As we continue our examination of commercialization and implementation at Stop Three of the Innovation Roadmap, our development process is beginning to draw to its conclusion. Already, MIDI CEO Chris Montalbano and Matrix Requirements co-founder Wolfgang Huber have guided us through the first stages of this third and final Stop, expounding upon class identification, planning, and requirements. Bringing our investigation of the Innovation Roadmap to a close is Andrew Martin, Vice President of MIDI, who visits the MIDI Innovation Vault to outline risk management, design inputs, verification, validation, and the confirmation of product design.

With safety being of the utmost concern when developing any medical device, risk management is arguably the most important part of the commercialization and implementation process. Designing and following through with a thorough and effective Risk Management Plan not only ensures that the device will meet all necessary safety regulations, but significantly decreases the likelihood of harm befalling end-users. But what exactly does such a Risk Management Plan entail, and how do those steps tie into relevant regulatory controls such as ISO 14971?

First, Continued Design Control Management: Design Inputs, Verification, and Validation Testing

Sometimes referred to as design specifications or specs, design inputs “exactly define the quantifiable acceptable criteria for any one feature” of a product and are derived from device requirements defined in the previous section on commercialization and implementation. These inputs form a range of characteristics which device features must adhere to in order to be considered acceptable, and each is verified through verification testing as defined by MIDI and the International Standards Community. MIDI most often performs these tests in-house, working with external laboratory partners like TÜV and Intertek who are intimately familiar with the IEC 60601-1 family of regulatory standards and possess the facilities to verify devices to these standards. They are crucial to ensuring a device’s compliance with regulatory controls, an often-daunting obstacle that must be surpassed before market introduction is made possible, and are an effective tool for development teams looking to understand the scope of safety concerns surrounding medical products.

Where verification testing is specifically concerned with design inputs, validation testing is somewhat more nebulous. Validation testing pertains to user requirements and relies on feedback collected from established stakeholders as well as clinical trials, test cases, and other data-collection strategies which determine a device’s efficacy for end-users. As its requirements are considerably less straightforward than that of verification testing, validation tests are often considered to be the more challenging of the two. Yet, they are an essential step to ensuring a device meets the needs of its users. MIDI deploys its qualitative evaluation methods to perform validation testing.

Executing Your Risk Management Plan

As explained by Andrew, the overall goal of a Risk Management Plan is to define what a device is meant for, how it is to be used, and how it may be misused, and to act on this information by planning for risk reduction, eventually acting upon those plans to produce a device that is as safe as possible for users. Risk evaluation, analysis, and control are all crucial parts of this process, along with residual risk evaluation. This procedure begins with risk analysis, where hazards, opportunities for misuse and mishaps are identified. These may be anything from the possibility injury due to moving parts, to radiation hazards, to weaknesses in cybersecurity. Every aspect of the device must be carefully examined to ensure that every possible avenue of potential harm has been properly accounted for, visualized and carefully considered.

Once this analysis is complete, risk evaluation is the next order of business. At MIDI, the risk evaluation tool built into the MatrixALM is utilized to document and quantify the severity of risks posed, the probability of their occurrence, and their detectability. This evaluation produces an RBM, or Risk Before Mitigation, value. This value determines the intensity with which risk management efforts should proceed; if it is found to be above a particular threshold, close attention must be paid to the next step in the process, risk control. Risk control entails creating and deploying strategies to mitigate or eliminate potential hazards identified in earlier steps. Applying a classification system to these hazards, MIDI uses in MatrixALM one of three strategies to categorize and respond to them.

The first of these categories is what is referred to by Andrew as “inherently safe.” These risks are addressed by linking them to design inputs already created to mitigate them. The second category consists of those risks which require the design of a new input or protective design feature. Finally, the third of these classifications require information safety measures, which are comprised of features such as training, labelling, and instruction. Per Andrew, these are the least desirable of risks, as their mitigation relies heavily upon the user. Once risks have been categorized and responded to accordingly (via new design feature mitigations), the MatrixALM system provides a new value— a RAM or Risk After Management value— which is then measured against the benchmark of acceptability as defined by the Risk Management Plan. The new design feature mitigations are loaded into the design control documents as new design inputs.

Commercialization Engineering Execution

Once each of these risk management steps have been performed and an exact product definition has been constructed, design confirmation is the next and final endeavor to be undertaken before a device is ready to enter production. In this process, proof of concept breadboards are created and utilized in the development of prototypes, from formal alpha prototypes to beta, or pre-production, prototypes. At each step, verification testing through clinical evaluations and other strategies are performed to ensure that the predetermined product definition is being adhered to and executed upon. It is at this point that MIDI formalizes the technical manufacturing package/documentation and performs a Design Transfer of the Design History File to one of numerous strategic manufacturing partners and production may begin in earnest.

While this series has only touched on a small selection of the copious number of challenges a program may face, our goal has been to demystify regulatory controls and illustrate how their implementation may be a boon, rather than bane, to the development of a successful medical device. Working with a vast range of medical product development teams, MIDI’s DevelopmentDNA™ approach provides the framework for generating predictable success no matter the device in question.

For those looking to learn more about MIDI and how their Innovation Roadmap may help you, contact us today at www.midipd.com.