In recent years, NOVO has been the engineering design partner on several development projects that include an electromechanical device, a mobile app, and a connection to the cloud. In fact, it is becoming the exception for us to get a new project inquiry for a medical device that is not architected as a connected medical device.

Definition: connected medical device

A connected medical device is a device that gathers patient data through sensor, patient, or caregiver inputs and communicates this data to servers in the cloud for the purpose of data analytics, data storage, monitoring, or machine learning.

The convergence of ubiquitous wireless communications, data analytics, and entrepreneurial spirit has produced business models with huge potential benefits in healthcare as well as almost every segment of the economy. Having the opportunity to be involved firsthand in a few such projects has showed us just how far-reaching the benefits of connected health devices can be.  

In one example, the added value represented by services managed in the cloud helped to justify the substantial investment required to develop this sophisticated system. The product is a vaccine management system called AccuVax™ that we developed for TruMed Systems™. This system, intended to be used at the point of care, fully automates the processes of administering vaccines to both adult and pediatric patients.

The secure cellular and WiFi network connectivity provides data to the cloud for inventory management, status monitoring and maintenance program administration. A tablet computer used as the touchscreen user interface, automatic recordkeeping, and biometric access control make the system convenient to for medical staff to use. Multiple fail-safe systems protect the valuable inventory. The resulting workflow automation transforms the traditionally unprofitable, error-prone, and time-consuming process of vaccine management into a profit center for small clinics, which motivates clinics to inventory a wider array of vaccines, particularly for adult patients. Drug companies, clinics, and patients benefit from ready access to critical vaccines that are recommended by the Centers for Disease Control (CDC) or the Advisory Committee on Immunization Practices (ACIP). These vaccines have been shown to reduce overall healthcare expenses by preventing a large number of more costly cases of disease. (1 – 4)

An even more compelling example of the potential for connected medical devices is a closed-loop insulin delivery system that we worked on for BigFoot Biomedical™. This system combines an insulin pump, a blood glucose meter (BGM), a continuous glucose monitor (CGM), a cloud-connected smartphone, and an algorithm for optimizing insulin administration. The platform is targeted at type 1 diabetics and insulin-dependent type 2 diabetics. It is intended to alleviate much of the anxiety and wasted “mind share” for patients managing diabetes. The cloud connection enables data analytics for continual improvement of the algorithms that control insulin delivery, and serves as a remote monitoring tool for timely blood glucose information that can be accessed by physicians and other authorized recipients.

Connected medical device

Historically, the incorporation of commercially available smart phones into medical devices was viewed as a non-starter for device companies because of the software validation issues. The FDA recognizes the potential value to patients of medical devices that incorporate mobile devices as controllers, user interfaces, or conduits to cloud, and they are developing guidance and regulations for the device industry. NOVO is excited to continue helping our partners in the medical device industry improve patient outcomes and enhance quality of care through our work designing connected medical devices. We’re also working with clients in other industries to design a variety of other products that provide additional value from being connected to the cloud.

References:

  1. US Government Accountability Office. Health Prevention: Cost-effective Services in Recent Peer-reviewed Health Care Literature. August 11, 2014. Available: http://www.gao.gov/assets/670/665276.pdf
  2. Johns Hopkins Bloomberg School of Public Health. Vaccines Work: Key Facts and Figures. Available: http://www.jhsph.edu/research/centers-and-institutes/ivac/resources/vaccine-cost-effectiveness.html
  3. US News and World Report. Vaccines Prevent Millions of Infections, Save Billions in Costs: CDC. Available: http://health.usnews.com/health-news/articles/2014/03/03/vaccines-prevent-millions-of-infections-save-billions-in-costs-cdc
  4. JJ Kim. (2011, Oct. 19). The role of cost-effectiveness in US vaccination policy,” in N Engl J Med. 365:1760-1761. Available: http://www.nejm.org/doi/full/10.1056/NEJMp1110539#t=article