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In order to leverage its talent, ideas and energy to create a high performing company, a small business must be focussed and clear on precisely h

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

ow it intends to conduct its affairs. Small business plans create this clarity and focus. They take the critical issues identified within a com

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

Examples of combination products may in

pany’s strategic thinking and align them with the necessary tasks, then allocate the resources required to achieve the targeted goals.

The follo

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

wing 4 “musts” are the keys to effective small business plans.

1. Must keep them simple
Effective small business plans embody the fo

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

lowing characteristics. They:

- Spell out the goals that need to be achieved
- Establish milestones along the way
- Document the requ

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

Combination pro

ired tasks
- Allocate those tasks
- Transform those tasks into step-by-step processes
- Identify the resources required
- Ass

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

ign accountabilities and responsibilities
- Create the appropriate deadlines
- Become a measure of progress
- Allow for incorporat

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

ing emerging opportunities.

2. Must keep the business on track
Small business plans make sure that all employees are pulling in the

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

ame direction, in keeping with the human, technological, physical, time and financial resources that the small business has at its disposal.

The

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

y do not have to be overly complicated, but they do have to be clear, understandable and tailored to the needs of the business. In essence, they

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

have to be easy to use by everyone in the organization, and they have to cascade down to the individual level.

3. Must be applicable to ever

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

Following aspects would a

yone
When a company implements its small business plans in this manner, the plans become the living blueprint for all of its daily activ

dd to the challenges in developing combination products:

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

ties. The plans are not meant to sit in a nicely bound folder on a shelf somewhere. They ensure that the small business gets its priorities righ

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

t and that it is tackling the most critical issues, within a structured approach. All the people in the organization are involved and are attend

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

ing to the right issues and handling them in the right way in their particular part of the business.

4. Must tell the business how it is trav

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

eling
Small business plans facilitate the measurement of results. Business plans that are implemented in this way become the daily meas

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

Professional from academic institutions, pharmaceutical industries, health care indust

re of all the things that the company is paying attention to.

When cascaded correctly throughout the organization, small business plans create t

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

he framework for the body of work that has to be done for the organization to be successful. They enable people to self-manage and self-govern a

.

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

round the company’s priorities and expectations of them, and they give them the tools necessary to do so.

In summary small business plans must:

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

Companies that provide selfless information through particip

1. Be clear and simple
2. Keep the business on track
3. Apply to everyone in the company
4. Tell the business how it is traveling

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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