Advice You - Business

If you are the unit manager or finance controller or unit nurse in charge of the endoscopy centre, and your endoscope has been identified with damage

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

s,what are your alternatives for repairing it? Where do you send it to for repairs?What is your most important consideration in undertaking repairs t

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

Examples of combination products may in

your endoscopic equipment?

The endoscopist spends his time on the technical work involving the endoscopy and its various areas of work, while the f

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

nance controller of a health center or hospital holds the purse strings in allocating funds to repair equipment. It is very important that both the e

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

doscopist and the financial controller take correlated action to get the endoscope repaired and functioning in excellent condition at all times in th

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

Combination pro

interest of patient and clinician safety, and of establishing optimal efficiency, and in the savings of costs.

What then are the centers of repair

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

nd maintenance available for endoscopes?

Endoscopes can be repaired by sending them back to the Original Equipment Manufacturers (OEM) who provide r

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

epairs on all their original equipment. For endoscopes, the market in America has been dominated by at least three big OEMs, namely Olympus America I

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

c., Pentax Precision Instrument Corp and Fujinon Inc. For many years, OEMs consider themselves to be the only authorized entity to perform repair and

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

refurbishment of their endoscopes, using specific proprietary parts, adhesives, lubricants, specifications, and repair manuals.

OEMs must comply wit

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

the FDA’s Quality System Regulations (QSR).The repair and refurbishment process is subject to regular FDA audits and must comply with Medical Device

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

Following aspects would a

Reporting (MDR) requirements.

In recent years, there have been newer Third Party Repair companies called Independent Service Organisations(ISO).

So

dd to the challenges in developing combination products:

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

e ISO's do not work independently by themselves but are aligned to the original OEMs' and so become authorized ISO service partners.

Some of these O

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

Ms', notably Pentax and Fujinon provide their authorized ISO service partners with access to proprietary parts, adhesives, training, and repair manua

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

ls. In contrast, independent ISO's develop their spares and parts through reverse engineering to make them compatible to the original equipment.

The

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

complexity of the repair will determine the cost of repair of the endoscope. So the first step in locating a repair service center is to know whether

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

Professional from academic institutions, pharmaceutical industries, health care indust

your repair work is a minor repair or a major repair.

Negotiated financial arrangements with repair service centers may be set around fee-for-servic

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

, cost-per-procedure and capitated service contracts, with the ISOs competing on cost and convenience, with some providing on-site endoscope replacem

.

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

nt during repair.

Irrespective of whether you decide to have the endoscope repaired by the OEM, or a OEM authorized-ISO or a third party ISO, patien

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

Companies that provide selfless information through particip

safety is of prime consideration and must never be compromised. This is your main factor to consider in sending your endoscopic equipment for repair

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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