Subjects - Business

Do you feel thrown around like a rag doll, keeping up with the pressures of today?

Do you feel as if you don’t have time to do the important things?

Do you feel as if you are spinning, but not sure where you are headed?

The world is

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

moving at an incredibly fast pace. More is expected of us than ever before and the opportunities and threats to our success and well-being are increasing. The typical businessperson experiences 170 interactions per day and has a back

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

log of 200-300 hours of uncompleted work. Focusing on the important is critical. Yet if you are like most people, you find yourself just reacting to the pressures of the moment. You may feel as if you are on automatic pilot and have

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

no choice in where you are headed. But where you are today is a result of the choices you made yesterday. We all have choices in how we invest our time and our resources and what we deem is important.

Identifying What is Important

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

More often than not, people do not take the time to identify what is most important. We live in a quick fix society where we look for instant gratification and a fast, painless solution to our challenges. Yet without taking the time

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

to identify what is most important in any situation, we don’t solve any problems or identify the core issues. I see it often in organizations that decide they want training but don’t take the time to really identify the type of train

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

ing that would offer the greatest results and leverage for the future. They blindly select a topic because it hasn’t been done before without taking the time to consider the results.

Only through identifying what is most important ca

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

we expect to wake up from the cloud of information overload, move forward through the maze and make a difference.

To identify and focus on what is most important there are some things to keep in mind:

Are you clear on the vision and

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

mission?

Are you clear on the vision for the company? Are you clear on the vision for your department? To identify what’s important at any given moment, you have to have a clear picture of where you are headed and how the things yo

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

u do on a daily basis contribute to that. In most organizations, this is easy for the people high in the ranks because they are in charge of making sure the vision gets fulfilled. But what about those further down the ranks? How cle

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

r are they about the vision? Do they know how their daily work contributes to that vision? Often frustrations occur because daily actions are not directed or focused in a specific direction. The actions are simply reactions to the p

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ressures of the moment. It is like driving a long way and then realizing that you weren’t on the right road. Having a vivid picture of where you are headed makes the journey shorter and more fun and allows you to identify and focus

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

on what is most important.

Values

If you aren’t clear or don’t honor your core values, business and life can feel empty. Until you are able to identify what is most important to you on a deep level, and to honor those values, you wi

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ll feel thrown around like a rag doll. When you feel distracted and out of touch, you are most likely honoring someone else’s values and not your own. Honoring what is important to you brings clarity of intention.

Get Your Needs Met

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

We all have primary needs such as security and appreciation. Abraham Maslow, in his hierarchy of needs, says that you can’t fully move to the next level until you satisfy the current need. Maslow’s theory is often shown as a pyrami

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

d with 5 levels: Physiological (biological needs), Safety, Love, (belonging), Status (esteem), Actualization. The lower the need is in the pyramid, the more powerful it is. Too often we stay stuck in life because we are not taking

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

care of our more basic needs. If you are struggling to pay your mortgage and electricity every month, you are still at the second level of security and will have trouble moving on to the next until you find a way to take care of that.

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

A sales rep will have a hard time focusing on increasing sales (What’s Important for the organization) when he is behind in his mortgage. Unidentified and unfilled needs become distractions from focusing on the things that will make

.

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

a difference in your work and in your life.

Unless we are able to identify and act on what is important, we are thrown around by the forces of nature and our actions lack clarity and effectiveness. However, in order to identify and

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

act on what is important, we have to have a road map with a clear vision, defined values and fulfilled needs so that we can effectively pursue our deepest desires.

We are either the masters of our time or victims of fate. What are you

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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