Main Subject - Business

Let me start out by saying that it is not my intention to be inflammatory in any way in this article. The purpose of the article is to share my impressions as to how a newly onshored software developer can succe

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

ed in the U.S. These impressions are based on many years of hiring offshore software developers to work onshore.

I've worked with many developers that had never worked in the U.S. prior to joining my company.

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

Examples of combination products may in

Typically, these are developers from India. Most of these developers were very frightened and unsure of themselves, and it is understandable. I try to imagine what it would be like for me to go to work half-

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

ay around the world, trying to take in a new culture while trying to suceed in my new job. Some outsourcing firms do a fairly good job of preparing their workers for the U.S. Others don't.

Some of these deve

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

opers turned out to be the best I've ever worked with. I'm going to be honest here about what it takes to succeed in your first onshore gig.

- BE AGGRESSIVE. This is the most important thing that I look for

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

Combination pro

hen interviewing someone. When I started out in this business, everything was about technical know-how. Over the years, I've learned that it is just as important, if not more so, to be aggressive. What do I

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

ean by aggressive? I mean that you are willing to give 100%, and most importantly, you are willing to express unhappiness with someone who is not doing so. Yell at people. Argue. If you don't agree with 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

design of a solution, make your point known, loud and clear. Expect people that you are working with to get things done. There are some really lousy developers that were born and raised here in the U.S. Don

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

t let the fact that you are "on their turf" diswade you from confronting them. This kind of aggressiveness will get you noticed in a good way. The best developer that I have ever worked with (and I mean EVER)

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

came to the U.S. from India 5 years ago. And he's good because he's smart AND aggressive. Being timid will result in failure most of the time, no matter how smart you are.

- SOLVE PROBLEMS. Don't wait for

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

someone to give you a solution to a problem. You need to try to fix something that isn't working instead of going to the lead or manager at the first sign that there is a problem, expecting them to help you solv

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

Following aspects would a

e it. Pretend for a minute that there is no one else that can help you, and if you don't fix it, it won't get fixed. That is a scary situation to be in (I know, because I've been in it), but I can tell you t

dd to the challenges in developing combination products:

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

at nothing is more rewarding than working through it. Nothing will turn off a manager more than the person who is standing at their desk with a printout of a compiler error. I've seen this many times with new

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

y onshored developers. The developer is often horrified by the fact that something is wrong, and they are bringing it to you to get it fixed as soon as possible, so that they don't need to worry about it anymor

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

. I was the same way when I started out as a programmer. Keep your manager informed as to progress, but make it clear that you are the one fixing it.

- COMMUNICATION SKILLS. There are some people in the U

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

S. who simply cannot understand the english language when spoken with an indian accent. I've seen developers shipped back offshore simply because someone believed that they had poor communication skills, and th

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

Professional from academic institutions, pharmaceutical industries, health care indust

problems was just that they didn't understand the accent. Take a course to work on reducing your accent somewhat. You will be suprised how far this can take you. It is really not fair to have to do this, b

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

t I promise that this will have a positive effect on your career in the U.S.

- BE A SOLUTION PROVIDER. Recommend technologies that you think will be valuable. Go out on a limb and suggest the architecture f

.

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

r a new application. This is something that developers that have lived in the U.S. their whole lives struggle with as well. It is easier to sit in a corner and wait for someone to give you a spec that you can

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

Companies that provide selfless information through particip

build from. There are times that I want to do this as well. But I know that I won't last more than a year or two being invisible.

Let me know what you think of this article. If you think I'm nuts, tell me so

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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If you have ever been to a seaport it is a busy place with heavy cranes and material handling equipment everywhere. Containers lined up sometimes 6-8 high, it is a scary place for some but for a material handling equipment supply and services company it is a dream come true.

Anybody can look over a company’s Web site before an interview and try to impress an interviewer with random facts about the company. However, to show that you have a significant interest in the organization, it is best to avoid a simple regurgitation of the company’s “about us” section. Therefore, smart job applicants turn to business searches to gain an edge.

Polyester is a synthetic fibre derived from coal, air, water, and petroleum. Polyester fibres are formed from a chemical reaction between an acid and alcohol. In this reaction, two or more molecules combine to make a large molecule whose structure

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