At Northeast Biomedical, we created, and adhere to, an ISO 13485:2016 certified Quality Management System. Within this system, we use a 7 Phase development process. This exclusive process allows us to provide a structured and custom approach to each project.
Our individualized solutions help each client navigate through the device development journey with a solid management plan in place, a full understanding of budgetary considerations, and a reliable and experienced engineering team ready to transform its device concept into a fully-realized marketable product.
From the initial concept through market launch, Northeast Biomedical applies strategic planning and medical device design expertise to ensure a quality final product.
Phase 1: Evaluation
This phase is primarily a planning phase of the entire development program. This stage includes an investigation into the specific customer needs and idea generation to define the technology of the project. Throughout this phase, several key milestones are accomplished including an initial assessment of the technology, rough order of magnitude (ROM) budgets, selecting tentative development team members, and looking at a preliminary schedule. Northeast Biomedical has significant experience in this phase of the program, understanding how to turn ideas into the foundations of technology and successful product launches.
Phase 2: Feasibility
In the second phase, a detailed prototype build and test per engineering protocols of the product or a subsystem of the product will occur. The prototyping activities will further prove the feasibility of the product and de-risk the development efforts. This phase concludes with the best option being chosen from the initial research and planning with a focus on design details, engineering analysis, preliminary cost of goods sold (COGS), and manufacturing techniques
Phase 3: Alpha Development
The Alpha design is the first complete product design cycle that the system or device will go through. Based on the work that has been done up until this point, the team at Northeast Biomedical will understand the requirements, limitations, and performance characteristics that we can expect. Once the design is analyzed for potential failure or complications, alpha manufacturing will take place where we will build revision controlled or “frozen” products or parts that will represent the final product. The production methods will be slightly different, typically more hands-on or with higher-skilled labor, but the components will be representative of the final design. Once a complete design is done, bench and/or verification testing will be completed.
Phase 4: Beta Development
Phase 4 is the final stage before launching into production. The phase begins with a quick review of the results up to this point, followed by a final design iteration, if needed, to make sure that the device or system matches expectations of the market and customer. Beta units, devices, or systems will be manufactured, and the system will be tested. Once the product is tested, a plan for the First in Human testing will be developed. In this stage, all processes and product needs will be validated. This will be the final step before the program is released to market launch and pilot production.
Phase 5: Launch/Pilot Manufacture
During phase 5, there will be an initial production run of the device for products that could be sold to an end-user or customer. As part of this phase, all records and documentation will be reviewed. The manufacturing line will be improved to increase throughput as needed. Before the products can be sold the customer will create and release the marketing information needed to sell the products. This will include any commercial literature, instructions for use, and establish internal processes for the proper sale and distribution of the devices. Additional training will be performed for manufacturing, marketing, sales, and service personnel. All engineering documentation and forms will be reviewed, and a final release will be made into production. Once the products, system, or devices are produced they will be stored and prepared for shipment.
Phase 6: Production
Upon successful launch of the product, cost-effective manufacturing is assessed and the best production methods are selected. Northeast Biomedical looks for creative solutions for production solutions including outsourcing and in-house production as well as blended methods of manufacturing. The marketing acceptance rate and demand will be determined, and manufacturing plans will be put in place to work with both sales activities and marketing projections. This is the establishment of continuous serial production and order fulfillment of the product.
Phase 7: Project Close-Out
In the final stage, we have the opportunity for us to revisit the project and ensure that the project was successful. This is a time to document the lessons that were learned and make notes of process improvement from both a project and a company perspective. The design team will be released from this program and reallocated to another program.
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