Digg It - Business

Another year is just about ready to finish and it is time to start thinking about next year. If you own your own business or you manage a business division, then you need to ask yourself if all of the expectations that were set forth at the beginning of the year were met. If not then maybe what stopped you w

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

as a lack of goals and objectives, or just a lack of a good process to use when planning them. The goal setting process is essential to the success or failure of the business, and many careers have derailed due to a lack of them. Goals and objectives apply to everyone involved.

Being a business owner or a m

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

Examples of combination products may in

anager implies an inherent responsibility to insure plans are worked on, followed through on, and accomplished. The process that is used can and will determine whether or not you will finish the year with your hat in hand, or be congratulated for a job well done.

If you are a business manager, you were given

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

a mission statement by the organization. This mission statement is the overarching goal of the organization. It does not tell you how it will be done. It just implies that it “is” done. It is your job to determine what resources you will need in order to make them come to fruition.

If you are the owner of

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

the business, then you either have a business plan and or a mission statement. You should have both. Take this information and begin to formulate the things that need to be accomplished, the time period in which they need to be accomplished and by whom they need to be accomplished by.

This is goal setting.

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

Combination pro

Understanding and expressing “what” needs to be done, “why” it needs to be done, “when’ it needs to be done, and finally, “how” it will be done is the goal setting scenario. Goals should be just beyond your reach. Just past your fingertips. If they are too far out there, you will not reach them and will be

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

come disappointed. Too close, and they will not be worthwhile at advancing your company or your career.

Start using the SMAC method in setting goals and objectives and always remember goals and objectives are not one in the same, though many people think they are. Goals are where you want to end up. Objectiv

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

s are the steps to get there.

S stands for Specific. Make the goal as specific as possible. Stating a goal that says you want more customers is not specific. How many more customers? More customers than when? If you state you want more customers, then getting one customer today is more customers. Th

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

is is not a goal, it is a hope. To be more specific, simply state that you want to increase your customer base for the first quarter of next year by 20% over your first quarter in the previous year. If you know what that number needs to be, that is even better.

M stands for Measurable. The goal must be

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

measurable otherwise, how will you know if you are making progress? How will you know if you have accomplished the goal if it cannot be measured? Anything that is specific enough can be measured. The measurement method may take you some time to work up, but it can be measured if it is specific.

In the examp

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

le above, if we stated we want more customers. Can you measure that? Now look at the rewrite: increase customer base for the first quarter of next year by 20% over the first quarter of the previous year. Can this be measured? Of course it can. Your goals need to be fluid enough that you can tweak them, ma

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

Following aspects would a

ke small adjustments here and there as needed in order to insure they are accomplished. Again, if you are the manager or the owner, you need to have a method that you will be able to periodically check the goals to make sure you are on track.

A stands for Achievable. Is the goal achievable by you or who

dd to the challenges in developing combination products:

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

ver needs to accomplish it? To say you want to triple your businesses income in the next 3 months is probably not achievable. Oh, you may hit the lottery or sell your business, but most likely, the goal of tripling your income over the next 3 months is more of a dream than it is a goal.

If you were to state

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

that you want to increase your businesses income by 10% over the next 3 months you have a more achievable goal. It is just beyond your reach, can be measured and is achievable by means that you have or knowledge you can go and get. Another words, the learning curve is not going to be straight up in order fo

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

you to accomplish this.

C stands for Consistent. Is the goal consistent with the business plan and or the mission statement? If it is not, then achieving the goal will not move you, the business, or your career forward. And after all, isn’t moving forward what it’s all about? Make sure you set the goa

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

l consistent with the overall plans. To have a plan to have the best customer service response in your industry and then setting a goal to respond to customer inquiries in 7 business days or less, certainly does not seem to be consistent. A goal of responding to customer inquiries within 12 hours would be mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

e consistent with the overarching plan.

Set a timeframe that you will accomplish the goal. By setting a timeframe you instill a sense of urgency that it needs to be paid attention to and accomplished. If you don’t set a timeline, then there will be a tendency to put it off, or start it at a later date. The

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

goal will not seem as important.

Set goals with the people that work for you. In order for you to get more done as the owner or the manager, your people need to be advancing the organization as well. Teach them this process. Take the time and work with them to set 3 or 4 goals that will make them stretch

.

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

heir abilities. It will help improve them and the company at the same time. And don’t forget the most important part of working with your people: Following up. By having goals that you helped them to create and they participated in, you can step in at frequent intervals, measure the progress of the goals a

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

Companies that provide selfless information through particip

nd discuss with them what challenges they are having and how to resolve them in order to successfully complete the goals.

When 2006 is over, your business or career will have advanced and you will be proud of your accomplishments knowing that it didn’t just happen by chance, but by good planning and execution

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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