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If you are now or ever have been part of a large company or corporation, you are familiar with planning exercises—business planning, financial planning, marketing planning, all sorts of planning. Some of it is done in groups, while some of it is done by individuals. And if it’s done “right,” there will be some kind of document at the end of process, which will either

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

be used as a reference throughout the period the planning covered, or will get put away and never looked at again.

I have a theory that in large enterprises the more “intangible” the plan, the more fanfare goes with it, and the less useful the outcome is. For example:

-- A financial plan—with lots of numbers and forecasts—is tangible and trackable; i

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

Examples of combination products may in

can be checked and compared with actuals at pretty much any point along the line. This type of plan is invariably prepared by only a handful of people with very little muss or fuss, and is used regularly to track business profit and loss status.

-- A business plan tends to be less tangible and trackable. Though there is certainly a financial component, there are al

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

o more ephemeral bits—things like goals, say—that are more difficult to check on. This type of plan is usually done by a group of “key” managers in one or more formal (sometimes facilitated) sessions, and may be referred to periodically to take the business pulse.

-- A marketing plan is about as intangible as one can get, and it requires creativity, discipline, and

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

ommitment to craft trackable elements for it. This type of plan is often accompanied by the blare of trumpets and lots of meetings, and the resulting document is likely to be full color with lots of charts and graphics--and is never used.

Though I’ve oversimplified and generalized these three types of plans, the bottom line is that, in my experience,

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

Combination pro

the marketing planning process in large corporations tends to be a wastefully resource-intensive exercise that doesn’t provide much value to the actual pursuit of the marketing function. There are a lot of flourishing gestures and intense facial expressions, and not a lot of really useful work gets accomplished. No wonder that smaller businesses rarely proactively en

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

age in marketing planning. They don’t see the point.

But hold on.

Isn’t that—pardon the clich?—throwing the baby out with the bath water? Just because marketing planning is ineffective in many cases, does that mean it shouldn’t be done at all?

I say no. In fact, I say that smaller businesses must plan their marketing programs—map out what they need to accomplish a

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

d how they will do it—preferably prior to the start of their business year. They need to step back and think creatively about how to use marketing most cost-effectively to meet business objectives, and how marketing can help them gain or retain competitive advantage.

Smaller enterprises cannot afford to waste their resources—either human or fiscal. They cannot affor

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

to pursue ad hoc initiatives that may or may not produce results. And they definitely cannot afford to implement marketing tactics whose results can’t be measured in some way.

A marketing plan does not need a lot of fanfare, facilitated meetings, or fancy graphics to be effective—quite the reverse, in fact. It needs to be a useful reference document that spells out

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

what programs will be pursued and why, and how those programs relate to each other. It also needs to specify how the effectiveness of the programs will be measured and how often.

Here is an overview of the steps to take to arrive at a useful marketing plan for your business:

Clearly state where you are today. What was your marketing expense for 2004 (assu

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

ing you work on a calendar year basis)? What percent of revenue does this represent? What specific programs did you implement? What results did they produce? What does the competitive landscape look like today? How about your market? Have there been changes over the past year that could affect you?

Define your marketing goals. Based on your 2005 business ob

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

Following aspects would a

ectives, what specific marketing goals are appropriate? Clearly state these goals in active terms (e.g., “Participate in five industry trade shows with at least a 20% qualified lead rate,” “Realize at least fifteen media mentions in local and trade press.”).

Identify appropriate marketing tactics. Considering your goals individually and as a whole, what marke

dd to the challenges in developing combination products:

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

ing activities are most likely to be successful? Think about how the activities can interrelate to give you the most bang for the buck (e.g., a newsletter that is put on your web site, emailed to your contacts, and printed in hard copy format maximizes your preparation/publication expense). Also, identify activities or tasks that will require third party assistanc

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

e (e.g., graphic design, copy writing, or—ahem—4-R Marketing’s services!

Determine how and how often you will measure the effectiveness of your activities. Marketing results can be intangible—how do you know whether your web site leads to sales or whether your trade show exhibit was as effective as it could have been?—but they still need to be measure somehow

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

Come up with proxy measurements that you have confidence in—the number of hits on a certain web page, for instance, or the number of visitors to your exhibit who stay for more than five minutes—and that you can use to measure the degree to which your activities are hitting the mark in terms of achieving your goals.

That’s basically it. A marketing plan in four pag

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

s (more or less). A fifth page might be a marketing budget that encompasses all the activities you have planned; this can serve as another metric to gauge marketing effectiveness.

Now that you have a marketing plan for the year, here’s what to do with it:

-- Communicate marketing goals and activities to your staff and be sure to illustrate how they re

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

Professional from academic institutions, pharmaceutical industries, health care indust

ate to overall business objectives.

-- Create and implement a project schedule that spells out at least high level timelines and milestones for your marketing activities. A lot of marketing tasks are long term (some conferences call for papers a year ahead, and trade show planners will want stuff from you months prior to the show date); putting a schedule into play

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

will keep things from falling through the cracks.

-- Refer to the plan periodically (once a month? once a quarter?) to see if you are on track relative to the status of the business as a whole. Are your goals still appropriate? Are your activities on track?

-- Also periodically, gather and review the metrics you’ve identified for your marketing activities. What do

.

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

they indicate? Are you getting what you need from your programs, or are changes called for? Tracking marketing metrics gives you the opportunity to modify your activities “midstream” if they aren’t producing results, rather than waiting till the end of the year and realizing you’ve wasted resources on the wrong things.

If you are in any kind of busine

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

Companies that provide selfless information through particip

s, no matter how large or small, you do need a marketing plan. But your plan does not need to be accompanied by a herald blowing a trumpet, and does not need to be a huge document with loads of graphics and tables. Create a plan that is concise, actionable, and measurable—and you will have an invaluable tool that will help you grow your business the way you want to

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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