Main Subject - Business

I remember it all so well. The dot-com had just dot-bombed, the stock market was suffering from a sucker punch to the throat, and we were beginning to hear about some guy named

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

Ken Lay. A little while later, news came out about Arthur Andersen, WorldCom, and Adelphia, among others. It seemed that companies were going under and CEOs were getting indi

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

Examples of combination products may in

cted faster than you can say ‘stock option’. And then came the layoffs. Thousands upon thousands began losing their jobs on a regular basis. We started hearing about places o

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

verseas that were getting all kinds of work from US companies.

I’m pretty sure that most everyone has heard that many jobs have been ‘outsourced’ through something called ‘off-

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

horing’. What that means is that a job that used to be based in the US is now done by someone in another country. You see, many companies started thinking about how nice it wo

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

Combination pro

uld be to pay someone in India 50% less to do the same job they were currently paying a US employee. They evidently didn’t stop to think that the new employee didn’t speak Engl

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

ish as their first language, was half a world away and lived in a completely different culture… I guess it’s sometimes easy to miss those little, really minor details such as t

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 ability to communicate with an employee and not having to deal with a time difference so great that it could take days to accomplish what would otherwise take hours.

Surprise

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

, surprise… It would appear that some US companies are now starting to reconsider this whole ‘off-shoring’ thing. Yea, they save money directly in the form of paying lower wage

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, but there are other, more hidden, costs in terms of customer satisfaction, phone charges, etc. What’s a company to do?

The answer is something called ‘home-shoring’ or ‘nea

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

-shoring’ or ‘rural sourcing’, or whatever other buzzword they’ve come up with. What it means, and why you should care, is that some pretty smart entrepreneurs started thinking

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

Following aspects would a

that there are some really bright folks living in some rural parts of the US. And these rural areas of the country are usually the places that need jobs. Hmmm…. Is there a bu

dd to the challenges in developing combination products:

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

siness model there somewhere?

In fact, there is. IT consulting companies and call centers are starting to pop up in the most unlikely of places. Take Lebanon, Tennessee for e

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

xample. No, not Knoxville or Nashville, that’s Lebanon, TN. And then there’s Beckley, West Virginia, which is doing quite nicely, thank you, when it comes to operating success

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

ul high-tech consulting companies.

What does that have to do with those of us here in Eastern Kentucky, you ask? Good question and here’s the answer: West Liberty. You see,

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

there is a little company in the small but beautiful town of West Liberty, KY whose goal is to provide high paying technology jobs to folks within the region. They are called N

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

Professional from academic institutions, pharmaceutical industries, health care indust

atural Bridge Technologies; visit them on the web at www.NaturalBridgeTech.com.

When I graduated from Morehead State University back in the 90’s, the thought of having a softwa

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

e job in Jackson, Kentucky was laughable. I first moved to Lexington, then to Atlanta. Finally, after too many years, I was able to move back home. With the concept of ‘home-

.

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

shoring’ and companies like Natural Bridge Technologies, future geeks can have the best of both worlds: making good money writing software during the day and spending evenings g

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

Companies that provide selfless information through particip

azing at the beautiful foothills of Appalachia in which we live.

As always, if you have any questions or suggestions for future articles, please email me at mike@MikeBryant.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/32776/mainsubjects-Rural-Sourcing.html">Rural Sourcing</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/32776/mainsubjects-Rural-Sourcing.html]Rural Sourcing[/url]

Bring a list of potential questions to ask at the job interview. This sample of 10 questions will help get your list started.

Should you get reimbursed for interview travel expenses? I've helped a number of job searchers who had to travel a fair distance to get to an interview. In most cases the hiring manager I was dealing with would...

Getting along with your co-workers is critical to your happiness and success at work. You may find yourself spending more time with your co-workers than with your spouse and family.

Tags

Links

Main Subject - Rural Sourcing

Related Articles: