Many companies treat product development as if it is equivalent to manufacturing. In reality, the two are tremendously different. In the arena of manufacturing physical objects, activities are reasonably predictable and tasks are repetitive, whereas, in product development, tasks are unique, the project needs constantly change, and the output with respect to the widespread use of computer-aided design and simulation can reside in multiple places at the same time.

“The failure to understand product development, and appreciate and manage associated changes will lead us in considerable fallacies that enfeeble the planning, designing, execution, and evaluation of product development operations.

So let’s take some time to understand product development, associated changes and how to manage these.

What is product development?

In the device world, product development is a chain of steps namely, conceptualization, design, development, manufacturing, and marketing of a newly created or re-branded device that is safe and effective and meets user needs and intended requirements.

What are the associated changes?

There are numerous changes that can be encountered in the product development process, some of these are:

  • Change in design
  • Change in suppliers
  • Change in material
  • Change in process
  • Change in target country

How do we manage these changes?

“The best way to handle change is to be prepared for it”

And how can one be prepared……

By understanding the core concept of product development. The picture below elucidates this further:

Product development life cycle

This life cycle demonstrates how customer requirements (identified through user need assessment and post market surveillance) shall derive the design inputs and the medical device development throughout its life cycle. At each stage of the device development a review and FMEA (which is a risk assessment tool) shall help companies in constantly monitoring associated risks. Irrespective of any change, through these activities a company, at all times, can:

  • Identify the user needs and understand the competitor product
  • Meet regulatory requirements to deliver high-quality products, from inception through production
  • Identify and mitigate risks along the way
  • Be reasonably sure that the end product meets the customer needs and satisfaction

To get a medical device into a new market it takes a lot of work, effort, new technology and time. The product development process continues (as depicted above) even after the regulatory approval and market release.

ELEXES provides regulatory, clinical, nonclinical, and quality expertise to an existing project or takes on the role of the project leader in setting up and managing a core team from scratch. Our approach and network of contacts aids in supporting the product development program from inception right through to marketing authorization – helping you to execute your product development plan and navigate seamlessly through changes to achieve regulatory and commercial success.


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Expert's Desk

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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