Clinicians desire medical devices that address regulatory compliance and deliver accurate and effective health care outcomes. Medical device consulting companies play a critical role in medical device design and development. These firms gather and analyze the medical device market, competition and risk related data to determine the commercialization potential of the device. Medical device consulting companies create a medical device commercialization strategy that helps in attracting investment. An effective medical device that delivers the desired value to clinicians can capture a profitable market share. Designing such a device requires a polished approach and precision in every stage of the medical device development cycle from ideation to marketing.
Importance of medical device design
The medical device design and development is a crucial phase. This ensures that the device meets regulatory needs and end-users’ needs. This further helps the medical device company with accelerated adoption. A medical device design is more than conceptualization, product development and manufacturing.
Medical device design and development
Developing a device that is accurate and effective and also reduces healthcare costs requires a significant amount of effort.
Ideation and conceptualization
Medical device development begins with medical device market identification and analysis. A new medical device is expected to improve healthcare outcomes, meet unmet needs, reduce overall healthcare cost and improve workflow. The following are the steps involved in medical device ideation and conceptualization:
Identification of needs
Identifying the end-users’ needs is the primary step for successful medical device development. The following two things can make the end-users’ needs identification more successful:
- The gap between medical device developer’s perception of the target market’s needs and the actual target market’s needs. Reducing this gap delivers better inputs for medical device product definition.
- Medical device market research and analysis companies extract a strong product definition.
Note: This definition defines design and desired healthcare outcomes for a specific need.
Medical device classification
The Food and Drug Administration requires a medical device company to classify its device. After product definition and idea, the medical device company has to consider the FDA’s procedures such as classification and intellectual property rights. Medical device classification is a legal requirement. A medical device is classified on the basis of risk associated with its use. A medical device developer should also look for pre-existing intellectual property rights similar to the idea. It is critical to ensure Intellectual Property rights as this can disallow medical device design and development based on that idea. It is critical to find a medical device consulting firm and have a strong development team to complete the discovery phase. The consultants and medical device development team should be well experienced. The team should have experience in the following areas:
- Design and engineering
- Human factors and usability engineering
- Aligned scientific and clinical knowledge
- Intellectual property laws
- Regulatory affairs
- Quality assurance
Transition to Discovery Phase
The third step is the idea’s transmission into the discovery phase. The discovery phase contains the following:
- Initial design
- Prototyping
- Proof of concept
- Iteration driven redesign
After successful completion of the medical device conceptualization and discovery phase, the medical device company proceeds for FDA approval. After FDA approval, the medical device company can use a medical device commercialization strategy to commercialize the device.