right controls and documentation, and a team that understands
what regulators expect when they show up to audit a process, must
be capabilities without question. Other considerations depend on
the desired relationship and scope of the project. Selecting a CMO
with a medical-qualified global footprint and workforce mitigates
risk in managing future regulatory and political hurdles. A strong
supply chain and the ability to scale provide risk mitigation and defend against disruption. Design and innovation expertise becomes
even more valuable if the CMO can provide technology“building
blocks” that enable new and differentiated solutions.
Kaiser: Develop a comprehensive assessment to take into
account overall quality management systems and their effectiveness, supplier financial stability, stability of the management team,
and review of supply chain metrics and how they are tracking.
Understand their vertical integration capabilities, investment in
latest equipment, and demonstration of how they are innovating.
A critical area is to determine if they have adequate engineering
resources and expertise to root cause and solve issues in a timely
manner as they arise. An overview of their quality management
system and on-time delivery metrics are also key considerations
as they relate to cost efficiencies to bring a product to market.
King: A CMO must have broad manufacturing capabilities
combined with a robust quality management system that can
handle everything that is required to take the OEM’s products
from prototype to finished device. The CMO must have the engineering resources that can seamlessly work with the OEM as
an extension of its engineering teams. The CMO’s engineers
must be able to explore and find new manufacturing processes
to meet each challenge of the OEM’s product to make it cost effective to manufacture.
Miclot: Look for quality suppliers that have a long history of
serving the medical device market. We are in a large but, at the
same time, small industry; many folks have worked for several
medical device companies. Ask your friends in other companies
who they use and would recommend.
Neal: Seek out CMOs experienced in their respective field/
competency. Also, see how they handle process validations and
supplier audits as an indicator of quality and timeliness of addressing deficiencies.
Welch: OEMs need to find a CMO they trust, and can truly
partner with. The CMO they choose should have the knowledge
and expertise in the areas they need.
TAKE YOUR CHANCES OR TAKE COMMAND.
CommandMedical.com • Sales@CommandMedical.com • P: 386-672-8116 • F: 386-677-7781
EXTRUSION R. F. WELDING ASSEMBLY & PACKAGING
‣ 100% Medical Contract Manufacturing
‣ Clean Room Assembly and Packaging
‣ FDA Registered, ISO 13485
‣ US and Nicaragua Manufacturing Sites
‣ Formal Technology Transfer Program
‣ Product Design Assistance
‣ Component Selection Assistance
‣ Injection Molding and
‣ Inventory Programs