Advice You - Business

Donna had a problem, and she had come to me for help.

Her firm offers a complex service to organisations - they help emplo

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

yees deal with workplace changes. Donna and her partner teach employees (in client organisations) new communication skills,

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

Examples of combination products may in

coach them on how to handle change, and mentor managers to help them cope with the demands of staff during the period of c

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

hange.

Her clients are CEO’s, senior executives, and Board members of large companies and public sector organisations. The

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

problem was that her clients saw her simply as a “trainer” – providing one-off training programs.

You see, in the past Do

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

Combination pro

nna had trouble getting clients to think past the “training” component of what she offered. They didn’t seem to grasp what

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

she wanted them to see. What they perceived was a relatively low-value short-term service. To them, Donna was just like all

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

the other “trainers” that they had seen.

What Donna actually offered was a longer-term solution to help the organisation

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

avoid the pitfalls of change – low productivity, low morale, and high staff turnover.

As part my work with Donna to improv

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

e her sales process, I recommended she prepare a “picture” of how she helps her clients. Sort of like a time-line.

Donna’s

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

picture (you may prefer to call it a diagram, schematic, or flow chart) clearly shows where her “training” events fit into

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

Following aspects would a

the bigger picture of the process she implements.

What would happen next?

Now Donna didn’t really know what to expect. Sh

dd to the challenges in developing combination products:

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

e had never used this approach before. And she had her doubts about how helpful her “picture” would be.

Her very next meet

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

ing was with a senior executive from a large potential client. Donna had met this fellow before but had never been able to

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

make progress. This time she used her picture.

Donna carefully explained the process her firm uses, highlighted the traini

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

ng events and the other services offered, and discussed why each step in the process was necessary.

She was delighted to h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ear her client say “Ahh… now I see why you are different to the rest.”

Finally, she was able to differentiate her services

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

. At last Donna could get her client focused on the overall picture of what they can do. As a result she was asked to prese

.

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

nt her solution to the Board. A fantastic outcome.

All this from a picture – and a pretty simple one at that!

If you offe

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

Companies that provide selfless information through particip

r a complex service maybe you need to paint a clearer picture to get more sales. If you need help with that, give me a call

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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