Considerations When Introducing a New Medical Device

There is, as you know, a complexity in creating a medical device and bringing it to market where it will be used for patients. Here, we’re not necessarily talking about the device or component itself being complex, but the design, manufacturing, assembly, and regulatory navigation processes.

To manage this complexity, Flexan has created a 7-phase process to help companies navigate through each of the steps involved. Let’s break down the three steps we feel are the most crucial, to bringing a product to market. They are:

1) Predictability & Risk Management

Mitigating risks and creating an assembly and manufacturing method you can rely on is key. No one wants surprises when they’re manufacturing a new medical device or component. The right contract manufacturing partner can ensure the component meets rigid specifications and will be manufactured with repeatable quality.

This is where a rigid and formal NPI process will result in both a predictable schedule, as well as a consistently manufactured product that meets all product specifications and requirements. The right process will also identify design and manufacturing-related risks to ensure product risk is appropriately managed and controlled, enabling a predictable user and patient safety profile. This involves creating a risk management plan for each client. This should include:

• A definition of the product or products for which you’re planning.
• A description of the product’s intended use.
• A description of all risk management activities.
• Identify your risk management team and include their roles and responsibilities.
• Create criteria for the product’s risk acceptability.
• Clearly define methods to verify risk control
• Definition of how post-production information will be recorded and used
• Creation of a Risk Management File, which is the section of your QMS where you keep all your risk management activities, records, and other documentation, which should include:
  • The risk management plan, risk analysis, risk evaluation, risk controls, evaluation of overall risk acceptability, risk management report, and production and postproduction risks.
  • It is also crucial that you consider the overall impact on risk when making all design decisions. Because of this, you need to make sure there is a clear connection between your design controls and risk management information. Your Risk Management File should contain this information and documentation.

2) Regulatory Compliance

Regulatory strategy is one of the most, if not the single most, challenging aspects of launching a medical device. There are regulations for every country and navigating them all is enough to drive just about anyone crazy. However, the right manufacturing partner, with years of experience in navigating the regulatory maze, can help.

How soon do you need to start planning for regulatory compliance? Right from the beginning at the business plan stage. In fact, there should be a detailed, written, specific regulatory plan for your medical device. When creating this, remember that every device is different, and every device will have its own regulatory strategy. There is no “one size fits all” regulatory strategy you can use for every device you create. The best strategies involve proactive planning with clearly documented and sound rationale for each of the decisions made.

Agencies such as the FDA and other international regulatory agencies invariably come into play with all medical device introductions. So, clearly, there are challenges here to understand and navigate these ever-changing rules, but the right partner can help. A partner with a proven, phased, plan for NPI and years of experience in the regulatory area will help ensure the required submission data and documentation are identified and compiled, enabling timely and efficient approval.

3) Timeliness.

Of course, this is key. Everyone in the medical device industry will probably say that timeliness is one of the most important aspects of New Product Introduction. As a reminder, let’s look at why it’s so important.

The most important component to timeliness is that innovation translates to profits. Once you innovate, beating the competition to market is, of course, key, but particularly so in the highly competitive medical device industry. Stagnation leads to being left behind and loss of revenue.

Keeping timeliness in mind from the start creates a speed advantage. This comes from risk mitigation, which will increase time to market for new products. Like so much of NPI, we must accomplish this early in the process. Why must it be part of the earliest discussions?

The type of manufacturing and assembly techniques used affect speed and timeliness. Since we know that speed is so important when introducing a new product to the market, there are important elements you need to plan for even before a single part of the device is manufactured. Identifying the product, process, and timeline risks up-front will enable both partners to appropriately resource the project and ensure that contingency planning is incorporated.

The proper manufacturing and assembly process is important to determine from the start. The packaging will determine shipping requirements, for example, or even how the medical device can be stored once it reaches doctors or hospitals. All that said, there is some flexibility in manufacturing which can help get a device or component to market faster. Therefore, having the right partner in the process from the start can help with the successful introduction of a new product.

Flexan partners with clients to create a holistic approach. Our experts study the entire assembly process to determine pitfalls and possible stumbling blocks early on. Our years of experience allow us to understand how to determine assembly, design for manufacturability, mitigate risks, negotiate regulatory problems, and provide a timely solution with speed-to-market in mind.

NPI is complicated, but it doesn’t have to be something you do alone. The right CMO partner can help make it less intimidating, mitigate the risks and help with the crucial speed to market phase. Contact Flexan to see how we can help you and discuss our Flexacution process.