Advice You - Business

For many of us, our job is our primary source of income. For some, it is the only source of income. We all invest time and effort and in return we receive a paycheck. That paycheck (in theory) allows us to take

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

care of our families. It helps us buy food, clothing and shelter. If we work hard and control our spending, we may be able to save some of the money we bring home. This savings provides us with a sense of secu

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

Examples of combination products may in

rity. All of these basic needs – food, clothing, shelter and security – are linked to our job because work provides us with the means to satisfy them.

It is not surprising that we bond emotionally with our jobs.

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

We are attached to them because of their important role in meeting life’s basic needs. When we think about being fired, images of our children on a street corner begging for change flash through our minds. We te

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

nd to be guarded around people who have the power to take our jobs away from us. We often react emotionally when they critique our performance because that is a not-so-subtle reminder of the power they have over

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

Combination pro

our lives.

The emotions associated with work influence our career choices. Every career decision we make has an impact on our ability to meet our basic needs. Making good career choices requires that we shift

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

our perception of work. We need to take a business-like approach to our careers.

Well-run businesses follow a logical decision-making process. Contrast the emotional decision-making associated with fulfilling t

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

he basic needs of life with the aggressive growth-oriented decisions made by a well-run business. Each business decision is examined logically. Rational thought is given to the possible consequences of each alte

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

rnative. Contingencies plans are discussed and then a choice is made. If the decision has negative consequences, the business adjusts.

There are a few decisions associated with business that we can apply direc

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

tly to our career.

It makes sense to diversify income streams. Businesses that focus on one target market are vulnerable to the demands of that market. We are vulnerable when we depend only upon our job

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

for income. Investing savings in a passive source of income helps reduce the power our employer has over us. This can be as simple as investing in a growth mutual fund or as complicated as getting a part-time

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

Following aspects would a

job. People who have significant savings may want to consider real estate as a source of passive income. Rental properties require significant effort but they can also provide some healthy income if managed cor

dd to the challenges in developing combination products:

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

rectly.

We should always prospect for new opportunities. Good businesses are never satisfied with the amount or the quality of customers in their portfolio. They are always marketing themselves. We sho

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

uld do the same with our careers. It is our responsibility to get out and network with influential people as often as possible. We must make sure we are “known” in our industry and in our local community. Ther

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

e are a number of ways to do this without raising red flags with a current employer. Volunteering with a high-profile non profit organization is a great way to make contacts and “be seen”.

Keep growing and i

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

mproving. A one product company is limited in the ways it can serve its customers. Businesses are constantly changing and evolving to meet the needs of the environment. We must keep our skills and knowledg

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

Professional from academic institutions, pharmaceutical industries, health care indust

e up to date as the business environment evolves. This is a minimum requirement for ensuring continued employment. People who lead the pack set the standards by which others are judged. They become the benchma

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

rk that others strive to meet. This comes from immersing themselves in the details of their business. We must do the same. Strive to become a thought leader in the company. Set the standard that others must fo

.

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

llow – just as the market leader in an industry sets the standard that the other companies follow.

Taking the emotional power away from your employer is not an easy thing to do. It requires effort and dedicatio

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

Companies that provide selfless information through particip

n. Being aggressive and pro-active is the best way to control our destiny. When we view our careers as if they were businesses, we level the emotional playing field and we take back the power to shape our future

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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