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Subjects - D.I.Y. Production I - Vendor Selection
In our industry, one of our jobs as design experts is to maneuver pitfalls that arise for our clients both experienced and inexperienced. There are four primary
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
areas where we provide this kind of guidance to our clientele; strategy, conceptualization, layout and production. The funny thing is the most detail-oriented
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
area, production, seems to be the one arena where many clients retain an overwhelming do-it-yourself mentality. In the next series of newsletters, I would like
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to explain from a fairly high level view and from professional experience what goes into production of a project; vendor selection, production costs, file prep,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
press checks and the outcome.
Vendor Selection Thinking that all printers can produce your file properly is like saying all cars are the same. As you
Vendor Selection Thinking that all printers can produce your file properly is like saying all cars are the same. As you
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
know, some cars ride smoothly, some bumpy, some are sleek and others just plain get you from point A to point B (most of the time) but it all falls back to the
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
old clich? "you get what you pay for." Each printer is setup differently with different equipment. Many printers can handle all trim and finishing effects, lik
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
e foil, in-house while others have to outsource your job to be completed. Some printers can handle a 7-color job on one press while others only carry digital so
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
lutions. Have I confused you yet? No? Good. Then here are four basic things to think about when selecting a vendor
1. Let your design firm handle it. They have
1. Let your design firm handle it. They have
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
a list of vendors that they work with routinely and trust implicitly to get the job done right. This expertise comes from being burned a few times and committi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ng to a "not-the-cheapest" solution.
2. Do your homework. Get samples of previous work from a couple of different printers so that you can compare quality and
2. Do your homework. Get samples of previous work from a couple of different printers so that you can compare quality and
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
know what to anticipate from them.
3. Get a list of their capabilities. If your job requires die cuts will they be handling that in-house? If you are ordering
3. Get a list of their capabilities. If your job requires die cuts will they be handling that in-house? If you are ordering
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
stickers, is that in their capabilities or will they be playing middleman? What kind of presses are they printing on, offset, digital, flexo, gravure? Ok. the l
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ast two were not exactly fair. Flexo is mainly for odd substrates (what you are printing on) and if you are not printing enormously large quantities gravure isn
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
't even in your ballpark.
4. Make sure they are responsive to you from a customer service standpoint. Dealing with a good printer representative that will advi
4. Make sure they are responsive to you from a customer service standpoint. Dealing with a good printer representative that will advi
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
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
se you along the way is extremely important, even for professionals.
Notice I talked nothing of selecting based on price; we'll talk about that next. Here is t
Notice I talked nothing of selecting based on price; we'll talk about that next. Here is t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
he fun part, you cannot get a quote from a vendor until you know what you are printing (i.e. dimensions, number of colors, quantities and any special finishes)
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
and your design firm will not want to start design until they know your printer's capabilities (i.e. are they digital or can we produce spot colors, can they ha
.
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
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
ndle specialty paper, die cut) ... a fun conundrum right?
Remember, not all printers are created equal. There are Porsches, Toyotas and Pintos, the trick is di
Remember, not all printers are created equal. There are Porsches, Toyotas and Pintos, the trick is di
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
scerning between them and which one you are willing to ride in. Don't forget to catch the next article in this series, D.I.Y. Print Production: Production Costs
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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