#MDOWebinar
#MDOWebinar
q  This webinar will be available afterwards at
www.medicaldesignandoutsourcing.com &
email
q  Q&A at the end of the presentation
q  Hashtag for this webinar: #MDOWebinar
Before We Start
#MDOWebinar
Introducing the Featured Speakers
MODERATOR FEATURED SPEAKER
Nic Abraham
Senior Editor
Medical Design & Outsourcing
Brian Matachun
Director of Technical Sales
MTD Micro Molding
Challenges	&	Emerging	Solu2ons	
through	Micromolding
5	
About	Us	…			
•  Experience:		40+	years	of	miniaturiza4on;	tool	making	à	molding	
•  Focus:		Engineering	Focus	with	a	Manufacturing	Objec4ve	
•  4	class	100k	cleanrooms;	11	self-contained	work	cells	
•  100%	Medical	
•  100%	Micro	
•  Development	programs	à	Millions	of	produc4on	parts	
•  Ver5cal	Integra5on:	
•  100%		In-house	tooling	
•  Technology:		
•  Con4nuous	investment	
•  Necessary	Credits	
•  ISO	9001:2008	
•  ISO	13485	(July	2016)	
•  Processor	of	the	Year	Finalist	2015	
MTD	Introduc4on	
Part	Weight	.
00000313gms
6	
Typical	Micro-sized	Part	Characteris4cs	
Bone	Anchor:	40%	carbon-filled	PEEK	
overmolded	over	.031”	stainless	rod	
Implantable	Tack	(Bioresorbable)	
Micro-op4c	lens	(Polycarbonate)	
Frac4ons	of	a	plas4c	pellet	~520	
parts	per	pellet
7	
MTD Six Sciences
Material	Selec4on	
Thermoplas5cs	
Thermoplas4cs	are	polymers	that	become	pliable	
and	moldable	above	a	specific	temperature,	and	
returns	to	a	solid	state	upon	cooling.	
	
Any	thermoplas5c	material,	with	proper	tes5ng,	
can	be	used	for	a	medical	implant.	
	
A	SELECTION	WE	WORK	WITH:	
8	
•  ABS	(Acrylonitrile	Butadiene	
Styrene)	
•  ABS	+	PC	
•  Acetal	(including	Barium	Sulfate-
filled	Acetal)	
•  COC	(Cyclic	Olefin	Copolymer)	
•  COP	(Cyclo	Olefin	Polymer)	
•  Hydrogels	
•  LCP	(Liquid	Crystal	Polymer)	
•  Nylon	(Polyamide	PA)	
•  PEBAX	(including	Barium	
Sulfate0fille	PEBAX)	
•  PEEK	(PolyEther	Ether	Keytone)	
•  PEI	(PolyEthermide,	Ultem)	
•  PEIK	(Linear	PolyEthylene)	
•  PELLETHANE	
•  PBT	(Polybutylene	Terephthalate)	
•  PEKK	(Polyaryletherjetone,	
including	Barium	Sulfate-filled	
PEKK)	
•  PET	(PolyEthylene	Teraphthalate)	
•  Polycarbonate	(PC,	including	PC	/	
ABS	Blends	and	Glass-filled	PC)	
•  Polymide	
•  Polypropylene	(PP)	
•  Polysulfone	(PSU)	
•  Polyurethane	(flexible)	
•  Polyurethane	(rigid)	
•  Tecothane	
•  Tecoflex	
•  TPR	(ThermoPlas4c	Rubber)	
25	of	the	MORE	COMMON	THERMOPLASTICS		RUN	
at	MTD	MICRO	MOLDING:
Bioresorbables	
Bioresorbable	materials	are	popular	in	micro	medical	
applica4ons	as	the	materials	can	dissolve/absorb	
into	the	body.	
	
IDEAL	FOR:	
•  Medical	bioabosorbable	anchors	
•  Implantable	staples	
•  Bioresorbable	micro-plugs	
•  Micro-screws	
A	SELECTION	WE	WORK	WITH:	
9	
•  Purasorb	PLG	8531	
(85/15	L-lac4de/glycolide	copolymer)	
•  Purasorb	PLG	8218	
(85/18	L-lac4de/glycolide	copolymer)	
•  Purasorb	PLG	1017	
(10/90	L-lac4de/glycolide	copolymer)	
•  Purasorb	PDLG	5010	
(50/50	DL-lac4de/glycolide	
copolymer)	
•  RESOMER	L210S	
(Poly-L-lac4de)	
•  RESOMER	LR	706	
(Poly-L-lac4de-co-D,L-lac4de)	70:30	
•  RESOMER	LR	708	
(Poly-L-lac4de-co-D,L-lac4de)	70:30	
•  RESOMER	LR	704	
(Poly-L-lac4de-co-D,L-lac4de)	70:30	
•  RESOMER	RG	509	S	
(Poly-L-lac4de-co-glycolide)	50:50	
•  P4HB-based	
(poly-4-hydroxybutyrate)	
•  PCL-based	
(poly	epson-caprolactone)	
•  PLGA-based	
(poly	lac4de-co-glycolide)	
•  PLLA-based	
(Poly-L-Lac4de)	
•  Other	
(Customer	Proprietary	Bioresorbable	
Materials)	
Material	Selec4on
•  MICRO-FILL:		Specialized	micro	molds	for	tes4ng	material	
flow	of	different	materials	and	fillers.	The	data	from	the	
flow	tes4ng	is	u4lized	to	predict	feasibility	of	product	
features	when	reviewing	new	part	designs.		
	
•  MICRO-FLOW:		Micro-Plaque	to	evaluate	flow	of	materials	
into	various	thicknesses.	
	
•  MICRO-RUNNER:	A	tooling	based	strategy	that	examines	
flow	proper4es	in	the	runner	system	to	reduce	scrap.	
10	
Micro	Design	
Micro	Technologies
•  Model	vs.	Molded	part	
•  Iden4fy	failure	modes	(PFMEA)	
•  Prototype-bridge	tooling	–	high	cavita4on	produc4on	
•  Son	tooling	vs.	Hard	tooling	
•  Exact	execu4on	with	work	piece	accuracy	of:		
.000042”	[~	1µ,	0.0010668	mm]	
•  Sarix	3D	EDM	milling	
•  All	maintenance	performed	in-house	
•  EOAT	in-house	–	Automa4on		
11	
Micro-Edge	Tooling		
Micro	Tooling
•  Overmolding	and	insert	molding	
•  True	zero-defect	
•  In-process	vision	inspec4on		
•  Screw-over	plunger	
•  RJG	eDART	–	sensing	&	control	integra4on	
•  Lights-out	manufacturing	
•  Custom	tray	and	packaging	
•  Custom	End	of	Arm	Tooling	(EOAT)		
o  Pick	and	place		
12	
100%	Cleanroom	Molding	
Micro	Molding
•  Robust	valida4on	process	-	standardized	
•  IQ/MT1,	MT2,	OQ/PQ	methodology	
•  Custom	in-house	fixturing	
•  Non-contact	fully	automated	OGP	
measurement	systems	
•  CT-Scanning	
•  Gauge	R&R1	(analysis	of	the	
effec4veness	of	the	measurement	
system)	
•  IV,	DSC,	and	Tensile	Tes4ng	
•  Standard	capability	goal	of	1.33	Cpk		
13	
Micro	Metrology	and	Tes5ng	
1	Gage	Repeatability	and	Reproducibility	
Micro	Metrology
•  Reviewing	what	is	possible	
	<R.001”	
	.002”	wall	thicknesses	
	250:1	aspect	ra5os	
	Zero	dra]	
•  Micro	Medical	Applica4ons:	
Endoscopy	
Laparoscopy	
Abla5on	
Brachytherapy	
Drug	Delivery	
Fixa5on	
14	
Micromolding	Opportuni4es	
Material:	30%	GF	Nylon	12	
Challenge:	U4lize	the	micro	molding	process	to	insure	a	polymer	rich	
surface	which	would	not	allow	a	possible	electrical	leak	path	as	well	shut	
off	on	delicate	wiring	ranging	from	.010”	up	to	.015”.	Handling	6-8	n	of	
delicate	wire	assembly.	
Descrip5on:	Electrocautery	device	used	in	a	new	laparoscopic	platorm.
CASE	STUDY:	Stairs	
PROBLEM:	Failure	of	Addi5ve	Mfg	for	Rapid	Prototyping	
•  16µ	layer	thickness	&	25µ	step-over	=	fuzzy	parts	
•  Finished	parts	brivle	and	broke	when	flexed	
•  Not	suitable	except	as	a	model	for	display	
SOLUTION:	
•  MTD	built	a	single	cavity	tool		
•  Useful	for	prototyping	
•  Acceptable	for	clinical	trials	
•  Scalable	for	produc4on		
15	
~	.040”	
~	.007	X	.006”	
Each	stair-step	is	
approx.	diameter	
of	a	human	hair	
Compe4tor’s	avempt,	using	3D	prin4ng	
technology	in	a	“polypropylene-like”	prin4ng	grade	
polymer	
MTD’s	micromolded	acetal	part	 Detail	of	MTD’s	micromolding
CASE	STUDY:	Bioabsorbable	Screw	
PROBLEM:	
•  Goal=	bioabsorbable	product	
•  6+	months	of	failure	in	thermoplas4c	(surrogate)	
•  S4ll	unable	to	fill	in	ANY	thermoplas4c	filling	
“violently”	
•  Lost	market	share,	delayed	entry	to	market	
SOLUTION:	
•  Unique	approach	to	tool	design	to	fill	“gently”	
•  MTD	4meframe:	4	weeks	
	
	
PHASE	II	RESULT:	
•  Produc2on	capability:	over	170K	per	week	
•  7.5%	average	IV	loss	
•  38%	cost	reduc2on	over	4	years	
	16	
RESCUED
CASE	STUDY:	Drug	Delivery	
PROBLEM:	
•  4	piece	manual	assembly	
•  Worst	plas4c	design	part	ever		
•  Leakage	between	assembled	Parts	
•  Standard	manufacturing	was	not	possible	
•  Tolerances	
•  High	cost	
SOLUTION:	
•  Mold	all	components	together	at	once	
•  MTD	4meframe:	8	weeks	
•  Scalability	to	produce	50MM	
•  24/7	(lights	out)	
•  Custom	packaging	
•  Cost	reduced	by	50%	
•  I.D.	Cpk=4.5	
	
17	
RESCUED
.0008”	Wall	Thickness
•  Only	Molder	who	focuses	on	Micro	Molding	
•  Only	Micro	Molder	in	North	America	solely	focused	on	Medical	
•  Only	Molder	in	North	America	with	3D	EDM	Milling	Technology	
•  90%	documented	on	4me	project	comple4on	
•  20%	of	MTD	successes	have	been	FAILURES	by	others	
•  30%	of	successes	have	been	NO	QUOTED	elsewhere	
18	
Differen4ators	
Medical	micromolding	is	what	we	do.	And	all	we	do.	
Material:	Carbon	Filled	PEEK	
Dimensions:	Micro	Overmolding	over	a	.031”	diameter	stainless	steel	rod.	
Descrip5on:	Micro	Overmolding	and	Carbon	Filled	PEEK	Micro	Molding	materials	
with	a	400	degree	F	mold	temperature	both	present	many	challenges.
#MDOWebinar
Questions?
MODERATOR FEATURED SPEAKER
Nic Abraham
Senior Editor
Medical Design & Outsourcing
nabraham@wtwhmedia.com
@NicsMedTechNews
Brian Matachun
Director of Technical Sales
MTD Micro Molding
bmatachun@mtdmicromolding.com
@MTDMircoMolding
#MDOWebinar
q  This webinar will be available at
www.medicaldesignandoutsourcing.com & email
q  Tweet us! #MDOwebinar
q  Connect with Medical Design & Outsourcing
q  Discuss this on EngineeringExchange.com
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Challenges & Emerging Solutions through Micro Molding