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What happens when your company receives a solicitation (RFP, PFQ, IFB, etc)? If you’re earned the right to bid by passing through all of the up-front, pre-proposal gates chances are the bulk of your proposal is written and is just waiting to be fine tuned. On

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

the other hand if the solicitation catches you by surprise someone will hit the panic button and pandemonium will be the word of the day for the next 30, 60, or 90 days. However, there is a vast difference between motion and movement and having the entire propo

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

Examples of combination products may in

al team racing to fill the war room walls with boilerplate and generic themes may not be your most productive course of action.

Einstein said that one should use 90% of the available time to understand the problem. I’m not suggesting anyone spend 27 days of a

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

0 day cycle analyzing the solicitation but five to seven days isn’t unreasonable and it will save you time and energy on the back end. So what do you do during this time? Well… 1. Read the solicitation – Too many times we just read the sec

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

ion that seems most important to us. The Proposal Manager focuses on sections L and M, the technical folks concentrate on section C, contracts group will assume that the Certs and Reps are standard and don’t need reading until the last minute, and chance are tha

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

Combination pro

no one will notify pricing. At a minimum, the person responsible for each area proposal area should read the entire solicitation to catch problem areas, or areas of concern, before they cause you to either no bid or rewrite significant portions of the proposal

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

t the last minute.

2. Identify all performance risks – After reading and understanding the solicitation identify and record all the risks and concerns of the individual readers. During the proposal development process all of the identified

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

isks should be eliminated or mitigated.

3. Formulate the basic approach – How are you going to solve the customer’s problem? If you’re selling products rather than services what products meet the requirement? Will product integration be a p

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

oblem or time consuming? If you’re selling services rather than products will you bid contingent hires? Will project management be billed as overhead or direct? The more components involved the more difficult it becomes to build the approach. The more difficult

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

r convoluted the approach, the more time that should be devoted to casting it in concrete before writing starts.

4. Select teaming partners – If you can’t or don’t want to bid the job alone you’re going to have to select one or more teaming

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

partners. Don’t select a teaming partner because of their availability or a relationship you had in the past. Choose a teaming partner for what they can do to add value to the bid. If you’re going to expect your teaming partner to provide any portion of the prop

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

Following aspects would a

osal make certain they have the commitment of their management and that their management understands the solicitation so they can assess their risks before delivery day.

5. Develop a “should cost” model – Of course if you haven’t been close

dd to the challenges in developing combination products:

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

to the customer or if you don’t really understand their needs you probably have no idea what they expect to pay for the solution which makes this task rather difficult. None the less, if you can’t identify all the key cost drivers and their cost you are shootin

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

at a target you can not hit except through luck.

6. Outline the proposal – The order of precedence when outlining a proposal is Section L, followed by Section M and finally Section C. It should go without saying that Section L being the “I

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

struction To Offerors” dictates the proposal outline. It may very well tell you that such and such a volume will address some other section (such as Section C) but not necessarily. If it does, by all means do as instructed. If it doesn’t don’t panic it isn’t al

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

ays necessary to respond to the statement of work. If, given the latitude and the room, it makes you comfortable use Section C as the basis for outlining the Technical Volume/Section.

7. Decompose the solicitation – Whether you storyboard

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

Professional from academic institutions, pharmaceutical industries, health care indust

r work off of an expanded outline the solicitation must be broken down into requirements. Section L determined the outline decomposition determines what will be addressed in each outline segment. Word processing software makes this task simpler by allowing you

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

o search on the word “shall” which indicates a requirement.

8. Prepare the proposal development schedule – I’ve found that the easiest way to schedule is to work back from the delivery date and consult with each of the effected groups to en

.

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

ure they have time to complete their assigned tasks. Undoubtedly you’ll need good negotiating skills to gain everyone’s cooperation and remember, you only have a limited amount of time so spread the suffering around equitably. Also, even with everyone using spe

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

Companies that provide selfless information through particip

l checker schedule time for proof reading and editing by a trained editor. You will be amazed at how this improves the quality of your proposal, they will catch mistakes that you read right over. Beyond that ensure that you leave time for an independent review

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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Wood machining refers to the process of converting wooden logs into planks, fabricating them into desired shapes and sizes, and polishing them for use in the final product. Wood machining has acquired great importance in recent years due to the short supply of wood and increasing environmental awareness among users and manufacturers. Wood machining techniques that are in use, stress on the maximum utilization of wooden logs and help in reducing wastage.

Direct reports—people who need direction and leadership—rely on their leaders to give them feedback and mentoring, not just management and evaluations. However, these people who most need their boss’s help frequently lack the guidance that would enable them move to the next levels of success—theirs, their team’s and the company’s. Too often leaders are not prepared or trained to conduct an appraisal that stretches performance and ensures their direct reports’ development. Instead, the appraisals become confrontational and judgmental; goals are not clear; neither person is prepared; and the discussion occurs when it’s too late to do anything about the problem...

One major issue not being addressed right now in the regulatory definitions which guide consumers and lawyers in business opportunities and franchising is the new term being used; Private Franchising. The Federal Trade Commission decided it would revise its definitions of such opportunities in 1995, but failed to address this issue.

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