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FUSE AE No.1213 MICREL Ltd

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FUSE Demonstrator Document

Application Experiment No. 1213 by MICREL Ltd.

ASIC Based Infusion Pump for Medical Applications

TTN: INTRACOM S.A.

January 1999

AbstractMicrel Medical Devices Ltd. designs and manufactures portable infusion pumps for medicaluse since 1981. The company’s current product range consists of both syringe driving pumpsand peristaltic ones. They are used in pain control, cancer chemotherapy, antibiotic infusions,etc. These products have to be low powered (battery power supply) and at the same timeextremely safe from any possible hazard, that is called a first fault. A third constraint is the needfor small size (portable devices). Prior to FUSE project, standard CMOS logic in SMDpackages was used in one actual product line, and dual microprocessor safe architecture wasused in a second line. They both had limitations, the first because of lack of features, the secondin power consumption and size. The objective of this FUSE Application Experiment (AE) wasto develop an ASIC for the syringe type infusion pump, in order to perform all the necessarycontrol and fault handling needed for a correct operation of the pump, while at the same timeproduce a compact low power portable device. This AE had offered MICREL the basic know-how into the appropriate CAD tools and ASIC design methodology based on VHDLapproach, that will drive the company’s future products. A new line is being developed with theASIC built, with great International sales potential, i.e. return on investment. The paybackperiod is estimated to be two years while the lifetime of the product before renovation will bemore than 10 years. The ROI over the lifetime of the product is estimated to be at least 10. ThisAE assisted the company to attract as marketing partner ALARIS, the biggest manufacturer ofinfusion pumps in the world. ALARIS is now marketing MICREL’s pumps under its ownname. The cost of the AE was 91 KECUs and it was completed in 21 months. MICREL willcontinue next ASIC steps for the upgrade of their complete product range based on its ownfunding.

Target audience concerns companies which produce safety critical products that have to beimproved in order to become safer and stay competitive in the market. Special emphasis shouldbe given to companies specialising in medical and surgical equipment as well as to companiesspecialising in instruments and appliances for measuring, checking and testing.

1. Company name and AddressMicrel Medical Devices Ltd.Ithakis 4Pallini 15344Athens Greecetel. +30 1 6032334


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fax. +30 1 6032335Email: [email protected]

Contact person: Mr. Alexandre Tsoukalis

2. Company Size

MICREL has 20 employees in all, 4 engineers, 7 electronics bachelor degree, withexperience in hardware, software, VHDL (not yet proficient), safety and low powertopologies, ISO 9001 quality procedures, sensor development, implantable devicesinteraction with live tissue. An implantable pressure sensor has already beendeveloped under ESPRIT funding.

The company has ISO9001 and CE mark on all of its products from SGS YarsleyU.K., and FDA in USA, Homologation in France type approvals, and a BritishStandard test for IEC 601-1 type approval has just been given to us. Company’sturnover is about 1 million ECUs.

3. Company business description

MICREL is founded in 1980. Since then, is heavily searching marketing potentialof all new product ideas, so it is marketing oriented, it searches all relevantinformation in patents and publications, and then in co-operation with co-operatingUniversities, it prospects new technology. MICREL was chosen from IMPACT IIprogram as one of the two industrial examples for exceptional use of ElectronicInformation and Information Technology in the design of its products. A video hasbeen made for this, under the aegis of the European Commission. MICREL ownsthree European patents. It designs and produces two product lines, one of syringepumps and one of peristaltic ones. They are used in pain control, cancerchemotherapy, antibiotic infusions, etc. In addition to infusion pumps andtherapeutic devices, the company had designed and marketed in the past laboratoryequipment and specifically a lab line with a UV - VIS spectrophotometer anddifferential cell counter.

In 1997, MICREL signed a distribution agreement with Alaris, the biggest

manufacturer of infusion pumps world-wide, for distribution of MICREL’s pumpsunder the Alaris brand name world-wide. So, concerning the client list it should bementioned that currently MICREL keeps some countries with its own distributors.Apart from Alaris other major clients of our company are the CyprusPharmaceutical Organization which is responsible for distribution of medical andpharmaceutical products in the Cyprus region and also Al Badr the biggest pumpdistributor in Egypt .

The prior syringe pump MICROPUMP line uses standard CMOS ICs in SMD

package, and has two BCD switches for Rate adjustment. This pump has beenreplaced with one having a custom built LCD display and buttons for theadjustment of the Rate (ml/HR), using the ASIC built under this FUSE AE.Another product is a peristaltic pump RYTHMIC, that uses a plastic reservoir forthe drug, all contained in a small housing. This pump has two microprocessors in a


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safe topology, and custom LCD display. All products are portable, for both HomeCare and Hospital use.

There are few manufacturers of this type of pumps in the world, while market is

increasing rapidly, by almost 30% annually. It should be mentioned also thatconsumables are marketed. Specifically our pump generates sales of its consumablebag and infusion line, which as turnover is quite considerable. In the coming yearsit is foreseen that will exceed sales of our RYTHMIC pumps.

Fig. 1 MICROPUMP MP-20

Company’s turnover split among syringe type pump, peristaltic pump andconsumables is given in the next table.

Before ASIC After ASIC

(estimated)

Syringe type pump 10% 30%

Peristaltic pump 60% 40%

Consumable 30% 30%

Concerning product development it should be mentioned that the products are designed

with concurrent engineering methodology, where in design meetings, key people


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from all departments of the company agree on specifications, features and then onserviceability of the products. Safety of the product is a major concern duringdesign, so that it is built in. A pump may cause the death of a patient if a faulthappens due to ASIC’s misfunctioning. So, the ASIC has built in redundant pathsand voting points, which alarm if a single fault is located in any path. All this safetymethodology greatly lengthens design time, sometimes by a factor of five. As aresult, time to market is delayed as careful extensive testing of each componentstructure must be done before release to the market.

Fig.2 Rythmic Portable Linear Peristaltic Pump The safety structure is designed by the company which also carries out the system

assembly and various validation tests. The industrial design /plastic packaging areoutsourced as well as the ASIC design/fabrication and PCB manufacturing.

4. Company markets and competitive position at start of the AE

The potential market size for the simpler form of the pump (which due to the ASICgot lower cost and higher safety) in Thalassaemia decease, is about 20000 unitsper year and the growth rate is 30%. This market sector used to be limited becauseit exists in poor countries, where the pump cost as well as blood for transfusion anddrug cost are prohibitive. This situation is starting to change, in far East. Efforts ofWorld Health Organisation and Ciba Geigy (Novartis now) plus theindustrialisation in the area, are overcoming slowly the problems. In the developedcountries there are only two other manufacturers namely Graseby of UK (a bigcompany with a well established base in the market for years with full line ofportable and stationary pumps) and Medis (a small Italian manufacturer having asmall syringe driver and a new specialised pump for insulin infusions) plus ourcompany with its increasing market share up to 50%.


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ALARIS (alarismed.com & Nasdaq ALRS) is the unification of the American infusionpump inventors IVAC, and the equally big IMED. Alaris also bought up theBritish infusion pump manufacturer Welmed and produces syringe pumps in U.K.The unified company is No 1 or 2 in 11 European countries, No 1 in the US and inthe total world market. MICREL has an exclusive distribution agreement withALARIS for its existing and forthcoming infusion pumps and other therapeuticdevices. The pumps are sold world-wide. Previous year (1998), in September theyofficially launched in the world markets our RYTHMIC pump under the ALARISname. The RYTHMIC pump has got CE Mark, and BSI certification according toIEC 601-1 safety standard. Our existing syringe driver MICROPUMP is to belaunched by the spring of 1999, and a high increase of our market share is expectedto follow. The ASIC based syringe pump will follow.

The competition has models that since long time have the same as our pumps

characteristics, with old fashioned BCD switches. One competitor use an oldASIC, but still it combines it with BCD switches, single unsafe clock etc. BCDswitches have a safety problem, as any short or open contact may cause a differentrate of infusion than the one that is selected. This is a major problem in CE markingof such devices. Our ASIC based improved products, have no major competitionregarding safety. It should be pointed out that such a pump may cause the death of apatient if delivering drug at unspecified rate! So it is important to prove the safety todoctors, which is a simple matter with the new ASIC based pump, thanks to thisFUSE AE.

5. Product to be improved and its industrial sectors

The product to be improved concerns MICREL’s portable infusion syringe pump(a device that pushes a syringe to the patient slowly for hours or days and itssyringe is connected to the patient with a catheter) used for the continuous andaccurate infusion of various drugs in hospital or home care treatment. We have twosuch pump types, MP-11 with standard rate of 1ml/HR, for thalassaemia andadjustable rate model MP-20 from 0.1 to 9.9 ml/HR for cancer chemotherapy,heparin infusions, neonatal infusions etc.

Clock + Counter Frequency Rate Multipliers Motor safety Motor

Feedback

BCDSwitches

Fig.3 MP-20 Block Diagram

Prior to FUSE, the technology that was used was standard CMOS circuits, in a safetopology. In this model, two BCD switches were adjusted with a screw driver, toadjust the rate. The above block diagram shows a clock generator and subsequentdown counters, usually a CD4060 circuit was used, the BCD switches that adjusted


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the Rate, and BCD input circuits such as Frequency rate multipliers or downcounters such as CD 4527 or MC40102, depending of the rate expression infrequency divisions or in time divisions (mm/HR or min/mm).

Following the Frequency Rate Multiplier module was the Motor Safety Modulewhich was checking if the motor completed a step cycle. So, after the downcounting, a motor pulse was generated, and time was measured for motor motionstep feedback response, after failure of which, an alarm was generated. Also a selftest of the module was done at start-up, looking for a dummy alarm pulse whilesecondary safety transistor was short circuited; following this test, a beep was heardand pump started infusing. In all this circuit, there were no redundant paths and anyclock or counter failure could damage the health of a patient.

The reason to innovate is to have a pump that is safer and also to have a modern userinterface, avoiding to read errors, all in a small portable size and low powerconsumption package, not possible with microprocessors. The low cost productMP-11 also benefits from cost reductions.

6. Description of the technical product improvements

An improved syringe pump with totally new concept was designed thanks to theFUSE project. The product was improved by a number of significant changes asdiscussed before. Specifically an ASIC was developed to increase the deviceperformance reliability/patient’s safety adding also low power consumption andportability features to the new product. It should be emphasised that the ASIC is apure digital one and all analogue processing ( e.g. battery level detector and triplefrequency generators) is performed externally. In the following paragraphs wediscuss in more details the new product as well as the ASIC that was developed.

In a typical syringe pump you adjust the internal clocks from a constant main clockafter getting the information of the syringe type (sometimes by measuring syringediameter) and calculating the rate from the syringe parameters. In our case we foundthat we can make a clock that can be changed according to the syringe type. Also,pressure P (for an occlusion alarm) inside the syringe is measured by a Force sensorat the end of the screw that makes the syringe piston advance, but since P=F/S wemay have syringe diameter (S) information from the frequency!

By the way we should mention that Volume Infused information that will be placedon a new design with a separate LCD, needs machine constant informationdependent also from syringe size (again given by frequency). So we may calculateall these parameters by simply counting internally output pulses in a constant timeframe. Besides looking like microprocessor driven from its User Interface, ourupgraded system can perform complicated functions at an extreme simplicitywithout any background calculations.

An external LCD driver was added to the system serially connected to the ASICwith 3 Buttons for UP, DOWN, ENTER functions. The UP or DOWN buttons actfirst slowly, then faster rolling up or down the set rate. ENTER is needed forconfirmation otherwise the old rate remains.


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Fig. 4b: Custom LCD and Buttons

Two outputs for safety turn ON-OFF the motor. They are both tested for failure,one shuts OFF motor if the other fails. There are three clocks: one f at 32768 Hz forinternal ASIC and timing (subset-min) clock, two for infusion; these are checkedinternally if they have low difference. A safety alarm activated in case of drift.

Concerning the digital ASIC structure, we should mention that inside the ASICthere is an internal RAM for data storage along with the central unit and threeexternal clocks as shown in fig. 4a. The ASIC has two separate modes of operationthat are selected after examining the level of two special inputs.

Central Unit withRAM and threeexternal clocks

Keyboard Controller& Interface Unit Watchdog

Unit

Test MotorCircuitry

Unit

MotorController

LCDController

BuzzerControl

Unit

DigitalBattery Test

HallSensor

MotorDriver

LCD Driver

External AnalogueBattery Test circuit

Fig. 4a: Block diagram of the ASIC

ml/h

Up

DownEnter


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The first mode of operation, concerns the device with the buttons that are used toinsert the dosage rate of the device and the display and the other concerns operationwith a fixed dosage rate. During the transition of the device to On state, the chipchecks the display and the ability of the motor driving circuit to stop the infusion. AtON state, the chip uses one clock 32KHz for its internal function and two otherclocks in the central unit to redundantly generate the dosage rate that must beprovided based on the external settings and saved again redundantly at the internalRAM which is battery backed up at OFF state.

A 5% deviation of the clocks is permitted by the Central Unit, at the voting point -end of the two redundant paths, which uses one rate generator for infusion and thesecond for check. Frequency is capital for accuracy of dose, as internally whatever isdone is a multiplication f * Rate; Each Rate is taken from respective RAM positionand f from respective clock. The user Rate settings can be set at any time duringoperation, processed by the Keyboard Controller and Central Unit. The 32KHzclock is also checked by the Central Unit, using one of the two Rate clocks. Sosingle fault condition safety is met.

After the dosage rate is calculated, the Central Unit outputs a pulse chain to theMotor controller Unit which drives the motor of the pump that infuses themedicine and at the same time it monitors the dose given at any time to avoidoverdose or underdose. The frequency pulse chain must correspond to a Hall effectsensor pulse chain.

The Motor Controller Unit checks if safety transistors work perfectly and if a singleHall pulse corresponds to any Rate pulse within 5 sec. Failure of which show theinability of the infusion driver to move. Each type of pump is characterised by thenumber of Hall pulses needed for 1ml infusion. This is the machine constant.Frequency is factory adjusted to make Rate pulse train correspond to the inherentmachine dependent hall train / ml train. So this ASIC is a universal infusioncontroller for any pump type! Also, the duplicated safety inputs are examinedcontinuously to verify that they have the same voltage level. At last, audio signalsand standard messages on the LCD display are issued to inform the user on someinternal normal or error state.

An adder (instead of a PLL) is the main frequency synthesiser that adds the ratenumber at each clock. All subsequent stages are double, and checks are implanted tovote so if there is difference, alarm is being activated.

There is also a watchdog circuit that checks if the basic 32KHz clock is present,using one of the two other clocks and then it checks (using the 32KHz clock) if themotor hall arrives in less than 5 sec after Motor is ON, so in case of absence ofeither sends an Alarm signal. The user interface, lets the user time to change rate atstart up, and after this delay, it starts infusion at rate set. 000 rate alarms, so in caseof lost of data (power) the user is warned.

The circuit is turned ON and OFF by pressing two buttons simultaneously.Then the clock stops, and power remains for data retention. This is measured to 15Ì∞ at OFF. The simpler pumps that we have actually MICROPUMP MP-20,consume 200 Ì∞. On the contrary our Rythmic pump (where dual microprocessorcontrol needed for safety) consumes 1m∞ and we have to notice that it is one of thelowest power consumption pumps in the world! As it is evident the ASIC (as an


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alternative technology to standard ICs and microprocessors) is much better inlow power/portable and safety critical applications.

7. Choices and rationale for the selected technologies, tools and methodologies

The circuit has been implemented in an ASIC using the AMS 0.8 Ìm CMOStechnology and fabricated through the EUROPRACTICE MPW runs for low costprototyping. The choice of the ASIC (against microprocessor/FPGA/MCMsolutions) was made based on the low power/portable requirements of the device inconjuction with the demand for its increased safety and low cost.

Specifically concerning the microprocessor-based solution, as stated in the previousparagraphs the company’s former infusion pump (which was based on standard ICsand dual microprocessors) consumed 1 mA, compared to 200 Ì∞ of the new ASIC-based version while the volume and size of the device were much higher. Additionalreasons such as the high volume production forecast, the extra IC peripherals, theincreased PCB area and the higher testing expenses, ranked the microcontroller-based solution in second place.

The MCM solution was not justified taking into account the cost/mass productionfigures. Also the choice of the FPGA implementation had certain drawbackscompared to the ASIC solution. Implementing a design into FPGA technology thedevice that is required have to had a number of gates and pins much higher thannecessary, and the package dimensions are too large. This happens as FPGAvendors count gates in different ways. These factors make the device impractical asthe size and the power consumption are increased (many times dramatically). Alsohigh gate and pin count FPGA devices have higher cost. For the particular designthat was mapped on an FPGA, a table is presented below comparing the ASIC vsFPGA technology.

PowerConsumpt.

( mw)

Numberof

usableGates

PackageDimensions

(cm)

Numberof Pins

Costper

Unitfor

1000pcs

ASIC 0.8 7.103 1.6x1.6 44 $ 14

ALTERAFLEX

EPF81500

1.0on standby

mode

16.000 3.5x3.5 240 $35

The ASIC was designed based on the VHDL approach using MENTOR GraphicsCAD tools. It should be mentioned that initially the simulation strategy was tosimulate the whole system with VHDL. However due to the complexity and largedispersion of the clock signals (8 clocks ranging between 32 KHz down to 0.5 Hz)was prohibiting for full scale simulation. Then a segment by segment simulationapproach for a limited number of the chip units was tried. The problem was that,even though good simulation results were achieved separately, when the inter-


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segment simulation was tried the wide range of different clocks brought in the samedifficulties. Also the circuit is heavily sequential logic, so simulation which is easyfor combinatorial logic, is difficult to make. Furthermore the lack of goodsimulation models in VHDL for the Hall-effect sensor imposed additionalproblems. So, an emulation strategy was followed.

Apart from the simulation in some segments of the design, it was ported on anFPGA (ALTERA EPF81500AGC280-4) and was tested (after PCBimplementation) under real conditions. The results were really enthusiastic andproved the correctness and the functionality of the design. So next step was to go onthe migration from the FPGA to ASIC. Interesting to mention the reduction of thegate count when divert from FPGA to ASIC (14500 gates vs 7500 gates). Thefabricated chips were tested on two PCBs that were developed.

The new product is to be fabricated at several thousands pieces (around 20,000)which also justifies initial NRE costs for the ASIC .

Besides technical reasons, the use of FPGA for the design had another reasonrelated to business arguments. FPGA is a continuously developed technology thatis used in many applications of pure digital designs. It was a first touch with thistechnology that help us to understand its advantages and disadvantages comparingwith ASIC CMOS standard cell technology. Useful conclusions were extracted andwe keep them in our minds so as to use FPGA technology in new products of ourcompany if it is necessary taking into account that their prices will drop in the nearfuture for mass production achieving also better technical characteristics (size,power consumption etc).

8. Expertise and experience in microelectronics of the company and staffallocated to the project

The company had management experience on distributed design, as the productRythmic Pump, has been developed by internal software and hardware engineers,mechanical engineers, while the biggest part of industrial design and mechanicalimplementation-drawings has been done by third parties in close co-operation withthe internal engineering team. The company represented Greece in EuropeanCommunity Design Prize ’94, because of this ASIC development within FUSEproject.

The personnel allocated to the project is well trained in hardware, (mainlycommercial ICs, microprocessors, PCBs) software, safety and low powerintegration, now with FUSE has gained experience in expanding its technicalsolutions closer to marketing needs. We should emphasise that prior to FUSEthere was no major experience in microelectronics in the company. The biggestchange in the company is the new view we now have targeting these technicalsolutions to the marketing needs.

9. Workplan and rationale

In the following paragraphs we present the workplan that was followed for thisproject. It should be mentioned that the project had to be extended from 10 months


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to 21 months due to changes in specifications and problems faced with the ASICfunctionality as well as the extended system testing required.

Specifically as mentioned in previous paragraphs the design approach was first tosimulate the whole design with VHDL. However due to large dispersion of clocks(8 clocks ranging between 32 KHz down to 0.5 Hz) an emulation stategy wasfollowed and the design was first ported to an FPGA. After the working FPGAdesign was demonstrated to the company, we turned up, we were surprised andgot enthousiastic by the simplicity and functionality of the design, so we modifiedthe initial specifications and we asked for new functions and safety structures to beimplemented (so as the same chip could be used not only in our syringe pumpsbut also in our peristaltic pumps) and make sure that the product will be acommercial success. Then the FPGA implementing the specificationsmodifications was transferred to an ASIC and send to EUROPRACTICE forfabrication. After 3-month period we received the ASIC prototypes. However theASIC prototypes of the first MPW run could not work all the time as power ONresets were not placed. So we fixed the errors and send the design for re-fabrication through EUROPRACTICE and then we received the final prototypeswhich were working properly. Thus the final duration of the project reached 21months.

MICREL also developed the plastic mould that will hold the push buttons andcompress the elastomeric zebra strip of the LCD display and hold the display inplace within pump’s cavity. We also designed and ordered at Varitronix in HongKong the custom LCD display of the pump. The second run ASIC was receivedin end March 98’ (by the end of this FUSE project) and was working.

The work carried out was divided in the following 5 workpackages:

WP1: ManagementActivities included project management, dissemination of results andmeetings/reporting to the TTN. It should be mentioned that MICREL’srepresentatives were participated in the specific workshops for dissemination ofresults/experience to potential FUs and attended specific seminars for projectmanagement organised by the local TTN so they were able to manage the projectallocating the necessary resources and finding the appropriate subcontractors andASIC foundries for low cost prototyping.

Partners involvementThis task was carried out by MICREL’s personnel without any involvement of thesubcontractor.

WP2: SpecificationsWork for this task included the definition of the system fucntional specifications aswell as the definition of the ASIC specifications including its architecture.

Partners involvementFunctional system specifications were extracted by MICREL while ASIC’sspecifications were defined by University of Patras. Our engineers were co-operatedwith the subcontractor so as to benefit from know-how transfer.


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WP3: Training

In addition to the management training seminars which organised by the local TTN,the engineers of the company were trained (under the guidance of subcontractors) inthe use of CAD tools, the use of FPGA development tools, the VHDL-based designmethodology for the ASIC development as well as in the testing procedurefollowed.

Partners involvement Our subcontractor University of Patras was the trainer and MICREL the trainee.

WP4: DesignActivities included high level system design by MICREL and ASIC design underthe assistance and technical support of the subcontractor. As mentioned before thedesign was first implemented in an FPGA (an emulation procedure followed) andthen ported to an ASIC. The design has been interrupted and modified by MICRELseveral times as new findings came up, changing specs for making it universal andaccording to standards for such a biomedical product. So after the FPGA design twoMPW runs for ASIC were necessary until we have working prototypes. But alsothe complicated user interface and safety structure needed creative work than simpledevelopment. So the actual effort for this task was higher than the one originallyplanned.

Partners involvement System level design carried out by MICREL, while ASIC design/ simulation andsending out for fabrication by the subcontractor University of Patras.

WP5: EvaluationThe EUROPRACTICE MPW runs (AMS technology CMOS 0.8 micron), werechosen for low cost ASIC prototyping. Work for this task included also the ASICtesting, the board development, system components integration and extensivetesting. It should be mentioned that to validate the design first we tested it in anFPGA since full simulation could not be done as mentioned before. Then we portedthe FPGA to ASIC and after its fabrication we tested the ASIC prototypes whichshowed a problem with the reset of the two parallel modules generating an error thatprohibited the motor activation. It was determined that this error was activated fromthe redundant path of adders that were used to calculate how frequently the motormagnetic drum of the infusion pump will turn, due to the omission of the resetsignals to these units. So another MPW run was necessary and we tested again thenew ASIC prototypes we found them working properly. Due to this extensivetesting procedure more effort required for this task than originally scheduled.

Partners involvement Board preparation an system integration and testing by MICREL while ASICprototype testing was done by Univ. of Patras in co-operation with INTRACOM.

MICREL cost and effort of Application Experiment

Scheduled Labour Actual labour


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Labour(person days)

Cost (kECU) (person days)

Workpackage 1, Management 18 2,85 76Workpackage 2, Specification 36 5,7 77Workpackage 3, Training 18 2,85 60Workpackage 4, Design 108 17,1 270,5

Workpackage 5, Evaluation 54 8,5 218Totals 234 37 701,5


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OVERVIEW OF PLANNING

Activities Month

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

WP 1

T1: Management

T2: Dissemination

T3: Reporting

WP 2

T1: System specs

T2: ASIC architecture

T3: ASIC specs

WP 3

T1: Management Trainig

T2: Specs training

T3: CAD training

T4: Design training

T5: Evaluation training

WP 4

T1: System design

T2: ASIC design

WP 5

T1: ASIC prototypes

T2: Test set up

T3: ASIC testing

T4: System lab testing

T5: Real life testing

Overview of delays due to MPW runs dead times (for two ASIC Runs)

All independent from foundry delay (ASIC 2nd MPW run) tasks were completed ontime i.e. WP2, WP3 except task 5,.All tasks that had reports on the finished product or tests on it, were extended untilwe received the 2nd run chips i.e. WP1( T1,T3), WP4.All tasks that deal with the final chip or report, were transported to final months i.e.WP1(T2), WP3(T5).Tasks that were duplicated were done twice, every new ASIC run i.e.WP5(T1,T2,T3,T4,T5).


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MICREL Scheduled vs. Actual Task effort in MAN

1.Managmen t2.Specificatio

3.Training

4.Design

5.Evaluation

0

50

100

150

200

250

300

Scheduled

Actual

Scheduled vs. Actual Task duration in MO

1.Managmen t

2.Specificatio

3.Training4.Design

5.Evaluation

0

5

10

15

20

25

Scheduled

Actual

10. Subcontractor information

Technical training on the use of CAD tools, on ASIC design/testing methodologiesas well as design support for the ASIC development were provided by Universityof Patras while technical consulting on ASIC prototype testing was provided byINTRACOM.


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The choice of subcontractors was done based on their expertise in the relevantfields and their acceptance for the type of the contract we wish to have. Specificallya subcontracting agreement signed between MICREL and University of Patras andbetween MICREL and INTRACOM. These contracts assured also us that IPR-related issues would be kept for MICREL.

The initial specifications were changed by the company after the first FPGAdemonstration, but the modifications were accepted without additional cost by thesubcontractor due to the existed good collaboration. No serious problems werefaced with the subcontractors and the collaboration was a successive one.

A brief profile of our two subcontractors is presented below:

University of Patras (Applied Electronics Laboratory) Applied Electronics Laboratory has long proved research capability in the area ofElectronics/Microelectronics. For a long time, the Laboratory has been involved inthe development of systems based on microprocessors/micro-controllers andmicroelectronics/ASICs. The Lab is very active into designing VLSI chips rangingfrom FPGAs and simple Gate Arrays to advanced mixed A/D ASICs for sensorinterfacing and state of the art high frequency Communication chips. ASIC designis supported by an extended infrastructure. FPGA technology has also been usedin many applications such as image processing and communication systems.FPGAs design is supported by: ALTERAs MAX + PLUSII for PCs andWorkstations, XILINX XACT software.

INTRACOM S.A.INTRACOM S.A. has established since 1993 the Centre of Microelectronics(CEM) within the framework of Special Action in Microelectronics in Greece.CEM is the national industrial VLSI design and Testing centre in Greece and alsoacts as TTN centre for Greece. It promotes R&D activities in the area of VLSIdesign for INTRACOM's needs and simultaneously provides similar services toSmall-Medium- Enterprises (SMEs). CEM's main activities include SystemDesign, VLSI Design, FPGA Design and migration to ASIC, Prototype Testingand System Production. CEM has currently designed over 70 ASICs fortelecommunication applications, image processing and power control applications.In addition is has gained a lot of research experience through its participation toseveral National and EU-funded programmes. Finally training courses ondesign/testing methodologies, fabrication technologies and CAD tools have beenoffered by CEM to various local SMEs.

11. Barriers perceived by the company in the first use of the AE technology As described in previous sections, the biggest barrier in completely using thetechnology available and making an upgrade and competitive product instead of asimple one, was the past history of every one of us that was separating thetechnologies, giving to the hardware the simple work and did in software the bigthing when speed was not a problem. When low power, safety and limited spacecome into play, the above reasonment is hard to implement. For example, to make


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a safe Rythmic pump, the concept of two processors and associated circuitry, plussoftware, had taken almost 6 years, while a pump with one processor wasworking within the first year! This is because the software has become too muchcomplicated with the two processors, everything running as state machine, in amultitasking operating system we built ourselves on a 68705C9 processor. Thenew idea after FUSE experience is to integrate as much as we can in hardware, andlive the rest to the software.

Before the FUSE experience, the certainty we had that hardware is for simple things, orfor big companies, limited even our thinking! This was the real barrier, althoughwe are an innovating company with lots of patented (or not) innovations.

The second barrier was that according to our former experience as in earlymicroprocessor days, there were limited resources available, we needed trainedpeople in microelectronics, expensive CAD tools (already this is no more true) andalso we feared for high cost due to ASIC technology in our products. Specificallythe barrier was that for low production scale, ASICs are not cost effective, and theright FPGAs are not available yet. Even more, PIN count in actual FPGAs isexcessive, making the limited space applications problematic.

Another barrier was that in a local SME scale, industry didn’t know who and at what

cost could subcontract with confidence the work. As a matter of fact company sizewas another barrier if ASICs are involved, so that small companies would havedifficulty to pay for an ASIC the high NRE costs involved; from medium size thisis no more an issue as a product has much other hidden costs of comparativeamount. Again here experience is needed to evaluate the best strategy for acompromise between software and hardware that at the end is really more costeffective than it appears from a quick calculation.

12. Steps taken to overcome the barriers and arrive at an improved product

Contacts with the local TTN’s engineers assisted our company to be aware of theFUSE initiative and the benefits of microelectronics technologies in general.Specifically the workshops organised by the TTN introduced us to the basicmicroelectronics issues and also to the EUROPRACTICE services which werecontributed to overcome the barriers for high cost of ASIC fabrication.Furthermore we co-operated with the TTN so as to prepare a workplan and definethe various tasks in order to carry out the specified work.

We also signed a subcontracting agreement with the University of Patras after a good

collaboration we had with them in previous to FUSE activities. Our subcontractorcontributed in our work to overcome certain technological barriers and to changethe way of our thinking for hardware and software and introduced us to theVHDL-based design flow for an ASIC design development. ASIC technologyknowledge we had before FUSE as described above, was not turning us on, tospecify a product according to the true needs of the market. These specificationswere restricted by technological possibilities, at the state we thought they were. So,only after the close cooperation with our subcontractor and after the first FPGAworking demonstration we had been in depth and professionally involved into theproject .


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During the implementation phase of the AE we faced actual barriers concerning theknowledge of the testing and validation of the device using the ASIC. Afterconsulting the engineers of our subcontractor we decided to follow together withUniversity of Patras an emulation strategy (full simulation prohibited due to largedispersion of clocks included in the ASIC and lack of good simulation models inVHDL for the sensor) and the first PCBs developed hosted an FPGA (withincreased power consumption, area and volume). When basic functional testscompleted successfully we ported the design to an ASIC.

13. Knowledge and experience acquired

Thanks to FUSE we learned the possibilities/features of the new technology as wellas its limits, and we applied that knowledge reshaping all our future products. Weinvested a lot of time and we are still keeping doing it . This process will never stop,maybe the technologies will change, FPGAs will be adequate, but the hardware willplay definitively a central role in our products against software.

The company has bought the ORCAD Express 7.11 & Layout 7.10b package with

VHDL plus simulator possibilities, and two books on Hardware DescriptionLanguages.The engineering staff learned VHDL if not at a proficient level, at least ata level to verify the code received by third party developers. Personnel of thecompany that assisted on the training courses : Kassapakis Stamatis, TzanetosChristos, Tsoukalis Alexandre.

The subcontractor’s experienced personnel provided training to our engineers in all

stages of VLSI design such as specifications analysis, architecture exploration,VHDL development, design simulation, synthesis, layout implementation andFPGA programming.

MICREL engineers had the opportunity to fully observe and participate in whole design

procedure during the experiment execution. The on-job training that was providedby the subcontractor, was very effective and complete referring to all phases of anASIC design process.

Furthermore we should mention that significant know-how and expertise has been

gained at the management level (through the relevant TTN’s seminars) so as to beable to apply microelectronics technology in a product (allocating the necessaryresources, choosing the appropriate subcontractors/foundries etc.) as well as to beable to decide when it is beneficial to employ such technologies.

We are now looking back at an old book we purchased long ago, the Ferranti /Interdesign CMOS “the monochip” with stencils and layouts of its very first gatearrays, since 1981. At that time we evaluated that our pump needed 400 gates, withBCD switches of course! As someone can easily realised the difference is that whatwe thought as “circuit” with our past experience, has nothing to do with the one wedeveloped within FUSE where we used the appropriate design methodology andspecifically the power of HDLs and the relevant CAD tools. So, prior to FUSE wemade a specification more like a “project” and less than a product. When the firsttest based on FPGA was successful, we did not believe in our eyes !


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MICREL also has recently got approval for a new project, ESPRIT Design Clusters,

proposal 28593 CoSafe. This project will design an ASIP that is a safe and lowpower processor together with ASIC part of the pump itself, but more advancedthan the FUSE one, for our peristaltic pump RYTHMIC which has no costproblems as it lies in the upmarket section. This shows that the experience/lessons got by FUSE is proliferating and iscompletely changing our concept thinking of new infusion pumps and implantablesensors that we are involved.

14. Lessons learned

We have the following lessons to give to other interested parties:

• Check carefully the features of the ASIC technology combined with VHDL’spowerful potential and believe us that you can make a product more competitivethan you think thatt can be and leave marketing people enthusiastic.

• Make as early as possible the old good calculations about “to make or to buy” thistechnology, use or not subcontractors for the following up the A.E. projects. Thereare tricks into the code that experience is hard to get.

• Since it is very likely (specially for biomedical products) for the specifications to be

modified during the project, it is better to plan enough time for the subsequentdelays in design/testing phases. Enough time is also advisable so as to fix possibleproblems related to the ASIC functionality.

In our case, we did not really believe the microelectronics technology benefits untilwe saw the first FPGA prototype. We then realised the potential of the technologyand the impact on our total product line. We changed the specifications so that safetyto be increased and the design became expandable to other products with possibleaddition of a microprocessor taking side tasks, not safety critical. Another concern ishow to find possible design bugs, to validate the design and how to make testvectors for the foundry, which will pinpoint any possible manufacturing fault. Incombinatorial systems this is easier than our deeply sequential system.

Concerning what we would do differently if we started the project now, the answeris that we would have planned more time for intermediate ASIC runs and systemtesting, until we achieve the required standards for selling this medical product. Inour case we made also faults in calculating our expenses, but this is minor.

15. Resulting product, its industrialisation and internal replication

We plan to order a third run for this ASIC, after we finalise the Debugging andSafety Validation of the existing one, and evaluate all the marketing possibilities byMICREL and ALARIS, with the working prototypes we build, so that the third run(out of the FUSE project then), will be the final one.

The current ASIC is working, properly in general. In order to produce a userfriendly device we will solve some user interface problems encountered at thecurrent design together with the subcontractor, and we hope that the third run will bethe final one.


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It should be mentioned that the release of such biomedical product to the market isnot a simple procedure. Actually the internal and certification tests are very longsince a failure in the ASIC may cause the patient’s death.

We have no technical problems for the infusion pump itself, as the moulds forplastic components needed and custom LCD are already done by us during theproject. The design was integrated in our Quality System, so a Technical Fileaccording to Medical Device Directive is being done, the product will automaticallyget CE marking after tests on Electromagnetic Compatibility, which normally is noproblem at the clock rates we work.

Time to market for the product is estimated to be at the end of 1999.For product industrialisation, the NRE costs for AMS are 30.500 ECU and for avolume production of 20.000 pieces the estimated cost is 4 ECU per piece. We arewaiting better prices for the increased quantities we plan to order. We had analternative offer of a gate array production at Thesys with 13.850 ECU for NRE and9,8 ECU per piece which is not good for the quantities we expect. In addition to theNRE costs and the FUSE financial contribution of 91,000 ECUs, other costs are17.000 ECUs for patent on the name of MICREL, now in preparation, dealing witha wholly new concept of infusion pump, including the ASIC, but not exclusivelybased on it. We invented a completely new type of pump, in lots of functionsnowadays carried by more complex methods. Our system is a fully transportabledesign, not possible with actual microprocessor technology. The agreements withUniversity of Patras and ALARIS allow and specify this action for patentapplication as such.

The maintenance of the code produced will be carried out by University of Patras,under separate contracts for each change/improvement/variation needed. They willfirst complete and finalize the FUSE specification with a third RUN. An internalVHDL development team is planed for the next two years. As mentionedpreviously, the validation of the design process is a very long one, as a pump maycause the death of a patient if a hidden bug or poor safety design persists. TheNotified Bodies that according to Medical Device Directive give the CE Mark arereluctant or slow to take the risk of a new technology, so several steps have to bedone on this direction. If the FPGA technology becomes preferable (cost effective,smaller size and lower power dissipation) for mass production in the near future, thefinal product could be based on an FPGA because the ASIC that we have alreadydesigned is pure digital.

There are two infusion pumps that will contain the ASIC developed. One startedalready with the above budget, the next will start by the end of the year. Themarketing of the two products is agreed that will be done by Alaris, which is waitingthe output of the design process. Their penetration in 120 countries gives thecertitude of a good success.

Finally we should mention that two other products are to be designed within this andnext year, using microelectronics technologies: one new ASIC and one ASIP willbe produced. For them, we will use the same subcontractor for the ASIC and a newone (but all within University of Patras) for the ASIP. Specifically MICREL hasgiven to the University of Patras the specs of a second ASIC, that will be put into acompletely new pump for the near future, that is based on the main features of the


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one developed within FUSE project, but has some significant add ons. Thisdevelopment will be funded completely by our own capital.

16. Economic impact and improvement in competitive position

The rationale is that as we expect to produce more than 10.000 pumps per year, thechoice of ASIC technology is cost effective.

The economic impact of the A.E. is difficult to be shown, as our company only thisyear started to increase its sales because of the agreement with ALARIS MedicalSystems. And this is because of the success of another new product Rythmic,which pulls up older MICROPUMP sales too.The technology developed is so important that makes another category in thisbusiness by product’s innovating features, and thus allows us to position this withproud and respect within ALARIS organisation, the biggest, older and mostrenown infusion business player in the world.

In the following chart, our sales of the existing technology syringe pumps in theprevious years is shown, the impact of ALARIS sales this year is also shown, andfrom 2000 the new ASIC pumps will greatly contribute to our sales. Theinternational market as described is exploding. The lower line is the old productsales projection, without the ASIC introduction.

0

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1996 1997 1998 1999 2000 2001 2002

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sale

s in

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Fig. 5 Sales of MICROPUMP product

There are two market segments, the low cost simple pump market and the highercost programmable pump one. The higher cost market will be grown because ofsuperiority of the product against competition, until its reaction.

The sales increase with the new line of products leads up to 50 % of the marketshare. The more advanced specifications of the products and the well establishedselling network give the warranty for the realisation of our targets. In the same time


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the new technology will help us to increase our profit by changing the selling priceto cost ratio. Our profits are to be increased by almost 30% due to the technologiesdeveloped. Taking into account a 10-year period as product’s lifetime the estimatedROI is more than 10 while the payback period is estimated at 2 years.

17. Target audience for dissemination throughout Europe

It is expected that the results of the current application experiment can be replicatedby companies small or medium sized which are being running by an engineer (soas to understand basic technological issues) and their business activities fall into thecategory of precision instruments (PRODCOM code 33). Special emphasis shouldbe given to companies specialising in medical and surgical equipment-orthopaedicappliances (PRODCOM code 3310) as well as to companies specialising ininstruments and applications for measuring, checking, testing (PRODCOM code3320). These categories of companies will have similar to MICREL applicationsand their current design practice and the way of “thinking” about hardwaredevelopment will probably be similar to MICREL (prior to FUSE). In additiontheir current design practice should be based on standard ICs and probably PCBdevelopment while their expertise in FPGAs / ASICs should be very low.

Finally the approach we had in our safety dependent ASIC maybe of interest toautomobile manufacturers for ABS and fuel control systems, aircraftmanufacturers for distributed safety Fly by Wire transponders. Military automatedsystems like missiles may also benefit. For all these non medical groups,MICREL is willing to transfer experiences and safety concepts.

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