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Illustration of a typical medical product development lab.

What Is the Medical Product Development Process?

Constructing a medical product is not an easy task, and will add several additional steps to your project outside of those typically needed with non-medical products. The idea of medical product development will be the same as any other product on a fundamental level, but there are additional goals that need to be met to gain the necessary approvals for full-scale manufacturing and distribution to medical practitioners.

The Birth of an Idea: From Concept to Risk Analysis

Illustration of a typical medical product development lab.

If you are reading this, you probably have an idea for a product that could potentially perform a valuable task in a medical setting. But there are a few important tasks that must first be performed before finding a manufacturing partner to bring your product to life:

  • Define the market fit for your product, including its intended customer, cost entry points, and its potential for being accepted in a clinical setting.
  • Determine all regulatory aspects for the product, including testing, certification, and medical classification requirements.
  • Formalize and execute a comprehensive risk assessment plan.
  • Identify similar products on the market, as this can lead to quicker certifications and reduced clinical trial requirements.
  • Conduct a financial viability study that considers the costs associated with meeting regulatory standards as well as design and production costs.

Using this shortlist as a guide, you will gain a realistic idea of your product’s potential place in the market. A comprehensive idea around any testing or regulatory requirements and their associated costs will also result from performing the listed steps. This gives you the information needed to perform an in-depth risk analysis, which will either push your project forward or keep it on the drawing board for further work on its concept and purpose.

Align Product Verification and Validation Tasks to Medical Quality of Standards

Although customer needs will still drive the initial design and functionality of a medical product, the increased scrutiny of getting a product through clinical trials adds new layers to the project’s design stage. All steps of the design process must be conducted consistently and transparently, following a circle of design, development, and review. And, all of these processes must adhere to strict quality standards.

As with the design and development of general consumer-based products, holding to a high level of quality standards is necessary. However, the primary tasks of product verification and validation will differ slightly due to the higher levels of scrutiny that medical products must undergo. Here are some examples of each verification and validation as they apply to the increased due diligence necessary for medical certification:

Verification

Establishing viability and quality standards of medical products starts with verifying your ready-to-be-tested design against the engineering design specifications (EDS) created during its conceptual stage. This involves confirming that features operate as expected and can be documented and applied to the next stages of testing.

Validation 

In this step, the final product design or prototype will undergo validation against both the EDS and the expected user requirements. An audit trail is extremely important in this step, as this is where the product’s properties are closely examined and its final design outcomes are compared to the conceptual and desired customer outcomes. It is here where prototypes come into play and are exhaustively tested and evaluated in clinical trials.

You must perform a series of scripted and concise quality control checks throughout the design process, regardless of whether your product is medical or not. The audit trail of design and testing will lead to an improved prototype which will, in turn, give you more realistic performance attributes, making your product a better product. This audit trail will also provide the precise information required by medical regulators that can be used for its final certification.

Build, Distribute, and Support the Final Product

Once you have reached the point where there are no more tests to run and have passed clinical trials with flying colors, the time has come to get your product out to customers. Before you begin to manufacture your product, you will need to have a marketing plan in place. But unlike other types of products, medical product marketing must be backed up by data and cannot make exorbitant claims. Doing this builds truer customer relationships and mitigates your risks and future liabilities.

Seeking a contract manufacturer that specializes in ground-breaking products is ideal. Also ideal is finding a partner that offers short-run and small-scale manufacturing options. This adds an extra element of quality to your product while keeping inventory at a minimum. And, when the contract manufacturer can offer design and development services of its own, you may find improved ways of building your product that you never before considered.

A Manufacturing Partner Simplifies Medical Product Development

Producing a medical product introduces layers of complexity that must be carefully managed. The project must be run with accurate documentation auditing in mind, and the design must be carefully tested to ensure that it can get past clinical trials in a breeze. But before you invest time into your project, partner with an experienced, all-inclusive white-glove manufacturing partner that can present volumes of experience and industry know-how to guide your project to a successful conclusion.

Partnering with the experienced manufacturing team at Pacific Research Laboratories can eliminate many of the early errors that can lead to costly project overruns. We use our experience in small-scale manufacturing and design to help certify, test, and produce your product as needed to meet the expectations of your medical customers. To learn more about our services, please visit our contact page or call (206) 408-7603.