Commercialization of a medical device is the process of transitioning from design and development to a realized, manufacturable, and sellable product. This article describes how our commercialization team “Make it Real” by developing robust commercialization strategies that engage a cross-functional team from engineering, production planning and supply chain.

1. Engage the commercialization team early

It is essential that commercialization and subsequent manufacturability of your medical device be considered early in the design process to ensure a successful and smooth transition from design to production. Design and manufacturing engineers possess unique skill sets and consider product and processes from different perspectives.

A design engineer may focus on the function of a device whereas the manufacturing engineer may consider the effectiveness of that design in a commercial setting. Manufacturing engineers often ask questions related to ease of manufacturing, serviceability, stability of supply chain, and scale up potential. These are essential elements to consider early in the design phase to mitigate increased cost and time to market during the commercial transfer or sustained manufacturing phase.

When a commercialization team is not engaged early, unplanned delays can occur. For example, while working with a medical device manufacturer our team were called in to address adequate adhesion between two critical components. The design team chose a specific UV adhesive due to its high bond strength. During small scale assembly, no issues were observed. However, during commercial production, the joint continued to fail.

Upon investigation, the manufacturing team observed that the glue was curing within 10 seconds under ambient light resulting in insufficient time for the operator to assemble the parts thus yielding insufficient adhesion. This discovery resulted in a redesign of the gluing operation including fabrication and qualification of a new system and validation of a new process.

This increased cost to transfer and delayed the program schedule, but likely could have been averted if manufacturing engineers were engaged earlier in the design process.

2. Engage in detailed planning

Commercialization of a medical device, also described as design transfer, is governed by both U.S. Food & Drug Administration’s Code of Federal Regulations (21CFR820.30, subchapter H) and the International Standards Organization’s ISO 13485:2016. Neither regulation specifies the steps needed for this process to be successful. It is essential to engage an experienced team with well executed procedures to be successful.

Here is a comprehensive list of commercialization deliverables to be considered and planned for appropriately. Based on the complexity of your design, supply chain or transfer process, the commercialization process can take a substantial amount of time. Sufficient time should be dedicated to deliverables such as process characterization and pre-production builds to de-risk the manufacturing process as much as possible. Additionally, pre-BOM (Bill of Materials) planning is an essential tool to adequately de-risk your supply chain.

Often teams can focus on components that are critical to essential performance, however, failure to de-risk noncritical items in a changing supply chain landscape can lead to significant delays downstream. Although it is important for start-ups to be lean and agile, the team should always take time to recalibrate on critical milestones.

3. Manage stakeholder expectations

Business managers outside the commercialization team can sometimes fail to grasp the scope of the design transfer effort and underestimate the amount of time and resources required to transition smoothly. Reinforced by the previous tip to partake in detailed planning, it is wise to engage business leaders frequently – through core team meetings or gate readiness reviews.

Build a strong business case for leaders to understand the value of taking time to effectively transfer a product. Post transfer Non-Conformances or Correction Actions can severely hinder the commercial momentum of a product launch.

4. Understand business objectives

It is paramount to identify and understand your post-commercialization business objectives. Are you intending to immediately scale-up; if so, have all processes been designed with scale up potential? Has a sustainable and robust supply chain been established?

If left until post-commercialization, these additional requirements can cause major delays and be very expensive. When the commercialization team is aware and understands the post-commercialization business objectives prior to launch, they can plan and complete a lot of the work upfront to mitigate any delays post transfer.

5. Utilize a risk-based approach

The final insight I’d like to share is the importance and value of utilizing a risk management strategy when designing and validating the manufacturing process. In my experience, teams have used pFMEAs (process failure mode effect analysis) and other tools as close-out activities to record risks observed. This is doing them a disservice. The pFMEA should be started once you have process outputs, work instructions and a process flow chart loosely defined.

Using your pFMEA to identify risks in both incoming materials and process steps allows you to build a more robust manufacturing process in a timely manner. Further, understanding any high-risk controls/inspections, and the subsequent level of verification or validation required early on, streamlines this planning effort and mitigates delays with process validation strategy changes.