by William Mann on February 24, 2013

In our previous post titled “Mobile Medical Applications: Classification and Revenue Models”, we discussed several different approaches you can take to positioning your mobile app. We believe that medical apps will slowly begin creeping towards higher regulation and will therefore require more clinical data to prove that it provides value for a patient.

Many people who are getting into the mobile medical app space will have experience in the tech sector and little-to-no experience in the medical device sector. They may find themselves asking why they should even bother with clinical evidence. Make it. Ship it. Done deal, right? Well, when your app moves higher on the regulatory scale, it begins to have less in common with a mobile app and more in common with a medical device. If your business model includes selling into healthcare institutions, gaining buy-in from health professionals, or securing reimbursement, you will need to treat it like a medical device. That being said, if we need to prove that a technology provides patient value, HOW do we do that? The answer is that there needs to be a focus on both scientific and clinical development, in parallel with product development.

As this is a complex topic, this will be the first in a series of posts titled “Building a Clinical Evidence Package”. We will discuss a high-level overview of scientific and clinical strategy, and then take a deep dive into each topic.

Publication Opportunity Flow Diagram.ai

This figure gives an overview of the entire scientific and clinical development process. The product and business development paths have been simplified to show only the relevant actions necessary to work in conjunction with scientific and clinical development. All companies do some form of identifying a business case or writing a business plan before they mindlessly create a product, but we would encourage those in the healthcare space to do two of these: one from the market aspect and one from the scientific aspect. The scientific aspect begins with some form of literature review to get an exhaustive picture of what the landscape looks like in your target health state (ie. diabetes, obesity, arthritis etc.) and what kind of products or services are being created for these health states. This will be used in combination with your business case to create a prototype. This prototype will be refined through beta testing and more specifically, human factors testing, to create a commercially viable product. Depending on what type of device you are creating, the sales cycle may actually begin now. However, for more complex business models the sales cycle may require clinical testing or health technology assessment as a prerequisite. Once the device is out on the market, data collection and analysis can be used for post-market evaluation.

At many points in this process, the opportunity for publications will arise. Publications are the de-facto method of getting your product into the knowledge landscape for your target health state. These publications can be used for marketing, sales, and gaining buy-in from key opinion leaders.

In the next few blog posts, we will tackle each of these scientific and clinical development milestones in more depth.