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Genesis Plastics Welding

Contents
When should you outsource your manufacturing? 3

Make outsourcing work for you 4

Plotting a course for long-term success 5

Begin your journey by establishing criteria 6

Keeping your search on course 7

Navigating an internal audit 8

Ensuring a route to contract manufacturing success 9

 When should you outsource your
TOP REASONS OEMs OUTSOURCE
manufacturing?
It’s common practice for businesses to outsource support services such as accounting, marketing or recruiting
when they don’t have the resources to get it all done in-house. For many, the decision to farm out such
services often comes down to cost reduction. But when it comes to outsourcing your manufacturing, there are
far more reasons to consider outsourcing beyond reducing company expenses. While ultimately outsourcing
is an effective cost cutting method, it also can create greater efficiencies, allow you to refocus on your core
competencies and (with the right contract manufacturer) can support innovation – all of which help you gain
a competitive edge within your marketplace and promote long-term success.

Is it time to hire a contract manufacturer?

Do any of these pain points sound familiar?

I’m being challenged to get products to market more quickly.

I’m being pressured to cut costs.

I don’t have the resources to spend on research and development.

I’m struggling to find qualified labor and keep up with production demands.

Source: Outsourcing World Summit Our energy is being invested in production, rather than focused on the core competencies that give
us a competitive advantage.

If so – it’s time to consider outsourcing your manufacturing. The right contract manufacturer (CM) can assist
you at various stages of the manufacturing process, from research and development to production. Once
you begin to consider outsourcing, it’s important to find out which services different CMs offer and how
outsourcing will work into your overall business strategy.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 3

 Make outsourcing work for you
TESTIMONIALS There is no “one size fits all” solution to outsourcing. The decision to outsource should be in line with your
business strategy and enable you to get closer to big picture business goals. Through careful analysis and

“ Over the past two years, the Genesis

Plastics Welding team has become
a true consultant for us – identifying
preparation, outsourcing can give OEMs a competitive advantage.

What are the benefits of outsourcing?

Lower operational and labor costs
new methods to make our products
better, leveraging prior experience
Frees up valuable resources to focus on core competencies
to ensure higher quality standards,
finding new materials that we Leverages specialized capabilities of outsourced partners (i.e. better technology, knowledge
hadn’t thought of, and developing of product and market, quality processes)
innovative solutions to problems with
our initial designs. GPW has been very Improves efficiencies to get products to market quickly
responsive to our needs, and able to
react to unforeseen challenges. Respond quickly to production demand variables
GPW’s strict adherence and attention
Enable innovation and access to new markets
to quality, combined with their
ISO-13485 certification, has A lot can be gained from outsourcing some or all of your manufacturing. As with any other business decision,
strengthened their standing as a
before you move forward it’s important to consider exactly what you’re looking to achieve.
supplier of choice for us in the medical
products arena. Prior to gathering a list of potential CMs, take the time to analyze your company’s own capabilities and
overall business goals. Also, determine which services you realistically will require from a CM. Consider major
stakeholders and garner input from critical team members in departments such as engineering, production,
President and COO quality control and finance. The more work you do upfront, the more you can be certain you find the right CM
turer
Medical device manufac
to get the best return on your investment.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 4

 Plotting a course for long-term
CREATING YOUR CHECKLIST success
Finding the time to search for a qualified manufacturing partner is an initial roadblock OEMs struggle to get
past. While the process can take time, outsourcing can reap significant rewards for your company. Preliminary
time spent flushing out the details of exactly what you need in a CM and how outsourcing will work into your
company’s long-term goals will set you up for a more successful contract manufacturing relationship.

Early stage planning for a smoother journey.

Work with others in your organization to develop a selection process and establish search criteria. While it’s
tempting to cut time by automatically selecting the lowest bid, a manufacturer’s quote typically only covers
around 70 to 80 percent of the total supply chain cost. Different manufacturers will also have varying pricing
structures and can’t always accurately predict unforeseen circumstances that may arise during production.
Choosing a CM based on price alone also does not guarantee that they will have the proper capabilities and
established processes you need to get the most out of such a partnership. The following pages will give you
an outline of criteria to consider when evaluating potential CMs.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 5

 Begin your journey by establishing
criteria
To begin your search for the perfect CM, select a handful of potential companies based on the following
initial considerations:

Location – Consider where the CM’s facilities are located in comparison to your company as well as
your customers. Would it be more convenient to outsource locally?

Capabilities – Compare the CM’s range of services to what your company needs. For instance, if
your team will need assistance with R&D or material selection, be sure the CM has such expertise.
Make sure the CM’s facilities will be able to handle the size and scope of your production needs.

Breadth of experience – Look into how long has the CM been performing its services, what
quality certifications it has and consider the level of knowledge and training of its staff.

Company culture – Consider the goals, vision and mission of your potential CMs. Are they
committed to continuous improvement and are all of its employees aligned with these
ideals? A CM will function as an extension of your business and therefore it’s important
to have compatible philosophies.

Financial stability - Are they a well-established company that has the means to take on your
production needs? Longevity can be a great indicator of stability and give you the confidence
needed to enter into a partnership with the company, whether your goals are short or
long-term.

This first audit should give you a basic overview of your potential manufacturing partners and help you
narrow down your list to three to five companies to which you will then send Request for Qualifications
(RFQ) and eventually audit in greater depth.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 6

 Keeping your search on course
During all stages of your search for a contract manufacturing partner, it’s important to keep a running list of
information to keep you organized and help you narrow down your search. Keep track of information such
as: which companies you have contacted, date they responded, contact information, status of confidentiality
agreements, and information on whether they fit your most important criteria.

Solicit Proposals
The next step on the road to a CM partnership is to send out RFQs to those top three to five companies.
RFQ documents should include enough information for the CM to be able to respond with a meaningful
proposal without giving away too many details. Include information sufficient for understanding the
product and provide a quote for the cost of goods, tools, timeline, etc.

Once proposals are returned, you can use them to assign a score to each potential CM as a means of
narrowing your search further. Use these scores to select the top two or three companies that you will visit in
person for a facility audit.

Tip: Easily keep track of each

CM’s score as you receive their
RFQ by creating a scorecard like
the one seen here. Remember
to adjust the scores according to
which criteria is most important
for your company.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 7

 Navigating an internal audit
Once you’ve narrowed down your list of potential CM’s based on your chosen criteria, it’s time for more
thorough facility inspections. When auditing on site, it’s important to pay attention to a CM’s processes and
controls. Quality assurance is imperative for any OEM, but especially those in strictly regulated industries,
such as medical device manufacturing where proper compliance is paramount for product success.

Production and process controls – Pay close attention to whether a CM adheres to good
manufacturing practices and industry certifications - which serve as a roadmap for quality processes.
Find out how product and process risk is assessed and how controls are applied in mitigating the
risks. Qualified CMs should use preventative quality measures and have processes in place throughout
production in order to save you time and money while ensuring a quality product.

Management controls – Your CM should have fully documented and accessible records detailing
their management review and quality audit procedures. This verifies that the CM has an efficient and
sustainable quality policy in place. Having access to critical documents outlining what you can expect
with production is a crucial part of maintaining control and lessening potential risks associated with
outsourcing.

Design controls – Design control systems ensure full control over the design process and assure
devices meet specified requirements and keep intended uses and end users in mind. The OEM, as the
owner of the design, should pay attention to the CMs change controls, transfer of design to production
procedures, device master record (DMR) and the assigned responsibilities between the core team
members.

Management of Corrective and Preventative Actions (CAPA) – Even with the best quality systems
in place, mistakes can sometimes happen. The best CMs are highly responsive in resolving issues, have
the proper systems in place for correcting problems and will use them as opportunities to improve
their processes.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 8

 Ensuring a route to contract
manufacturing success
Finding a manufacturing partner takes time, but it’s important to put in the effort to find the right fit. After
all, the CM you select will essentially be an extension of your company – one that can give you a competitive
advantage in your marketplace.

The journey to successful outsourcing truly begins once you’ve found your CM. Moving forward, it’s critical
to foster a successful partnership through open communication. Communication is essential for OEMs in
maintaining control and ensuring their CM is on the same wavelength. Establishing and communicating
your role as an OEM and your CM’s role is also important. Make sure your team and your CM know exactly
what you need. Take full advantage of your CM’s expertise and use it to fill in the missing links your company
had prior to this partnership.

Ready to hit the road?

As one of the industry’s leading experts in the contract manufacturing of thermoplastic products, at Genesis
Plastics Welding we’re confident our qualifications will meet your needs. For nearly thirty years, we’ve
created heat sealing solutions that ultimately help OEMs in a variety of industries bring viable products to
market in the most efficient and cost-effective ways. Visit www.genesisplasticswelding.com to find out about
our capabilities from research and design services to the licensing of our proprietary ecoGenesis technology
to contract manufacturing.

Genesis Plastics Welding Contract Manufacturing: Roadmap For OEMs 9