Main Subject - Business

Here's a brief story I encountered while leaving Newark International Airport following a recent business trip. Hard to believe, but true.

After a long f

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

light home from the West Coast, I took a short train ride to the long term parking facility, located my car (which is becoming more difficult with age it

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

Examples of combination products may in

eems), and proceeded to the parking exit. Note that it's been a while since I've used the long term parking facility, as I normally use a car or taxi serv

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

ce, so I was largely unfamiliar with their new "high tech" customer solutions.

As I pulled up to the pay station (expecting the attendant to inform me of

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

my charge), she immediately looked at me with the gaze of a very frustrated woman who's obviously done this before. In a short tone, she barked out an ins

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

Combination pro

truction suggesting that I had passed an automated ticket booth, from which I should have inserted my ticket and noted the charge. I complied with the ins

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

ruction, quietly wondering why this woman was in the booth at all, given the fact that the machine and I pretty much had this thing licked. I concluded of

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

course that she must be there to collect the money, so I proceeded to pay her. Not a good assumption as she pointed me back to the machine to insert my pa

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

ment. OK, I get it, I interact with the machine for this too...no problem, thinking that this is a pretty good solution. I wait for the machine to give me

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

my receipt, an obvious assumption given how the first two steps went. Nope...wrong again. This time she wants me to drive to her and pick up my receipt,

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

t which point she presses a button, lifts the gate, and I'm on my merry way.

I can't help thinking about all the time and money went into implementing th

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

Following aspects would a

s slick new solution, that probably cost an arm and a leg, had little to no impact on cost savings, destroyed customer satisfaction, and obviously put the

dd to the challenges in developing combination products:

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

employee in a perpetual stae of 'grumpy'. No...what this was, is yet another example of "technology for technology's sake".

When I work with organization

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

s on business impovement, one of the most important themes I try to drill home is PROCESS FIRST, then technology. You don't implement technology on top of

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

a broken process. Nor do you attempt to fix a broken brocess with technology only.

The right path is to measure the effectiveness of the process before y

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

u begin. Establish a baseline. Understand how the process works today ('As Is' State). Look for places to improve the process. Define changes. Examine the

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

Professional from academic institutions, pharmaceutical industries, health care indust

effect of each potential change on overall performance. Then, and only then, define the technology, systems, skills, and organization needed to support th

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

e new process. Develop cost benefits and business cases. Re-examine the degree to which performance will be improved over baseline. And then your almost r

.

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

ady for implementation.

It's a simple principle, but one that often get overlooked. Try to pay some attention to this in your everyday life and you'll pr

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

Companies that provide selfless information through particip

bably see many similar examples. Then, use these as lessons learned, and start living by the mantra- "First Things First"- process first, technology later

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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Good customer service is an easy way to keep ahead of your competition. Learn how even customer refunds can have a huge upside when it comes to profits. Company’s that are able to see the seed of opportunity in customer refunds will have cheer leading loyal customers who will be good log term assets.

Over the years thanks to competition it seems that the Big Box Hardware Stores like Home Depot and Lowes have gotten progressively better with their customers service. Why has this taken place? Well two reasons; one is competition and the other is because the customers have demanded it and by delivering better customer service the customers come back to shop more often and have a better shopping experience.

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