Cases - Business

Do your customers (and potential customers) know the full value you bring to the table? Before you automatically answer, “Of course, they do!”, consider this: I was at a nail appointment recently and my nail technician mentioned that she had just put her father’s house on the market through a lo

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

cal REALTOR and had received an offer within 2 days. She was probably going to accept the offer, since it was very close to asking price. However, she then made the following comment: “In fact, we’re going to go back to our REALTOR and ask her to reduce her commission because it sold so fast, and she

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

Examples of combination products may in

doesn’t have to do any more advertising OR MUCH WORK on it, so we think she should reduce her commission.” Yikes! Being a former REALTOR myself, I know that the effort involved in getting an offer and successfully negotiating it is often the EASIEST part of the real estate transaction. However, t

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

his comment does bring up a very important point: our customers have no idea that this is a reality, nor do they have any idea of what it really takes for us to do our jobs, bring transactions to a successful close, and handle all the negotiations and other details (usually invisible to the client) tha

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

t bring about a successful closing. Is it the same way in your business? Do you often do so many things behind the scenes that your customers have no idea how hard you're working for them? Do they know the expertise it takes to get the job done right - or do they think they can do just as good a j

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

Combination pro

ob as you can, without any education or training at all? Do they know that there is a cost (often a very high one) of doing business properly? Think about this: when an attorney charges a large amount of money to bring a criminal or civil matter to trial for his or her client (and gets paid that l

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

arge amount of money, whether or not the client wins or loses), does anyone even CONSIDER asking for money back if the trial takes less time to complete than anticipated? Especially if the client wins? Of course not! This is because everyone knows the extent of the training and expertise necessary to

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

a) go to trial, b) competently represent clients, and c) win. The client is usually so happy at having been represented at all - and when they’re successfully represented and win the case, they’re even happier - that the thought of asking for money back never even enters their mind! Lawyers have d

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

one an excellent job of showing just how much work goes into becoming a lawyer. Have we done as good a job in our industry? If not, we need to do a better job of educating our clients and potential clients. Let’s do a few things to make it clear to our clients exactly how much value we bring to th

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 table: 1. Let our clients know how much education we received to get our licenses - and then how much continuing education we receive (mandatory or not) to continue to improve our skills and value. We could proudly display our educational documents on our walls, as lawyers do; or list our additio

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

nal education, degrees and designations on our marketing materials. Even if people don’t know exactly what all those initials stand for, they know it stands for something - usually a higher level of education and commitment to knowledge.

2. Let our clients know what we’re handling behind the scenes, s

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

Following aspects would a

o they don’t have to be concerned with handling those details themselves. In fact, we should list these items up front in our sales presentations to clients. We don’t have to inundate them with details, but we should at least be mentioning/listing these items so they know all that’s going on in their

dd to the challenges in developing combination products:

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

transaction.

3. Let our clients know not only what costs we incur on their behalf, but the fact that there is a cost of doing business every day, regardless of which client is being served at that particular moment. If you have educational fees, licensing fees, certification fees, insurance and other

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

costs, you can diplomatically mention that there is a cost of doing business - but that this is what allows you to fully and expertly work on their behalf and/or represent their best interests. If you didn’t have all your education and other “business ducks in a row”, you couldn’t be in business at all

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

, nor could you competently, legally and ethically serve your clients. This same type of situation arose once for me when I was on a real estate listing presentation. The potential client asked me, “If our home sells quickly, will you reduce your commission?” I replied, “No, just as my commission

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

will not increase if your home takes longer than anticipated to sell, it also doesn’t decrease if it sells quickly. My commission is a set fee, no matter how long it takes. Does that sound fair?” They answered, “Yes!” (Once they realized that I was also being fair to them and willing to do a LOT mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

e work if necessary, for no more cost, they were fine with the fixed fee.) I then added, “However, allow me to explain all the other ways I serve my clients during our time together...” I then went on to explain all the other things I did, which further justified the fee in their minds. They signed t

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

he listing agreement, I went on to sell the house for them, and everyone was happy. Clients just want to be treated fairly; however, like all of us, they are human. They just don’t see the other side when they are looking at the issue from their side. Help them to: a) see your side; put them in y

.

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

our shoes - or the shoes of another party in the transaction, which will help negotiations go more smoothly;

b) realize you're being fair to them (and it will help them realize they have to be fair to you); and

c) see the FULL value you bring to the table That being said, remember that all of this

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

Companies that provide selfless information through particip

depends on your actually being VERY competent, VERY knowledgeable, and VERY fair to them. If you do this - and then let your clients know by your every word and action that you are a professional, are working on their behalf and are being fair to them - you will not have a problem justifying your fees

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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Are free background checks available online? Are there any public records which are useful for background checks? What sort of public information can I discover about an individual?

We have finally reached the end of our installments on medical billing of oxygen claims and the CMNs that go with this billing. In this review we cover the GX2 record, which is facility information.

Nonprofit organizations are institutions that are established in order to raise money for educational, religious or scientific purposes. These organizations are run by a group of people who come together with an ad hoc purpose, more like volunteers than employees. As an example, an organization that is established for disaster relief or literacy can be classified as a nonprofit organization.

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Cases - Your Full Value: Do Your Customers Know It?

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