Advice You - Business

Two of our recent clients, one construction company with over $100 million in revenue and exceptional personn

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

el, training, and controls in force, and another with under $2 million in revenue without any controls, had 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

he same problem that so many of our clients face…lost profits from lack of controls of material deliveries in

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

the field.

Our larger client builds homes valued over $5 million and sells them at cost plus a profit perce

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

tage. The smaller client builds residential renovations and decks at a fixed price. In both cases, we found t

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

Combination pro

hat their materials were being delivered to their job site without being checked in by their field superinten

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

dent.

The result of that mistake was that the larger builder lost $80,000 because their client rejected an i

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

nvoice where the costs for mill work and lumber were $80,000 over budget. Was the material stolen? Was it eve

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

delivered?

We discovered that the materials were never used in the construction of the home!

The smaller c

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

ompany had material costs averaging 10-15% over budget. The materials were dropped off at the job site withou

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

t anyone checking them and the materials were often short and spot purchased in the field.

Our one day analy

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

Following aspects would a

sis of “jobs” showed that the supplier was short delivering, back ordering material and billing the client fo

dd to the challenges in developing combination products:

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

the full order, while our client purchased the backordered material and then paid for the material not deliv

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

ered!

The Burruano Group instituted one week of “delivery testing” in which the field supervisor received ma

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

terials and checked them against the PO.

We discovered hundreds of dollars of material erroneously billed by

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 building materials distributor to our client. In addition, their labor overruns were made even higher du

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

Professional from academic institutions, pharmaceutical industries, health care indust

to their employees finding it necessary to take the time to locate, pick up and deliver the shorted material

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

!

To avoid this loss of dollars, provide your field superintendents with a report of materials to be deliver

.

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

ed, copies of the purchase orders and an instruction to check the materials delivered against the report and

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

Companies that provide selfless information through particip

PO.

Follow this procedure, and you’ll find thousands of lost dollars in material deliveries!

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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Advice You - Construction Company Profits - Save Tens-of-Thousands of Dollars INSTANTLY

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