Medical and wearable devices, remote in-vitro diagnostics, and digital therapeutic products - the rapidly evolving world of digital health is bringing more and more devices into patients’ hands. But along with the benefits, there are safety considerations for people and data.
From tradition to technology: patient care evolution
The traditional view of the patient is evolving. The patient is no longer the silent recipient of curated information and care directed by medical professionals. Today patients are entitled to their own data and expected to take more responsibility for their health behaviors and health management. Patients may struggle with technological advances that introduce complexity and potential safety issues. At the same time, healthcare providers have struggled for the last decade to provide digital services comparable to those offered to consumers by other industries. This is a disturbing thought when we consider the significance of the healthcare sector in public and individual health and well-being. The SARS-19 pandemic accelerated the traditionally slow evolution of healthcare delivery into new trajectories and settings, particularly in the digital space.
Lessons from other industries
Unfortunately, too often the devices offered to patients have failed to incorporate the lessons from other consumer industries. Giving medical devices to patients brings two product development disciplines into sharper focus: user experience and design. Manufacturers of digital health devices are familiar with models of care delivery via highly trained clinicians. In those cases, the risks and human factors aspects are minimized because devices are administered by “experts”. Relatively simple physiological measurement devices and diagnostic tests have been on the market for decades. However, the increasing technological advances reflected in modern devices drive a steep learning curve to move from the expert-directed model towards a patient-centric one. In this new model, patient risk and human factors are vital components of a successful patient-administered device. Notably, the medical device industry lags the consumer device industry in design terms. Pioneers like Apple simplified technology usage instructions through streamlined user interfaces with recognizable icons, natural language, and intuitive design.
Digital disruption and new frontiers in healthcare
For patients, medics and researchers, digital devices offer multiple benefits. They allow patients and health professionals to track early warning signs and symptoms without travelling to, or waiting for, an appointment. For researchers these devices can help retain participants in clinical studies by reducing the burden on patients. Data can be recorded easily and remotely. Automation and reminders mean that patients don’t need to rely on memory to know when and what to record. Digital devices may be more cost effective in the long-term, allowing medics and patients to be more proactive with treatment and lifestyle adjustments. While there are challenges with design, data security and user experience these are not insurmountable. When the device industry overcomes them, patients will realise the true value of digital health in the home and other non-typical healthcare environments.
Digital safety was described by Flott et al. (2021) as the next frontier for patient safety.1 At ICON we put risk management, human factors, and cybersecurity front and centre as we work with our customers to bring their devices to market.
1 Flott K, Maguire J, Phillips N. Digital safety: the next frontier for patient safety. Future Health J. 2021 Nov;8(3):e598-e601. doi: 10.7861/fhj.2021-0152.
In this section
-
Digital Disruption
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
-
Oncology
- Paediatrics
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Flexible delivery models
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel