Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

Ultimately, the end goal in commercializing a medical device is to create a device that makes it into public use. It’s an obvious desire to get that device into the marketplace and start manufacturing as soon as possible. But first, understanding the device and whether it’s the right flavor of device for the market is paramount. There are the fine details of transferring, of course, but the key question is not so much when you should transfer, but what you should transfer.

Adding Value

For start-up companies, demonstrating a device has technical and market potential is important in creating value. Demonstration prototypes are a key milestone, yet additional value for the company can often be created by pushing the maturity of the product beyond those initial development steps.

Showing the product can not only meet product requirements, but also that the manufacturing process is capable of producing the device at scale, requires a shift in the development path. There is often limited capital available for development and deciding what to develop can be critical for new companies. Focusing on manufacturability and developing the manufacturing process may mean foregoing additional or optional device features. Developing a manufacturing process takes time and effort but may create more value than continued refinement of device features and functionality.

Gaining Market Knowledge

Medical devices begin with an idea. Surrounding that idea is the product definition, the initial risk management of the device, followed by development of requirements, specifications, and other aspects of the product design cycle. Human factors and usability are an important factor of development, as well.

What some of these activities don’t answer, however, is the question of the market and business case for the design. How solid of a business case is there for the medical device? What will be the likely adoption rate of the new device? It would be great if we knew the market acceptance ahead of time and could design the perfect device, but precognition is a skill none possess.

One frequently chosen option is a minimum viable product (MVP) that can be designed and reach the marketplace sooner than a more polished device. The choice of going the route of an MVP is a key question that must be asked when looking ahead to design transfer. This is the “what” question: Not just when to transfer, but what to transfer.

It may be that initial adoption requires more than just an MVP—anything less than a complete product may create a poor impression for future sales or investment. However, spending more development time refining the device without testing the marketplace may create a device that misses that target market window. There are numerous examples of failed products that famously missed their target from the Amazon Fire phone (2014) to Google Glass (2015) and many others.

High vs. Low Volume

Creating an initial (or prototype) device that achieves all the product requirements is a difficult task. Creating hundreds or thousands of devices that work identically is an equally difficult task. During the development process, an “alpha” device that meets the product requirements is often built by using processes that aren’t efficient at larger scales. Looking toward the future, the goal should be a well-designed, highly manufacturable device that can be pumped out in high volumes.

The development process is often long and expensive. Choosing how much to refine before launch and how much to address after launch takes long term planning. To achieve an efficient scaled device will require considerable investment in equipment such as injection mold tooling or automation, which initial capital may not cover. Going to market with a design that uses processes matched to the volume levels anticipated in the first year or two after launch will create a revenue stream moving forward but leaves some design work and verification for later, as the device is designed for the processes for launch and not for processes used at the higher volumes.

Final Thoughts

It’s important that—regardless of which path is initiated—to have a plan for the future. Knowing what the device could be capable of being will help generate interest and aid in garnering investment. Additional value can be created by showing the device has the ability to achieve a manufacturing process that meets target costs. But most importantly, the device must meet market needs, and having the right features will be a key to success.

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Dana Trousil is a StarFish Medical Mechanical Engineering Team Manager. He has successfully launched many products, with experience in a variety of processes, including NPI for medical devices.