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Advice You - Like New, Only Better
Material handling systems (conveyors, sorting systems, shelving, etc.) represent a major purchasing decision, no matter how you slice it. The wrong decision can be costly, and making the right decision can be difficult, largely because of the number and nature of the options available.
Of course, you could just pay top dollar for new equipment. You k
Of course, you could just pay top dollar for new equipment. You k
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
now exactly what you are getting, assuming the equipment performs up to specs. Your only concern is the possibility that you have paid more for it than you really had to.
You could save money (or at least spend less, which is not always the same thing) by purchasing used equipment. Now all you have to worry about is dependability-or, at worst, the co
You could save money (or at least spend less, which is not always the same thing) by purchasing used equipment. Now all you have to worry about is dependability-or, at worst, the co
; 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
st of replacing the equipment if it doesn't do the job it was intended to do.
Finally, there is reconditioned equipment. This saves some money, but not as much as buying used. On the other hand, it should perform better than used, if not as well as new. That's the theory, but you can never really be sure what was done to the equipment other than a qu
Finally, there is reconditioned equipment. This saves some money, but not as much as buying used. On the other hand, it should perform better than used, if not as well as new. That's the theory, but you can never really be sure what was done to the equipment other than a qu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ick paint job. Ideally, reconditioned equipment should be the perfect compromise between the quality of new and the cost savings of used equipment. However, unless you know exactly what to look for, you will have a hard time predicting performance and measuring it against the cost of the equipment.
Fortunately, there is a fourth option which attempts
Fortunately, there is a fourth option which attempts
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
to eliminate this uncertainty by specifying - and guaranteeing exactly what has been done to used equipment before it is once again offered for sale. "Renewed" equipment permits informed purchasing. You can calculate, as with new equipment, the value of the purchase based on anticipated performance versus cost.
Who Do You Trust?
Of course, a
Who Do You Trust?
Of course, a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nybody can slap a "renewed" label on some old piece of reconditioned equipment, so you have to ask yourself who you are dealing with. How do they "renew" equipment? How do you know what is done to the equipment? If the equipment doesn't per-form as promised, what is the supplier going to do about it?
If possible, work with a material handling equipme
If possible, work with a material handling equipme
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
nt supplier you know. Barring this, it is important to identify a supplier with experience in refurbishing the kinds of equipment you are considering, and who has an established reputation in the industry for standing behind the products they sell. Talk to other customers. To be on the safe side, try to talk to customers that aren't on a list given yo
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
by the supplier.
Visit the supplier's facility, if at all possible. Do they have the engineers and qualified shop personnel to inspect, test, rebuild and retrofit the equipment? Do they make the product cosmetically attractive, but neglect the additional work needed to revitalize the equipment's performance. Do they have a process that includes exte
Visit the supplier's facility, if at all possible. Do they have the engineers and qualified shop personnel to inspect, test, rebuild and retrofit the equipment? Do they make the product cosmetically attractive, but neglect the additional work needed to revitalize the equipment's performance. Do they have a process that includes exte
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nsive inspection and testing? Do they offer a guarantee that the equipment will perform as advertised?
The Renewal Process
A true equipment renewal program adds value to the equipment at every stage, from disassembly at its previous location until it is installed and functioning in your facility.
Disassembly. Material handling equipme
The Renewal Process
A true equipment renewal program adds value to the equipment at every stage, from disassembly at its previous location until it is installed and functioning in your facility.
Disassembly. Material handling equipme
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
nt undergoes wear and tear throughout its working life. Regular maintenance and intelligent operation of the equipment can keep this to a minimum, but all this good work can be wasted by careless disassembly. Before accepting the equipment as potentially renewable, the supplier must examine the equipment on site, along with any maintenance records. Ev
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
en more critically, an experienced, reliable crew must be employed to tear the system down, categorize, palletize and transport it to the renewal facility.
Evaluation. As mentioned earlier, a certain amount of wear and tear is inevitable. Some is acceptable, and is one reason that renewed equipment costs less than new. Excessive wear, however,
Evaluation. As mentioned earlier, a certain amount of wear and tear is inevitable. Some is acceptable, and is one reason that renewed equipment costs less than new. Excessive wear, however,
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
is not acceptable. Some elements of a system may be rejected, or sold as used at a lower price. Frequently, the wear and tear is concentrated in easily replaced parts such as seals, rollers, bearings, etc. A good renewal program will replace critical parts in this category even if they still look good.
Testing. Renewed equipment should operat
Testing. Renewed equipment should operat
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
e up to the specifications of the equipment when it was new. (It may not hold to those specs as long as new equipment would, but that's why you're spending less.) A good renewal program will test each component, so that you know exactly what performance to expect from the reassembled system.
Design. You probably won't be using this equipment e
Design. You probably won't be using this equipment e
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
xactly the way the previous owner did. A good design and engineering team can help you integrate the equipment into your existing system.
Cosmetic Work. You'll get a repaint job with any reconditioned equipment, but the paint on renewed equipment is not there to cover up flaws. It's simply there to enhance appearance.
Reassembly. Renew
Cosmetic Work. You'll get a repaint job with any reconditioned equipment, but the paint on renewed equipment is not there to cover up flaws. It's simply there to enhance appearance.
Reassembly. Renew
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
d equipment may not assemble as easily as new, although it is easier to work with than used equipment. A certain amount of additional adjustment will probably be required, along with the re-drilling of holes and other minor modifications, to retrofit the system so it integrates properly. A trained crew can be a real asset here.
Living with Renewed
Living with Renewed
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
Equipment
Renewed equipment will continue to perform within spec for a certain amount of time (less than new, more than used). However, this is not a simple "you get what you pay for" compromise. The fact is that most material handling systems have a limited shelf life. Growing volume changes in business processes or materials handled, the avail
Renewed equipment will continue to perform within spec for a certain amount of time (less than new, more than used). However, this is not a simple "you get what you pay for" compromise. The fact is that most material handling systems have a limited shelf life. Growing volume changes in business processes or materials handled, the avail
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
ability of new material handling technologies-all of these can and will make your new system obsolete at some time in the future. Why pay for more time than you need?
Of course, taking advantage of this factor requires careful planning. Sometimes it's a fairly simple matter. For example: your present system is completely inadequate for your needs and
Of course, taking advantage of this factor requires careful planning. Sometimes it's a fairly simple matter. For example: your present system is completely inadequate for your needs and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
absolutely must be replaced. On the other hand, you are planning on consolidating material handling operations at a single facility in four years. Paying extra for a new system that will last ten years simply makes no sense. Renewed is the obvious choice.
On the other hand, it's not always an either/or question. Frequently, some combination of new,
On the other hand, it's not always an either/or question. Frequently, some combination of new,
.
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
renewed and even used equipment makes the most economic sense. For example, you may wish to take advantage of recent developments in control systems. You may want the newest, quietest and fastest-rated conveyors for your high traffic, populated areas. Buy new in these cases. Renewed, on the other hand, may be the best answer for the bulk of your conve
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
yor component. Used or conventional reconditioned equipment may be adequate for all or part of your shelving requirements.
The point is that you should examine all of your options, realizing that complex systems may benefit from a combination of those options, and then make the best choices to suit your requirements, your budget and your future plans
The point is that you should examine all of your options, realizing that complex systems may benefit from a combination of those options, and then make the best choices to suit your requirements, your budget and your future plans
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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