How We work

At Nextern, we provide dynamic collaboration that works. With manufacturing flexibility, a tightly managed supply chain, and a complete quality system,  you will experience the Nextern commitment to supply chain and manufacturing excellence with every order.

The nextern Difference

Greater than the sum of our parts.

While the exact shape and details of each collaboration flex based on the needs and capabilities of the collaborator, a typical project looks like this:
Collaborator

A clinical problem to be solved and an idea to make things better.

Nextern

We ask the right questions, uncover blind spots, and offer new perspectives rooted in deep market knowledge to get things started right.

Collaborator

Well-defined business case, an understanding of market needs, clear priorities, and a project scope

Nextern

A detailed project plan is created based on discovery and our extensive experience getting products to market, taking into account cost, quality, timeline and risk, giving our collaborator the complete project picture.

Collaborator

Market expertise and clinical access to guide development to meet customer needs for commercial success. 

Nextern

Top-notch engineers turn your vision into reality – contributing innovation and experienced insights along the way.

Collaborator

Provide input on requirements and test protocols, and guide any needed modifications prior to design freeze.

Nextern

Utilizing a risk-based approach to verification, confirm device meets all design inputs.

Collaborator

Regulatory is readying for submission and launch planning is in full swing.

Nextern

Ensure device meets user needs; perform all the testing and documentation required to support a strong regulatory submission.

Collaborator

Product is launched, sales begin, and revenue is realized. Post-market work is on-going.

Nextern

Flexible manufacturing with a tightly managed supply chain and robust quality system for ongoing support.

DISCOVERY

COLLABORATOR

A clinical problem to be solved and an idea to make things better.

NEXTERN

We ask the right questions, uncover blind spots, and offer new perspectives rooted in deep market knowledge to get things started right.

PLANNING

COLLABORATOR

Well-defined business case, an understanding of market needs, clear priorities, and a project scope.

NEXTERN

A detailed project plan is created based on discovery and our extensive experience getting products to market, taking into account cost, quality, timeline and risk, giving our collaborator the complete project picture.

DEVELOPMENT

COLLABORATOR

Market expertise and clinical access to guide development to meet customer needs for commercial success.

NEXTERN

Top-notch engineers turn your vision into reality – contributing innovation and experienced insights along the way.

VERIFICATION

COLLABORATOR

Provide input on requirements and test protocols, and guide any needed modifications prior to design freeze.

NEXTERN

Utilizing a risk-based approach to verification, confirm device meets all design inputs.

VALIDATION

COLLABORATOR

Regulatory is readying for submission and launch planning is in full swing.

NEXTERN

Ensure device meets user needs; perform all the testing and documentation required to support a strong regulatory submission.

COMMERCIALIZATION

COLLABORATOR

Product is launched, sales begin, and revenue is realized. Post-market work is on-going.

NEXTERN

Flexible manufacturing with a tightly managed supply chain and robust quality system for ongoing support.

Working with Nextern

Offering the best of both worlds.

Device Design & Development

Transforming innovative concepts and technology into realized medical devices

 

Employing a sprint-to-design freeze strategy and leveraging vertical integration and global operations

 

Implementing intelligent product design grounded in real-world manufacturing

 

Conducting bio-simulation and pre-clinical testing to drive a clinical path

The nextern difference

Nextern offers project flexibility, vertical integration, expertise in our capabilities, and reduced time to market – providing each one of our collaboration partners with the resources for success.

Full Spectrum Manufacturing

Utilizing adaptable design and manufacturing processes to efficiently commercialize complex medical device systems

 

Providing the ability to rapidly scale fully-kitted product lines to meet volume demands

 

Presence in strategic global manufacturing locations with localized supply chains

 

Full life cycle management including service, warranty and continuation engineering

Device Design & Development

Transforming innovative technologies into realized medical devices

 

Conducting bio-simulation and pre-clinical testing to drive your design and IP

 

Vertically integrated processes and experienced teams enable rapid iterations

 

Mutually aligned design selection, speed-to-market and manufacturing readiness

The nextern difference

Nextern offers project flexibility, vertical integration, expertise in our capabilities, and reduced time to market – providing each one of our collaboration partners with the resources for success.

Full Spectrum Manufacturing

Presence in strategic global manufacturing locations with localized supply chains

 

Phased approach for seamless transition from development to commercialization

 

Leverageable assets and capacity to enable duplication or full line transfers

 

Life cycle management including service, warranty and continuous improvement

Contact Us

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