Market Analysis and Feasibility for Medical Devices

Market analysis and feasibility assessment are the first critical stages in the medical device product development cycle. To communicate the product concept effectively, it’s crucial to understand the client’s needs and define the product clearly. Identifying the regulatory pathway early on is vital for medical device verification and validation as well as ISO 13485 process validation.

A robust Quality Management System (QMS), which includes risk management and comprehensive planning, plays a key role in this process. The product design concept must be thoroughly evaluated to ensure clinical utility and project costs. Confirming clinical relevance is essential for ensuring market acceptance and reducing risks in medical device packaging validation. Understanding these requirements saves time and money during product development by streamlining efforts and minimizing unnecessary revisions.

Operon Strategist is a leading medical device regulatory consulting company offering strategic guidance to healthcare manufacturers. We support manufacturers throughout the product development cycle, ensuring compliance with international standards and validation requirements.

Market Research, Market Analysis, and Feasibility for Medical Devices

Market research is the foundation of any successful medical device project. Price points vary across countries and regions, but it’s not just about numbers; cultural research is equally important. For example, certain cultures may favor or reject specific medical procedures or devices. Understanding these nuances is crucial for the verification and validation medical device process.

The size of the target market is another important factor to consider. If a target market is too small, you may need to determine early whether pursuing it is worthwhile. Additionally, the market size can impact capital-raising efforts. While it’s easier to determine market size in local regions based on existing data, international markets present a more significant challenge.

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Two Major Segments for Medical Device Manufacturing

a) Electrical devices: like ECG machines, Pulse oximeter machines, and X-rays.

b) Disposable devices: Like syringes, Masks, IV cannulas, IV sets, etc.

For marketing and feasibility, depending on choice, we might require using different pool of expertise. This can also be decided on area of expertise, like if electronics then with electronic regime or if any moulding, plastic expertise in disposable products.

1) Identification of targets and suitable manufacturing technologies

Medical device manufacturers strive to be more efficient and fast in their manufacturing processes, while also being responsible corporate citizens. Thus, manufacturing demands constant insight into renewable resources, sustainable materials, equipment that is more energy efficient, suitable manufacturing technologies, and methods to reduce waste creation.

2) Infrastructure requirement to support product strategy

Early development encompasses fundamental steps such as the definition of the device specifications, foreseen intended uses and indications for use, and the gathering of relevant data to support product safety for market and feasibility studies. A thorough risk analysis is performed to support the product’s global development plan. The infrastructure is dependent on the location of manufacturing and the intended market. Particularly when it comes to serializable and disposable products.

How Can Operon Strategist Guide You in Market Analysis?

 Operoon Strategist is a team of technical experts in the medical device industry who are well aware of the market and all related updates. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. Operon will provide you complete guidance on with the market analysis and feasibility of the medical devices, and the complete product development process. Contact us now for further queries.