Connected ingestible capsule for diagnostic and drug delivery applications
Ingestible capsule for diagnostic and drug delivery applications

A proliferation of at-home, self-service medical devices and an increasingly digitally-connected always-on medical system has led to higher adoption of connected medical devices. The market is expected to reach $52.2 billion in 2022, with more than 50 billion devices in use within the next ten years.

A connected medical device is a device that gathers patient data through sensor, patient, or caregiver inputs. It communicates this data to cloud servers for the purpose of data analytics, data storage, monitoring, or machine learning. Connected medical devices are IoT devices – Internet of Things devices – that link directly or through a proxy to the internet. Examples of connected medical devices range from a closed-loop insulin delivery system to a vaccine management system and many more. Connected medical devices offer a host of features that can improve the quality of care, including:

  • Making diagnostic or treatment data visible through web portals to patients and caretakers.
  • Allowing healthcare providers and payers to assess compliance with treatment plans.
  • Personalizing care through direct communication interfaces and by sending unique insights to be sent to individual users.
  • Updating software to fix bugs, deploy new features, or resolve security threats.

Because connected medical devices transmit patient data, they also need to comply with rigid standards for data encryption and security. Not only must you follow medical device standards (such as 21 CFR Part 820), you must also plan for data security standards (such as ISO 27001). This all must be accounted for in the development process.

The Development Process for Connected Medical Devices

Veriskin TruScore skin cancer screening device
Veriskin TruScore skin cancer screening device

For medtech devices, the product engineering development process follows many of the same steps as the typical development process but with increased rigor in the overall execution and documentation. Connected medical devices are generally systems composed of a number of different hardware and software components. Often, these various components each require different skill sets. In order to accelerate the overall product development, it can be advantageous to treat them as separate development engineering projects.

The typical medical device development phases include the following: 

  1. Product Definition
    Key activities and deliverables include product requirements development, technology assessments, feasibility demonstration, risk analysis, concept development, and product architecture
  1. Estimate and Planning
    Key activities and deliverables include development, quality, manufacturing, clinical, and risk management plans.
  1. Detail Design
    Key activities and deliverables include design development, manufacturing development, test development, and verification development.
  1. Verification
    Key activities and deliverables include executing verification plan, verification report, risk management report, and requirements traceability matrix
  1. Validation and Transfer
    Key activities include product or device validation and manufacturing equipment qualification & process validation. 

Connected Medical Device Development

As the name implies, connected medical device development adds a layer of connectivity – usually wireless – to the system. Some of the development steps specific to this task include:

  1. Assessing existing infrastructure and processes
  2. Documenting integration and connection strategy
  3. Planning your infrastructure
  4. Configuring infrastructure and connecting devices

The development of these components in parallel adds significant complexity to the process. Not only is the pace of development different for each component, but in most cases, the development of the components is highly interdependent. Incorrect prioritization or identification of dependencies in the development plan can lead to significant delays in the program. For most of these systems, emergent properties within the system become critical to the user experience and success of the product. Emergent properties are things like reliability, quality of service, latency, and more. These aspects of the system cannot be tested and measured until late in the product engineering development lifecycle. Finding root causes and solutions when a deficit in an emergent property is detected during testing is generally more difficult and time-consuming than correcting a failure in an individual component.

Once the connected medical devices are developed, they still need to meet a variety of standards. There are increasingly higher standards regarding the security of medical devices—even devices that are not connected. A compromised medical device could leak personally identifiable information or potentially cause harm to a patient. Connecting a device to the internet can make the device more vulnerable to attack.

Still, even with that consideration, the advantages of connected medical devices far outweigh any potential security drawbacks. Medical device companies without prior experience implementing compliant connectivity in their medical devices will very likely benefit from a relationship with an engineering design firm experienced in this area.

Future Advancements in the World of Medtech

The promise of connected medical devices is to transform the way we engage with our own health care. Connected medical devices can offer a greater quality of care with lower barriers to retention and compliance by bringing the treatments out of the healthcare setting and into the home. Still, connected medical devices are inherently complicated. They need to be reliable, safe, and controlled. Additionally, they have to be secure and functional.

The FDA and other regulatory entities have been increasingly scrutinizing cybersecurity in medical devices. The attack surface provided by connected medical devices is significantly larger. Designing such a safe, effective, and secure system is a complex and challenging task. As connected medical devices become more ubiquitous, they may become more vulnerable to attacks by cybersecurity threats.

Other advancements in medtech include developments in the regulatory environment that facilitate medical device systems that incorporate several products from different manufacturers – for example, incorporating continuous glucose monitoring or pump from one company into a closed-loop insulin delivery system from another company. It seems likely that medical devices will continue to become more connected and will require more collaboration between manufacturers.

(H2) Product Development Engineering Companies and the Medtech Industry

Developing connected medical devices requires a broad range of experience with multiple engineering disciplines and technologies. For most teams, especially startups, acquiring this broad range of skills is not feasible through hiring alone. Even if those employees could be found and recruited, it is a long process of careful investment to turn those employees into an efficient and effective team.

A good development partner will not only be able to provide the expertise you lack but will have experience with a wide range of relevant technologies. A product development engineering company already has a team, processes, and a tech stack that work well together. They also have all the synergies in place to start designing and engineering immediately. Furthermore, a product development engineering company with experience in connected medical devices will have processes to ensure expeditious development and meet compliance.

Connected devices draw heavily from products developed in the IoT space, a highly dynamic and evolving technology landscape. An experienced team will be able to help select the modern technologies that are appropriate for use in a medical device, which often has very different needs than commercial devices. Not only will the development of your connected medical devices be much faster, but your partner will give you innovative insights into the medtech space.

A product development engineering company can help develop medical technology that is empowering, innovative, and secure. By blending knowledge from the Internet of Things and manufacturing processes, a product development company can create the appropriate risk assessments, feasibility studies, and mitigation plans.

Soon, medtech advances will be empowering patients to take more control of their healthcare—and deliver better, deeper data to healthcare providers. But for most companies, it’s not possible to control all the product development of a connected medical device internally. Connected medical devices demand the attention of expert specialists who can develop a project with many moving parts running in parallel.

Are you interested in learning more about medtech and connected medical devices? NOVO can help you develop your connected medical devices or work with your team to improve and innovate. Connect with NOVO today.