New product development methodology to assist the medical device industry in optimizing their processes and developing relevant solutions – Reviewing the Biomedical Literature & Primary Research
• Statswork’s chemical scientists explore the new or known chemical substances, determining their quantity, based on an evidence-based literature review process.
• User Needs and Market Potential: We apply systematic review a) to identify the most effective and innovative design to solve the problem, b) to understand a user requirement that could be met with innovation to an existing device or a new device, c) to identify whether existing process or technologies already serve the market and d) to examine whether the proposed medical device performs better than existing devices that meet similar needs.
• We also conduct surveys and interviews to identify customers’ needs and demands and translate them to design targets.
Statswork conducts Biomedical literature reviewing services for PMS, part of a Clinical Evaluation Report (CER).
• Identifying adverse events for a medical device from the biomedical literature database, along with comprehensive strategies for literature triage and analysis
• Collect relevant useable data in the clinical evaluation, including device performance, device safety, comparison of device with existing devices (if applicable)
• We use EMBASE, QUOSA and another database for PMS
Successful reimbursement strategies.
• We review the biomedical literature for cost analysis, quality of life and treatment outcome.
• Identify medical benefits of similar devices and offer a comprehensive estimation of the proposed device.
• To explore the computability of the device within existing insurance
Design based on the International Organizational for Standardization and the Health Technological Assessment (HTA)
• Research design planning to conduct usability testing and evaluation based on end-users needs and functional requirements.
• Quantitative research design methodology for validating prototypes (proposed design) in simulated setting or real-life environment to create the final device.
• Qualitative research design planning for medical device design studies and techniques – to look at varied aspects of design like comfort, perception, behaviour, information communication.
• Qualitative research through focus groups (in-facility and online), in-depth interviews (face-to-face and telephone/web-assisted) and ethnography.
• Quantitative research – telephone, face-to-face and online
Hybrid or mixed methodology
Connected Medical Device – Turn data from medical devices and systems into analytics
• Comparative effective research & analytics
• Outcome-based analytics.
• Economic modeling
• Simulation modeling
• Real-world data analysis
• User device interaction – Normative path deviations
• Instrument utilization and performance analytics
• Patient usage data analytics
• Predictive analytics (e.g. in assessing the past performance of devices), predictive analytics (e.g. forecasting device performance)
Reference regression models for longitudinal validation testing
Meaningful Interpretation & Visualization
• Executive Level Report for investors
• Reports for strategic decision making.
• Regulatory reports for approvals
• Marketing materials from the insights
• Customized content and report periodical and commercial approaches.
