Coming up with a Medical Device Design that adds value to the end-user and also brings profitable market share is a very challenging job. Besides, healthcare is a critical segment where you don’t have the scope for making mistakes. It is related to the lives of people and involves complex procedures.
Hence, you need experts and competent consultants who can help you seek a holistic approach to design a medical device. It requires precision in every stage right from brainstorming to compliance, designing, testing, and marketing of a medical device.
In short, the medical device design process is more than just conceptualizing a solution, developing a prototype, and mass production.
What approach should I take for Medical Device Design and Development?
To deliver the right medical product that addresses consumers’ requirements, it takes a great deal of effort, knowledge, skill, and holistic approach. This type of product demands everybody staying on the same page with strong scope from end-users’ needs, collaborative efforts from design and development team, adherence to the specifications and requirements, mitigating risks, and sticking to the best possible quality.
How should I approach Product Ideation and Conceptualization in the Medical Segment?
You need to start by analyzing and identifying the market, what needs of people in this sector are untapped or unmet, or figuring out if there is a more efficient way to address particular needs or accomplish a task. It could be anything that provides a solution to problems or enhance the efficiency of already-available devices and methods for monitoring health, better administration, or anything that supports health and life.
You don’t have to create a device that addresses a particular problem. You can also create something that adds convenience to the routine lifestyle or situation. In medical terms, solutions are termed as ‘vitamins’ if they are improving health/lifestyle or ‘painkillers’ if they are addressing a problem.
Here is the step by step approach for the Medical Product Ideation and Conceptualization:
- Identifying the need for demand is the first step for creating a medical device that will have customers in the market apart from being compliance-ready.
- You need to know the gap between the need of the target market and what your design team perceives as the need. The smaller the gap is, the better the idea for product definition will be. A strong product definition is formed by analyzing market needs.
- Once you have the product idea and definition, you need to consider procedures, such as FDA defined classification and intellectual property rights.
- The classification of a medical device is based on the risk associated with product use and enforced by law. Besides, you also need to look for any existing Intellectual Property on the proposed idea or similar. If there is, it may disallow you to use that particular mechanism or technology.
- Gather a team with great skills and experience. The best thing you can do at this point is to hire medical device Design Consultants who can help you with medical device engineering.
- Whether you choose an in-house team or third-party Medical Device Design team, it should have experts in engineering and design, human factors and usability engineering, clinical & scientific knowledge of the medical industry, regulatory affairs and quality assurance, and intellectual property law.
- Then, you will move to the discovery phase which consists of initial designing, prototyping, PoCs, and iteration-driven redesign.
Once you have successfully completed the product conceptualization and discovery phase, you can proceed further for FDA approval and commercialization.