By Carole C. Carey
Emerging technologies in medicine, biology, life sciences and engineering are focusing more than ever on innovative products in delivering safe effective medical devices, novel therapeutic treatments, and efficiency of health care systems around the world. The aim is for patients to have early access to innovative devices as well as reduction in costs of medical products.
Standards Do Matter
Standards are published formal documents that establish uniform specifications and procedures to ensure quality, compatibility and reliability of materials, products, methods and/or services. They support and facilitate interoperability between devices made by different producers. Standards are often derived from innovative technology and are based on the consensus participation of multidimensional views; manufacturers, researchers, policy makers, interest groups, and users. Effective approaches are required. Standards can help reduce the timelines from scientific research discoveries to clinical practice to product technology commercialization. One proven approach is the recognition and consideration of incorporating the use of standards in every stage of the translation roadmap from ‘bench to bedside’. Conformance to high quality standards provides assurance to stakeholders on the quality of products and consistency of processes and production methods.
We are witnessing a rapid increase of innovative products and wearables from emerging technologies in both the consumer and healthcare space, such as artificial intelligence, 3D-based bioprinting, brain computer/machine interface, medical robotics, and blockchain for life sciences among others. Standards are lagging behind. The development of standards needs to catch up with technology innovations. Collaboration among standards developers around the world should expand and intensify.
Regulatory Challenge and Opportunity
Medical devices are highly regulated products. One of the challenges that manufacturers face, particularly multinational firms, is overcoming complex government regulatory review of new devices. A lengthy market approval process can impede innovation and delay the availability of better health and healthcare systems. Regulatory bodies across international jurisdictions recognize that established industry consensus standards help simplify the process of designing, developing, testing and manufacturing new technologies. Regulators support the use of harmonized standards as one of the regulatory tools that augment the supervision and management of medical products. The harmonized process, allows innovative devices to reach patients quicker, is considerably streamlined. Moreover, the cooperation between government and regulated industry greatly reduces the regulatory burdens on both sides.
IEEE Standards Development: Guiding Principles
International standards are generally developed through a voluntary consensus process that brings together volunteers and subject matter experts with an interest in the standards’ topics to be considered. One purpose of establishing standards is in response to technical, safety, performance, regulatory, societal and market needs in order to serve the public good. Most standards are generally made available to the public. Through an accredited consensus process, standards setting bodies or standards development organizations (SDOs) like IEEE, IEC, ISO and others manage and facilitate the development of standards. Although the goals of SDOs are essentially the same, each SDO applies its own set of rules, terminology, processes, policies, and guidelines. They help ensure the integrity of the standards development process.
The IEEE organizational unit that oversees the standards development process is the IEEE Standards Association (IEEESA). The IEEE-SA Standards Board (IEEESASB) and its Committees provide the policies and guidelines for the development of individual and entity-driven standards in order to ensure a fair and equitable process. These Committees include the New Standards Review Committee (NesCom), Standards Review Committee (RevCom), Procedures Committee (ProCom), Audit Committee (AudCom), and Patent Committee (PatCom). IEEE-SA adheres to the Open Stand paradigm and supports the principles and requirements of WTO (World Trade Organization’s Decision on Principles for the Development of International Standards, Guides and Recommendations). It should be noted that the IEEE-SASB does not develop the standards. Collaborative teams or standards working groups (WGs) are formed to develop standards. IEEE-SA staff provides guidance and operational support.
Participation in WGs is also guided by five basic principles.
- Openness: Participation in IEEE standards development is open to all interested parties, IEEE members or non-IEEE members alike.
- Due Process: Highly visible operating procedures are followed.
- Balance: No one party has an overwhelming influence in the ballot group.
- Consensus: Resolving differences of opinion and a clearly defined percentage of those in a balloting group vote to approve a draft of the standard.
- Right of Appeal: Anyone may appeal a standards development decision at any point, before or after a standard has been approved.
It All Starts with An Idea or Concept
A standardization project usually gets under way when a person or a group of people with similar interest identifies a specific topic in need of standardization. The idea or concept can be broad or very specific. An example is standardization of common terms, definitions, or symbols. Standards projects can be about technical characteristics, performance, and safety requirements associated with devices, equipment, and systems. They can also be about recommendations reflecting current state-of-the-art in the application of engineering principles. There are many more examples.
In IEEE, the term Standards encompasses three types of projects and/or documents: Standards (“shall” contains mandatory requirements), Recommended Practice (“should” outlines preferred procedures), or Guide (“may” offers suggestions for working with a technology). When deciding on starting a standards project, the potential working group should take into consideration the following criteria: (1) Broad market potential, (2) Technical feasibility, (3) Readiness for standardization, (4) Distinct identity or substantial technical merit when compared to other standards, and (5) Adequate participation, enough participants to step forward to develop the standard.
The Six Stages of the Standards Development Life Cycle
1. Initiating the Project. Project authorization request (PAR) is a small structured document that defines the scope, purpose and need for a standard. An IEEE standard project also needs a Sponsor, the entity that assumes the responsibility for a particular standards idea. The Sponsor provides technical oversight, including the organization of the standards development team and its activities, from inception to completion. Sponsors are typically from the IEEE technical Societies and Committees. An IEEE-SASB approved PAR marks the official start of the standards project. This is the time to submit a PAR through myProject (a web-based tool that facilitates the IEEE standards development process)!
2. Mobilizing the Working Group. “Working Group” is term IEEE uses to refer to the collaborative team that actively develops a standard, recommended practice or guide. Other SDOs may refer to their groups using different terms or may follow slightly different processes. Working Groups are comprised of individuals and/or entities (people, companies, organizations, non-profits, government agencies) who volunteer to support the development of standards. The WG Chair calls for participation. This is a good time to sign up and join the “Kick-off” meeting and attend future meetings!
3. Drafting the Standard. Under the leadership and guidance of the WG Chair, who also acts as the point of contact for technical questions, the WG makes technical decisions in the process of developing the standard. The WG’s first milestone is completion of the first mature draft in order to move the project for Sponsor approval/ballot and ultimately IEEE-SASB approval. This is the time to make contributions to the standard draft development and help the WG move forward!
4. Balloting the Standard. The goal in balloting is to gain the greatest consensus and balance with no dominance by any one group of interest or company. Balloting process starts when the sponsor determines the draft of the full standard is stable. Sponsor will initiate the invitation to form the balloting group (persons interested in the standard). Anyone can contribute comments through the Public Review Process. However, only votes from eligible members of the balloting group count toward approval. This is the time to enroll and join the ballot pool and participate in the consensus ballot!
5. Gaining Final Approval. The completed standard and supporting materials are submitted to RevCom to ensure the WG followed all procedures and guiding principles in drafting and balloting the standard. Similar to the PAR, the completed standard will be presented to IEEE-SASB for approval/disapproval. IEEE-SA professional editor reviews multiple drafts during development. After IEEE-SASB approval, the editor prepares the final text for publication. Your primary task is completed once the standard is approved and published!
6. Maintaining the Standard. An IEEE standard is valid for 10 years from the date of IEEE-SASB approval. Amendments and Corrigenda (corrections of technical errors) can be developed and balloted within the 10-year validity rule. If the standard becomes outdated, a Revision can be initiated. After 10 years, one of two actions can occur: revision or withdrawal. It would be beneficial to stay up-to-date on technology developments, new information from research and product field experience.
Standards help ensure consumer safety and interoperability across devices. Participation in developing global, consensus standards in an open platform encourages innovation, drives competition among product designers and developers, and promotes international trade.
Please, get involved!
- IEEE Standards Association
- Open Stand
- IEEE Adherence to WTO Principles for International Standardization
Carole C. Carey, IEEE Senior Member
Chair, IEEE EMB Standards Committee Liaison to IEEE-SA Standards Board
Standards Chair, IEEE Life Sciences Technical Community