Advice You - Business

Let's say you have been tapped to bring a "best practice" to the employees of an organization. You may be helping your colleagues improve their performance, or you may be an outsi

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

de contractor brought in to produce a valued change.

You have to put together some tools for communicating the best practice so that it takes root in the organization.
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
trong> Perhaps you plan a meeting, an online course, develop a procedure guide, create a seminar . . . whatever works for your audience and your topic.

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

rganization, so you have to do it right. That's why you rely on colleagues, and even perhaps some outside help, for help you wherever your skills (or time and resources) aren'
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
enough to ensure success. Who is on your team? Take a moment and write down the name and phone number or e-mail of the first person or resource you
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
will contact:

for technical help. If you need to construct web pages, or project a presentation from a laptop, or wrestle with any kind of software
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
and hardware to get the job done, who will help you?
for content details. Who are the experts on the best practice, who did the research, who developed t
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
e product, who can give you the specific, accurate information you need to support your efforts?
for guidance on procedures and standards. Who can deal wi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
th human resources guidelines, quality assurance, compliance, standard procedures, appropriate channels?
to maximize the impact of your communications. Wh
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
o will help you organize your information, who will tell you if what you're saying and writing is clear and effective? I'll go out on a limb and predict it was a l
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t easier for you to come up with the first three contact numbers than it was for the fourth one. In a way, this is understandable. We all communicate, all day, so sometime
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
s it's hard to see when we need expert help. But most of us drive cars, yet wouldn't dream of entering the Indianapolis 500. Most of us can swim and run, if we have to, but we are
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
n't going to win any medals at it. If the company saw benefits from fast driving or swimming or running, they would apply a professional touch to those act
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ivities, even though nearly all of their employees can do all of those things satisfactorily for everyday purposes.

You wouldn't make an important presentation on best pract
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ces without knowing in advance whether anyone would be able to see your 'slides', whether the equipment would work. Why make an important presentation without having someone check
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
whether or not anybody's going to understand, and embrace, what you say?

It's a matter of return on investment. The greater the potential return from implementi
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ng a best practice, the greater return on your investment in high quality communication.

Where do you get that help?

Start internally. Some of your coll
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
agues at work have a gift for effective communication, and others -- such as those working in marketing and PR to start -- are communication professionals.
Be read
.

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
y to consider professional outside help. When the stakes are high, invest in getting communication expertise, just as you would other kinds of expertise. Grea
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
t ideas remain just ideas if you can't get employees to act on them. Add a communication expert or two to your team to deliver the impact your organization is counting on

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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Advice You - Communicating Best Practices - Is Someone Missing From Your Team?

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