Cases - Business

In the IT industry, the white paper has become a popular tool when promoting a product or service and is frequently used in tandem with case studies, and other sales collateral.

In this article, I'll show you how to

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

write an effective white paper that gets your company noticed --- and the pitfalls to avoid if you're new to this areas. Like other types of publications, such as a Case Study, the white paper has an accepted format that is rec

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

Examples of combination products may in

ognized by its readers. Stick to this approach. Readers are familiar with this style and will expect it from you. Only very experienced writers should try more adventurous and radical formats.

Before You St

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

art
Define your target audience. Once you have defined your audience, you can begin to tailor your material to reflect their needs.

It's very important to stress this point. Many novice writers—especiall

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

y those with a technical background—will focus on the low-level aspects of the software or technology. Avoid getting stuck in the details. Though this has its place, it's probably not here. Executives, and those in the manageme

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

Combination pro

t layer, are your target readers. So, write with them in mind.

Determine Your Topic
Next, determine the main topic for your white paper. This may sound obvious but many writers overlook this and

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

ramble from one vaguely related subject to the next.

Keep to one topic per paper. Avoid the temptation to discuss other features, functionality and innovations. Stay focussed.

Setting Objectives

Write your wh

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

ite paper so that it achieves several objectives. For example:

Establish you as the definitive authority on the subject in question, i.e. that you

stand head-and-shoulders above the competition in this area.

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

>Create awareness of a new market trends and/or product offerings.

Demonstrates how you are uniquely qualified to achieve this objective.

Ensures that decision-makers select you over competitors by providing

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

them with

persuasive arguments backed up with trustworthy references.

How To Structure Your White Paper

Every white paper have the following sections:

Introduction — t

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

is opening section covers the high-level issues and trends in the industry that you are involved with. It may also include recommendations or conclusions you have made about the topic.

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

Following aspects would a
rong> — this describes the relevant technologies at a high-level, especially those you have designed and intend to promote. Support your arguments with tables, charts, and graphics. All of these add weight to your argument and
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
provide a contrast to the main text.

Solution Details — this explains how the service, technology, or business model works. This is the heart of the white paper. It provides very detailed descriptions of the pr
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
oposed solution. You can also use tables, charts, and graphics for this section, with cross-references to external supporting documents if required.

Business benefits—This discusses the return on inve
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
stments, usability, and adherence to standards. Customer quotes are always very helpful. It demonstrates that you are an authority in your field and can back it up with these endorsements. Don’t take references for granted—not
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
ll your competitors will be able to supply such endorsements.

Summary — close the paper with a concise summary of your main points. As many readers will skip the entire document and read this section
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
only, summarize the main selling points about your solution here.

Here’s a suggestion: write the summary as if it were an entirely standalone document. Distill it into one page and conclude with the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
most important point that you want the reader to remember. If this section is compelling enough, you might persuade them to go back and read the entire document.

Finally, remember that your white paper is a sales document; it's
.

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
not a technical guide. Once you have finished it, leave it aside for a few days. Then go back and read it.

Ask yourself: would I buy this solution?

Hopefully the answer is Yes.

If not, don’t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
be too hard on yourself as it takes time to write a persuasive white paper. Instead, identify the areas you feel are weak and go about strengthening them. Soon, you’ll have a nice, sharp document that you can proudly stand over

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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Cases - Writing Effective White Papers

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