Medical device design and development FAQ

Medical device design and development FAQ’s based on how the design and development adds value to end user and simultaneously captures profitable market share is really a tough job.Is it because healthcare is a life-critical segment? Or is it because it involves complex procedures? Apparently, both. In addition, it needs to be aligned with healthcare regulatory requirements, solution specifications, and should deliver functionalities to satisfy end user needs.

Hence, it seeks a holistic approach to design a medical device rather than being an isolated part of the complete process. It requires precision in every stage — right from product ideation to compliance, designing, testing and marketing of the product.

These Medical device design and development FAQ’s will guide you through all your queries.

How do you design a medical device?

Medical device design is the first stage in the production of new tools, appliances, and instruments for use in a wide variety of medical and surgical processes. It includes not only the mechanisms and implements used to treat patients at hospitals and other medical facilities but also implantable, wearable, and portable medical devices that can perform the functions of human organs, deliver medication, and monitor patient vitals in real time. The functionality of the final product is dependant upon the design stage.

Medical devices design and development is the urgent stage for its prosperity Operon strategist is there to guide you with the design consulting for medical devices.

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How long does it take to Develop a Medical Device?

Developing and gaining approval for a new medical device is not a fast process and can take many months or even years depending on the type of device being developed. Studies show that it takes three to seven years to bring a device from concept to approval. This may seem like a long time, but it includes the entire device lifecycle, including research, development and testing.

Does a Medical Device need FDA Approval?

All medical devices that are manufactured, repackaged, relabelled or imported for sale in the United States need some level of FDA approval. The FDA’s ‘Center for Devices and Radiological Health’ are responsible for regulating these products as well as medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens and even colour televisions.

The required level of regulatory control increases with each class of medical device, from one to three. Most class one devices do not require Premarket Notification 510(k); most class two devices require Premarket Notification 510(k); and most class three devices require Premarket Approval.

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What is Design Controls in Medical Devices?

Design controls is a formal methodology to drive medical product development activities, which are often mandatory. Medical device manufacturers must follow design control requirements under 21 CFR Part 820.30 to market all class 2 and 3 devices as well as certain class 1 devices such as software controlled devices.

Design control is a set of quality practices and procedures that control the design process to assure that the device meets the user needs, intended uses and specified requirements as well as improve and prevent future issues.

Operon Strategist is the leading medical device 21 CFR 820.30 design control consultant who has extensive experience and has done practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes.

What is Design Verification in Medical Device Development?

Design verification is a qualification testing methodology that ensures that a medical device is designed as it is intended. Verification is an internal process, which evaluates whether a design output meets the specified requirements, specification or regulation defined in the design input. Verification testing may occur at any point in the process, beginning from the ideation & conceptualization phase to the post-production phase.

What is Design Validation in Medical Device Development?

Design validation is a testing from the market perspective. It is intended to validate whether a medical device is meeting the user’s needs. Successful validation proves that a device meets needs of users in the targeted market. Although validation comes into the picture at a later stage of product development process, it still measures the very first part of the complete process, which is defining user needs. Validation must involve testing and clinical evaluation. Also, it requires a device to be developed in the production environment with an involvement of end-user for actual or simulated testing.

Why is Design Verification and Validation needed?

Medical device users look for effectiveness and safety of devices that they use to address a particular problem or condition, which are sometimes critical to life. This is why iterative testing with verification and validation of these medical devices becomes imperative. Verification and validation of medical devices in the design process aim to ensure that the device is aligned with the need of targeted users and delivers the intended solution. It also helps ensure whether all the requirements are being satisfied. It helps to comply with regulations as well as designing the highest quality product.

Design and development of a medical device is the most crucial phase for its success. A loosely-defined and designed medical device cannot comply with the regulatory needs and make it to the market. We’ve tried compiling all the important questions regarding the medical device design and development faqs