ISO 13485

low volume prototyping in ject ion molding clean room assembly

val idat ion protocol in -house tool ing LSR

WE’RE NPI/MEDICAL AND WE’RE ANYTHING BUT PROTOTYPICAL™

N PI /Med ic a l a cce ler a te s N ew Prod uc t

I n t rod uc t ion s (N P I) w h i le rede f in in g yo ur

supply ch a in th ro ug h a f i r m under s t a nd in g

of th e prod uc t deve lopm en t l i fec yc le .

From new produc t s tar tups and large med ica l

OEMs to des ign shops and contract manufacturers,

we’l l take your new produc t from protot ype

to produc t ion (P2P) w i th a focus on speed,

process development , techn ica l prec is ion and

customer ser v ice.

Depend ing on your program needs , we create

complex , in jec t ion - molded components and

assembl ies for med ica l dev ice, l i fe sc iences and

hea lthcare customer s .

We do more than just mold plast ics — we shape

your produc t ’s success through the chaot ic

produc t development l i fec ycle .VALUE VALUE

VALUE PROPOSITION

Accelerat ing New Product Introduct ions (NPI) While Redef in ing Your Supply Chain.

OUR STORY

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PRECISION INJECTION-MOLDED

COMPONENTS AND ASSEMBLIES

FOR YOUR NEXT MEDICAL DEVICE

From protot ype to produc t ion (P2P),

our qu ick-turn manufac tur ing (QTM)

process rap idly turns your CAD f i les into

high-qual ity, inject ion-molded parts based

on your spec i f ic pro jec t requ i rements .

SEAMLESS COMMUNICATION FROM CONCEPT DEVELOPMENT TO FINAL LAUNCH A s ing le po int- of- contac t dur ing the QTM process

ensures t ransparenc y and e l im inates mult ip le channels

of commun icat ion . We take pr ide in max im iz ing

e f f ic ienc y and sav ing t ime dur ing the produc t

development protot yp ing phase. I n fac t , customer s

rout inely c i te our pro jec t management capab i l i t ies

as a va lue - added benef i t of work ing w i th NPI /Med ica l .

PICKING THE RIGHT RESIN FOR YOUR PARTSSelec t ing the r ight mater ia l for your nex t pro jec t is

cr i t i ca l . W i th thousands of d i f ferent res in grades from

wh ich to choose, an erroneous selec t ion could delay

your pro jec t s ign i f icant ly.

NPI /Med ica l has vast

exper ience w i th h igh ly

eng ineered res ins , such as

PEEK,® ULTEM® and LEX AN.™

O ther h igh ly eng ineered

res ins we process include

(but are not l im i ted to):

// ABS

// F luoros i l i cone

// HDPE

// LCP

// LDPE

// N y lon

// PBT

// PC

// PE

// PETG

// Polyst yrene

// PP

// Radel®

// Santoprene®

// S i l ast ic LS

// TPE

// TPV

// Udel®

PROTOTYPE TO PRODUC TION

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IN-HOUSE TOOLING SHAPES YOUR PROGRAM’S SUCCESS

QTM (qu ick-turn manufac tur ing ) re fer s to our

process for rap id ly turn ing your C AD f i les in to

h igh qual i t y molded components , based on

your spec i f ic pro jec t requ i rements . Selec t ing

the r ight tool ing opt ion is cr i t i ca l to the

success of your med ica l dev ice program.

At NPI /Med ica l , our eng ineer ing team leverages

our un ique DynaClass ® Tool ing System to help

you selec t the appropr ia te level of tool ing for

your protot ype program. Wi th four DynaClass ®

tool ing opt ions ava i l able , NPI /Med ica l can

accommodate mult iple protot ype tool ing needs.

NPI /Med ica l under stands complex des ign

expec tat ions cannot be met w i th a s tandard

“b lack- box” tool ing approach . Thus , we have

C AD eng ineer s des ign a l l of our mold ha lves

and use CNC- mach ined EDM to burn or w ire a l l

cr i t i ca l geometr y that cannot be mi l led .

Up front DFM (des ign -for- manufac turab i l i t y)

ass is tance is of fered w i th a l l protot ype tool ing

programs. Par t geometr y is never compromised

dur ing the tool ing process , un l ike other “rap id”

tool ing processes where ex tra draf t and rad i i may

be requ i red . Your result : med ica l dev ice protot ype

components w i th t r ue -to -form C AD geometr ies .

DYNACLASS ® TOOLING

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All of our DynaClass ® par ts come standard w i th

three to s ix C TF (cr i t i ca l- to -func t ion) inspec t ion

requ i rements to ensure accurac y and par t func t ion .

Process va l idat ion ser v ices are of fered as requ i red ,

p lus custom qual i t y p lans depend ing on your

program requ irements .

Our seasoned pro jec t manager s under stand

prec is ion tool ing and speed -to - market are v i ta l to

your pro jec t ’s success . At NPI /Med ica l , one pro jec t

manager w i l l g u ide you from concept to launch dur ing

the produc t development l i fec ycle . B y work ing

d i rec t ly w i th your pro jec t manager, mult ip le channels

of commun icat ion are e l im inated to max im ize

e f f ic ienc y, save t ime and ensure on -t ime del i ver y.

DYNACLASS ® TOOLING

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DynaClass 5 DynaClass 4 DynaClass 3 DynaClass 2 SPI Class 101 USES Prototype Tight Tolerance, Low Volume Molding Bridge Tooling, Pre-Production Tight Tolerance Production Advanced Prototypes

APPLICATIONS Form, Fit, Function Part Validation / Production High Volume, Pre-Production Extremely High Production Design Verification

COST / COMPLEXITY Low Low to Moderate Moderate Premium Premium

MAXIMUM PART SIZE 3" x 4" 6" x 8" 6" x 8" 8" x 8" 10" x 10"

LEAD TIME 1-4 weeks 2-4 Weeks 3-6 Weeks 4-8 Weeks 12-14 Weeks

MOLD LIFE Up to 5,000 Up to 50,000 Up to 100,000 Up to 500,000 1,000,000 Plus

MOLD BASE Aluminum / P-20 Steel P-20 or #2 Steel P-20 or #2 Steel P-20, #2, #3 and #7 Steel #2, #3 and #7 Steel

MOLD INSERTS Limited / Hand Loads Hand Load and Actions Automated Automated Automated as Needed

CAVITY CREATION Machined with Limited EDM Machined with Some EDM Machined and EDM Machined and EDM Machined and EDM

INSERTS Hardened Steel Cores, Cavities Hardened Steel Cores, Cavities Hardened Steel Cores, Hardened Steel Cores, Hardened Steel Cores, and Inserts as Needed and Inserts as Needed Cavities and Inserts Cavities and Inserts Cavities and Inserts

ACTION Limited / Hand Loads Hand Load and Actions Automated Automated Automated as Needed

STANDARD +/-.005" Unless Otherwise +/-.005" Unless Otherwise +/-.005" Unless Otherwise +/-.005" Unless Otherwise Standard Production TOLERANCES Predetermined Predetermined Predetermined Predetermined Molding Tolerances

CONTROLLED Clean Room Molding Options Clean Room Molding Options Clean Room Molding Options Clean Room Molding Options Clean Room Molding Options ENVIRONMENTS

QUALITY SYSTEMS Custom Quality Plans / Custom Quality Plans / Full Process Validation Full Process Validation Full Process Validation Process Validation Process Validation

CLASS EQUIVALENT Class 105 Class 104 Class 103 Class 102 Class 101

DynaClass 5 PROTOTYPE TOOL OPTIONS

PROTOTYPE TOOL OPTION

MATERIAL Aluminum Steel

COST / COMPLEXITY Low-Moderate Premium

LEAD TIME 1-2 Weeks 3-4 Weeks

YOUR KEY ADVANTAGE // Work with one project manager throughout the entire project lifecycle.

CONSOLIDATE YOUR SUPPLY CHAIN, GAIN TIME, SAVE MONEY

Med ica l dev ice, l i fe sc ience and hea lthcare OEMs face

in tense market pressure to consol idate the i r supply

cha in and dr ive down costs . NPI /Med ica l has a f i rm

under stand ing of these market pressures and of fer s

in i t ia l concept d iscuss ions a imed a t supply cha in

opt im izat ion from protot ype to produc t ion .

A well-des igned supply cha in net work can s ign i f icant ly

improve marg ins , suppor t expans ion in to new

markets , enhance the customer exper ience and

reduce operat ing costs .

NPI /Med ica l’s solu t ion to these pressures is to redef ine

trad i t ional supply cha in management through opt imized

processes a imed at reducing your supply base. Examples

include reduc ing customer inventor y by warehous ing

molded and purchased components to f ina l i ze produc ts

for just- in -t ime del i ver y, and rap id ly reac t ing to

increased demand for custom - packaged produc ts .

From in i t ia l concept development to produc t ion launch ,

le t NPI /Med ica l redef ine your supply cha in .

BENEFITS// Cons ignment programs

// Cost conta inment

// Ful l lot number

produc t t raceab i l i t y

// On -t ime del i ver y

// Order and rece ived

quant i t y reconc i l ia t ion

// Procurement and fu lf i l lments

to s ing le - source vendor

// Supply cha in management

SUPPLY CHAIN OPTIMIZATION

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NPI/Med ica l of fer s comprehens ive assembly

and k i t t ing ser v ices to help manage your

supply cha in .

We have the exper t ise to package your

produc t in accordance w i th FDA 21 CFR 820

Qual i t y System Reg ulat ion . From n i t rogen -

purged fo i l pouches to Ty vek® - sea led r ig id

thermoformed trays to vapor- proof bags ,

NPI/Medical can meet your requ irements and

del i ver your produc t d i rec t to d is tr ibut ion .

ASSEMBLY OPTIONS// Automat ic l abel pr in t ,

bag and sea l

// Ful ly automated assembl ies

// Heat , sea l and bag in a C lass

10,000 cleanroom env i ronment

// H igh tonnage thermal heat

s tak ing in a C lass 10,000

c leanroom env i ronment

// In - l ine func t iona l test ing

// Laser e tch ing

// Mult i - colored pad pr in t ing

// Semi - automated assembl ies

// Sub - assembl ies

// Thermal inser t ion and sea l ing

// Two Gr ieve automated

anneal ing ovens

// Ultrason ic weld ing in a C lass

10,000 cleanroom env i ronment

ASSEMBLE, KIT, CONSOLIDATE

KITTING AND ASSEMBLY CAPABILITIES// One Grade 8 (C lass 100,000) c leanroom, w i th s i x

in jec t ion - mold ing mach ines (three 40 -ton and three 110 -ton)

// Two Grade 7 (C lass 10,000) c leanrooms for assembl ies ,

sub - assembl ies , test ing, packag ing and decorat ion

// Two por table Grade 7 (C lass 10,000) c leanrooms for assembl ies ,

sub - assembl ies , test ing, packag ing and decorat ion

// Ded icated, c l imate - control led wh i te room env i ronment for k i t t ing

// Three sh i f t operat ions , 24/5

// Low-volume k i t t ing and assembl ies (200 -500 un i ts per day)

// H igh -volume k i t t ing and assembl ies (1 ,500+ un i ts per day)

PACKAGING OPTIONS// 1D and 2D barcode capable

// C lamshel l packag ing

// D i rec t thermal pr in t ing

// E-Z open plast ic bags

// Iner t gas purged

// Label pr in t ing

// Laser engrav ing

// Trays , l ids and pouches

// Ty vek ® s ta t ic d iss ipat ive

// Vacuum packs

// Vapor- proof

ASSEMBLY AND KIT TING

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QUALITY IS NEVER COMPROMISED

An ISO 13485:2003 and ISO 9001:2008 cer t i f ied

organ iza t ion , NPI /Med ica l ma inta ins a Qual i t y

Management System to ensure our customer s’

s tr ingent requ i rements are met . Our env i ronmenta l

mon i tor ing program includes par t icu la te and

microb io log ica l test ing.

O ur fu l ly equ ipped me trolog y l ab w i th modern

technolog y offer s comple te process va l idat ions

for your nex t med ica l dev ice program.

// ZEISS CONTUR A 700 CMM us ing C ALYPSO

sof t ware w i th VAST X T Gold Sensor System

// Two opt ica l v ideo probes (R A M Opt ica l) :

Omis I I 4X8 and Omis I I 6X9

// Three OGP SmartScope® systems, two with CMM

capab i l i t ies and laser capab i l i t ies

// L ighthouse Systems L im i ted SPC l ight

// Measurement sof t ware: Automap ver s ion 3.0

// M in i tab

// Mo is ture ana ly zer

// N ikon ® Prof i le Pro jec tor w i th sof t ware

// Prol ink QC- C ALC ver s ion 3

N PI/Med ica l’s in ternal Q ual i t y/

Process Eng ineer ing team prov ides

comple te process va l idat ions

cons ist ing of:

// APQP

// IQ, OQ, PQ

// Low-volume protot ype

va l idat ions

// Process development us ing

sc ient i f i c in jec t ion - mold ing

pr inc ip les

// FA I (F i r s t ar t ic le inspec t ions)

// MSA stud ies

// Process capab i l i t y s tud ies

// FMEA

// F low char ts

// Control p lans

QUALITY ASSUR ANCE

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THE ART OF LSR

LSR PROTOTYPE TOOLING// N PI/Med ica l’s propr ie tar y custom - heated

master frame and inser t system

Vacuum vent ing is s tandard

( i .e . , “p laque mold”)

// MUD (Master Un i t D ie) opt ion

Bu i lt from standard s i zes and

components are purchased

from cata logs

LSR PRODUCTION TOOLING// Runner less uses pneumat ic va lve gate

Vacuum vent ing as s tandard ( i f requ i red)

LSR CAPABILITIES// Two in - house, 55 -ton LSR produc t ion mold ing mach ines capable of

hor i zonta l /ver t ica l mold ing and featur ing fu l l robot automat ion

// One 55-ton press dedicated to LSR prototype and shor t-run product ion

// Brand - new Gr ieve post- mold cur ing oven

// Post- mold cur ing opt ions (batch or automated)

// Two 5 - and 55 - gal lon microprocessor- control led dr um feed pumps

// One 5 - ga l lon , manual ly reg ula ted feed pump

// One microprocessor- control led car tr idge pump

// Al l mach ines are protot ype in jec t ion mold ing capable w i th heated LSR

master frames and custom manual m ix /feed ing system

For more than a decade, NPI/Medical’s propr ietar y

l iqu id s i l i cone r ubber (LSR) capab i l i t ies in both

protot ype and product ion offer solut ions for your

nex t med ica l dev ice appl ica t ion . Our in - house

tool ing and process ing of LSR components

results in qu ick , cost- e f fec t ive, m ixed -volume

protot ypes and produc t ion components .

LSR

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A WINDOW INTO OUR PROCESS

NPI/Med ica l operates out of a 66,000 - square -foot manufac tur ing

fac i l i t y des igned for med ica l dev ice, l i fe sc ience and hea lthcare

in jec t ion mold ing and tool bu i ld to accelerate the new produc t

development l i fec ycle . Catch a qu ick g l impse for your self.

REQUEST A QUOTELet us help you f ind the best solu t ion for your pro jec t .

Contac t our sa les team:

Terr y G leason, D i rec tor of New B us iness Development

tg leason@np i - med.com 516.581.8891

Dan S inger, Sa les E xecut ive

ds inger@np i - med.com 203.4 46.7 118

FACIL ITY

18

401 B i rmingham Blvd. Anson ia , C T 06 401 P : 203.7 36.5200 F: 203.7 32.2075

sales@npi-med.com

npi -med.com