Medical Device Product Feasibility & Detail Project Report
Market Analysis and Feasibility for Medical Devices
Market analysis and feasibility for the Medical Devices product development cycle must be the first critical stage of any project. For the concept to be effectively communicated, it is important to understand what the client wants and characterize the product.
To create technology for product development and commercialization, a regulatory pathway must be resolved. A Quality Management System (QMS) including risk management and the executives arranging is vital. The product design idea must be assessed to decide clinical utility and gauge costs.
Operon Strategist is a medical device regulatory consulting company that provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
About Market Research, Market Analysis and Feasibility for Medical Devices.
Market research is the key – different countries and regions will pay different prices for the same device, but it’s not just about crunching numbers. Cultural research is one major factor to keep in mind – certain cultures may be biased towards or against certain types of medical procedures or devices.
The size of your target market is important for a number of reasons. If a target market is too small, you will want to determine early on that it’s not worth pursuing. Market size will also likely dictate how much capital you can raise if you decide to go that route. While it’s possible to determine the size of certain individual markets based on existing data, international markets are more difficult to gauge.
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 the choice, we might require using a different pool of expertise. This can also be decided on the area of expertise, like if electronics then with the 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?
We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. Operon will provide you with complete guidance on the market analysis and feasibility of the medical devices, and complete product development process.