Advice You - Business

To Grow (Catapult) Your Business That's Why.

When it's in your head it's not as likely to happen--too much missed.

Before becoming an executive business coach, in my previous career as an electric

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

al engineer I discovered some key practical things about business planning that showed me how to explode the growth of a business.

When I was in college if I was asked to design something my designs alway

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

Examples of combination products may in

s worked….on paper.

When I got out of college, my boss would frequently come to me and ask if I knew how to design this or that. I always answered confidently, “Sure, I know how. Pointing to that space be

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

tween my ears.”

Then I would design it on paper. And the first aha I learned was that once written down I could see more than I could when it resided between the ears. This piece just didn’t come together

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

with that piece….and that one….and that one….

So, I would gradually work out all of the gotcha’s until all of the pieces worked on paper.

Then I’d go build one…..

And it almost never worked. I had made

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

Combination pro

an assumption about something in the real world that wasn’t quite right. I’d missed something about the real world. So, I’d work back and forth from the ideal paper design to the real world result until it

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

started working in the real world. Then I’d go back and document that on paper.

Now the real BIG AHA!

I don’t believe there is a self-respecting engineer anywhere in the world that is ready to re

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

lease his design to production when production is screaming for it. The reason??? Once the engineer has a real working example on paper things start jumping off the paper at you. You can see things you did

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

n’t even think of before. There are new concepts there.

“Gee, I didn’t see that. If I change this…it’ll work better.” Or..”Wow, over here, if I do ____ then it’ll be cheaper to produce” Actually, once it

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

’s on paper and working it’s almost never ending what you keep finding.

Business Planning Between the Ears Doesn't Allow You to Find the Opportunities or the Gotcha's That Paper Planning Shows You Cle

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

rly

I had said to my boss, “Sure I know how” when he asked me if I knew how. But it was between my ears. I learned that you have to get it on paper to start seeing the gotcha’s before you can fix the

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

Following aspects would a

m, and once you build a real one you start learning new things about how to optimize, how to make it cheaper, how to make it work better, and it never ends. There are so many opportunities to make it bette

dd to the challenges in developing combination products:

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

r. Now, let me ask you one more question:

How many people do you know that are running their business “between their ears?” How many are saying “I know how”?

I actually have had companies tell me “Get o

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

ut of my way, I don’t have time to plan. I have to produce NOW” Then they call me back in a few months asking for help after they have lost hundreds of thousands of dollars.

That’s when the real aha hit

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

me. After putting it on paper I’ve seen those same business jump 5 times, 10 times in revenues in just weeks.

So, how many do you know that are running their business between their ears and have never put

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

it on paper? Or, some may have put it on paper, but it’s setting somewhere on the shelf.

The opportunity to grow your business, BIG TIME, is

Having a written plan on paper, determining the KEY measur

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

Professional from academic institutions, pharmaceutical industries, health care indust

ements that will be important and will deliver the results we want. Having clear targets and goals, evaluating what you see and fixing all the gaps, on the paper, BEFORE finding them in the real world.

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

i>Then implementing the plan, again finding what is different between the paper and the real world and fixing them.

Then evaluating the results from the real world, comparing against the key measureme

.

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

nts and where we expected to be.

Optimizing the results—If we are tracking the RIGHT things, keeping good results measurements, I guarantee that you will find an AHA moment that will increase the outp

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

Companies that provide selfless information through particip

ut of your company, a department, a work group, by 2-10 times. And many times we find several ways to multiply a business over and over. It’s almost always been a given with the companies we’ve worked with

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 - Why Do a Business Plan?

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