Vita Group is an innovative, research, design and development agency. Vita Group specializes in serving healthcare innovators through patent applications, product prototyping, product manufacturing, FDA regulatory, distribution, marketing and sales. The development process comprises six crucial phases, from Phase 0 to Phase 5, and each phase plays a critical role in the development of medical devices.
Vita Group's Medical Device Development Timeline
Phase 0: Exploration
Phase 0 is the primary step in Vita Group's development process. It involves a series of activities such as brainstorming, problem definition, market assessment, concept development, CAD design, CAD analysis, rapid prototypes, IP strategy, and user research. This phase is crucial in determining the feasibility of a product or service and identifying potential challenges that may arise during the development process. By conducting thorough research and analysis, Vita Group can ensure that products meet the needs of the target market and are competitive in the industry. Phase 0 sets the foundation for a successful development process by providing a clear understanding of the project's goals and objectives.
Phase 1: Prototyping
Phase 1 is the next step in Vita Group's development process, which is known as the exploration phase. This phase includes several important steps such as concept refinement, problem solving, low-fidelity prototypes, bench testing, user assessment, business strategy, CAD for manufacturing, manufacturing quote, and regulatory pathway. During this phase, the team works on refining the concept and identifying any potential problems that may arise during the development process. They also create low-fidelity prototypes to test the product's functionality and usability. Additionally, they assess user feedback to ensure that the product meets their needs and expectations.
Phase 2: Refinement & Testing
Phase 2 is the next step in Vita Group's development process, which involves refinement and testing. This phase includes various activities such as creating high-fidelity prototypes, conducting user testing, refining concepts, identifying supply chain requirements, and preparing manufacturing RFPs. The main objective of this phase is to ensure that the product meets the desired specifications and is ready for mass production. The team works closely with stakeholders to gather feedback and make necessary adjustments to the product design.
Phase 3: Design for Manufacturing
Phase 3 primarily involves designing for manufacturing. This phase includes several important steps such as feature freeze, regulatory development, functional prototypes, pre-DV testing, design freeze, supply chain, RFQ quotes manufacturing, BOM development, and product development. During this phase, the team focuses on finalizing the design of the product and ensuring that it meets all regulatory requirements. They also work on developing functional prototypes and conducting pre-DV testing to identify any potential issues before moving forward with production.
Phase 4: FDA Submission/Approval
Phase 4 involves several critical steps, including FDA submission and approval. The team works on documentation, tooling and low volume runs, design verification and validation testing, and regulatory submission. During this phase, Vita Group must ensure that all necessary documentation is completed accurately and efficiently to meet regulatory requirements. Design verification and validation testing are performed to ensure that the product meets all design specifications and is safe for use, and then regulatory documentation is prepared and submitted to the FDA for approval.
Phase 5: Commercialization
The final phase in the development process is Phase 5, also known as commercialization. This is when the product meets the market, and involves the production orders, inventory, marketing material, plug-n-play sales team, website, social media, distribution, fulfillment, and customer service. The marketing team creates content to promote the product, and the plug-n-play sales team works on selling the product to customers. A website and a social media presence are implemented to reach a wider audience while fulfillment processes are put in place. Ultimately, Phase 5 is crucial for successfully launching a product into the market and ensuring its success.
Vita Group’s development process covers every aspect of the product development cycle. From concept to commercialization, Vita Group is there with you every step of the way to guide our clients through the different phases of product development and ensure projects’ success. So, if you are looking for a reliable partner for your medical device incubation needs, look no further than Vita Group.
Want to learn more about Vita Group and our medical device development? Book a call to meet with our CEO Jason Scherer.