Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC03.16.21
Regulatory requirements and limitations have a pronounced impact on new product development in the medical device industry. Further, each stakeholder in the development process brings inputs that impact the final product. From the inception of a new or novel design, incorporating considerations from all stakeholders early may allow the final product to harness all potential uses, benefits, and features.
Early Development
Early product development often focuses on feasibility, material selection, manufacturing requirements, supplier capability, and design inputs for the formal development project. The focus of this column is on this early stage, which typically precedes the formal development project. The involvement of quality and regulatory expertise at this stage is usually lacking due to resources, a perceived lack of contribution from these areas, or simply because the project is in its infancy and these elements have not yet been considered. While it does not make sense to implement design controls prematurely, some considerations can be made at these stages without hampering the progress of development.
Design Controls
The time at which product development transitions from feasibility to design controls is critical. Often, startups and other lean organizations conduct some design activities and verification testing before enacting formal design controls. In these cases, “backfilling” is required to generate the documentation required for design controls in various regulatory jurisdictions. For example, an organization may create the preliminary device design and then perform some testing as a combined effort to assess feasibility and also verify device function. While such testing might be leveraged as a verification activity, such an effort is not commensurate with the spirit of design control requirements and does not meet best practices for the risk management process for medical devices. With an increased focus from regulatory agencies on risk-based QMS (quality management systems) and product development functions, conducting verification testing without links to the risk management process is not recommended.
Early Participation
When conceiving an idea for a new or improved medical device, consider how stakeholders, or surrogates for stakeholders, can weigh in with preliminary guidance. Solicit feedback from experts in all fields within the development process early to consider any limitations when transitioning to design controls. Such a process need not be formal or leverage design control procedures. An informal assessment early carries significant value in giving the team an early understanding of these variables. A brief concentration with representative experts alone will be beneficial:
Medical or clinical affairs representation can ensure the design will address intended indications and ensure that verification and validation are clinically relevant and support the desired claims.
Other Areas of Consideration
Regulatory and quality considerations are not the only elements to evaluate during early development. Marketing strategy and claims are beneficial to consider early on; highly desired claims may be limited by the regulatory classification or may only be possible with supporting verification and validation testing. Project management resources have a more global perspective of the project and experience in identifying development challenges that may delay the undertaking. A seasoned project manager may be able to preemptively identify potential delays in project deliverables and delays resulting from links between deliverables. Stakeholders outside of research and development should share their insight as soon as possible to avoid any potential project delays.
Organizations not already doing so should consider discussing early design projects during management review or when establishing quality objectives. It’s never too early to begin assessing the necessary resources when an idea transitions to a development project. Even if on an informal basis, enlist the participation and guidance of all stakeholders in the development process early. If early feasibility or development work is restricted to only research and development staff, the project may not yield all the intended benefits and promise.
Bryan Brosseau’s experience has been forged in 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he drives quality and compliance without impeding progress. Bryan implements, manages, and improves quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas. Bryan received his bachelor’s degree in biology from the University of Georgia, maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 and MDSAP Lead Auditor.
Early Development
Early product development often focuses on feasibility, material selection, manufacturing requirements, supplier capability, and design inputs for the formal development project. The focus of this column is on this early stage, which typically precedes the formal development project. The involvement of quality and regulatory expertise at this stage is usually lacking due to resources, a perceived lack of contribution from these areas, or simply because the project is in its infancy and these elements have not yet been considered. While it does not make sense to implement design controls prematurely, some considerations can be made at these stages without hampering the progress of development.
Design Controls
The time at which product development transitions from feasibility to design controls is critical. Often, startups and other lean organizations conduct some design activities and verification testing before enacting formal design controls. In these cases, “backfilling” is required to generate the documentation required for design controls in various regulatory jurisdictions. For example, an organization may create the preliminary device design and then perform some testing as a combined effort to assess feasibility and also verify device function. While such testing might be leveraged as a verification activity, such an effort is not commensurate with the spirit of design control requirements and does not meet best practices for the risk management process for medical devices. With an increased focus from regulatory agencies on risk-based QMS (quality management systems) and product development functions, conducting verification testing without links to the risk management process is not recommended.
Early Participation
When conceiving an idea for a new or improved medical device, consider how stakeholders, or surrogates for stakeholders, can weigh in with preliminary guidance. Solicit feedback from experts in all fields within the development process early to consider any limitations when transitioning to design controls. Such a process need not be formal or leverage design control procedures. An informal assessment early carries significant value in giving the team an early understanding of these variables. A brief concentration with representative experts alone will be beneficial:
- A regulatory affairs colleague may advise on classification, the regulatory pathway, or limitations for a device within a given product code or classification.
- A medical device engineer can assess the preliminary design verification test plan for certain design features or to support product claims.
- A clinical researcher can assist with real-world validation scenarios, collection and evaluation of supporting clinical data, or considerations for clinical trial design where required for device validation or to meet regulatory requirements.
Medical or clinical affairs representation can ensure the design will address intended indications and ensure that verification and validation are clinically relevant and support the desired claims.
Other Areas of Consideration
Regulatory and quality considerations are not the only elements to evaluate during early development. Marketing strategy and claims are beneficial to consider early on; highly desired claims may be limited by the regulatory classification or may only be possible with supporting verification and validation testing. Project management resources have a more global perspective of the project and experience in identifying development challenges that may delay the undertaking. A seasoned project manager may be able to preemptively identify potential delays in project deliverables and delays resulting from links between deliverables. Stakeholders outside of research and development should share their insight as soon as possible to avoid any potential project delays.
Organizations not already doing so should consider discussing early design projects during management review or when establishing quality objectives. It’s never too early to begin assessing the necessary resources when an idea transitions to a development project. Even if on an informal basis, enlist the participation and guidance of all stakeholders in the development process early. If early feasibility or development work is restricted to only research and development staff, the project may not yield all the intended benefits and promise.
Bryan Brosseau’s experience has been forged in 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he drives quality and compliance without impeding progress. Bryan implements, manages, and improves quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas. Bryan received his bachelor’s degree in biology from the University of Georgia, maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 and MDSAP Lead Auditor.
