Main Subject - Business

Proper goal setting is a critical element of any successful business. Without realistic goals, business owners and employees are often left to follow a vague and winding performance roadmap. A clear set of goals helps

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

a business continuously improve, compete more effectively, and fine tune its operations and processes over time.

For many entrepreneurs, goal setting is not always the easiest endeavor. Most business owners are so foc

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

Examples of combination products may in

used on their daily operations that they may often confuse tasks with goals. To be clear, goals are used to directly support a strategic objective or business plan. Tasks are short-term activities that keep the busines

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

running. Finally, goals consist of a series of actionable tasks to achieve the desired results.

To help in the goal setting process, most successful businesses follow the S.M.A.R.T ("SMART") methodology. This handy a

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

cronym helps simplify the process of goal setting and ensures that objectives are defined in the most effective manner possible. When following the SMART process, all goals must be Specific, M<

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

Combination pro

strong>easurable, Achievable, Realistic and Time-limited. How does this work? Let us take a simple business example and walk through each of the SMART steps.

Sophie i

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 an entrepreneur who owns and manages an architectural design firm. Her business is growing rapidly. She has grown from four employees to 15 in less than two years. She has a solid client base with several concurrent

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

rojects. Despite her firm's growth, her cash flow is a concern. Several of Sophie's clients rarely pay on time. This delinquency, if left unchecked, could cause a financial burden when trying to cover fixed costs such

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

as salaries and office rent.

To help improve her cash flow situation, Sophie uses the SMART methodology to assist her in defining a cash flow improvement goal.

Specific - The statement, "Improving ca

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

h flow" is not a specific goal and would not prove useful to anyone trying to accomplish this objective. The goal must include more specific and actionable language. In this instance, Sophie wants to improve cash flow

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

by reducing the time it takes her clients to pay.

Measurable - The statement, "…reducing the time it takes her clients to pay" is not measurable. Simply stopping here would make it difficult to achiev

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

Following aspects would a

e success. What amount of time is Sophie trying to reduce? After studying industry benchmarks, she quantifies her improvement goal. She wants to reduce the average payment cycle time from the current 45 days to a goal

dd to the challenges in developing combination products:

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

f 35 days.

Achievable - Is this goal achievable? Can she work with her clients and somehow encourage them to pay more quickly? After doing some analysis Sophie determines that part of the payment dela

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

y is the infrequency with which she sends out invoices. She also rarely calls her clients to follow up on past-due bills. A significant portion of this goal is within her immediate control. As such, Sophie feels this g

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

al is clearly achievable.

Realistic - How realistic is it to expect a reduction in payment cycle time by 10 days? Again, using her research and industry benchmarks, Sophie feels that this amount of ti

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

me is quite realistic. Besides, the payment term included in all of her project contracts is 30 days!

Time-limited - Finally, Sophie needs to place time limitations around her goal. A goal that linger

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

Professional from academic institutions, pharmaceutical industries, health care indust

is not useful. Expectations must be set around when the objective is to be accomplished. Establishing time limits also helps business owners prioritize and plan for goals throughout the year. In this example, Sophie d

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

ecides that she wants to achieve the reduction in client payment cycle time within six months.

Using the above process, Sophie's formal goal reads as follows: Within six months, reduce the average time it take

.

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

clients to pay invoices from 45 to 35 days.

Using the SMART approach to goal setting, business owners can set specific, measurable, achievable, realistic and time-limited objectives. While the process may se

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

Companies that provide selfless information through particip

em difficult at first, it quickly can become second nature. This method ensures consistency across goals and helps business owners and employees alike clearly understand what is expected to accomplish any goal they set

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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Main Subject - Setting Business Goals-Use the SMART Method to Achieve Dramatic Results

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