Optimizing the New Product Introduction (NPI) Process for Medical Device Contract Manufacturers

Taking a new device from invention to innovation and then to the global market while navigating the ever-changing complexity of the world’s regulatory environments is a constant challenge in the medical device industry. The goal is to end up with a safe, reproducible, manufacturable device that can pass the regulations and help people.

Flexan has designed a process to help with this complex journey to market. We call it our Flexacution method incorporating the Design, Develop and Deliver aspects of this process. We know what the efficacy and economic headwinds are that make all of this such a challenge.

What are the Early Stages of the New Product Introduction Process?

One of the stumbling blocks that can occur is a communication breakdown between CMO and OEM. We overcome this by creating an open, transparent process at the beginning of a partnership, and we start that by asking questions.

When we begin a partnership with a customer, we always start off by asking a few basic questions. Such as:

  • What are the requirements and specifications of your medical device?
  • Are there opportunities to modify or improve device designs for manufacturability?
  • How do we best assist in getting your new medical device to market?
  • How do we best assist in getting your new device to market safely and effectively?

From those questions, we build a long-term solution to bring the device to market while also bringing costs down. Our understanding of how NPI works helps us manufacture a consistent, safe, new product in such a way that it will ultimately bring costs down. However, cost is not the only factor we consider.

There’s a term within the medical device industry known as Health Economics and Outcomes Research (HEOR), that we also factor into our process. This process looks at:

  • Whether or not this is a new innovative device and if it is going to have a long-term cost effectiveness for patients.
  • Whether or not this medical device is going to allow patients to have a better life and live longer.

Another term we sometimes refer to is the medical device company’s Health Economic Goals. These goals cannot only include those listed above, but also:

  • Speed through the regulatory process
  • Speed to market
  • Manufacturing needs to determine whether or not the device will need:
    • Semi-automated assembly
    • Fully automated assembly

This is where our years of experience comes into play. We know the ins and outs of the new product introduction process and we can help guide you through all of these areas and ensure you get to the finish line sooner, but also with a product of high quality.

We understand that introducing a new product is what drives growth, but we also keep in mind how your device differentiates itself from everything else on the market, while also ensuring the device is durable. We know innovation is key and how that can differentiate a device from others, even if they do similar things.

Navigating the Regulatory Rapids

Whether the device being manufactured is a Class I, II or III, because the device will interact with, touch, or be implanted within a patient’s body, there has to be a stringent and detailed New Product Introduction Process. In the United States, the regulations guarding patients against potential harm are changing all the time.

Fortunately, Flexan can help. Flexan’s business model includes an integrated global Quality Management System that spans all Business Units. What does this mean for you? It means:

  • Our medical manufacturing facilities are ISO 13485-2016 and U.S. FDA 21 CFR compliance.
  • We hand-built our New Product Development Process to support design transfer from a single mold up to a 50+ component medical device.
  • Our process offers an extensive joint Customer-Supplier Risk Assessment, including PFMEA & Control Plan Development.
  • A gated New Product Introduction process offering a robust internal and external audit process We ensure all Incoming, In-Process, and Outgoing Quality Controls are tailored for both CMO & customer compliance.


Throughout the process, Flexan asks how we can bring the device to market, but also how we can bring the device to market safely, putting the long-term needs of the patient at the forefront. It’s our goal to produce high-quality medical devices that innovate, but also provide beneficial solutions to patients.  Both the robust regulatory world and our process help us provide to you:

  • Predictability and Risk Management. We ensure the manufacturing process developed is predictable to reduce or eliminate mistakes or problems. This also helps us mitigate risks to the patient. Our process ensures quality standards are met in order to remove any concerns about field quality. The right management partner will make sure the component meets rigid specifications and can be manufactured with repeatable quality.
  • Regulatory Compliance. We’ve talked about this already, but it’s worth mentioning again as it can be one of the most complicated aspects of bringing a new device to market. The regulations change constantly, which is why we have someone on staff who monitors this in order to help plan for it and get your device through it. Agencies associated with the FDA and regulatory agencies with other countries have very strict standards often come into play with medical devices. Navigating these ever-changing rules can be a bit of a challenge, but the right manufacturing partner can help.
  • This is really where Flexan’s combined years of experience come into play. We understand the importance of reaching the objectives on time. If you are not on time, delays can result in increased costs or lost revenue. When introducing a new product to the market, speed and on time delivery is key. Negotiating the risks, and ensuring regulatory compliance reliably allows for an effective and timely introduction to the market. Having the right partner in the process from the start can help with the successful introduction of a new product.

Given those three points, our Flexacution process can be and is customized to your organization’s needs. The goal of this method is to create a manufacturing and creation process that is standardized across all sites. Flexan takes on the burden of ensuring the entire work force is trained in the building of the device.

We also create a check and balance with you to ensure we are always on the right track. This goes back to our past issues with lack of communication between OEM and CMO. Our process does not go forward unless there is agreement with you, so you can trust that we know what we are doing and will do it right.

Flexan’s 7-Phase Approach for Predictable, Timely New Product Introduction

Executing an effective new product introduction process in compliance with global device requirements will also resolve the vast majority of quality concerns. Following a clear, methodical, and robust design control process upfront will prevent lots of tears and anguish when the production machines are turned on.

Flexan’s NPI is composed of seven distinct phases and each phase comes with required deliverables for each client. Each of the deliverables provides evidence of the New Product Introduction activity and can be anything from an approved record or protocol or a report to show what has been done. We identify these deliverables during the earliest of phases. In fact, the process will not move forward unless we have met all of the deliverables.


  1. Phase I: Concept. This is the early “dating” phase of the relationship. It is during this phase we determine if we are a good fit for each other. As such, we will both be asking a lot of clarifying questions. The answers to these questions help us develop a manufacturing solution that achieves both parties’ goals. During this phase, we will also answer your questions and discuss the scope of the project. The ultimate result of this phase is for a Request for Quote.


  1. Phase II: Quotation. After we’ve discussed the concept and determined the feasibility of the project, Flexan will create a customized quote for the manufacturing solution. The quotation is a formal economic estimate of the statement of work and addresses the majority of the questions outlined in the concept phase.


  1. Phase III: Contract Review. In many ways, this is the most crucial early step in the entire process and our contract review process is robust. We have learned that a robust contract review performed by Flexan is the most effective way of meeting customer standards and requirements.

Based upon the outcome of the formal Contract Review, a project plan is created, identifying the required resources.


  1. Phase IV: Manufacturing Transfer. This is where we move the entire medical device product to our manufacturing process. We move from a design into a manufacturable product with a corresponding manufacturing process. The ultimate goal and deliverable for this phase is to transfer your design to an effective manufacturing process without any mistakes.


  1. Phase V: Process Design/Verification. We put the manufacturing process into action and build cross-functional teams to design the tools, equipment and create the processes that will create your device to your specifications. We customize this phase to match your needs, but also keeping the end-goal and patient in mind.


  1. Phase VI: Process Validation. Mandated by ISO and the FDA, this is where the manufacturing equipment and the manufacturing process are validated.

For this, we engage the Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualifications (PQ) components of our process to make sure every aspect of the manufacturing and assembly process is working. The end result is a repeatable, safe, manufactured device.


  1. Phase VII: Production. We’ll do a final check to ensure we are ready to manufacture and proceed with the production in two steps. Step one is the initial release and production surveillance to make sure you end up with the product you want and have contracted us for. Step two is the final production release. This is the official last phased gate of our 7-step Flexacution process and allows us to show support through the lifecycle of the product.


Flexan Understands New Product Introduction

Here’s the good news: Flexan’s 7-phase Flexacution approach ensures that your product is right for our manufacturing capabilities and our experts use their years of experience to guide you from medical device concept to a stable and reliable manufacturable process for your medical device. Flexan is ready to become a partner with you and to get the journey started and bring your medical device to market.

The first important step is to contact one of our representatives to discuss your medical device.