The key strategic driver of success 20 years ago in the medical industry was R&D. Over time, however, the role of the regulatory strategy has moved up in importance and is now playing a major role in the strategic success of companies. A poor or out-of-date regulatory strategy can result in delayed times to market, significantly higher regulatory, clinical and R&D costs and, in the worst case scenario, failure to get a new product approved. In years past, regulatory professionals were brought in at the conclusion of an R&D project to initiate the regulatory process. These days, their input is sought in the early stages because new product design or drug development is now heavily influenced by potential regulatory pathways.

All of this is becoming important to CIOs because of a rapidly emerging discipline in the medical industry – Regulatory Intelligence. Regulatory Intelligence is the systematic analysis of large amounts of regulatory information to serve a variety of strategic needs. It is used, for example, in the analysis of new regulations and guidance or the shifting interpretation of existing regulations. It is also used for analyzing potential regulatory pathways and hurdles and in many other strategic areas.

The blessing of Open Data in the medical industry is that it is providing much more information that can be used to successfully navigate this regulatory maze. The curse is that it is becoming a massive amount of information to collect from the various sources and analyze. The FDA alone now maintains more than 130 public databases and data sources. Adding to this is the increasing amount of information being made public by the Centers for Medicare and Medicaid Services (CMS). Unlike other regulated industries which focus primarily on compliance issues, the medical industry also deals with the need to get new products approved and reimbursed.

Fortunately, new tools are beginning to emerge to manage and assess all of this Open Data. These tools are focused on integrating and normalizing all of this information. They are also utilizing more advanced search capabilities and cross-referencing so that regulatory professionals can pull together otherwise disparate pieces of information and begin to develop big picture, strategic insights. Additional functionality is providing surveillance capabilities and the ability to monitor real time shifts in the regulatory landscape.

Beyond that, various forms of analytics will be added to detect patterns and trends. Visual analytics will make it easier to derive insight from large volumes of information. Ultimately, predictive analytics will help regulatory professionals be able to more easily detect emerging trends or predict potential events.

CIOs will play an increasing role in sorting through the various technology options. At some point, the major medical product companies that have developed large document management systems for their internal regulatory documents will want to be able to integrate their internal system with Open Data systems. This will provide the ultimate tool for their regulatory staffs to develop valuable, real-time intelligence.

Much of the focus in Big Data has been on the need for CIOs and Chief Marketing Officers to work hand in hand. In the medical industry, CIOs will need to integrate their work with that of Chief Regulatory Officers and Chief Technology Officers as they jointly embrace the challenges and opportunities of Open Data.