Data Registry Development Helps a Medical Devices Manufacturer Improve Performance and Benchmarking Using Real World and Clinical Data
Client: A leading medical devices manufacturer in the United States, Typically, the global medical devices industry includes medical devices that are utilized in orthopedics, cardiovascular, wound care, neurology, endoscopy, minimally invasive, anesthesia, respiratory, audiology, ophthalmology, aesthetics, urology and gynecology, and other durable medical equipment such as hospital supplies, and so on. Globally, the medical devices […]READ MORE >>
Client: A leading medical devices manufacturer in the United States,
Typically, the global medical devices industry includes medical devices that are utilized in orthopedics, cardiovascular, wound care, neurology, endoscopy, minimally invasive, anesthesia, respiratory, audiology, ophthalmology, aesthetics, urology and gynecology, and other durable medical equipment such as hospital supplies, and so on. Globally, the medical devices industry is moving away from an input-based approach to a value-and outcome-based approach. The primary aim of this transformational shift is to provide the best benefits to a large population set. Moreover, the pressure to reduce healthcare expenditure, intensifying competition, and consolidation of health systems and hospitals in the past few years have resulted in unprecedented changes in the way medical devices companies do business. The transformation of the medical devices industry is driven by aging population, increasing emphasis on quality of care and treatment, the proliferation of chronic diseases, stringent regulatory landscape focusing on cost-containment and patient safety, empowered and informed customers, and evolving technologies.
Let’s take a look at some of the vital factors that will influence the growth prospects of the medical devices industry in the coming years.
- More demanding and diverse customer base: In today’s dynamic environment, customers have more choices and are demanding superior medical devices and equipment. They are also trying to get more out of their reduced capital and expense budgets and are asking for higher incentives.
- Increased complexity of medical devices and equipment: The increasing complexity of medical devices results in difficult diagnosis and repair processes and spurs the cost of field service. This is subsequently raising the cost of training field service technicians.
Such factors are forcing firms in the medical devices space to leverage the use of data registry development services. Data registry development allows firms to improve and benchmark performances using real world and clinical data. .
The Business Challenge
The client, a leading medical devices manufacturer, wanted to build a data registry that included detailed patient-level data, device information, pathology, co-morbid conditions as well as clinical outcomes for transcatheter aortic valve procedures. Through the systematic collection of key data elements, the client also wanted to supplement existing registry infrastructures and support device benefit and risk evaluation based on treatment, adverse event, and longitudinal level patient data.
Key Implementation Activities
- Developed a data collection module (using dropdowns and free text fields) for collection and aggregation of patients’ quality-of-life data based on pre-defined guidelines like:
- 30 days and 1-year post-implant
- Mortality at discharge and 30 days
- 1-year follow-up reports for major procedures undergone post implant
- Created a normalized database for longitudinal level patient data
- The personal information (name, age, DOB) was stored in a separate data table
- Created a customized schema based on TVAR procedure terminology and device information
- Migrated data for 10,000 patients, as part of the pilot
- Provided an adverse event tracker module at the patient level, for assessing pre-procedural complications. E.g., stroke and re-interventions, etc.
- Technologies used to build the registry were Amazon Redshift, Elastic Search, Restful API using PHP Laravel, Perl, and jQuery & Google Charts library.
- Amazon Redshift provides a platform for creating data cubes, query execution, and database administration
- PHP Restful API and jQuery to create secure user interface with mobile responsive dashboard
- Elastic search provides high performance & fast search engine with big data support
- Linux & Apache HTTP server: an open-source web server used to host the online registry
Key Maintenance Activities
- Developed automated data integration scripts for ingesting data from other registries based on 1 to 1 mapping of data fields
- Ensured minimum possible manual intervention
- Integration scripts were manually customized if additional or dummy fields were needed
- Provided support for the following
- Registry administration functions
- Maintaining and resetting passwords
- Creating private user groups for Adverse event studies
- Creating group level user access
- Ad-hoc report requirements requiring customizations
- Executing and updating ETL scripts in case of manual uploads
- Testing and debugging in case of process disruptions
- Registry administration functions
- Expanded the registry to include the following
- Mitral Valve Procedures
Insights and Business Benefits for the Client
Strategies that we recommended based on our analysis to Improve Performance
The client utilized the registry as a database for Investigational Device Exemption (IDE) studies, (e.g., TAVR alternative access), post-approval studies and continued access programs. They also improved and benchmarked performance using real world and clinical data, to allow HCPs to identify procedures and activities that matter most to health outcomes and give them the ability to measure, evaluate, and improve TVAR procedures.
- The patient module allows the user to add a new patient or edit an existing patient’s personal information (name, birth date, age, co-morbid conditions, etc.).
- The medical information module allows the HCPs to enter lab results and another clinical trial related information
- The treatment module allows the HCPs to update and save the patient’s line of therapy and medications prescribed as well as the information about the HCPs and support staff.
- Longitudinal reports are available at the patient level. Patient-level reporting can be visualized as tables and charts.
- Segment level reports are available in the “Segment Statistics” section, which includes aggregate population statistics pertaining to demographics, treatment outcomes, etc.
To know more about how data registry development helped a leading medical devices manufacturer in the United States