Beat Your Medtech Competition To Market Launch With Streamlined Processes

By Philip Remedios, director of design and development, BlackHägen Design

According to Fortune Business Insights, the global medical devices market is projected to grow from $495.46 billion in 2022 to $718.92 billion by 2029 at a CAGR of 5.5% over the forecast period. Technology advances in medical devices and users' adoption and comfort level with in-home devices and wearables have set the stage for lucrative market growth. Additionally, an aging population and the increasing prevalence of associated non-communicable diseases like diabetes, hypertension, and cardiac disorders will significantly boost the need for innovation.

There’s plenty of room for profit, but the overachievers will be those organizations with the agility and focus to outsprint their competition to market launch.

Streamline Processes To Move Quickly And Decisively

Research and development (R&D) teams and manufacturers must move quickly to outpace stiff competition from traditional medical device purveyors and entrepreneurial startups, who rely on fresh ideas and agility to move swiftly unburdened by hierarchical organizational structures. To compete in the same landscape, designers must streamline processes and eliminate silos that often stymie the ability to operate with efficiency. Open-source cooperation and effective communication enhance the opportunities for collaboration and information-sharing. This approach will allow device companies to reduce time-to-market schedules and revise strategies on product specifications and iterations to reduce scope iteration, risk, and, ultimately, time.

Traditional “waterfall” approaches to new product development, derived from quality-based guidance, are no longer efficient as new technology drives the pace of medtech devices faster than ever before. Instead, the focus should be on three main areas:

1. Establish and maintain stakeholder alignment at the earliest possible stage. This process should include executive, technical, marketing, manufacturing, sales, and service representation to ensure that every group focuses on the same outcome and that each set of requirements builds into the overall development plan. Reaching the outcomes desired by each stakeholder team usually require some compromises, but establishing alignment from project initiation will serve as a solid foundation to mitigate conflicting goals that slow down development.
2. Perform up-front tasks, such as design requirements definition, concept development, market research, technical feasibility studies, resource recruitment, and regulatory strategies, in parallel to accelerate and focus design activities – again, with shared knowledge across teams.
3. Embrace the inclusion of discrete, iterative, and rapid development cycles (also known as an Agile process) of mockups, breadboards, and prototypes, qualified with end-user evaluations, to frontload design specifications and direction. This “bottom-up” process supports concurrent efforts that can still operate within the stage-gated waterfall plan that is mandated by most corporate quality management systems (QMS).

Let’s take a look at the various elements that contribute to this streamlining of processes: discovery/design research, user-centered design, regulatory strategy and risk assessments, a phased approach, and manufacturing timeline considerations.

Discovery Research Creates An Initial Platform For Design

Qualitative usability studies and product definition combine to form discovery (or design) research. The process should work in parallel with quantitative market research and will result in a well thought out and valid foundation for design guidance.

Discovery research, qualitative and interpretive in nature, will help benchmark user aspirations, setting up and distinguishing between “must-have” and “would-like-to-have” functionality and features. During this discovery process, other areas are addressed, such as:

• pipeline wishes for downstream implementation and technology acquisition strategies
• innovation and product definition before design phases
• marketing requirements with user expectations
• buy-in from involved stakeholders
• establishment of high-level guidelines and priorities for the design team
• measurable performance for validation testing

The marketing strategy intends to “work backward from the label” by bringing in the expertise of patients, caregivers, and other stakeholders, and not just key opinion leader (KOL) guidance. A full-spectrum end-user team will determine market acceptance requirements, barriers to entry/exit to the channel, market penetration, product life cycle, and more.

The User-Centered Design Process

Usability engineering is a series of coordinated steps, beginning with (immersive) contextual inquiry and simulated studies, including iterative prototype and use-risk evaluations, and concluding with summative usability validation and a human factors engineering (HFE) report. This early voice of customer (VOC) research baselines design inputs, clarifies the competitive landscape, and helps determine required features and functions. Subsequent evaluations using mockups and prototypes establish use-related risks, effective workflows, and safety needs that balance the desired ease-of-use.

Feasibility research, technical specifications, concept designs, and systems architecting should run in parallel with VOC research to reduce the overall schedule but must remain flexible in structure to optimize the design approach to meet emerging user needs. While quantitative market research, or voice of business (VOB), forms the foundation for a competitive strategy, product requirements, features, and pricing structure, the conjoint research must be combined as early as possible to deliver an accurate road map for developing the definitive product.

As with any design process, there’s always a chance of “feature creep.” By reviewing and prioritizing functional value, as well as establishing a multigenerational “product pipeline” approach (if needed) during design definition, the development can remain on-track. This is another critical function for a cross-disciplined stakeholder review at project inception.

Regulatory Strategy And Risk Assessments

Simply put, regulatory and test agencies should be treated as partners, not adversaries. Involving authorities at critical stage gates ensures alignment and familiarity with the device and claims. For example, involve the FDA early on to manage efficacy claims and develop critical test verification and validation (V&V) protocols, which will streamline downstream approvals. Include regulatory authorities in other market regions where there might be specific deviations in requirements for approvals. Global devices need a thorough review of all major market deviations to ensure that designs reflect the linguistic, cultural, demographic, and other human factors considerations that could require costly conformance modifications at a later stage.

For medical devices it is essential for the development team to keep a close eye on project risk to ensure the evolving design meets stakeholder goals. The risk plan should be continuously reviewed and updated during development using iterative FMEA (failure mode and effects analysis) methodology. By assessing areas of regulatory, technical, usability, logistical, and legal risk, appropriate mitigation strategies can be implemented to identify and address potential problems before they become entrenched in the design.

Shorten Time To Market With A Phased Approach

With rampant competition in the medtech market, streamlining development processes lies in the ability to compress timing while maintaining the integrity of the final product. In the product development cycle, for example, integrating rapid, cutting-edge “bridge” manufacturing processes can provide validation test units in weeks vs. months, providing an opportunity to enhance device performance before committing to a mass market capital expense. These test units may also provide a shortcut to regulatory approvals.

Early involvement with the manufacturing and sustaining teams helps to define system architecture and the breakdown of parts, sources, and material specifications early on. Accommodating desired manufacturing and assembly requirements early, including logistics, packaging, sterilization and test protocols, user training, servicing, and maintenance requirements, streamlines design transfer and minimizes the need for design “debugging.” Business continuity plans and operational assessments of scale-up and costs of goods sold are crucial for a commercially viable device launch.

The Manufacturing Life Cycle

Manufacturing challenges have changed over time. The global supply chain, the convergence of multidisciplinary technologies, open innovation, and consumerization demand flexible, scalable solutions.  Technological advances provide novel options for packaged component availability, automation, and standardized testing. The manufacturing timeline should consider the time required for suppliers and, if appropriate, third-party contract manufacturing organizations (CMOs) to overcome steep learning curves, as they need to develop and validate processes, test and assemble fixtures, and train an entire team. Consider how this might be accomplished in parallel with other tasks such as agency submission and foreign market compliance reviews.

End-of-life and multigenerational product planning becomes part of the streamlined process for subsequent product development. Generative research provides a strategic road map for derivatives and upgrades of the initial device. The design team should begin to assess the next-generation feasibility needs as soon as possible during the product life cycle. Leveraging as much of the existing device design “platform” as possible can be accomplished by establishing a modular approach that reuses components and technical solutions and streamlines sub-systems development.

Beating the Competition Is A Team Sport

Effective communication and collaboration while deploying a user-centered methodology is the secret sauce of the accelerated design process. Frontloading project planning and product definition efforts set the stage for a fast-paced cycle. Aligning manufacturing, packaging, sales, training, and service needs with the marketing and design teams up front and throughout the development process builds cooperation and reduces conflict, technical churn, feature creep, and other avoidable hurdles that slow momentum and contribute to time and budget overruns.

Prototype and test rapidly and often to quickly understand issues and emerging risks that will not always be apparent or predictable in virtual representations. Advanced tools and printers can produce sophisticated parts and assemblies within days, even hours, to help evaluate designs at each stage of the development process. Leveraging product pipeline and bridge manufacturing strategies minimizes design scope and time-to-market launch.

By embracing a disciplined and cooperative philosophy to manage concurrent workflows, it is possible to streamline a robust product development cycle. This results in early product launches and a more favorable return on investment (ROI) model, which is sure to delight every stakeholder who helps to make this all happen.

About The Author:

Philip Remedios is principal and design director at BlackHägen Design, an R&D consultancy focused on medical device innovation. With a combined design and engineering background, Remedios has spent most of his 35-year career in executive consulting roles, developing project plans and managing integrated technical teams, schedules, and budgets. He has a Bachelor of Science in industrial design/transportation from the Art Center College of Design in California and is a named inventor on 34 patents to date.