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Think about it. You seek them out to provide some knowledge, skill or experience your company doesn’t have. And, in the process of providing that help, they learn

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

more about your business than even some on your management team know. Then, in return for you laying your corporate soul bare – sharing information about processe

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

Examples of combination products may in

s, customer files, financials, etc. – some consultants also attempt to pick your pocket.

I am a consultant. Have been for a good many years. I’m neither rich nor

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

famous. Not likely to be. Never really wanted to be. But that was a choice I made long ago. Since then I’ve seen a good number of consultants – male and female

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

individuals and corporations – achieve fame, fortune, or both. It’s not envy that prompts me to write what follows. It’s disgust.

What I find disgusting is how

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

Combination pro

little some consultants value their professional relationships with clients. How much more they value the dollar.

Let’s look first at the relationship. Nothing s

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

ays it can’t be pleasant, cordial, perhaps even friendly. But it is first and foremost a business relationship, a professional relationship, one that should be roo

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

ted in confidentiality. Any company hiring a consultant should insist – before any business is ever discussed – that both parties sign a Mutual Confidentiality Agr

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

ement.

Do you want people outside your company to know your firm’s inner most workings? Without an MCA you have no assurance of confidentiality

By signing an MCA

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

, the consultant agrees not to discuss your business – perhaps even mention your company’s name, if the MCA is drawn that tightly – with any third-party without you

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

r both agreeing that third-party has a need to know. Those third-parties typically include printers, mailers and the like.

Now let’s look at the dollars. Consult

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

Following aspects would a

ants absolutely love working on retainer. Why not? It’s guaranteed income. Put enough retainer arrangements together and there’s good money to be made. The chec

dd to the challenges in developing combination products:

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

s come in like clock work every month. Life is good. For the consultant. Not necessarily for your company.

If a firm requires long-term assistance, they should

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

think about hiring an employee with that talent. The expense is almost sure to be less that a consultant’s retainer. But there’s that budget problem, right? Got

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

to keep visible payroll costs down? Consultant retainers don’t show up as a payroll expense.

Want to cut your consulting expenses? Try this: Instead of agreeing t

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

o retainer arrangements – you pay them so much a month in return for which they promise you X hours of their time – hire consultants to work on individual projects.

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

Professional from academic institutions, pharmaceutical industries, health care indust

That means you pay for work done, not time “promised” to you.

The are a number of other good points about hiring project consultants. You know up front just what

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

each project will cost because they commit to it. You also know when the project will be completed. Again, because they commit to it.

Put price, terms and other

.

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

details of each project in writing. Your corporate attorney can easily include those details in something called a “Project Scope” that becomes part of the MCA si

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

Companies that provide selfless information through particip

gned earlier by you and the consultant. But however you and your attorney choose to do it, always require consultants to sign your Mutual Confidentiality Agreement

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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Finding products to sell is fundamental to those who have Internet stores, auction sites, or sell through stores such as Amazon or Ebay. However, it may be difficult to determine where you will find those products to sell.

In the past decade the typical day for an admin is no longer typing letters and memos, making coffee and filing. Admins today may be expected to plan planning meetings and events, coordinate coordinating projects, use desktop publishing, display leadership, and liaison between staff and management and much more

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