Medical Devices and Diagnostics for Diabetes Management


Diabetes: A global health issue

The global prevalence of diabetes has increased progressively over the past 50 years, with 375 million adults diagnosed as having diabetes in 2014, a figure that is expected to rise to almost 600 million by 2035. The vast majority of whom have type 2 diabetes. 1 As the frequency of diabetes rises worldwide, studies show that children are at increasing risk of developing the disease. Many countries are documenting higher numbers of newly diagnosed cases of type 1 diabetes, particularly in younger children. Recently, type 2 diabetes has increasingly been reported in children and adolescents. In some parts of the world, type 2 diabetes has become the main type of diabetes in children.2

ICON’s Medical Device & Diagnostics experts have managed more than 50 clinical and regulatory consulting projects to support clients in the commercialisation of diabetes management technologies and the development of medical devices intended to treat serious, downstream diabetes related complications, including: wound care, cardiovascular, ophthalmic, neurologic, and nephrology devices.

Our expert team has a proven record of success in assisting clients with the development and approval of diabetes testing, treatment, and monitoring devices, including:

  • Insulin delivery systems, including traditional and wearable infusion pumps, and novel infusion technologies
  • Glucose monitoring systems, including finger stick meters, continuous glucose monitoring systems, and novel non-invasive technologies
  • Intravenous blood glucose monitoring systems
  • Insulin dose calculation software
  • Neuropathy detection and monitoring technologies

Diabetes management technology

New mobile health technologies can provide education and support to patients with chronic conditions, such as diabetes, while simultaneously empowering providers with real-time information about an individual’s health through remote monitoring and prescription mobile health interventions.

Diabetes management products are often complex, involving the integration of multiple components with many unique design and development challenges. Due to the sophistication of software-controlled technologies for diabetes management, regulatory authorities are increasingly focused on the ability of patients and healthcare professionals to operate these devices safely and with optimum effectiveness.

Supporting medical device and diagnostic manufacturers

Operating under specific medical device SOPs and ISO 9001-2008 certification, the dedicated Device & Diagnostics team has the experience, knowledge and flexibility to meet the unique challenges faced by both emerging and established medical device and diagnostic manufacturers.

  • Regulatory (US and OUS) with both pharma and device (IVD and traditional)
  • Clinical strategists, biostatistician
  • Clinical operations
  • Software
  • Pre-clinical testing requirements
  • Quality

In addition to managing all phases of clinical studies and regulatory pre- and post-market filings, we have the expertise to develop regulatory and clinical strategies. Our teams can support the assurance case development required by FDA as well as pre-clinical, human factors, and clinical testing programs, design software development and testing programs, develop product labelling, and support reimbursement.

Broad experience in innovative diagnostic and treatment therapies – including non-invasive glucose monitoring systems involving unique biosensor design and smaller, more accurate body-worn insulin pumps - allows ICON to quickly understand client needs and assemble a cross-functional team to develop an approach to meet changing FDA and international regulatory and clinical data requirements.