With the development of a medical device, how do you best achieve a balance between time to market, cost savings, and regulatory compliance?

Joseph Havrilla
CTO, Strategy Officer, and Sr. VP for Corporate Development & Innovations, MEDRAD

MEDRAD balances requirements of medical device development through focused teams and rigorous, consistent processes. These components, part of MEDRAD’s unchanging core, help exceed customer, compliance, and business standards, allowing us to maintain performance excellence despite challenges. Regulatory compliance and patient safety cannot be sacrificed for schedule or cost.

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.

In order to help a medical device meet regulatory compliance in a time efficient, cost-saving way, we created an Early Design Evaluation (EDE). This program incorporates an early stage design review and evaluation addressing the electromagnetic compatibility and the product safety requirements of electrical and electronic devices. This program covers world wide EMC and Safety directives including, but not limited to, FCC, CE, UL, CSA, ACA, FDA, FAA, IEC, CCC, and other government and regulatory agencies. This process greatly reduces the time to market by eliminating design flaws and identifying applicable standards early in the design phase.

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.

Damien Plisson
Solution Leader, Medical Devices, Dassault Systèmes

Regulatory compliance is usually discussed as a negative. Costs, bureaucracy, and costly technology are greeted with disdain by the medical device community. When viewed strategically, though, regulations often pave the way to business benefits like cost savings and quicker time to market. One need look no further than the systems engineering regulation in 21 CFR Part 820.30 “Design Controls.”

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

Designers that integrate proven commercial-off-the-shelf (COTS)-based embedded computing platforms significantly increase their ability to focus on core competencies, maximize compatibility, and avoid repeatedly developing applications from the ground up. COTS platforms reduce development time and allow next generation devices to make the jump to new processor architectures without major redesigns. Long-term embedded module platforms, such as computer-on-module (COMs) and PC/104 single board computers (SBCs) continue to offer designers the latest technologies in terms of performance, power consumption and graphics processing. Customization is simplified and cost-effective without impacting the CPU and board layout, while allowing improved performance, adding application features and the ability to reduce the device footprint.

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.

Newton Defaria
Business Development Manager for Life and Analytical Sciences, National Instruments

In a way, achieving a balance among these various factors can be largely influenced by a company’s positive or negative perspective around compliance. Rather than looking at regulatory compliance as a limitation, it can be helpful to view it as a way to attain a faster time to market and cost savings by developing a product more effectively and efficiently.

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.

Medical device development is a long and costly process, impacted by the continuous changes to regulatory requirements. The best approach to finding a balance between meeting FDA/ISO requirements and bringing the device to market within a reasonable timeframe and cost is to take regulatory requirements into consideration at the beginning of device development. For Class II devices, a predicate device should be identified early; equivalence will be more easily demonstrated with appropriate data collected during development. Design attributes drive the cost and time it takes to bring the device to market, and choices made in the selection of materials are not easily changed later in the development process. Ideally, materials selected for the device should have a long history of safe use. Devices that include novel materials, lack readily available chemical characterization, are not exempt from certification (color additives), or lack a master file (drugs, polymers) will require additional analytical testing, risk assessments, toxicology, and biocompatibility testing. Understanding requirements, selecting appropriate materials, and setting goals for equivalence early are critical in staying on the most direct path to approval. Finally, communicate with FDA as early and as often as possible to avoid surprises that can cost both time and money.