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Other Articles - 5 Steps To Turbochare Your Success!
Let's take an imaginary journey. Better yet, imagine that you wish to take a driving trip across the country from New York to San Francisco. There are more than a couple of ways to head out on this trip. But, you have limited time and resources, AND you want this trip to be productive, enjoyable, and NOT
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
stress-inducing.
Which of the two following approaches makes the most sense: (A) Saying "I'm going to San Francisco" then jump into your vehicle, and head out with no planning? Or, (B) creating a mental picture of how you'd spend your time (and money) in San Francisco? Would you know the reason for your t
Which of the two following approaches makes the most sense: (A) Saying "I'm going to San Francisco" then jump into your vehicle, and head out with no planning? Or, (B) creating a mental picture of how you'd spend your time (and money) in San Francisco? Would you know the reason for your t
; 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
ip? In other words, how would you prepare for the trip? Would you map out how to get there? Would you know who would be traveling with you, and what their responsibilities for the trip might be? Would you figure out how much money you would need to get there (not to mention, get back home)? How much tim
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
will you allow for the trip? How many stops will you need to make? And, finally, how will you keep from running out of fuel (emotionally, physically, and financially) before the trip is completed? (This last question is addressed in my "Running on a Full Tank" class. The rest of the questions can be add
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
essed by thinking deeply, and following 5 major steps to success, below).
Using the above analogy, let's say that the destination is your success in business. How well can you define the following: your ultimate destination (your vision), why your business exists (your mission), how you measure your progre
Using the above analogy, let's say that the destination is your success in business. How well can you define the following: your ultimate destination (your vision), why your business exists (your mission), how you measure your progre
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s (your objectives), what ongoing steps you will need to perform (your strategies), and what projects need to be implemented (your action plans)?
In the examples above, most small business owners try to run their business using the (A) approach. They have sort of named a destination ("I want to have a busi
In the examples above, most small business owners try to run their business using the (A) approach. They have sort of named a destination ("I want to have a busi
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
ess doing_____"), and set out to "go there" with no real planning. With this approach, how much time and other resources are wasted on taking wrong turns, not having carity about where they're going, why, with whom, and what exactly needs to be done to reach their destination?
If you're really serious abou
If you're really serious abou
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
reaching your success destination, my challenge to you is to create a powerful, energizing, inspiring, step-by-step plan that clearly maps out everything needed to get there. I love using "The One Page Business Plan" system. So with this as my guide, I've mapped out your 5-step journey to success.
Vision
Vision
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
- (What are you building)
Describe with great clarity what your business will look like in 3 to 5 years. How much revenue will it generate, with how many employees, serving what geography, serving what type of client, and providing what service? You may even want to specify what technologies you will use,
Describe with great clarity what your business will look like in 3 to 5 years. How much revenue will it generate, with how many employees, serving what geography, serving what type of client, and providing what service? You may even want to specify what technologies you will use,
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
or what ideals you will incorporate into your company culture. If you have a goal of giving 10% of your profits to a favorite cause, include that, too. In other words, dare to dream...and dare to dream specifically and boldly!
Mission - (Why does your business exist?)
When I work with a client to create
Mission - (Why does your business exist?)
When I work with a client to create
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
usiness plans, this is very often the area on which we spend the most time...and for good reason. A well defined mission should not only inspire you and your employees, but customers as well. To do so, it should encapsulate the reason why, on a deeper level, you have chosen to be in this business, and what
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
sets your business apart. It's timeless. (Examples: The History Channel: "Where history comes alive"; Nature Concervancy: "Saving the last great places"; Lenscrafters: "Helping people see better, one hour at a time"). A mission can compel and impel you (and others) to action. And, when the going gets ro
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
gh, or you're feeling discouraged, it acts as the inspiration and energizer to keep you going.
Objectives - (What are the specific measures?)
Objectives must be graphable. They define your goals...what you need less of, or more of, to be successful. Maybe you want more revenue, profits, clients, or store
Objectives - (What are the specific measures?)
Objectives must be graphable. They define your goals...what you need less of, or more of, to be successful. Maybe you want more revenue, profits, clients, or store
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
locations. Great! How much more? Now, what do you want less of?...inventory, printing costs, automotive costs? Terrific! How much less?
Stated another way, what numbers do you need in order to assess the health, the pulse of your business? What statistics indicating the health of your business would b
Stated another way, what numbers do you need in order to assess the health, the pulse of your business? What statistics indicating the health of your business would b
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
on a single page...to be faxed to you while you're lying on a beach in Tahiti?
Strategies - (What are the right things we have to do over time?)
How will you grow and manage this business? Strategies provide a framework for what you will and will NOT do. They establish best practices, set the direction
Strategies - (What are the right things we have to do over time?)
How will you grow and manage this business? Strategies provide a framework for what you will and will NOT do. They establish best practices, set the direction
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
n such areas as marketing, product pricing, internet presence, strategic alliances, target markets, employee retention, and positioning. Examples include: Doing a product roll-out at a major trade show, forming a strategic alliance with a "power partner", setting up a testimonial or referral program.
Acti
Acti
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
n Plans - (What is the work to be done?)
What projects do you need to work on this year? Who is responsible for each of these projects, and when will the projects be completed (what date)? For example, my action plans include: by the end of April, schedule and announce 3 dates for my workshops; write and
What projects do you need to work on this year? Who is responsible for each of these projects, and when will the projects be completed (what date)? For example, my action plans include: by the end of April, schedule and announce 3 dates for my workshops; write and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ubmit 2 articles by the end of May; put 12 speaking engagements on my calendar by April 30th; complete new CD products by June 30th. Each of these is a project, which will support my objectives and strategies.
So, there you have it...5 steps to turbocharging your success. Are these steps simple? Yes. Ar
So, there you have it...5 steps to turbocharging your success. Are these steps simple? Yes. Ar
.
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
they simplistic? Absolutely not! Writing plans is difficult. Quality thinking and writing take time. But don't worry about getting it "right", just get it in writing. It can be edited later, undoubtedly in 3 months it will be significantly different, and probably much better.
You and I have the abilit
You and I have the abilit
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
to design our future, our lives, our success for as long as we can breathe and dream. By putting planning into the mix, you'll have the map and compass to reach your destinations and achieve your dreams far more quickly and better than you could have imagined. So, dream, plan, and move into your greatness
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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