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Quests are an important part of World of Warcraft. Apart from anything else they stop the game becoming boring too fast by adding to the imm

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

ersion into the WoW world. But even the quests become a necessary evil after a while. The first time you run through them they are all new a

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

Examples of combination products may in

d shiny. The next time you do them you may try a different option or two, but after that it starts to become about efficiency.

At a certain

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

point quests become about the most efficient way of completing them, and there are two approaches to developing that efficiency. The first i

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

s the route most people take. I call it the headless-chicken approach. This is where you stumble into a quest, say something along the lines

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

Combination pro

of “I remember this one, I think I need to go over there…”, and bumble through the thing in roughly the same way you did last time. The real

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

problem with that approach is you often find yourself saying things like “Oh, I actually needed to go THERE”, “Hmmm…this guy doesn’t have th

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

e Muffin of Doom at all, it must have been that other guy” and unfortunately “Where’s my corpse?”

The second route is the efficient one. It

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

involves recording your moves, refining the strategy each time until when you start a quest you follow it from A to B to C to completion.

I

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

learned this lesson long ago in a long forgotten game called Pools of Radiance, and it holds true to any game with any sort of replay value

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

t all. If you think you’ll be coming the same way again – make notes on the route. If you think you’ll be doing the quest again, make notes

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

Following aspects would a

on the quest. Travel a different route for variety by all means. Try different options in the quest, but if you don’t record what you do, an

dd to the challenges in developing combination products:

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

you don’t have a great memory, failure to record these things will lead to walking around in circles and mucho mucho frustration.

How much

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

Let’s go back to the game where I learned the lesson. Pools of Radiance was a forerunner to the likes of WoW. I look my group of heroes out

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

of the walls of Phlan and journeyed up the river to a lake. In the middle of the lake was a big pyramid spewing all sorts of pollution 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

Phlan’s lovely clean river and my heroes had to investigate. To cut a long(really long) story short, the pyramid contained a maze of the mos

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

Professional from academic institutions, pharmaceutical industries, health care indust

frustrating type. Not only was it twisty and turny and impossible to see any landmarks, but it also had teleporters which randomly jumped y

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

ou all over the place. I wandered that stupid maze for hours before I finally took out a pen and paper and started to map my exploits. When

.

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

ran through the game again with a new group I did the entire quest in ten minutes.

So Map, record, refine. It may sound a little dull to s

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

Companies that provide selfless information through particip

art, but when you carry it to it’s natural conclusion and you’ve leveled 4 times faster than everyone else the dullness doesn’t hurt so much

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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So you want to tap into the Minneapolis, MN Medical Device industry, aka 'Medical Alley'? Although this is a huge and rapidly growing industry, it seems impossible to tap into unless you already have medical device experience! As a Technical Recruiter, I have actually had great success placing folks into medical device companies who had little or no medical device experience at all! How did I do it? I would be lying if I said it was easy, but then again, I would be lying if I said it was hard! It seems to me that the number one most important skill that medical device companies look for is folks with strong experience in a HIGHLY REGULATED INDUSTRY!

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