With the development of a medical device, how do you best achieve a balance between time to market, cost savings, and regulatory compliance?
CTO, Strategy Officer, and Sr. VP for Corporate Development & Innovations, MEDRAD
MEDRAD’s recognized customer focus, process management, workforce focus, strategic planning, knowledge management, information analysis, and leadership processes help systematically balance the noted activities. Some critical aspects to these processes in relation to the question include:
Per time to market—A belief that the customer holds the answer is key. MEDRAD continuously collects and analyzes Voice of the Customer information to ensure employees have information to bolster customer engagement.
Per cost savings—A continuous search for profitability improvements through product and process efficiencies is key. Our corporate innovations group consistently evaluates competencies and technologies and we engage employees in cost cutting through capturing, measuring, tracking, and recognizing improvement ideas.
Per regulatory compliance—Excellence beyond regulatory standards through internal benchmarking is key. MEDRAD actively pursues the Malcolm Baldrige National Quality process, which we’ve won in 2003 and 2010. This journey evaluates our processes, allowing us to adjust accordingly to guarantee quality and performance excellence.
Donald L. Sweeney
President and Senior EMC Engineer, D.L.S. Electronic Systems Inc.
The EDE Four-Point Program:
Initial Review—The initial review develops a brief description of the product or device, including its intended use.
EMC and Product Safety Compliance Review—EDE Project leader and EDE Specialist review product or device for applicable EMC Directives and Standards, Review of individual standards, and Review Description of Testing Methodology.
EMC and Product Safety Design Evaluation—Detailed analysis of the product or device for EMC and Product Safety issues by EDE EMC Specialist and Product Safety Specialist. Review of EMC and Product Safety design issues/solutions:
- Board/Component related
- Cable Related
- Enclosure Related
- System Related
A Final Report is issued by EDE Project Leader. Specifically mentioned are recommendations in the areas reviewed and discussed. Included are proposals related to additional work needed for compliance to applicable standards.
We have found by addressing EMC and Product Safety requirements early in the design stage, we have saved many medical manufactures the cost, frustration, and loss of time of trying to add fixes and design changes to a product that is out of limits or that requires Product Safety changes.
Solution Leader, Medical Devices, Dassault Systèmes
The legislations asks organizations to fully document design history, rationales, and reviews for each decision, and provide full traceability between high-level requirements down to physical design and tests—both procedures and results—at each level. This is a good foundation to establishing quality processes that save costs and accelerate time to market. The rationales and reviews of high-level system requirements and models strongly reduce late, costly reworks. Finally, full traceability enables companies to find the exact impact of a design change to perform the needed verifications and, ultimately, avoid costly recalls.
Christine A. Van De Graaf
Embedded Products Business Unit Product Manager, Embedded Modules & SBCs, Kontron America
Many suppliers offer reference designs for these standardized platforms, which allow design elements to be more easily added or removed for faster development. Perhaps most importantly, FDA certification can be expedited if the chosen platform uses components that are certified and known to perform together effectively.
Sophisticated embedded technologies are enabling new medical applications like never before. The competitive advantage goes to the device developer that gets to market first—presenting both challenge and opportunity for smart designs that innovate by capitalizing on proven COTS-based platforms.
Business Development Manager for Life and Analytical Sciences, National Instruments
Below, I've included a few suggestions to implement such processes:
- Invest in multi-domain experts, such as biomedical engineers
- Provide multi-domain experts with productivity tools capable of enhancing their ability to solve engineering problems, abstract complexity, streamline, and automate the processes.
- Obtain, retain, and develop expertise on the regulatory guidelines and standards. Use these as productivity tools and not as policy to comply with for the sake of complying.
- Avoid keeping the "status quo" and tool chain affinity. Innovate not only your products but also your processes.
- Verify hypothesis and assumptions through experimentation and fully functional prototypes.
- Engage in development/deployment only after a solid and refined set of requirements.
- Design only the necessary components, leverage the available off-the-shelf technology for sub-assemblies.
- Implement concurrent engineering—from early research all the way to manufacturing and test
- Test extensively
Sherry P. Parker, Ph.D.
Director, Technical and Regulatory, Medical Devices, WuXi AppTec, Inc.