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I am writing this article because I have heard too many horror stories from clients about prior consultants they hired. From the maniac consultant that would hurl curses and insults at employees to the invisible consultant that only appeared to present his invoices. Reliable veterans of the co

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

nsulting industry all agree that businesses commonly fall into one of these five costly traps when hiring a consultant. Let's see what they are, and how you can avoid them.

Trap 1: Selecting a Consultant Without Expertise Knowing computers is one thing. Knowing the particular area of

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

Examples of combination products may in

business teshnology needed to solve your business problems is quite another. The interaction of software, hardware, networks and operating systems has become so complex that a lot of times you know you have a problem but you don't know in what part of your system the solution lays. All the mor

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

e reason to take more time laying the groundwork with interviews. You need to find someone with the right set of skills to address your business problems. Also, your consultant will ideally have experience in your industry. Logically speaking, the solutions used in the pharmaceutical industry

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

might not necessarily adapt well to the manufacturing.

In addition to technical and industry expertise, a consultant will also be well versed in applicable laws and regulations governing your industry. From personal experience, we worked with a client who was violating several laws simply bec

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

Combination pro

use their previous consultants were negligent. As quickly as technology evolves, so do the laws and regulations that govern multiple aspects of your industry. Make sure your consultant is knowledgeable on all areas related to your business.

Trap 2: Selecting a Consultant Without People Ski

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

lls Your computer consultant must have skills that go beyond the technical, into the realm of communications and training. In your interviews with consultants, find out which ones exhibit a real interest in solving the problems of your staff. Avoid the consultant who shows resentment at

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

speaking with your staff. You'll have problems down the road when they need technical assistance.

Consultants with an attitude can create havoc with your business. They will try to control how you run your business, or they will do something and not tell you what they have done. Then when som

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

ething goes wrong you are forced to run them down and find them. The consultant is there to make your life better, not worse.

Trap 3: Letting the Consultant Take Control Give specific instructions. Establish milestones with clearly stated goals. Develop metrics to measure success or f

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

ailure. Follow these simple rules, and you will avoid a common trap: giving the consultant too much free rein. Unchecked, the consultant will likely develop a "solution" that only solves his cash flow problems.

The first step is to plan out what you need before interviewing consultants. Get t

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

e big picture. Then fill it in, one small job at a time. Many managers resist taking time out of their day to figure this out. When you understand what your problem is, you can better explain it to the consultant. Set out what you want in plain English. Say what you want to accomplish and let

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

Following aspects would a

the consultant translate it into what the systems should do. Although something will be lost in the translation, your goal is to keep surprises to a minimum.

When you have no idea what is wrong, then ask your consultant to prepare a simple document outline a strategy to identify the root prob

dd to the challenges in developing combination products:

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

lems. If the document you receive is overly laden with jargon and industry terms, have them rewrite it into plain English. Remember, jargon is generally used to disguise meaning. If they cannot explain it in simple language than look for someone else.

Trap 4: Agreeing to Begin Work Without

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

a Contract The last thing you want to do is go into a business arrangement with a consultant that will be installing your technology systems without a contract. "Contracts are the best way to avoid misunderstandings," says Wendy Wallberg of Wallberg & Renzy, P.A. "A contract serves to mi

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

nimize the risk to both parties. But be careful. If your consultant presents you with a contract full of legalese you better contact your attorney."

In general, a good contract for consultant services does not have to be long or cumbersome. These contracts should spell out the services that

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

he consultant will provide and the agreed upon fee. If there is anything missing, be sure to get it added into the contract before you sign.

You want to avoid coming to the end of the project and being disappointed. You may say, "it doesn't do X, which is critical," and the consultant will s

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

Professional from academic institutions, pharmaceutical industries, health care indust

ay, "when did we talk about it doing X?" A well written and thought out contract will ensure that these issues are all settled before there are any surprises. Remember, a contract serves to protect all parties involved in the transaction.

Trap 5: Be Sure You Trust Your Consultant If y

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

ou follow the guidance in this article you will go a long way toward sidestepping the most common and costly traps when hiring a computer consultant. But there is one final, major hurdle to overcome. Never forget that the consultant has access to all your company data. Can you trust this perso

.

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

n?

"Most horror stories derive from a breach in one of two kinds of trust," says Wallberg. "The first is ability and the second is attitude." An untrustworthy person can create havoc with your business. Don't hire any consultant you can't trust as a human being. Trust your instincts, unless y

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

Companies that provide selfless information through particip

ou have a long history of trusting the wrong people! If you do not think you can trust any consultant then save yourself a mountain of grief and hire someone else.

These simple, common sense strategies can help ensure that you avoid the most common pitfalls associated with hiring a consultant

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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