Main Subject - Business

Recently I have been spending some time with my husband playing table tennis in our garage after work. I'm new to table tennis, so it's a steep learning curve. And even though a lot of my attention was on hitting the ball

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

back and landing it on the table instead of skewing it off toward the tool rack or up into the fluorescent lights, I couldn't help reflecting on how similar the experience was to any kind of performance improvement in bu

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

Examples of combination products may in

iness. In fact, here are the six tips that learning table tennis (or trying anything new) can teach us about improving the performance of anything:

Tip #1: Be very clear what result you want.

When you start out with som

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

ething new, aiming to be the best at it straight away is not what I call realistic goal. So rather than set my immediate sights on thrashing my husband by the end of our first table tennis match, my focus was more modestl

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

on just hitting the ball back and having it land where I intended it to go. With such a clear goal in front of you, it's so much easier to reach it, one logical step at a time. (Your eyes know exactly what to look at and

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

Combination pro

what to look for.)

Tip #2: If you're not good at it yet, expect high variability in your performance.

With little skill or knowledge about table tennis, I could only expect to have little control over where I put the b

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

ll, and with little control I could only expect to have little predictability in my results - the distance between where I intended the ball to land and where the ball actually landed fluctuated randomly and wildly. Under

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

standing (and measuring) your variability is your baseline - understand this natural variability before you attempt to improve anything.

Tip #3: To really improve, change only one thing at a time.

As simple as table ten

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

is is, there were many things that I could have changed to try for a better result. How I held the paddle, how I positioned my feet, how I moved my wrist, how hard I hit the ball, how accurately I read the spin that my cl

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

ever husband put on the ball (in his wicked attempts to make my returns even more unpredictable). I found I improved best (very satisfying) when I thought about just one thing to do better, like holding the paddle consist

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

ntly and at the right angle. Improvement happens so much faster when you bed down one improvement at a time. Trying to figure out the complex interactions among several changes at once is confusing, exhausting and takes m

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

Following aspects would a

ny times longer to get results.

Tip #4: Performance will probably grow worse straight after you start improving something.

The moment I became more conscious of how I was holding the table tennis paddle, things got wors

dd to the challenges in developing combination products:

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

e. The ball seemed to grow a mind of its own for the next 10 to 15 hits. Yes it did more often land where I intended it to, but it would also unpredictably ping off at the most obscure angles. However, it didn't take long

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

to get a feel for the new grip on the paddle and - lo and behold - the ball began doing mostly what I wanted it to. I had more control! Any kind of performance improvement can have a 'bedding in' period, but then things c

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

an grow better almost in an instant.

Tip #5: Keep focused - if you take your mind off it, you lose control again.

Pumped by my quick success at bossing the ping pong ball around, I thought I could let go and relax into

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

he game a little. Big mistake. A few fast and furious returns from my loving husband's paddle made me instantly aware that holding a table tennis paddle wasn't yet second nature. The ping pong ball 'pertwanged' out my con

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

Professional from academic institutions, pharmaceutical industries, health care indust

trol and was at the sole mercy of my husband. So remember, if you take your mind off an improved change before it becomes second nature, you risk losing control again and the variability widens once more.

Tip #6: Get fee

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

back regularly, and don't misinterpret it.

"You're hitting down again!" My husband was sounding like a broken record (now there's a metaphor that's losing relevance!). So again I lifted up my swing to correct for the mis

.

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

take. "You're hitting down again!" (He's a very patient man.) What?! Then I asked him what he meant and it turned out that his idea of hitting down meant my paddle was at the wrong angle, but I interpreted it to mean my s

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

Companies that provide selfless information through particip

ing was at the wrong angle. Assumptions! So make sure you track the changes made by your improvement frequently enough that you can correct things if they go askew - but make sure you know what the feedback is telling you

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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