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In part 1 of Dissecting A Smart Battery I mentioned that smart batteries have contained within them specialized hardware that when working in concert provides the power

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

necessary to run a device such as a PDA, digital camera, or ipod player. Continuing the dissection of a smart battery this article of the series will look at the smart b

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

Examples of combination products may in

attery’s fuse, charge and discharge FETs , the cell pack, and the sense resistor (RSENSE) to discover what role they each play within the smart battery.

Before we begin

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

let’s just recap some of the specialized hardware within the smart battery:

the connector
the fuse
the charge and discharge FETs

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

li>the cell pack

the sense resistor (RSENSE)

the primary and secondary protection ICs

the fuel-gauge IC

the thermistor

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

Combination pro

the pc board

the EEPROM

the SMBus

The Smart Battery Fuse

When we discuss fuses in relation to electronics we are speaking direc

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

tly of a fusible link that is responsible for protecting the device from over current. Fusible links have a metal wire that melts when heated to a predetermined electric

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

current rating. When melted the electrical circuit is opened and thereby protecting the circuit from an over-current condition. The obvious concern here is the selectio

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

n of the fuse – an improperly selected fuse will not protect from over-current conditions and the result will be a fire or damage due to a short circuits.

In a smart ba

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

ttery a typical fuse has three-terminal components that limit current flow based on the temperature, current, and or power across the heating wire. Besides temperature r

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

atings other important factors when selecting the proper fuse to work with each smart battery is hold current, trip current, maximum battery voltage, and fuse size.

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

Following aspects would a

The Smart Battery’s FET (field effect transistor)

Smart batteries must have a series FET (field effect transistor) switch to open and protect the battery’s cells. A

dd to the challenges in developing combination products:

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

FET is a transistor that uses an electric field to control the conductivity of a particular 'channel' in a semiconductor material. FETs at times are used as voltage-con

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

trolled resistors. As such field effect transistors are chosen based upon their designed ability to dissipate on demand power.

The Smart Battery’s Cell Pack

The

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

battery cell can be thought of as the holding area of the battery’s chemical. The battery cell pack is critical to the overall capability of the smart battery. Cell pac

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

ks have to be designed and integrated based upon the vitals of the battery including chemistry type (Li-ion, Li-po, NICD, NIMH, etc.) cycle life, storage-capacity loss,

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

Professional from academic institutions, pharmaceutical industries, health care indust

shelf life, impedance, capacity at different rates of discharge and temperature, and mechanical and environmental requirements. It is critical to say the least.

The

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

Smart Battery’s Sense Resistor

The final specialized hardware I want to review in this article is the sense resistor (RSENSE). In electronics, sense, is generally r

.

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

eferred to the task of producing the correct voltage. Current not temperered will cause damage so sense resistors need to be integrated in order to control power and tem

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

Companies that provide selfless information through particip

perature.

In my next article on the dissection of a smart battery I will cover secondary protection ICs, the fuel-gauge IC, the thermistor, the pc board, and the EEPROM

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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