Whether you are just starting out in a business or a seasoned "professional" you should have a contract when doing business - if not for your own safety, bu
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
t for the safety of your clients.
Not a day goes by that I don't hear horror stories about misunderstandings on projects that could have easily been p
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
evented with a simple contract.
Simply, they state the work you are providing and the cost involved. They should also indicate what is not included, such as
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ncidental material costs and excessive copy changes, etc. Always put into writing your intent and email it to the client.
His or her email response, along wi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
h the "deposit" is an contract of the agreement. For added security, have them sign a copy of the contract and mail or fax it to you. My policy is that I do not begin any work u
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
ntil the down payment has been paid and the contract is signed and delivered. This not only protects my business, but also shows me that the customer is serious about his or her
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
intents.
When you have developed a good, solid relationship with your client, then monthly billings are the norm. But until then, 50 % down is not unheard of
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
After all, you are taking a risk doing work - and more often than not, monies owed are not paid based upon the client "not liking the design."
Remember, you
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
are hired to do a job - and it is up to the potential client to research your design ability and make the decision to hire you, based upon the findings. You are not hired to "ma
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
ke them happy."
Now that may sound cold-hearted, and I care about each and every one of my clients, and the work I do for them. However, when I am hired, for
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
example, to do a logo - I am hired to design a logo - based upon their specifications. After a reasonable amount of time, if they just don't like the designs I come up with - th
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
y are still obligated to pay for my service. I do attempt to rectify the job and pinpoint the "problem", but unless the client can somehow convey their desires, I just haven't p
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
rfected "reading minds."
And I do expect to be paid for my effort. But a Professional Designer will be able to work with the customer, and eventually, comple
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ting the project to the clients' satisfaction. In the 23 years I have been providing marketing and design, there have only been 3-4 instances where I just wasn't able to design
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
he project to the satisfaction of the customer - and on one occasion, they refused to pay, as they decided to close the business. I eventually had to sue for the $100! Can you i
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
agine, tarnishing your credit, not to mention your reputation, over such a small sum of money!
The main reason I was able to collect the money easily is beca
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
se I had a written and signed agreement for the project. I also had documentation that the logos were delivered - it was basically "no contest".
I was able t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o satisfy the other clients, by hiring outside of my office. I found a compatible match for their needs and all were happy in the end. And that is your ultimate goal: Satisfacti
.
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 and service.
In closing, remember art is relative. You cannot be everything to everyone. And not everyone is going to like your design style - but many wil
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
. So, remember to be professional, and confident in your work. Have a portfolio of samples to display your design style, and above all, have a contract ready for the signing!
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
