Our Commitment for Best-in-Class Medical Device Management Solutions
To complement our strong expertise in Medical Device Tracking workflow development, we have been actively working to enhance our whole collection of software and service offerings to meet the rapidly changing regulatory environment facing the device industry. One of the greatest obstacles and concerns for the industry is the nascent and coming regulatory changes (1) being imposed upon the industry; the larger the company, the greater this burden is reported. In addition, there is always a core goal for providing health outcomes that meet the best practice that can be delivered for the medical community – Is what we manufacture and aid in the delivery to patients, safe and effective?
At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population. From a recently published report (2) it has been determined that the 510(k) program is in need of modification to support both patient safety and efficacy concerns.
“An alarming number of new medical devices sidestep FDA approval through a system known as the 510(k) program. The FDA typically evaluates new products with stringent premarket testing (PMA), but the process can be bypassed if a manufacturer can demonstrate that its product is “substantially equivalent” to one already on the market, a new medical device can be marketed and implanted in patients without any clinical testing or review of outcomes.
While the 510(k) clearing process provides patients with quick access to innovations in medicine, there is an unsettling consequence: The FDA has cleared a flood of new devices without requiring manufacturers to prove their safety and effectiveness.
From 2005 to 2009, for example, 71 percent of the class III (highest-risk) medical devices cleared through 510(k) were later recalled over safety concerns. Criticizing the potential risks of 510(k)-cleared devices, the U.S. Government Accountability Office has urged the FDA to improve the process for medical device review. Specific actions were suggested, and the FDA plans to fully comply starting in 2013 with full compliance 2020.”
We at Portford Solutions, have both a vision and a mission, to provide the best medical device management software to fulfill your requirements to manage the optimal outcome for your patients and medical providers. We began our initiative by providing a best-in-class Medical Device Tracking software solution accessible by all the required participants from manufacturing, distribution and eventual use of the device in patients. We built our system with an expansive specification that serves as a solid platform for the addition of many new integrated modules providing all the features and services needed to meet both best practice and all regulatory requirements.
Solutions Exceeding Regulatory and Medical Community Requirements
Our current software development is focused on providing the following features to aid your company in meeting and exceeding all the requirements for medical device management and reporting. Development has been ongoing on these enhancements and will be added as modules or incorporated into the core of our solutions in the near future.
- Seamless integration with the newly established FDA GUDID Web Service Database for delivery of unique, trackable device IDs. The FDA has established a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). Our software will manage the registration and link to the GUDID database beginning at the manufacturing point through eventual use in patients and subsequent follow-up.
- Cloud-based device tracking workflow integrated with manufacturing, distribution and disposition. We make sure nothing “falls through the cracks” with many integrity checks ensuring that all required tasks are performed, recorded and audited in the most secure environment that can currently be implemented.
- Support for the tracking and reporting on the use of complex, compound medical “device” that may be made up of many components being used in patients as a single entity.
- Integration into our workflow of industry-proven imaging repository and image analysis for disposition – from clinical trials, PMA support and post-operative monitoring. The imaging system supports pre-surgery diagnostic images, initial implant and all subsequent follow-up meeting all radiological and photographic standard and PACS compliance.
- Predictive analytics of time-series data to support early decision about device behavior. The analytics system takes as initial input engineering tolerances, expected behavior from previous trial/use data. The model is expanded to include such factors such patient demographics and device behavior collected from both the prescribing data and medical condition reporting. The collection of this Big Data and the predictive model can be used to measure device behavior moving toward exceeding or under-performing expected device behavior.
- The expansion of our current database model will be built on joint industry/government data standards using the harmonization of CDISC and HL7 managed by many EMR system currently in use in hospital, clinic and physician settings.
- Our next generation release will be fully compliant for full breadth of government mandated regulations published with compliance dates published through 2020.
- The expanded design of our system will provide an option for a subscription service to the newly defined FDA PMA reporting portal. The integration of our system and service offering will help you meet the requirements for the new FDA eMDR (electronic Medical Device Report) for electronic submission of required reports. As required, we can also help manage compliance to the Medical Device Reporting regulations supporting MedWatch form creation and submission to the FDA portal for reports.
We have a staff of experts from the medical device and pharmaceutical industries that have helped us define the specification for our expanded offerings. This group is available to provide essential services for your company including:
- Device trial definition, management and reporting
- Expert configuration to provide the best implementation of our system for your devices
- Regulatory preparedness consulting
We take the active position of being leaders driving the adoption of these technologies to tackle the ever-changing regulatory demands being placed upon the industry and to support best practice for delivering the best outcome for patients.
Solutions Delivery for Today’s Market
To deliver our best-in-class solution and services, we have incorporated, into the core of our design, delivery of our solutions on a cloud-based platform. We have adopted a Software as a Service (SaaS) model providing optimal cost and operational efficiencies. We will continue to provide key components of our software for deployment using in-house (On Premise) hosted model for those not ready to adopt our full SaaS model. We welcome the opportunity to discuss our SaaS model and any of particulars about our solutions.
From a published industry study (3), companies who initially implemented cloud technology to decrease costs have also achieved a competitive advantage through implementing this technology. The study found that one out of five organizations is ahead of the curve on cloud adoption. Moreover, they are achieving a competitive advantage by using cloud-based platforms, and not just cutting costs and driving efficiency through cloud computing. The study also points out the ability to use cloud-based big data to make more informed business decisions. This study shows that many businesses are seeing those advantages now, mostly after the initial cloud deployments.
From the well-published experience of others with SaaS systems, adopting our SaaS model for medical device management offers the following benefits:
- Lower and More Predictable Costs: SaaS technology solutions are often lower cost solutions, as they enable health care organizations to avoid the costs of purchasing expensive hardware (e.g., servers) and/or software. The costs of SaaS deployment are also more predictable than on-site technology. SaaS deployment typically requires providers to pay a fixed subscription cost (monthly or yearly). On-site deployment typically requires providers to pay for ongoing costs to support and manage on-site data servers.
- Simpler and Robust Security: SaaS technology deployment “reduces individual maintenance responsibilities and allows even small organizations to benefit, as responsibility for maintaining security is shifted from your organization to the Cloud-based service provider.
- Easier Upgrades and Updates: Our SaaS technology solutions allow us to make upgrades and fixes to the software without end-user involvement. Upgrades and updates to SaaS technology are less expensive and easier to deploy to our 21CFR Part11-complaint platform. Updates are typically deployed in one day; not weeks.
- Improved Accessibility: Using a SaaS solution allows your company, medical providers and staff members to access technology from remote locations. Our Co-located and replicated systems and storage architecture ensures reliability with up-time maintained at 99.7% providing worldwide access—24 hours, 7 days a week, 365 days a year.
- Better Data Exchange: SaaS technology solutions also enable better data exchange, as “data from many organizations are stored and processed in a more uniform way (HL7 and CDISC).”(4) You can use the technology to share information with other providers, health care organizations, and patients.
- Scalable Solutions:Our SaaS solutions are scalable and are designed to increase capacity, performance and number of users to match your business growth.
(4) Executive Office of the President – President’s Council of Advisors on Science and Technology. “Report to the President Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward ”, http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf