Selecting A Design & Manufacturing Partner: The Keys to Your Medical Device Success Presented by: Jim Rundo Phillips Plastics Representative – OH, IN, & SE MI (216) 956-7574 [email_address]

A Startup Company’s Dilemma… Does this sound like you? You have a great idea for a new medical device, and… You have investor funding to launch your idea, but… You lack the design and manufacturing resources to get it done So… How will you get it designed and manufactured?

Does this sound like you?

You have a great idea for a new medical device, and…

You have investor funding to launch your idea, but…

You lack the design and manufacturing resources to get it done

So…

How will you get it designed and manufactured?

An Established Company’s Dilemma… Or does this sound like you? You have many medical device programs in your pipeline, but… A promising new program is proposed by marketing, and… You find you’re short the resources to tackle this new program So… How will you get it designed and manufactured?

Or does this sound like you?

You have many medical device programs in your pipeline, but…

A promising new program is proposed by marketing, and…

You find you’re short the resources to tackle this new program

So…

How will you get it designed and manufactured?

Success or Failure Depends on Your Answer Some startups choose to go it alone assuming they will learn along the way – but this “tuition” is often very expensive: Lack of regulatory knowledge for medical device design and manufacturing results in costly program launch delays Delays = a higher chance of company failure Startups often underestimate the resources required to properly design and manufacture their medical device product: Inadequate design resources = design gaps which show up during manufacturing where it is more expensive to rectify Inadequate manufacturing resources = cGMP gaps which could result in non-compliance and regulatory scrutiny

Some startups choose to go it alone assuming they will learn along the way – but this “tuition” is often very expensive:

Lack of regulatory knowledge for medical device design and manufacturing results in costly program launch delays

Delays = a higher chance of company failure

Startups often underestimate the resources required to properly design and manufacture their medical device product:

Inadequate design resources = design gaps which show up during manufacturing where it is more expensive to rectify

Inadequate manufacturing resources = cGMP gaps which could result in non-compliance and regulatory scrutiny

Success or Failure Depends on Your Answer Established medical device companies face their own challenges: Putting off a new program represents a lost opportunity which impacts growth and may open the door for a competitive entry Trying to do too many programs at once often results in costly product launch delays Hiring new resources may be a poor option, especially if the additional workload cannot be sustained long-term

Established medical device companies face their own challenges:

Putting off a new program represents a lost opportunity which impacts growth and may open the door for a competitive entry

Trying to do too many programs at once often results in costly product launch delays

Hiring new resources may be a poor option, especially if the additional workload cannot be sustained long-term

So … What Are My Options? Well, you can do it yourself: Startups can “learn the ropes” (and hope they do it quick enough) Established companies can redistribute their resources (and hope they don’t fall behind on other programs) … or… You can partner with an organization who understands and is experienced your market and can handle your design and manufacturing requirements in a timely fashion

Well, you can do it yourself:

Startups can “learn the ropes” (and hope they do it quick enough)

Established companies can redistribute their resources (and hope they don’t fall behind on other programs)

… or…

You can partner with an organization who understands and is experienced your market and can handle your design and manufacturing requirements in a timely fashion

What Are The Advantages of Partnering? Startups… … can focus on developing their market and sales channels … will benefit from the expertise of their partner, who can draw on prior experiences to improve the startup’s product … can save money by not having to develop their own internal engineering and manufacturing operations Established companies… … can respond to quickly changing market dynamics … avoid adding headcount to their organizations as well as save money by contracting out only the services they need

Startups…

… can focus on developing their market and sales channels

… will benefit from the expertise of their partner, who can draw on prior experiences to improve the startup’s product

… can save money by not having to develop their own internal engineering and manufacturing operations

Established companies…

… can respond to quickly changing market dynamics

… avoid adding headcount to their organizations as well as save money by contracting out only the services they need

How do I Choose a Partner? Take time to learn about the companies which market their medical device design and manufacturing capabilities Interview potential candidates to gauge their experience and knowledge in handling your type of medical device Quickly weed out companies not qualified to help you with your business – they will cost you in lost time and added expenses Always keep in mind that YOU as the marketer of your medical device will always be design responsible and thus have to answer to regulatory bodies regarding your suppliers, so… The homework you do today will pay off down the road with a successful product launch and good regulatory compliance

Take time to learn about the companies which market their medical device design and manufacturing capabilities

Interview potential candidates to gauge their experience and knowledge in handling your type of medical device

Quickly weed out companies not qualified to help you with your business – they will cost you in lost time and added expenses

Always keep in mind that YOU as the marketer of your medical device will always be design responsible and thus have to answer to regulatory bodies regarding your suppliers, so…

The homework you do today will pay off down the road with a successful product launch and good regulatory compliance

Questions to Ask Candidate Companies Consider building a comparison checklist to benchmark candidate companies. Questions to consider are shown on the next few slides (note not all questions may be applicable to your situation). NOTE: These questions are not meant to be a substitute for a more thorough on-site audit, which is an important part of the supplier qualification process

Consider building a comparison checklist to benchmark candidate companies. Questions to consider are shown on the next few slides (note not all questions may be applicable to your situation).

NOTE: These questions are not meant to be a substitute for a more thorough on-site audit, which is an important part of the supplier qualification process

Questions to Ask Candidate Companies General Questions: What is your current financial condition (credit rating, etc.)? How long have you sourced to the medical device market? What are your core competencies? Are medical markets a focus for your company? Are you registered with the FDA for finished medical device manufacturing? Who are some of your key customers (note confidentiality agreements with customers may limit this answer)? Do you have a global footprint (important for companies considering global sales strategies)?

General Questions:

What is your current financial condition (credit rating, etc.)?

How long have you sourced to the medical device market?

What are your core competencies?

Are medical markets a focus for your company?

Are you registered with the FDA for finished medical device manufacturing?

Who are some of your key customers (note confidentiality agreements with customers may limit this answer)?

Do you have a global footprint (important for companies considering global sales strategies)?

Questions to Ask Candidate Companies Design Questions: Are you ISO-13485 registered, including design control? What is your experience with risk-based designs? How do you maintain design history files (DHF)? What experience do you have with validations? Can you assist with regulatory filings? What is the experience level of your design team? What is your design transfer process to manufacturing? How do you qualify and monitor your outside suppliers?

Design Questions:

Are you ISO-13485 registered, including design control?

What is your experience with risk-based designs?

How do you maintain design history files (DHF)?

What experience do you have with validations?

Can you assist with regulatory filings?

What is the experience level of your design team?

What is your design transfer process to manufacturing?

How do you qualify and monitor your outside suppliers?

Questions to Ask Candidate Companies Tooling, Production & Distribution Questions: Are you ISO-13485 registered? What experience do you have with medical devices? Tell me about your cGMP compliance activities… Tell me about your document controls (traceability)… What experience do you have with validations? How do you monitor your process capabilities? What is the experience level of your production team? Tell me about your distribution management process… How do you qualify and monitor your outside suppliers?

Tooling, Production & Distribution Questions:

Are you ISO-13485 registered?

What experience do you have with medical devices?

Tell me about your cGMP compliance activities…

Tell me about your document controls (traceability)…

What experience do you have with validations?

How do you monitor your process capabilities?

What is the experience level of your production team?

Tell me about your distribution management process…

How do you qualify and monitor your outside suppliers?

Who is Phillips Plastics? A developer and manufacturer of custom injection molded components and assemblies Strong medical market presence including partner relationships with many leading medical device manufacturers $225 million annual sales with 1400 associates Global footprint of 16 design and manufacturing centers totaling over 750,000 sq ft (70,000 sq m) and 200 presses Domestic (Wisconsin and California) Asian (Phillips East – China) European Union (Phillips CerBo – Ireland)

A developer and manufacturer of custom injection molded components and assemblies

Strong medical market presence including partner relationships with many leading medical device manufacturers

$225 million annual sales with 1400 associates

Global footprint of 16 design and manufacturing centers totaling over 750,000 sq ft (70,000 sq m) and 200 presses

Domestic (Wisconsin and California)

Asian (Phillips East – China)

European Union (Phillips CerBo – Ireland)

Who is Phillips Plastics? Our injection molding technologies include: Resin (includes multishot and in-mold decorating) Metal and Magnesium Multishot Liquid Silicone Rubber Ceramic Micromolding Our services include: Industrial, product and tooling design Rapid prototyping and prototype tooling Tooling fabrication Manufacturing (includes value-add) and distribution

Our injection molding technologies include:

Resin (includes multishot and in-mold decorating)

Metal and Magnesium

Multishot Liquid Silicone Rubber

Ceramic

Micromolding

Our services include:

Industrial, product and tooling design

Rapid prototyping and prototype tooling

Tooling fabrication

Manufacturing (includes value-add) and distribution

Phillips Plastics’ “Total Solution” Approach “ Design through distribution” – a complete life cycle approach Concurrent processes – reduces overall cost and time to market Our services are available either as a complete package or “a la carte” – use them all or only the ones you need

“ Design through distribution” – a complete life cycle approach

Concurrent processes – reduces overall cost and time to market

Our services are available either as a complete package or “a la carte” – use them all or only the ones you need

Total Solutions – Design & Engineering A design process with a focus on medical devices: Ideation > Design Inputs > Design Outputs > Validation > Transfer A risk-based approach ensuring regulatory compliance ISO-13485 registered including design control Industrial design (ideation, human factors, design concepts) Integrated product design (mechanical, electrical, software) Model and prototype assembly Design History File (DHF) documentation Design validation and clinical testing Regulatory documentation and submission support

A design process with a focus on medical devices:

Ideation > Design Inputs > Design Outputs > Validation > Transfer

A risk-based approach ensuring regulatory compliance

ISO-13485 registered including design control

Industrial design (ideation, human factors, design concepts)

Integrated product design (mechanical, electrical, software)

Model and prototype assembly

Design History File (DHF) documentation

Design validation and clinical testing

Regulatory documentation and submission support

Total Solutions - Tooling Prototype injection molding tooling for testing and market entry Production injection molding tooling fabrication Domestic (Wisconsin) Offshore (Phillips East – China) Tooling and process validations to ensure cGMP compliance In-house tooling storage and maintenance

Prototype injection molding tooling for testing and market entry

Production injection molding tooling fabrication

Domestic (Wisconsin)

Offshore (Phillips East – China)

Tooling and process validations to ensure cGMP compliance

In-house tooling storage and maintenance

Total Solutions - Production FDA registered Medical device manufacturing (21 CFR 820) Drug packaging (21 CFR 210 & 211) ISO-9001:2000 and ISO-13485 registered Facilities fully cGMP compliant Low volume medical production (New Richmond, WI) High volume medical production (Menomonie, WI) Global options are available Phillips East (China) Phillips CerBo (Ireland) Cleanroom options available (Class 7 and 8)

FDA registered

Medical device manufacturing (21 CFR 820)

Drug packaging (21 CFR 210 & 211)

ISO-9001:2000 and ISO-13485 registered

Facilities fully cGMP compliant

Low volume medical production (New Richmond, WI)

High volume medical production (Menomonie, WI)

Global options are available

Phillips East (China)

Phillips CerBo (Ireland)

Cleanroom options available (Class 7 and 8)

Total Solutions - Distribution Warehouse and distribution management of finished products Post-market surveillance

Warehouse and distribution management of finished products

Post-market surveillance

Questions? Please contact us: Phillips Plastics www.phillipsplastics.com (877) 508-0252 OH, IN and southeast MI customers please contact me directly: Jim Rundo [email_address] (216) 956-7574

Please contact us:

Phillips Plastics

www.phillipsplastics.com

(877) 508-0252

OH, IN and southeast MI customers please contact me directly:

Jim Rundo

[email_address]

(216) 956-7574