Advice You - Business

Often maintenance systems don’t reap the benefits that they promise through no fault of their own. How can you expect a system to improve underlying data? The answer is that

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

you can’t. What you need is to have good data in the system so that it can be accessed, processed and used to provide practical information for the organization.

Let me illus

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

Examples of combination products may in

rate the cost of not having good data with an example. A multi-site manufacturer has four locations, three of which are in fairly close proximity to each other. Each site ha

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

its own autonomous storeroom with inventory parts. At each site, there is a part time catalog manager responsible for all database activity. Because the plant is unionized a

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

d positions often change, the catalog manager may be replaced every few months.

The resulting inventory catalogs reflect this: inconsistent manufacturer naming; missing manufa

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

Combination pro

cturer part numbers; inconsistent use of symbols/abbreviations; spelling mistakes; incomplete descriptions and; duplicate items. System word searches are next to impossible an

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

finding a part is a frustrating, challenging, usually unsuccessful experience.

Maintenance workers at all locations had long lost faith in stores; each kept a stash of parts

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

idden somewhere for his own use. To plan for a repair job, they would attempt to find parts through the system, but if unable to locate what they needed, they would abandon th

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

search and just order the part directly; in the case of an emergency, they might call another location to request the loan of a part. Inventory value across the company topp

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

ed $80 million.

Recognizing that something had to be done, the company attempted to undertake the data cleaning themselves. They established a team of nineteen internal peopl

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

comprised of maintenance workers (Electrical, Mechanical, Instrumentation & Pipe Fitters) from all four sites as well as two support people and one Inventory Specialist.

Afte

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

Following aspects would a

more than a year of effort, and with only half the database cleaned, they decided to engage outside data cleaning experts to revitalize the effort. Systematically, the data f

dd to the challenges in developing combination products:

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

om each site was cleaned. In conjunction with maintenance workers from all sites, a common layout for item descriptions with acceptable noun/modifier pairs was developed; the

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

order of attributes was negotiated to satisfy all locations; terminology, symbols, abbreviations and industry nomenclature were agreed upon. It took six months to rework the e

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

tire database.

Having good data brings with it measurable rewards. Duplicates within sites were revealed to be in the 10% range. Common items across sites were identified in

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

the 25% range. Merging the three regional stores into a central warehouse reduced overall stocking levels and allowed sites to share common critical spares. It also freed up

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

Professional from academic institutions, pharmaceutical industries, health care indust

illions in cash savings.

Item searches successfully revealed part information that maintenance workers could count on. As confidence in the central stores grew, additional st

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

ock from private caches was repatriated, further adding to the savings realized. Overall, across the company, inventory was reduced by more than 20%.

The data cleansing effor

.

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

clearly paid for itself several times over. It also became the impetus for other corporate initiatives. The company went on to improve its item-equipment links to further e

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

Companies that provide selfless information through particip

hance the maintenance system. In addition, it consolidated items along product lines and reduced its supplier base for volume discounts.

Clearly good data yields good results

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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Do you sometimes wonder what's the point of setting intentions? Some solo-preneurs set goals and intentions with joy- but others sabotage their business success by subconsciously waiting for their intentions to bomb. Which is it for you?

Your company’s organizational strategy is centred around the development and communication of your Organization Chart. The Organization Chart takes the form of a graphical representation of the positions in your company.

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Advice You - A Case for Data Scrubbing

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