Best Practices

Beyond the device: From producer to problem solver


In 2013 PwC said that medtech companies need to expand innovation not just with new products or new features in existing products but need to place more focus on meeting industry demands for more “in financial, convenience and health terms.” This year’s PwC spotlight focuses even more heavily on the need for medtech companies to develop beyond just the device and tackle even broader problems in the health industry.1 The trend for companies old and new is to improve the connectedness of devices through software. Devices are being enhanced and designed to talk to each other and to clinical and hospital systems. As PwC points out even the business model for medical device companies is changing. Service-based solutions are now becoming a large part of what is driving innovation for both existing and new companies.

This demand for devices that can fit into an ecosystem of connectivity is being driven on two fronts, the consumer, and the provider. Consumers are expecting that their medical devices should function in much the same way as their cell phones. They want the convenience of real time control and monitoring of their health. In response new companies like Bigfoot Biomedical are “designing a comprehensive solution of device + software + service to help people with diabetes administer insulin more safely and access our service more cost-effectively.”2  Healthcare providers are trying to reduce costs by streamlining delivery of healthcare and want to use devices and medical systems to provide data to support new financial incentives and reimbursement models. In response to this, established medical device companies are looking for ways to enhance their portfolio of existing products to add additional software capabilities and create ecosystems of medical devices and health systems.

The trends that are playing the biggest part in the realization of new capabilities:

  • Power of the Cloud
  • On-demand Data
  • Consumer-centric devices

PwC summarizes nicely that, “the evolution of the medical device business model – from device maker to problem solver – is a direct response to an increasingly modular, plug-and-play health ecosystem defined by consumer needs and desires.” But it is not just the business model that needs to change; engineering approaches also need to change. Medical devices are now not just a single device but a “system.”  The practice of systems engineering for healthcare needs to be leveraged to an even greater degree as a proven approach to engineer the systems of the future to solve today’s problems facing medtech.

Systems engineering is uniquely poised to provide a systems view which facilitates adaptability of existing products to meet the needs of fitting in to the greater ecosystem of healthcare. Adaptable systems architectures and properly engineered allocation of functionality across mechanical, electrical and software leads to products than can adapt to changing market needs more quickly without the need to necessarily re-engineer an entire product. Good systems engineers know how to combine knowledge of the customer, business direction, and technical engineering to communicate to the various engineering teams the objectives of the device as a system.

Systems engineers find using Jama uniquely provides them the technical capability to manage the business requirements; maintain the system requirements and demonstrate their traceability to the business requirements; demonstrate the allocation of the system requirements to the functional areas; and assist with risk, verification and validation activities. More importantly using Jama for this technical activity allows systems engineers to easily provide a streamlined communication path to both the business stakeholders and engineering stakeholders that will be developing the medical device systems.

To find out more about how Jama can help with your medical or health systems development visit