Main Subject - Business

If you have not read parts 1 and 2 of this mini series on How To Get A Government Contract, I suggest you do so to help understand what has been said and how it applies to what is being said in this third and final

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

part of the mini-series.

Whether you are planing to seek government contracts at the local, state or federal level, or private contracts, it makes sense to see the acquisition process through the eyes of the purcha

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

Examples of combination products may in

sing agent/authority who will be making the decision to award the contract. There are three basic points to consider that a purchasing agent definitely considers: Planning, Participation, and Protection:

PLANNING:

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

Contracting procurement officers (CPO’s) and purchasing agents (PA’s) often rely upon the department, agency or institution for input regarding an acquisition planning and will consider a variety of issues that hel

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

identify the minimum needs of the agency or the end user. This information is used in the planning phase and the development of the request for proposal (RFP).

PARTICIPATION: After the planning and needs analysi

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

Combination pro

s, the development of the RFP is many times a collaborative effort with specifications provided by a person or team of experts who have carefully thought through the technical aspects of the acquisition. This techn

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

ical information is used to develop the RFP for release to the bidding market. CPO’s or PA’s will identify exacting specifications based on internal needs and, depending on the size and scope of the acquisition pro

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

ject, an exhaustive market research. The point is that purchasing agents do their homework before they release the RFP and they know a lot about the industry/commercial sector and have intelligent expectations of m

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

rket costs and services revolving around their potential purchase.

PROTECTION: CPO’s and PA’s want protection before they award a contract to any bidding party. The first thing they consider is the past performanc

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

e of the bidding companies and the winning company’s ability to satisfy all requirements of the contract at the absolute best possible price, with the best possible terms, service and warranty combination. They wa

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

nt protection and they know how to get it through the competitive bidding process.

I have been involved in government bidding a few times and there are pros and cons associated with the process. The “pros” of the

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

Following aspects would a

process is to win a contract and enjoy the revenue stream that results therefrom. The “cons” are that a hell of a lot of hard work can go into the bidding process without a payoff. One bidding situation I was invo

dd to the challenges in developing combination products:

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

ved in was with a state agency taking bids on a creative job placement process to help people with disabilities gain employment with a living wage. There were about 100 organizations involved with the bid and each

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

organization came up with the best pitch, price service and performance angle. We did not win the bid. But what the state got was 100 sources of free ideas from business in the field of marketing, job placement, ad

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

vertising, etc. and it didn’t cost the state a dime. If those same 100 businesses were contacted and PAID for their input, it would have cost the state a TON for the professional advice and ideas they received thr

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

ough the bidding war. The state really worked the crowd and milked 99 companies for the strategic information that was, presumably, kept by the state and handed over to the winning company to incorporate the best id

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

Professional from academic institutions, pharmaceutical industries, health care indust

as into the entire job placement system. It was a sleazy deal and convinced me to stray away from any further “creative idea type proposals” with any organization, especially the government. Just a point to ponder

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

…

There is money and revenue stability in government contracts for those with the capacity to deliver goods and services. As I said in (part 1) of this mini series, it makes sense to build up a track record (past p

.

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

erformance) by bidding on projects in your own backyard with villages, townships, small cities and counties before going after the big fish at the state and fed level. Although, going for smaller grants is not a pr

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

Companies that provide selfless information through particip

erequisite to pursuing state and fed contracts it does build experience with the process. I hope you have found this mini series helpful.

Thanks for reading!

Copyright © 2006 James W. Hart, IV All Rights reserve

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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Having built a business from a bucket of water and sponge, which started over 25 years ago in a National Franchise chain in 23 states, I feel comfortable discussing entrepreneurship...

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Main Subject - How To Get A Government Contract (Part 03)

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