Advice You - Business

THE STRUGGLE -- I was recently talking with one of my entrepreneur friends. He has started three businesses in the last several years—a budding entrepreneur. He was relating some of the joys he has experienced in those enterprises: a sense of fr

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

eedom from the corporate world, pursuing his dreams and passions, setting his own schedule, controlling his destiny and a large potential for financial rewards.

However, he did mention a few downsides: little to no outside accountability, lack

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

Examples of combination products may in

of consistent capital, feelings of loneliness, no steady revenue stream, feeling disconnected from others who don’t understand his drive to succeed, constant struggles to survive and a severe lack of work-life balance. Sound familiar?

I think m

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

ost entrepreneurs struggle with similar issues, especially balance. There are many reasons they can give for their lack of life balance and low satisfaction: “I have too much work to do. I just need a few more hours to finish this project. I nee

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

d more money. I have bills to pay. My business depends on my hard work. My family needs more income. I am solely responsible for developing, marketing, selling and servicing my product or service.”

Any or all of these reasons may be true, which

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

Combination pro

might lead entrepreneurs to find great difficulty in managing the two sides of entrepreneurship—balance and success. How often do you struggle with working longer hours than you know you should to try and secure the next sale? How many times ha

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

s your family and friends tried to pull you away from your office this last month? Take a moment and count up the actual hours you have spent working this last week or month. There is always the temptation to do a little more, work a little hard

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

er, talk to one more potential customer in hopes of making one more sale.

What specific things are you doing to take care of yourself: physically, emotionally, and spiritually? Many entrepreneurs overlook these vital areas of life in search of

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

professional success, yet these areas are full of potential for sparking the creative, outside of the box thinking that leads entrepreneurs like yourself to discover life changing products and services and find a new perspective on your business

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

venture.

ASSESS WHERE YOU ARE

Take a moment and write down these 8 life areas:

• friends & family

• fun & recreation

• physical environment & home

• romance & significant other

• fitness & health

• career

• finances

• personal & spiri

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

tual growth

Next to each area assess where you currently are. On a scale of 1 to 7, with 1 being “completely dissatisfied” and 7 being “completely satisfied” mark how currently you are satisfied in each area. Add up the totals of all eight area

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

Following aspects would a

s before reading further. The scoring is at the end of this article.

DEVELOP A PLAN

As you look at your current level of satisfaction what patters or themes do you see? Where areas are you the least satisfied with? The most?

For you who recog

dd to the challenges in developing combination products:

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

nize a change is in order, here are a five simple steps to help you start finding the work-life balance that leads to success:

1. Choose 1 area that you are dissatisfied with and would like to see some immediate improvement in. This should not

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

be your worst or best scoring area, but somewhere in the middle. Take a couple minutes and write down in detail what balance would look like for you in that area.

2. Now, get out your planner and make a note to yourself one week from today. In

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

the note, write down:

• the area that you want to improve your level of satisfaction in

• the “score” where you are now and the “score” you want to be at the next week

• 2 things you are going to do to move yourself towards that goal over thi

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

s next week

3. Tell someone about your goal and ask them to hold you accountable—whether it’s a friend, a mentor, or your coach. It’s easy to make “new year, new leaf” promises to yourself, but more difficult to follow through with unless you k

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

Professional from academic institutions, pharmaceutical industries, health care indust

now someone is holding you accountable to reach your goal.

4. Set up a time to talk with your accountability partner the next week. Did you reach your goal? If not, talk about what kept you from reaching it and what will you do differently this

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

next week. If you did reach your goal, congratulate yourself. Do something simple to celebrate your achievement.

5. The final step is to go back to step 1 and do it over again.

Creating life balance is never easy and it’s never complete. Ther

.

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

e will always be room for improvement. The point is that you can make your life more balanced by taking small steps in the right direction. Like most worthwhile things in life, creating life balance is a process, not an event!

SCORING RANGE

8—

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

Companies that provide selfless information through particip

16 Wow! Things must be pretty rough right now.

17—30 Average score of many small business owners

30—45 There are some very satisfying and very dissatisfying areas in your life

45—56 You recognize the importance of life balance to life success

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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Business law is one of the branches of the huge field of law. There are many things one has to keep in mind when starting a business; let it be a small or a large business. Breaking these laws may land you in deep trouble, so it is always advisable to have some basic knowledge of both small business law and business corporate law. With this knowledge, you are sure of being able to run your business smoothly without any hindrance from the law whatsoever!

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