again, there is no value in storing it in a computer.
The key to effectively organizing your
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
omputer is your directory, and the first step is to point all files into one directory, regardless of what program created those files. This will make it easier to retrieve what you need, regardless of what program created it, and make it easier to back it up for archives or for transfer to other locations.
In paper systems, people frequently get into trouble
In paper systems, people frequently get into trouble
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
ecause they have too many categories, while in computer systems, they get into trouble because they have too few categories (i.e., directories and subdirectories). It is easier to flip through one paper file that has 20 pieces of paper in it than it is to go through 10 files with two pieces of paper in each. On the other hand, it is easier to scroll up and dow
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n a computer screen looking for directories and subdirectories than it is to open documents. In addition, your computer gives you a “Find” feature that will help you locate any file you want by searching for key words without your having to actually open each file.
Two of my favorite directories are:
1. Pending. This is for files on w
Two of my favorite directories are:
1. Pending. This is for files on w
.
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
ich I am currently working. I can quickly see which documents are in process, or if necessary it will be easy for someone else to retrieve my work.
2. Outbox. Here I file work which I have completed, but need to print, fax, give to someone else, or send to another location.
Remember that in any organizing process, you may feel worse bef
2. Outbox. Here I file work which I have completed, but need to print, fax, give to someone else, or send to another location.
Remember that in any organizing process, you may feel worse bef
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
re you feel better. To change is difficult -- even when you want to. It takes time to learn new behavior patterns. Organization is like any other skill. If you want to play tennis, you can read books, look at videos, get the best coach, and go to the best court, but after a week you still won't be a great tennis player. It takes practice. So does organizing
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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