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Joanna was a great employee. She cared about her work. She worked hard. And she really wanted to succeed. But after a couple years of hard work and long hours, she felt like she was just spinning her wheels because she wasn't making the progress –

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

personally or professionally – that she had hoped she would by now.

She talked to Tom, a person she considered a friend and mentor, and shared her feelings. Tom asked her about her goals.

Joanna paused, feeling a bit tentative. Then she shared some

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

Examples of combination products may in

general comments about what she hoped to achieve in her work and how she hoped her work would contribute to her life.

Tom listened carefully, but she could sense he was waiting for more. And he was. Then Tom quietly suggested that Joanna’s goals wer

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

n't clear enough, and he encouraged her to set some more specific goals for the future. That action, he said, would be a way for her to both improve her results and lead to higher personal satisfaction.

Joanna walked away from that conversation resol

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

ed to set some goals. She bought a book on goal setting and read it cover to cover. The concepts in the book made sense, and she decided on the weekend she would set goals using the approach the book suggested.

But the weekend came and went, as did

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

Combination pro

he whole next week. Then the next weekend passed, along with the weekend after that – and Joanna still hadn’t set any goals. She rationalized that she was just too busy. She was working too hard, and she didn't have time to stop and set her goals;

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

esides she already knew what she wanted to accomplish.

Six months later she visited with Tom again. He asked how her goal setting had gone and about the successes he suspected she was having since they last talked. She replied with a mix of sheepish

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

ess and defiance that she didn't have time for goal setting, that she knew what she wanted to achieve, and that it would take too long to follow a goal setting process. She knew she just needed to get to work.

Again Tom listened closely and while he

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

idn't pass judgment, he did tell Joanna that when she was really ready to make greater progress, goal setting would be the answer. Joanna asked him why goal setting was so important, and he gave her b>The Seven Reasons Goal Setting Matters:

1. <

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

>Goals create accomplishment instead of activity. Most of us are extremely busy – running from meeting to meeting and task to task focused primarily on how to be more productive and get more accomplished in our day. But when our focus is on the t

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

sks and the busyness we lose track of any accomplishment – in effect we are focusing only on the activity itself. Goals help us look beyond the activity and get clear on what we really want to accomplish.

2. Goals give us direction. You woul

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

Following aspects would a

dn't get in your car to go on a trip without knowing your destination. A destination provides purpose for our effort. A destination gives us a reason for our efforts. A destination gives us a way to monitor our progress and keeps us on track.

3. <

dd to the challenges in developing combination products:

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

>Goals capitalize on the brain’s amazing powers. Our brains are problem-solving, goal-achieving machines. Our brains operate best when they are seeking a solution to a problem. When we have a goal, our mind sees it as a problem to be solved and

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

ets to work (with or without our conscious influence) on achieving the goal.

4. Goals make life easier. If nothing else, reasons one, two and three improve our productivity. They help us work smarter no matter what the work is. And when we

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

ork smarter, our life gets a whole lot easier. Who doesn't want to do things that make life easier?

5. Goals help us go faster. When we know our destination we can get to it more rapidly. Yes, any goal setting process requires some planning

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

time, but that time will be repaid many times over.

6. Goals create satisfaction. How do you feel when you achieve something you care about? How do you feel when you don't know if you're making progress? Goals create satisfaction by giving

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

Professional from academic institutions, pharmaceutical industries, health care indust

s the targets to shoot for and therefore the sense of accomplishment when we know we have reached them.

7. Goals create confidence. There’s hardly any greater confidence booster than achieving something you have specifically set out to do. S

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

tting goals and accomplishing them gives us the confidence to set even greater goals; stretching ourselves to greater performance in the future.

Joanna left lunch thinking about the seven reasons Tom had just shared with her and again determined to ma

.

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 goal setting a part of her immediate future. Only time will tell if she takes advantage of the many benefits goals setting would bring.

But more important than Joanna’s story, is yours.

Do you set goals? If so, are they ambitious enough and are t

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

Companies that provide selfless information through particip

ey focused on the great accomplishments that await you? If you don’t have any real goals right now, at least consider these seven reasons and the advice they suggest.

Set some goals. You can start small, but at least start. A brighter future awaits

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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You've now entered the down-season where spending decreases and everyone falls into the winter blahs. Now what do you do to keep your company sharp and exciting? Create a giveaway schedule that recognizes the lesser celebrated months and holidays.

Maybe everything you need to know you can learn from the movies. A friend of mine is a screenwriter in Los Angeles. Over a glass of wine, we were discussing his business and the nature of the beast in Hollywood. He’s a boy from Canada who gave up his much-loved Honda, his life savings, and his broadcasting career to move to Los Angeles to attend the American Film Institute. Not an easy feat in your mid-30s. After 8 years of hard work he is now becoming the new discovery of LA. He said the most difficult thing to adjust to was all the talking.

Financial management is one of the most important aspects of any business. If the company's finances are handled adequately and deployed in the right areas, it’s sure to prosper.

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