Advice You - Business

Friction is the force that opposes the relative motion or tendency toward such motion of two surfaces in contact. It is not a fundamenta

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

l force, as it is made up of electromagnetic forces between atoms. When contacting surfaces move relative to each other, the friction be

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

Examples of combination products may in

ween the two objects converts kinetic energy into thermal energy, or heat.

The mathematical theory behind the Spring Clutch was develop

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

ed by C.F Wiebusch in 1939. Although he analyzed the action between two cylinders placed end to end, rotating on a common axis and torsi

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

nally coupled by the friction between the cylinders and a coil spring fitted over the cylinders, the same analysis can be applied to the

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

Combination pro

wrap-around spring band technology.

The original clutches can be found in the old telephone-dial. Such mechanisms allow the dial to be

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

wound up without dragging the governor and to couple the governor to the systems with a negligible backlash for motion in the pulsing di

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

ection.

Clearly if the driving drum be rotated in the direction to wind up the spring and decrease the diameter, the spring will grip t

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

he cylinders and be capable of exerting more torque than it would in the direction of rotation which to unwind the spring.

C.F Wiebusch

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

developed the equations which permit the calculations of these two torque values in terms of the physical dimensions and the material co

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

stants when no torque is applied.

Hanaya adopted the wrap spring clutch over the other technologies because of its reliability in terms

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

Following aspects would a

of consistency of torque over the life of the hinge and its durability. When designing you device, use the following list of features

dd to the challenges in developing combination products:

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

to better find a suitable hinge for your application:

• Torque Requirement: Not only should you use our torque calculator but also feel

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

free to contact Hanaya Inc for free samples.
• Footprint: The smaller the envelop, the more flexibility in the design. Hanaya’s en

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

ineering department can help you find the appropriate model or can design a custom hinge at no cost.
• Life Requirement: Determine

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

he expected life of your application in terms of the number of cycles you expect the hinge to be opened and closed over the life of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

product.
• Consistent Torque Over Life: This is a key for reliable performance of the hinge over the life of the product. Quality

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

inges will meet your torque specifications over the entire life of your application.
• Dynamic and Static Torque: Both should be a

.

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

s close in value as possible. Hanaya offers the closest ratio of all the competitors, almost 1 to1. This will keep the spring back to a

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

Companies that provide selfless information through particip

inimum.
• Free Play: A precision manufacturing will eliminate free play. • Environmental: Hanaya friction hinges are RoHS complian

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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Would it be beneficial to you, the employer to be able to see and understand not only the negatives but also the positives in your job applicants without depending upon answers to questions? It can be done.

People who do not keep little commitments don’t keep big ones either. Winning, profitable companies constantly inspire customer confidence by their actions, and always conduct business in a trustworthy manner. They keep their word. Commitments that are kept create repeat customers, and repeat customers create profit.

Customer service and courtesy always go hand in hand. Customer service is not customer service if it is not courteous. Courtesy is usually defined as politeness originating from kindness and exercised habitually.

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