cdx logo


Empowering the Digital Future of Global Health

Connectivity is a crucial element to further the advancements of digital health solutions. This requirement is pushing medical device manufacturers to switch to a new business model—one driven by the data collected from medical devices. Effectively implementing this requires medical device makers to overcome numerous hurdles. Hardware limitations and manufacturing regulations are two major challenges to establishing connectivity in medical technology. Consideration must also be given to regional constraints on network telecommunication technology (4G,5G, WiFi, LAN) when developing these solutions. This is where Connected Diagnostics distinguishes itself. An expert in establishing connectivity, it guides medical device manufacturers in overcoming these challenges and helps them design, develop, test, and implement efficient digital health solutions.

“The knowledge we bring and our teachings help companies avoid pitfalls when thinking about connectivity," says Chris Isaacs, CEO of Connected Diagnostics.

Efficiently Establishing Connected Health

Connected Diagnostics has an extensive track record of overcoming challenges in developing connected solutions for medical devices. Keeping a close eye on the regulatory and technological landscape and anticipating new requirements allows the company to ensure the futureproofing of any device it works with. It collaborates with international bodies such as the WHO, the FDA, and the U.S. government to tackle one of the biggest hurdles—medical device regulations. This gives Connected Diagnostics an excellent grasp of industry challenges and needs, enabling it to come up with regulatory-approved solutions at a global level.

The swiftly evolving telecommunications industry poses another hurdle, as lead times for medical device development are relatively slow. However, Connected Diagnostics manages to synchronize the rapid advancements in telecommunications with the regulatory and manufacturing lifecycle of medical devices, ensuring its solutions always use leading-edge technology and maintain relevancy upon market entry.“

We don’t want to produce devices that will be left behind from a competitive advantage standpoint, but ones that will stay relevant for years to come,” says Isaacs. Apart from developing solutions for new medical devices, it retrofits legacy devices for seamless connectivity. It analyzes the architecture, hardware, and software capabilities of each challenge presented by legacy devices before determining the optimal solution.

In a notable case, a UK-based medical device company sought to enhance a sample testing device. The device provided binary results, and the company wanted to digitalize and transmit the results to the hospital datasystem. Connected Diagnostics offered a unique solution by developing a mobile app that addressed the client’s requirements without altering existing hardware or software.

Using Bluetooth technology, the app connected with the diagnostics device and gathered essential patient details such as names, addresses, contact information and symptoms related to specific conditions. Acting as a connectivity hub, the app efficiently digitized patient information for remote data collection, eliminating the need for new regulatory approval.

At the Forefront of Digital Health Solutions

To ensure successful projects, Connected Diagnostics prefers early engagement with clients, where it gathers an understanding of their goals and capabilities. Starting with strategy building, it guides clients in developing a unified goal for their projects by demonstrating how data collected from interconnected devices can be used to improve their business, cut costs, and streamline operations.

After finalizing the strategy, Connected Diagnostics creates prototypes to showcase project feasibility and confirms the client’s business, user, and functional requirements are met before production starts. All manufacturing operations adhere to IEC 62304 and ISO14971 standards, guaranteeing no device or solution fails regulatory approval.

Driving this excellence is a highly qualified team of experts comprising technical architects, hardware designers, software developers, program managers, validation specialists, and IT managers. Despite their diverse backgrounds, each member possesses comprehensive knowledge and expertise in the regulatory processes and standards governing the development ofmedical devices and software. This results in the multifaceted mastery that fuels Connected Diagnostics.

With substantial practical experience, paired with a deep understanding of connectivity challenges and expertise in navigating regulatory complexities, Connected Diagnostics takes the helm as the connected health partner for medical device companies venturing into enhanced connectivity.