Design and Development

We work with OEMs, entrepreneurs, venture capital, and angel investor backed companies to bring new medical devices and equipment to market. Have a concept? We’ll flesh it out. Have a design? We’ll help you prototype, test, and refine it. Has it all? We’ll help you produce it. Wherever you are in your product’s evolution, we’ll get you where you need to go.

Working together, we establish common goals – then we achieve them. Our innovative, high-value concept-to-supply services span design, development engineering, sourcing, assembly and packaging services.

We Offer

Whether you’re in the concept, development, or production phase, Salvation helps you bridge the milestones to medical device commercialization.

Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD)

SaMD Pre-Specifications

These describe ‘what’ changes the provider/manufacturer anticipates as the algorithm learning occurs. These changes could be to algorithm performance, inputs, or intended use of the SaMD in scope.

Algorithm Change Protocol (ACP)

Once the scope and quantum of anticipated changes are identified, the ACP specifies the steps to be followed to ensure patient sfety and device effectiveness. These include monitoring and even controlling for mitigating any significant performance loss of the SaMD and subsequent risk to the patient’s health.

Good Machine Learning Practices

These practices span across the SaMD solution components mentioned above, from data management to inference. They are intended to ensure the development and oversight of cutting-edge technologies used in these SaMDs – particularly with many ML methods being very opaque in terms of their inner workings. The FDA is working with other regulatory organizations, industry bodies, and standards organizations to define these practices for the manufacturers of AI/ML-based SaMDs.

Patient data transparency and security

There needs to be a clearly labeled indication that the SaMD employs AI/ML technologies that evolve and the end-use of its output. Patient engagement over these issues is imperative to drive adoption for the AI/ML based SaMDs.

Managing algorithm bias and robustness

Healthcare data has numerous demographic parameters that impact the overall delivery of health services. There is a possibility that training using this data unintentionally introduces these biases into the algorithms for AI/ ML based SaMDs. SaMD providers need to incorporate methods that eliminate or neutralize such bias from the solution specifications. Numerous industry and academic groups are working on enhancing these methods for SaMD applications.

To Know More About Design and Development

Business Intelligence and Market Fore cast

Effective planning, customer satisfaction and value are three key mantras for success in any business but to an even greater degree in the medical device manufacturing industry. And business intelligence is the best way to find a competitive advantage and helps the companies get quick and effective results to make it happen.

The key to growing your sales is through leveraging the data your medical device company collects into visually appealing and insightful dashboards and reports.

If you are in the process of identifying how to set up these reports, let us help you leverage the best BI solutions for your specific needs.