Great ideas in medical innovation can come from anyone, from engineers, healthcare providers, and even patients. Some of the biggest disruptors in healthcare development did not necessarily start with a large fortune 500 medical device company. Developers in any field have to go through a lot of thought experiments, but in the medical industry, they have a lot more risks and liability concerns. The potential risks and regulatory hurdles can overwhelm even the most enthusiastic developers. Here we break down the top priorities and tips for medical device design experts to consider – and consider early to stay focused during product development.
Tip #1: Market Assessments
A revolutionary breakthrough medical device is only suitable if the market is ready for it. One of the first things you will need to assess is if the market will adopt the new technology or change. Medical device developers might use surveys, online forums, or focus groups with healthcare providers, patients, or even insurance providers to gather information on the market. Some questions to ask are:
- What are the current challenges with this procedure?
- What is the current standard of care?
- What are your concerns with the current standard of care?
- What are the best outcomes? What are the risks of complications?
- How would (blank) change the patient’s experience?
- How does insurance currently reimburse this type of procedure?
The goal of collecting this data is to evaluate the current market needs and whether this new innovative device meets those needs or is there a gap. Is there anything in this new product that can be modified to lessen the gap if there is a gap? The data gathered from the market assessment should feed into the product’s development.
Tip #2: Regulatory Considerations
The FDA and other global regulatory agencies regulate medical devices to ensure the health and safety of the public. It is essential for all medical devices to comply with regulatory agencies. Early in development, it is important to start understanding the regulatory environment for medical devices. Initially, developers might find themselves on FDA’s website or DeviceLab’s blog to find information on device classification and potential regulatory pathways.
Tip #3: Discovery
Discovery refers to taking the initial idea and creating prototypes. Often, discovery is the most prolonged phase of medical device development. Medical devices go through several rounds of prototypes. To create a prototype, engineers will create drawings and specifications. These drawings and specifications will become more specific with time. Initially, the prototypes may only be 3-D printed models or computer-assisted designs. As time goes, the drawings and specifications will begin to look like blueprints with specified the materials and dimensions of the product. Eventually, the engineers will reach a working model and test the use of that prototype.
DeviceLab’s Medical Device Design
DeviceLab is here to help bring any medical device idea to market. DeviceLab can help guide you during your product’s development and bring your medical innovation to physicians. If you have an idea and want to explore the development, contact DeviceLab. DeviceLab’s medical device consultants and experts are here to put your product in the hands of physicians and users. Schedule a consultation to learn more about how DeviceLab can help.