Medical device startup consulting

medical devices

We are at the beginning of an unprecedented opportunity for medical device start-ups. This opportunity is made possible by two things: cheap sensors and powerful computers. Cheap sensors make it feasible to measure things directly and frequently that were difficult or impossible to measure before. Abundant computing power makes it possible to take advantage of this new data by feeding it into mathematical models and machine learning algorithms.

Business model

Many start-ups have this simple business model:

  1. Build a medical device to measure what we couldn’t measure before.
  2. Develop software to turn this data into useful information.

The algorithms to draw conclusions from the data can make or break a medical start-up. The analysis must be based on mathematical models that make accurate inferences from all available data and that properly assess how much confidence or uncertainty one should have in the predictions of the model.

Mathematical modeling

A company may have ingenious hardware but not reach its potential because it lacks the statistical component to correctly interpret its data. We have worked with companies to develop powerful and interpretable statistical models to get the most out of their medical device.

We have also worked with companies to go beyond statistical analysis to dynamical modeling, using sophisticated mathematics to integrate medical knowledge into forecasting based on input data.

Regulatory compliance

Developing a medical device requires navigating the regulatory environment as well as developing new technology. One piece of this regulatory environment is the HIPAA privacy rule. We have extensive experience helping companies with HIPAA expert determination of medical data.

Get experienced help

We have helped several start-up companies with this process. We have many years of experience in mathematical modeling, statistical design, and medical software development.

Call or email now to see how we can help your medical device start-up succeed.


Trusted consultants to some of the world’s leading companies

Amazon, Facebook, Google, US Army Corp of Engineers, Amgen, Microsoft, Hitachi Data Systems