Advice You - Business

"It takes courage to grow up and turn out to be who you really are." — e.e. cummings

The dictionary says that to survive is to remain alive or in existence, to carry on despite hardships, or to persevere. In contrast, the definition of the word thrive is to prosper, to grow v

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

igorously, and to flourish.

Which one of these words best describes your current business condition? Are you surviving, or thriving?

An impressive track record, quality products and services, and years of experience do not always add up to a prospering business with a thrivin

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

Examples of combination products may in

team. Demanding clients, stiff competition, intense pricing models and many other factors can create tremendous pressure for business owners (and their teams) to keep working harder just to survive. When combined with challenging market factors, most professionals and business

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

owners feel a tremendous sense of responsibility towards their customers, their employees and their reputations. They want to do whatever it takes to keep it all under control – but trying to control it all can create chaos and stagnate your business.

Perhaps you (or someone

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

ou know) can relate to the following:

"I should be focusing on strategy and new business development, but I am spending all of my time just making sure the work gets out correctly."

"No one else is really willing to step up to the plate. If I am not personally involved, thing

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

Combination pro

fall through the cracks. Mistakes are costly, so I need to be involved in every decision."

"The business is stuck and I can't even find time to read my email or clear off my desk."

"Time for planning -- you must be kidding? I haven't gotten home before nine this week!"

The

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

pressure to hold everything together single-handily is huge, and if you succumb to the "if I want it done right I need to do it myself" mentality then not only will you suffer, but so will those around you and so will the business.

When you are fighting to survive, it is criti

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

al to find time to step back and gain perspective. Working harder, but without the benefit of perspective and a solid strategy, will probably not change the situation. And it certainly won't get you out of "survival mode".

Step Back and Move Forward

"I know of no more encoura

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

ging fact than the unquestionable ability of man to elevate his life by conscious endeavor." —Henry David Thoreau

If you are ready to start thriving, it is time to stop dreaming and do something about it.

For the moment, stop worrying about "how" to thrive. Pull out your cal

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

ndar and schedule a 30 minute meeting with yourself (no one else needs to know who this meeting is with; label it as "business development" time). In that meeting your task is to think about YOU and about whom you are being when you are at your best. What is it that makes you t

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

rive? Think about the following questions and jot down your ideas.

If you could incorporate more of what makes you thrive into your business:

WHAT would you be doing?

WHAT would you be feeling?

WHAT impact would you be making on others?

WHAT impact would it have on the suc

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

Following aspects would a

cess of your business?

The "how" will become easier to tackle when you are really clear on WHAT is important. There are always obstacles and challenges in figuring out how, but if you start there you will quickly get stuck. There are always possible solutions when it is import

dd to the challenges in developing combination products:

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

nt enough. By first identifying what matters most to you, it will be easier to then determine the specific actions you need to take in order to make it happen.

Enlist Help

Being perpetually "busy" doesn't mean you're being productive. Many people, when they do this exercise,

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

discover that they have been spending the majority of their time on the "wrong" things, i.e. activities that are not moving them closer to what really matters most. If you have discovered the same thing about yourself, but can't figure how to change the situation, enlist suppor

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

!

Keep in mind that individuals on a team (employees, subcontractors, business partners, etc.) will only begin to take ownership when there is an environment that welcomes input, encourages participation, and rewards risk-taking. Relinquishing control is scary for a business o

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

ner, but it is even more frightening to think of the potential impact on the business when everything falls on the shoulders of one person. Can any business grow and thrive when one person is trying to do it all?

Here are a few ways to get your team involved in creating a thri

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

Professional from academic institutions, pharmaceutical industries, health care indust

ving business, starting right now:

Ask for their ideas, and then listen. Never automatically reject any idea just because it wasn't your own. It might have merit "as is" or at least be a starting point to a great solution. Delegate, and then let them learn. Implement a syste

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

of checks and balances to give yourself a sense of control over what's happening, even if you're not the one doing all the work and making all the decisions.

Empower others to take risks, and then reward them when they succeed. Give them ownership, and then measure their ac

.

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

complishment. Business owners and professionals need personal support as well. Everyone needs a safe place to think, problem-solve and innovate. Engage a coach, a mentor or a peer group as a sounding board and guide to help you determine an optimal course of action. It is imp

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

Companies that provide selfless information through particip

ssible to thrive if the weight of the world is sitting on your shoulders.

With clarity, purpose and a game plan you can still be in the driver's seat, and have less stress and more peace of mind. Your business will thrive, and so will you. Isn't it time you started to flourish

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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Your personal focus needs to be on the company and not yourself. This means that the company has your full support and you are willing to work towards a common goal - the success of the brand.

You are looking for a job and you are out to land the job of a lifetime. It can happen! Before you consider want ads, job websites, or making inquiries of companies you are interested in, you will need a resume.

These five tips will ensure that a reporter will listen to you, and be willing to listen the next time you call.

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Advice You - Business Owners - Are You Thriving or Simply Surviving?

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