Every medical device company faces the challenge of navigating through the FDA’s mandatory regulations, and companies have different needs that change as they mature. Early-stage medical device companies provide the innovation and intellectual property that feed the medical device industry with great ideas and life-saving devices, but understanding FDA regulations and reaching commercial markets can be extremely daunting for new companies.
In contrast, established medical device companies that have successfully traversed the complex maze of FDA regulations and are effectively marketing their devices have other issues to face. They are often left with a legacy of individual processes, systems, and tools known as “point solutions” that are fragmented and have broken down over time. Early-stage and established medical device companies are operating on opposite ends of the company growth spectrum, but the natural market evolution for most early-stage medical device companies is to get acquired, and anything that can be done to help make the mergers and acquisitions (M&A) process easier can result in big payoffs down the road.
Operating within the FDA mandatory regulations concerning medical device design controls is the way of life for any company that wants to improve the lives of others through the design and marketing of medical devices. It is not usually the technical hurdles that challenge the engineering team, but rather, the “bureaucracy of change” that impedes the progress of technical advancement. This “bureaucracy of change” includes formal design controls, peer reviews, document management, and technical/managerial oversight. This bureaucracy is very important to the design process and leads to high-quality medical devices, but can add significant overhead, in terms of cost and time, to a project. Most companies simply write off this overhead to the cost of doing business without realizing the price of these inefficiencies.
Instead of simply writing off this overhead, imagine being able to reduce the time to design a device by 30 percent on a multiyear project. Not only would overhead be reduced by 30 percent, but sales would also rise because companies could realize margin increases of new product releases much sooner. As one sales executive complained, “Why does it take engineering so long to develop product? Every month we delay, we are losing hundreds of thousands of dollars due to potential margin increases.” Simply said, the sooner innovative medical technology gets to market, the greater the impact on people’s lives, which results in improved business opportunities.
Automating the Design Process
One way to make the design process easier is to help development teams automate the medical device design process. Using process automation and integrated tools in the medical device design process can help pull a company through the FDA-regulated processes in much the same way that Turbo Tax pulls users through the process of efficiently filing their taxes. “Turbo Taxing” these processes can shorten design cycles and improve management efficiency, which could lead to increased cost savings and sales. Effective use of such a process automation (work flow) and integrated tool suite at the enterprise level could bring a device to market “faster, better, and cheaper” simply by reducing the waste in the design process.
To help medical device companies improve their navigation of FDA regulations, Tietronix Software (Houston, TX) has developed the Medical Device Accelerator (MDA), a web-based quality management system (QMS) that includes an electronic document management system automating the formal peer review process, audit trails to aid in FDA inspections, an integrated Correction Action, Preventative Action (CAPA) system, and the ability to capture patient complaints and report Medical Device Reporting (MDR) information. The MDA gives companies the ability to access their project files across multiple mobile platforms, including iPads, iPhones, and Android systems. The MDA includes a library of processes, process automation, document management, and an integrated database, all in a single system.
Library of Processes
The Medical Device Accelerator’s library of processes offers development teams a menu of tools to choose from as needed, including design control processes, risk analysis processes, document templates, and customizable processes. The library of processes creates easily repeatable design processes that lead to consistent development of medical devices.
Both early-stage and established medical device companies could benefit from using a library of processes and integrated tools to automate the medical device design process. Early-stage medical device companies, especially, need guidance on how to navigate through the maze of FDA regulations. Because this navigation requires scalable infrastructure to manage change control, design documents, assemble Investigational Device Exemptions (IDEs), and manage clinical trial information in electronic form, companies need an accessible set of FDA processes in compliance with FDA regulations, ISO standards, and industry best practices to draw upon.
However, startup companies don't always need all this capability in the early days, so a “cafeteria approach” to accessing these tools makes the package even more desirable, as it allows a company to pick and choose from the set of libraries and tools as they are needed. A company may choose the processes and tools required at each particular stage of company growth. For example, companies don’t need a patient complaint tracking database when prototyping a novel technical design. But, once that design is mature enough to enter clinical trials, a complaint database is required.
For mature medical companies that are looking to improve their overall company performance, processes from the process library can be modified with little effort, or new processes can be made from scratch based on the company's current standard operating procedures (SOPs). This process library can help established companies move past their fragmented “point solutions” and into a more organized development process.
Process automation can help guide the development team through the design process as well. As part of the design process, the FDA mandates that medical device design companies review past Design History Files (DHFs) of previous projects when entering into a new project. Often this review is done through a multiple step process, including reviewing paper files and pulling information from multiple electronic systems, but process automation could help reduce the time and effort needed to process and gather information.
The Medical Device Accelerator offers a single source where all documents, lessons learned, and project comments are located in one place and can be easily reviewed. Information like this could also be included in the processes definition, conveniently documenting objective evidence of such activities and making future visits from the FDA much smoother and more efficient. The integrated process automation features Project Lifecycle Management (PLM), which allows for easy adherence to FDA design controls. In addition, MDA offers development teams project transparency with real-time notifications, access to objective evidence, defect tracking, and Corrective and Preventative Actions (CAPA).
Document management is a key element of any medical device company from the earliest days of the company’s formation. Many companies still use paper systems or a nonintegrated “point solution,” but it is paramount that a company can demonstrate good change control of its documentation and show objective evidence of the approval process. The integrated document management system in MDA makes this information easily accessible.
Important documents must go through formal peer reviews to ensure appropriate technical and managerial oversight. Formally reviewing a document, however, is a laborious and timeconsuming task. Oftentimes, a document goes out for review and is rejected for some reason, but the author is never made aware of the rejection and the document goes into limbo. Document management through process automation can eliminate this document limbo. Information about the process, the state of the project, and the review process is constantly being “pushed” out to the team. No longer is it necessary to go and manually pull information about the “state of things.” For example, if marketing rejects the document, a rejection notice is automatically sent out, allowing the author to take immediate action.
In addition, document states and metadata can also be used to describe the maturity of a document and intended use. For example, a document with the state “pilot” indicates that the document has gone through a Technical Review Board (TRB) but is not fully tested. Documents can be tagged with metadata, helping to determine which documents get submitted to the FDA or are part of the Device Master Record (DMR).
Medical device companies can also benefit from the MDA’s integrated database. The database features include a mapping of compliant standards, an archive of changed documents, an audit trail, query reports, and the Electronic Design History File (DHF). The database gives development teams easy access to information when it is needed and provides tools to easily review past project information. The integrated database captures information throughout the design process and provides reports accessible to the development team. The database stores complete project information in the DHF, which makes it easy to comply with the audit process.
Developing and marketing medical devices is a noble and rewarding endeavor, but a very complicated and expensive enterprise. Through process automation and an enterprise suite of integrated tools, medical innovations can reach commercial markets more quickly and economically then ever before. Earlystage medical device companies could benefit from the flexibility of process automation, while remaining confident that they are in compliance with FDA regulations. Established medical device companies could benefit from a more streamlined development process, allowing them better organization and access to their important documents.
The Medical Device Accelerator was designed with the modern company in mind. Companies can access MDA through multiple mobile platforms, including iPads, iPhones, and Android systems. These flexible access options offer development teams the ability to quickly react to queries or action items, further speeding up the development process. Whether team members are traveling or working virtually, they can have immediate access to important project information, making the medical device design process smoother than ever before.
Tietronix Software’s Medical Device Accelerator (MDA) performs the tasks described in this paper with its library of processes, document management, process automation, and an integrated database, which can help medical device companies efficiently navigate the mandatory FDA regulations. This webbased quality management system can help companies design medical devices and get them to the market more quickly. MDA is available either as Software as a Service (SaaS) via a monthly subscription or through a perpetual license, with the software locally hosted.