Standard Development Process

Alfred Mann Institutes follow a Standard Development Process to ensure that each step tracks best practices in medical device and pharmaceutical development. The Standard Development Process details each step in the development, such as product specifications, feasibility plans, market requirement specification, custom component specifications and many more.

Medical regulatory agencies, such as the FDA in the United States, review standard development documents created in the development process to ensure the new product is safe and operates as described.

The scope of the Standard Development Process is a guide that includes all phases from idea conception thru commercialization including:

• Selection Process: Assessment of the potential opportunity
• Plan: Project Planning including proof of concepts as needed
• Development: Development of technology and or product
• Testing: Product verification and validation
• Transfer: Transfer and scale up of product for bench testing, animal, or clinical activity
• Launch: Launch of product into a clinical study if required
• Commercialization

1. The Selection Process for identifying potential technologies for the AMI provides for the Executive Director of an AMI to review disclosures provided by the university’s Tech Transfer office and also to seek out and regularly meet with scientists and inventors to confer about technologies that might benefit from and be appropriate for the university’s AMI development. University inventors and scientists are also encouraged to bring technologies to the attention of the AMI for consideration. Please refer to the Project Selection page that describes the selection process in greater detail.

2. For selected projects a Plan is created that maps out the first phases of activities in detail including an early version of a project plan which contains tasks to be completed with timelines. The plan may include a feasibility assessment which is aimed at modeling or building certain parts of the technology or product which are only crude ideas and need to be proven. The plan would also include the creation of a Market Requirements Specification that outlines the product in relation to customer requirements and market conditions.

3. The Development phase focuses on building and testing of engineering prototypes to prove that the concepts can be constructed with either manual or automated processes. Development of prototype devices for specific performance testing, initiation of performance tests, investigating and fixing of prototype defects are the major activities in this phase. Exit criteria for this phase requires stabilization of the product specifications to ensure consistent functionality of each device constructed.

4. The Testing phase involves testing to formalized and approved test plans to Verify and Validate that the product meets specifications and functions as intended. The samples used for testing are usually built to controlled specifications, ones which may be controlled through the use of drawing revisions, dates, and approval by the technical team. The results of this phase of testing would be used in support of regulatory approval submissions to show that the technology or product meets requirements and is safe. This phase may include animal testing as well as bench testing.

5. The Transfer phase focuses on completion of some of the Verification and Validation activities mentioned in the previous phase. It also includes a plan to construct a number of devices and is sometimes referred to as scaling up of manufacturing capability to allow the building of pilot production units. This phase can include a regulatory submission in preparation for entering human based clinical studies.

6. The Launch phase is focused on completing manufacturing scale up activities to support the first limited production builds, completion of the regulatory submission activities leading to permission to initiate human clinical studies for more complex products or first shipments to users for products that do not require clinical trials.

7. The Commercialization phase follows the limited launch phase activities. As needed, manufacturing processes may be modified to be able to meet higher volume requirements (e.g. some processes may be modified from a manual operation to one which uses automated equipment). Also most product issues identified in the launch phase will be resolved prior to full scale manufacturing.