Overview

Today’s Medical Device Manufacturers are faced with a variety of challenges from new innovations, to global regulatory compliance, to proving product performance and effectiveness, to anticipating a future of a “pay for performance” model for reimbursement. In addition, “implantable” or “life-sustaining and -supporting” products are required by the FDA (21 CFR Part 821) to track information about the patient and the device to ensure that healthcare professionals and patients can be notified in a timely manner of any risk of harm associated with the device or for product recalls.

Pilgrim Software’s Patient Device Registry (PDR) is a 100% web-based solution that goes beyond device tracking by providing complete lifecycle management and supporting a relationship among devices, patients, physicians and hospital data to help manufacturers understand overall product utilization and performance to improve marketing and sales effectiveness while meeting regulatory requirements.

 

With Pilgrim’s PDR software, medical device manufacturers have a strategic Patient Device Registry solution that provides:

• Improved overall workforce efficiency and performance for maintaining Patient Device records
• Removal of non-value added steps to reduce costs associated with processing and maintaining a Patient Device Registry system
• Improved patient and customer notification, communications and relationships
• Demonstration of effectiveness or comparative effectiveness in different patient populations for competitive advantage
• Reduced market research timelines
• Better decision making
• Improved time to market

 … a sound foundation for very successful and improved marketing and sales effectiveness.

Key Capabilities

Accurately Manage the Lifecycle of Patient Device Tracking

Due to HIPAA security and the domain expertise required, traditional patient device tracking data has typically been kept isolated in a separate department and database and not made available to the rest of the organization. Functional areas such as regulatory complaints and manufacturing may have inconsistent data as it relates to explants and deaths. Engineering and Marketing may miss key information related to changes for new indications/usage or label extensions. Pilgrim’s PDR provides an integrated view of a medical device manufacturer’s patient device data throughout the lifetime of the device – from intake to follow-ups to quality audits to patient relationships, and by integration to key compliance and quality business systems such as Complaint Handling, Corrective Action (CAPA), CRM and ERP - revealing unrivaled business analytics across your organization and improving your competitive advantage.

 

Streamline Data Entry and Improve Workforce Effectiveness

Pilgrim’s PDR solution enables organizations to easily intake a patient device form submitted from a hospital, physician or patient via scanned mail, FAX, or through self-service web portals. The Patient Device form is completely user-configurable to capture all the needed fields that may be specific to type of device or internal business requirements. Users can then easily continue data entry, perform and save searches and lookups for related data or duplications, select from pre-defined lists for data consistency, add attachments of the scanned form or other communication documents, and have a complete view of the state or history of the progress of the patient device record all in one single, easy-to-use form. The solution uses point and click functionality for intelligent drop-down menus so that data entry is quick and streamlined. Organizations can easily look up device serial numbers and product ship dates, as well as set up contact information for physicians, surgeons, hospitals and patients directly from the patient device record or by selecting from existing product and contact records pulled from CRM or ERP systems. Pilgrim’s PDR provides a complete activity history for the Patient Device record including capturing the reason for change and history of the record workflow. With this PDR solution, medical device manufacturers can increase speed in overall data processing of Patient Device records while reducing errors in data duplication through a fully automated and integrated solution.

 

Boost Quality through Automated Data Entry Validation and Audits

Since Patient Device record intake and follow-ups occur through a variety of media and sources, and by different users, ultimately data entry errors can be introduced and information can still be missing. Pilgrim’s PDR provides more than 20 out-of-the-box data validations against Patient, Doctor, Hospital and Device, preventing users from saving a Patient Device record, or warning the user prior to saving it. Data validation can apply at multiple levels and at different stages in the workflow, and both the validation and error/warning messages are completely customer-configurable. In addition, Pilgrim’s PDR solution can help boost the quality of your Patient Device data further by automating data record audits/verification. Organizations can set up regular, periodic or annual audits through a configurable data record sampling plan which can be quickly adjusted based on data and user accuracy or decline. Users can also perform manual data audits as needed. All data audits are captured as activities in the Patient Device record.

 

Improve Patient & Customer Relationships

A Patient Device Registry will improve your awareness of product utilization and patient outcomes, and provide you with a clearer understanding of how your product is performing in the marketplace. Real-time data collection and analysis can produce rapid reports of patient and customer trends. Current FDA regulations require user facilities that implant or explant certain medical devices to submit reports to device manufacturers promptly after devices are received, implanted, or explanted. After the report is submitted and analysis is completed, Pilgrim’s PDR can be a communication and value-adding vehicle.

This PDR solution provides a medical device manufacturer the ability to create stronger relationships with patients and customers through the generation of Patient ID Cards, exchange of data through a manufacturer’s self-service web portal, and enhanced literature and labeling information from product performance data.  PDR provides the ability to automatically generate a Registration Patient ID card and set up preferences for mailing – patient or customer. Users can easily create templates for product, language or regional regulatory requirements. The solution can easily configured to determine device model and regional parameters for printing of appropriate labeling on the Patient ID card, such as warnings. Through integration to a secure HIPAA-compliant web portal, Pilgrim’s PDR can intake registration submissions and follow-up physician activities, provide mechanisms for patients to update their record such as contact information or changes in physician, retrieve Patient ID cards, provide triggers on device changes or notices to subscribed users providing them immediate alerts. Key considerations in generating interest and incentives with customers include the relevance of the Patient Device Registry to the physician’s practice, its scientific credibility, and non-monetary incentives such as reports and ease of participation. Ultimately, patients and customers are more actively involved in the process, while improving the accuracy of the information – providing a collaborative relationship that will significantly enhance the company’s response in the case of a product recall.

 

Meet Regulatory Compliance

Pilgrim’s PDR solution provides organizations the ability to track, update, audit and analyze Patient Device information in order to enable compliance with 21 CFR Part 821. With pre-built integration to Pilgrim’s Enterprise Risk, Compliance & Quality Management solutions or to other legacy systems through Pilgrim’s web services integration framework, PDR can easily trigger Complaints and Corrective and Preventive (CAPA) business process workflows from a received Patient Device record for explants and death. In addition, it can easily trigger the creation of a Patient Device Registry record from a received patient complaint. Pilgrim’s PDR provides complete user and role-based security for HIPAA compliance to protect patient data, and is fully 21 CFR Part 11 compliant complete with multi-level security, electronic signatures and all information captured in an audit trail that provides easy search and reporting in human readable format.

 

Build Sustainable Intelligence for Comparative Effectiveness

With the increase focus on quality in healthcare, coupled with the rising interest in “pay-for-performance” initiatives, a well- run Patient Device Registry can be an important source of data for your comparative effectiveness. Pilgrim’s PDR solution not only provides the mechanism to track and manage the lifecycle of a Patient Device record, but provides real-time device and patient information with easy ad-hoc reporting and analytics that can be used by cross-functional departments. Users can easily generate periodic and annual reports for management and as required for regulatory bodies. Pilgrim’s PDR includes several sample template reports. Modifications and new reports can be easily generated by the company’s business analysts. With integration to key business systems, PDR also provides the ability to analyze and trend product/patient demographics and device/physician history over time.

Features & Benefits

Capabilities	Benefits
Data Entry
Single, easy-to-use form to perform all data entry functions for device, patient, physician, hospital and follow-up visits	Increase speed in overall data processing of Patient Device records
Perform searches for information and duplicates directly from data entry form and save and export results
Easily attach original scanned form or other supporting documents to Patient Device record
Provides pick lists (drop downs) and pre-populated fields	Remove non-value added steps to reduce time and improve data consistency associated with processing Patient Device record
Enables external look-up to existing legacy system data such as device, model, serial number, etc.	Accurately incorporate data from various databases without the added cost of data duplication
Simple setup of patient and customer records from master data or update directly from data entry form	Speed up deployment as master records can be added in an on-going basis as Patient Device record is processed
Patient Device form is completely user-configurable through drag-and-drop graphical user interface	Easy personalization to meet global and local organization-specific business needs
Integrates with OCR Scanning and Web Portals through Web Services	Reduce errors in data duplication through a fully automated intake process
Workflow Effectiveness
Provides a dashboard to guide users on what needs to be done	Improve speed on task completion without relying upon meetings and e-mail
Immediate information on where users are and what’s next in the workflow	Improve workforce effectiveness and increase user adoption through self-guidance
Users can easily see the history of workflow progress of Patient Device records	Gain instant visibility of progress of Patient Device records for real-time decision-making
All steps in the workflow captured in the Patient Device activity record
Patient Device workflow completely user-configurable through visual interface	Puts the power of flexibility into your business analysts hands – no coding required
Data Entry Validation
Includes over 20 out-of-the-box validation rules against device, patient and customer records	Minimize configuration time through pre-built best practices
Provides multiple levels of validation applied at the form and at different stages in the workflow	Ensure data accuracy and meet mandatory data requirements throughout entire Patient Device record lifecycle
Validation returns warning or error message upon save including hyperlink to actual form error

 

Resources

• Introducing SmartPDR: Patient Device Registry Product Showcase

• Patient Device Registry: SmartPDR Datasheet