Subjects - Business

Last week, a client chose to focus our coaching session on his Business Plan. He had read that 80% of businesses that

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

fail have no plan, whereas 90% of those that grow have a plan that they review and update at least once a year
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
>.

Although he had good headings, my client was struggling to write the narrative and fill in the numbers. He also worr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ed about maintaining a 20-page document until I suggested that between one and four pages would be more effective for hi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
company.

Set your goals clearly

So we started with "Why are you in business? What are you trying to achieve
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
" followed by "Who are your customers?” and “What benefits do they want to buy?"

As we made sense of this, w
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
e were able to insert the market research data that he had gathered. Asking him "What share of this market can you ex
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
ect?” naturally led to testing his hopes against his competitors’ strengths and weaknesses.

"How do you reach th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
se customers?" was easily answered along with his weekly marketing investment. Of course as a good coach, I encourag
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
d him to explore other ways to reach his market, and he decided to try a couple of them.

Use simple numbers to check
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
progress

Next we worked on "How do you measure progress?". I have found that the numbers that matter in my b
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
usiness are those that help me face reality … and do something about it.

I dislike the discipline required but I
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
find that collecting the numbers collapses my anxiety at not knowing and my complacency at thinking everything
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
is fine.

So we spent some valuable time finding some simple ways that my client could check his business progress -
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
and make a weekly habit of recording those measurements.

Stay on a profitable course

Quite suddenly, I
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
ad a client who was smiling because he saw the value of his business plan - the text and numbers told a compellin
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
g story.

He was anxious about interpreting his weekly results and thought he might need a quarterly review but I am sur
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
this worry will pass. He will find the simple numbers give him clarity to decide how to respond. Since he unders
.

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
ands how he wrote his plan, he should be able to re-jig his ideas as his market changes.

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

Companies that provide selfless information through particip
ere is a challenge for you: "Does your business plan tell a profitable story – and how do you keep it up-to-date?"

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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Subjects - Business Planning Strategy: How Can You Use Numbers To Aid Your Business Judgement And Marketing

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