Bioscientists, engineers, non-sick care entrepreneurs and health professionals have many ways to practice biomedical and clinical entrepreneurship e.g. in biopharma, medical device and diagnostics, small business medical practice, educational technologies, social entrepreneurship and intrapreneurship. Digital health entrepreneurship is another pathway.
Digital health is the application of information and communications technologies to exchange medical information. Like all other areas of biomedical entrepreneurship, digital health entrepreneurs pursue opportunities with scarce resources with goal of creating user/patient/customer/stakeholder defined value through the design, development, testing, validation and deployment of digital health products and services.
In some instances, digital health products and services can be stand alone offerings, usually providing the intended user with information, a communications interface and education, that are not defined as drugs or devices and therefore not subject to regulatory clearance requirements. Some, on the other hand, become a new part of a drug or device e.g.a remote sensor in an orthopedic implant or a “smart” pill or other innovative drug delivery device.
Much like the medtech innovation roadmap, the digital health innovation roadmap has several stops along the way including :
Early stage or prototype product development, customer discovery and development and validating the parts of the business model canvas. If you don’t do his right, there is not much point in moving to the next steps. In fact, not having a viable business model is the main reason companies, including digital health companies, fail.
Design and reduction to practice using established quality system controls, including technical validation and verification
The terms Verification and Validation are commonly used in software engineering to mean two different types of analysis. The usual definitions are:
- Validation: Are we building the right system?
- Verification: Are we building the system right?
In other words, validation is concerned with checking that the system will meet the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful.
The distinction between the two terms is largely to do with the role of specifications. Validation is the process of checking whether the specification captures the customer’s needs, while verification is the process of checking that the software meets the specification.
Following the appropriate regulatory approval pathway, when appropriate
Following the appropriate intellectual property protection pathway, when appropriate
Following the appropriate business model
Translational and human subjects research, when appropriate
Launch, marketing and sales
Post market surveillance
While the path may be clear, the journey is difficult and filled with hazards. Here are some posts, blogs and commentaries that might help you find your way:
Digital health entrepreneurs have a big challenge. Digitizing sick care, while inevitable, has already seen its share of failed products. bad rules and dysfunctional ecosystems. Most have failed because they did not achieve the 3Vs of sick care innovation, they set the bar too low or they quit too soon.
We are in the early stages of digital health entrepreneurship , trying to figure out what works and what won’t, what rules and regulations we need and which we should revise and the impact on society and the medical profession. I have confidence that digital health entrepreneurs will get it right soon, despite the efforts of many who are getting in the way.
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