医疗器械项目可行性分析报告英文版

No.:

Version:A0

Page:

PAGE

6

of10

ProjectFeasibilityAnalysisReport

ProductName:

XXXDevice

(XXXX)

Type/Model:

Issuedate:

1/9/2019

Release

Name

Occupation

Releasedate

Issued/changedby

Engineeringdepartment

10/9/2019

Checked/Approvedby

Marketingdepartment

20/9/2019

Checked/Approvedby

Engineeringdepartment

30/9/2019

Generalreleaseby

Engineeringdepartment

5/10/2019

Introduction:

Inthesummerorwhentravelling,youcanhardlyavoidbeingconfrontedbymosquitoes,wasps,bees,hornets,horsefliesandotherpests.Akindofantipruriticdeviceprovidequickeffect,simpleoperation,nosideeffectproviderelieffromtheitching,painandswellingcausedbyinsectbitesandstings.Importantissuchitemneedtobeeffectivebutmedicine-freeandnosideeffect,suitableforuseonmostoftheage.

Mainbodyofthereport:

Basedontheabovereview,ourcompanydevelopsanantipruriticdevice,wecallit“XXXX”or“BiteRelief”.Thedevelopmentcontainsbelowconsideration.

(1) ThematerialandcomponentuseddohavesuppliersinChinawithqualifiedstandard,stablequalityandreliableperformance.Also,withreasonablecost;

(2) Thecompanyhasgoodresourcestorealizethewholedevelopmentandproductionprocessofproducts,withstrongstability;

(3) Themarketprospectisgood.Ifwecandesignsuchproductwithreasonableprice,weexpecttoreceiveextensiveattentionandasubstantialmarketshare;

(4) Theprocessingtechnologyisfeasible;

(5) Theexpectedbenefitisgood;

(6) Theexpectedriskisacceptable.

(7) Thedesignandperformanceoftheproductalsoconformstotherelevantnationalstandardsformedicaldevices,andthefurtherdevelopmentandmarketingofthisproductcanbecarriedoutinthosemarkets.

GENERAL

A1 Projectbackgroundwithsocialdevelopment

Indailylife,especiallyinsummer,peopleoftenbeingconfrontedbymosquitoes,wasps,bees,hornets,horsefliesandotherpeststhatcauseditchyafterbeingbittenbyinsects.Peopleusuallyusesomekindofointmentforalleviatingitching,swellingorinflammation,butointmentcannoteffectiveintime,andmaycausedifferentlevelofsideeffectsandmedicinesensitive,thereforeointmentsomehowisnotthebestchoiceforeveryone.

A2 Projectoverview

Wearegoingtodevelopamedicine-freeantipruriticdevicethatisefficiencyandquickrelieffromtheitching,painandswellingcausedbyinsectbitesandstings.

A3 Targetspecification

- Batteryoperated(AAorAAAbattery)

- Pocketsize,useeverywhere

- Concentratedheattechnology

- Turboheatuptechnology

- QUICK!Effectivewithinafewseconds

- SuitableforEVERYONE!children,adult,senior,pregnantwomen,andevenforpeoplesufferingfromallergies.

- Medicine-free

- Chemicalfree

A4 Projectanalysisconclusion

Afteraninitialmarketandtechnicalevaluation,wearefullycapabletodevelopareliableandhigheffectiveantipruriticdevicemeetstheusabilityrequirements,technicalrequirementsaswellastherelevantnationalregulationsandstandardsformedicaldevices.Therefore,wedecidedtodevelopthisproduct.

B. MARKETANALYSIS

B1 Marketenvironmentaboutbitereliefdevice

Mosquitoesaretheinsectsthataremostlikelytoappeararoundlife,mainlyappearinsummertimemorethaninwinter.Recently,ithasbeenfoundthatmosquitoestendtoincreaseinwinterbecauseoftheworldwideglobalwarmingproblemthatcausedworldwideaveragetemperaturekeepincreasing.Warmtemperatureandhighhumiditygivethebestconditiontomosquitoestogrowup.

Markethasmanydifferentkindsofointmentforreliefofimpactofmosquitobite,butitcontainsdifferentkindofingredientthatnormaluserdonotunderstand.Therefore,adrug-freeandeasytousebitereliefdevicewillbeveryusefulandcangenerateabigmarket.

B2 Marketsurveyaboutthemarketsegmentofbitereliefdevice

Ourbitereliefdevice“XXXX”issuitableforallkindsofmosquitobites.HandydesignandjustoperatedbyAAAalkalinebattery,givesthemostconveniencetopeople,suitableforusenotonlyindoor,butalsoforoutdoorsports,champing,golfers,etc.

Besides,itissuitableforchildren,adult,senior,pregnantwomen,andevenforpeoplesufferingfromallergies.Thedevicewillnotcontainanymedicineingredientorchemical,useconcentrateheattechnologyforitchyrelief,issimplebuteffective.Thesalesmarketisworldwidewithwidesaleschannelssuchaselectricalstore,drugstore,pharmacy,on-line,clinic,etc.Thisproductexpectingbigvolume.

B3 Marketingstrategy

- Introduceinourownwebsiteandvarioustradeshow

- Introducetoclinic

- Throughon-linesalesplatformi.e.Amazon,T-Mall,

- ODM/OEMtocustomerundertheirownbrandandtheirowndesignifrequired

-

B4 Developmentplanandproductionsitecapability

Plantoself-developanddesignandoffertosuitablebrandsforworldwidedistribution

OEMwithcustomerfortheirownbrandanddesignbasedonourtechnology

Anengineeringteamwith3-5peoplewillhandlethisdevelopment

ThisitemwillbeMedicalDeviceClassIIstandard

Productionfactorysitewithanareaof5000squaremeters.Specialproductionlineandqualitytestprocedurewillbedesignedforproducethisitem

B5 Annualoutputvolumeoftheproject

Expectannualoutputisonemillionpiecesorabove.

Productioncapacityforthisitemexpecttobeatleasttenthousandpiecesmonthly.

B6 Productionsiteaddress

Companyname: DongguanDaMeiAppliancesLimited

Address: 6FuzhufourStreet,ZhangyangManagementDistrict,Zhangmutoutown,DongguanCity,GuangdongProvince

TECHNICALSCHEME,EQUIPMENTSCHEMEANDENGINEERINGSCHEME

C1 Technicalproposaloftheproject

Thisproductcontains:

Plasticmaterial

Hardware

Electroniccomponents

Ceramicmaterial

Function:Useofphysicalelectricpulsetechnology,heatuptheappliedpartto~50oCtorelieveitchy,swellingorinflammationcausedbyinsectbites.

C2 Mainequipmentschemeoftheproject

Majoruseoftheoriginalpipelineequipment,willbeproducedinthefactory’sproductionlinethatspeciallydesignforMedicalDeviceproduction.Besidestheexistingproductionandtestingequipment,engineeringteamwillalsodesigndedicatedjigtosupportproductionprocessandtestingprocessspeciallyforthisproduct.

C3 ProjectEngineeringScheme

Rentworkshop,installthree-phaseelectricity,layaircompressorgaspipe

Supplyofmainrawmaterialsfortheproject

D1 Majormaterialofthisitem

Cable,plastichousing,PCB,ceramicheater,packagingmaterial,etc.

E. GeneralPlanofProject

TransportationandSub-LoadingScheme

E1 Generallayoutoftheproject

Thegeneralplanoftheworkshopandthelayoutoftheworkshopoftheproject.

E2 Projecton-siteandoff-sitetransportation

Off-sitetransportationmode:entrustedlogisticscompany

On-siteTransportationMode:HydraulicVehicle

ProjectAuxiliaryEngineering:No

- Watersupply:municipaltapwater

- Powersupply:municipalpowergrid

- Powermode:electricandpneumatic

- DesignofCommunicationandInformationSystem:LocalAreaNetwork

- Lightningprotectiondesign:plantwithitsown

- AntistaticDesign:Yes

- EquipmentandFacilitiesMaintenanceScheme:EntrustingtheManufacturerormaintenanceUnitorConstructionUnitofEquipmentandFacilities

- Warehousingequipmentandfacilities:originalequipment,separatestoragearrangementforMedicalDeviceitems

F. Energy-savingmeasuresforprojects

F1 Energy-saving(power-saving,water-saving)measures:

Energy-savingmeasuresOfficepublicareasuseenergy-savinglights,ingeneral,officeandpublicareaslightingisnotopen,officecurtainsarenotpulled.Usenaturallight.Departmentscutoffpowersupplyafterlongtimeleavingofficeandoffdutytoreducestandbypowerconsumption.

Accordingtothesystem,hydropowerworkersregularlyinspectthewaterconsumptionoftheworkshop,andrepairthepipeline"running,risking,leakinganddripping"intime.

F2 Energyconsumptionanalysis

Theprojectisexpectedtoconsume3000-4000degreesofelectricitypermonth.

G. EnvironmentalImpactAssessmentofProjects

G1 Siteenvironmentalconditions:

Temperature0-35degrees

G2 Impactofprojectconstructiononenvironment:

Thisproductprojecthasnoimpactontheenvironment.

G3 Environmentalprotectionmeasures

Accordingtothecharacteristicsoftheproject,themainenvironmentalmanagementfactorsoftheprojectarenoisepollutionandovertimeatnightisnotmorethan9:30.

G4 Environmentalimpactassessment

ThirdPartyTesting:GuangzhouHuahangTestingTechnologyCo.,Ltd.isqualified

H. ProjectLaborSafety,HealthandFireProtection

H1 LaborSafetyandHealth

DongguanZhangMuTouLaborBureaupassedthesafetytestresults

H2 Firecontrol

Fire-fightingequipmentinfactorybuilding

SafetytestresultsofZhangMuTouFireDepartmentinDongguanCityarequalified

I. Organizationandhumanresourcesallocation

I1 Organizationchart

FormationPlanofTopManagementOrganizationsinEnterprises:TheGeneralManagershallberepresentedbyalegalperson

OrganizationPlanofMiddle-levelManagementDepartmentofEnterprise:AppointedbyGeneralManager

I2 Humanresourceallocation

Productionshifts

1Day1shift

Projectlaborassignment

~57productionlineworkers

2MaintenancePersonnel

1EngineeringTechnician

5managementandoperationpersonnel

I3 Wagesandbenefitsofemployees

ThetotalsalaryofthestaffisaroundUSD35,000.00.

Approx.USD3,000.00forboardandlodging

I4 Sourcesofstaffandrecruitmentschemes

TalentCompanyRecruitment

I5 Stafftraining

Trainingorganizedbycompanymanagement

J. ProgressofProjectImplementation

Implementationschedule

K. AnalysisofProjectInvestment

K1 InvestmentEstimationBasis

Tooling,Equipment,employeewages,rentaloffactorybuildings,decoration,etc.

K2 EstimationofTotalProjectInvestment

Estimationoffixedassetsandnewassets

Thedepreciationfeeofpipelineequipmentx1is~USD3,700.00

Leveragehandbeermachinexsetis~USD300.00

Constanttemperaturesolderingironx10setsis~USD600

Electricbatchex5setsis~USD100.00

CurrentTesterx2Unitsis~USD200.00

HighVoltageFrequencyTesterx2setsis~USD500.00

Voltageregulatorx2setsis~USD200.00

Aircompressorx1setis~USD2,500.00

Infraredtemperaturedetectorx5setsis~USD1,500.00(Newassets)

Injectionmold(tooling)is~USD20,000.00(Newassets)

Totalinvestmentofthefixedassetsis~USD29,600.00

K3 Estimateofliquidity

Approx.USD150,000.00

K4 Totalprojectinvestment

Equipment,plantdecoration,officeequipment,totalinvestmentof~USD15,000.00

K5 Totalinvestment

Totalinvestmentis~USD40,000.00

K6 Debtrepaymentplan

Nodebt

L. ProjectFinancialEvaluation

L1 Evaluationprojectandbasis

Accordingtothesalesvolume,economicbenefitandanticipatedmarkettrendofproductsinthemarketandtheexpectingfirstann