Useful Advices - Business

We get a lot of questions about how to adapt strategic planning to smaller companies. The model itself was initially developed for companies with 50-500 employees, but has been used with great success in much smaller companies as well as Fortune 500 companies

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

. This being said, there are a few tips we can offer which will make the process work much more effectively in the company with under 50 employees (or one with a very limited management staff).

There are several key differences between doing strategic planni

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

Examples of combination products may in

g in a business with 10 employees and one with 100 employees. First, the team is likely to be smaller, and contain people with greater front line responsibility. The sales manager might be the only salesperson, and the operations manager probably does a signi

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

ficant part of the operation. Even the CEO in such an organization is likely to have a big chunk of time required for routine sales, operations, and financial functions. It's also quite likely that there is no distinction between sales and marketing in the sm

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

ller company, and that some overhead functions, like IT, finance and HR, are largely or completely outsourced.

The second key difference is that the smaller company obviously has less resources to invest strategically, in terms of both time and money. This l

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

Combination pro

mits the strategic options available, which is a negative, but also makes the necessity of focus easier to understand, which is a great positive.

The third important difference is the availability of resources for the planning process itself. While it might

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

be a good choice, it is a significantly more difficult investment for a small company to invest a few days of management time and thousands of dollars in any process.

Given these three key differences, here are some important tips for making the strategic pl

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

nning process effective in a smaller organization:

1. Keep the team small — while 6-8 people is ideal for a 100 person company, 3-5 is likely to be better for smaller companies. Make sure your team represents the three points of the Tension Triangle - the ma

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

ket, finance and operations. Also, of course, make sure the CEO (or in some cases, owner) is fully involved in the process.

2. Don't have too many market segments — we routinely work with 5-10 segments in most client companies, but 3-5 is a good number in sm

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

aller companies. Remember, while you lose some ability to focus on specific customer behaviors, fewer segments also means less time is necessary for the planning process. A benefit of reducing the number of segments you use is that you may end up forcing your

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

elf to focus more.

3. Skip some of the less critical parts of the process — in past years, we have skipped some parts of the process with clients in order to focus on the most critical issues. While this can be dangerous, you might consider not doing the fol

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

Following aspects would a

owing exercises in a smaller company: Supplier Market Assessment (1.3), Significant Regulations (1.6), Other Assumptions (4.3), How Can We Shoot Ourselves in the Foot? (5.3), and Mission Statement (6.1). You can also save time by combining Measures of Success

dd to the challenges in developing combination products:

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

(2.3) with Goals (6.2), and reducing the number of Strategic Issues (5.2) you examine.

4. Understand you will have next year to tackle another set of issues — It's a good idea to do a great job understanding and dealing with a limited number of strategic is

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

ues each year. Some of the most successful smaller companies I know have a ''theme'' for each year - one year it might be sales, the next year it might be quality, margins, or employee development.

5. Push yourself — and your team — to keep the strategies as

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

focused as possible. A two million dollar company CAN play in a billion dollar market, but it's much more likely to succeed in a ten million dollar market. Always ask the question ''Can we realistically expect to dominate this market in five years?''.

6. Don

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

't have too many objectives — We often see 6-10 objectives in larger companies, but smaller companies will be well served to have 3-5 objectives. If you finish these off, you can always start to work on the next set of objectives earlier.

7. Pay much closer

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

Professional from academic institutions, pharmaceutical industries, health care indust

ttention to implementation — Because there aren't resources dedicated to strategic activity, routine functions will always demand a higher proportion of your team's time in a smaller company. This means you will need to be very careful about allocating time t

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

action plans, and must be highly disciplined about having monthly monitoring of action plan progress in order to keep the ball rolling.

8. Outsource as much as you are comfortable with in the process itself. It's hard enough to learn how to be the best at t

.

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

he things your company does, so consider outsourcing at least some of the planning process and possibly the market research to people who do those things professionally.

Remember, strategic planning should be viewed as a routine part of your year, rather tha

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

Companies that provide selfless information through particip

a separate event, so make sure the process fits into your normal business cycle with a minimum of hassle. If you use these tips, you should be able to get through the process described in our seminars in a reasonable amount of time and get tremendous benefit

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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Useful Advices - Tips for Better Strategic Planning in the Smaller Company

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