You Have A Medical Device Proof Of Concept. Now What?

By Peggy Fasano, Boulder iQ

In the course of developing a medical device, you’ll stress over hundreds of steps, challenges, and regulations. But every device starts at the “development” stage, just starting down the road from ideation to market introduction.

No matter what the device in development, the first major milestone is usually proof of concept. Typically represented as a workable prototype, a proof-of-concept item is all about demonstrating the device’s function. It will still have bugs to work out and it probably will not look like a “finished” device. Proof of concept is the stage that takes you beyond an idea and a presentation to something tangible that potential clients and investors can wrap their heads (and hands) around.

Getting to the proof-of-concept stage is worthy of congratulations…briefly. Once you have that, it’s time to get moving. But how do you go from a build-of-one device to something you can manufacture reliably and at scale? How you determine and execute the next steps will determine, in large part, whether you can get your device to market in a time- and cost-efficient way to be successful.

Plans, Budget, Time

These three words form the short answer to “What’s next?”

Medical device development follows phases established by the FDA. These phases make sure the device you are designing will do what it is intended to do.

• Design input: initial project documentation defining the device and initial hazards and risks
• Design output: iterative stage of device design
• Verification and validation: testing to assure the device’s efficacy and safety
• Manufacturing transfer: transfer of the device to manufacturing
• Market release: final regulatory body clearance and release for sale

Proof of concept is the stage before these five defined phases. So, “what’s next” entails going through each, with careful attention to meeting the FDA’s specific criteria. What’s key to keep in mind is that in each of these phases are engineering, quality, regulatory, and manufacturing factors and decisions that will affect how – and how fast – you will obtain a saleable device. Before you dive in to the five standard phases, stop, think, plan, and budget for each one.

Engineering And Design

Once you have the proof of concept, there are steps you want to keep in mind from the engineering and design perspectives. Your proof-of-concept device will likely be made of off-the-shelf components and rapid-prototyped components with breadboard electronics. Since these components are probably not what you will want to go to market with, you will need to design the next iteration of components with manufacturing in mind. In other words, your next design as you proceed should incorporate the goals of manufacturing ease and meeting well-defined needs of the end user. Doing both takes careful planning and thorough usability research – steps that many developers skip or skimp on, and then pay for dearly later on.

Important considerations include:

• Conduct preliminary human factors testing on the proof-of-concept device. Accept that there very well may be design changes at this stage to make sure the end user can use the device correctly and easily.
• Prepare detailed costing to gain an intricate understanding of cost to manufacture the device. Plan for tight margins, incorporate off-the-shelf components where possible, and understand that the iteration with which you enter the market doesn’t have to be your final one. It pays (literally) to involve a cost accountant experienced in device development.
• Design specifically for manufacturing. That means figuring out, early on, in the design phase, what methods will work to produce higher volumes. Determine the device’s realistic life cycle – does the device need to handle 20 years or 30 minutes of use? – and design accordingly.

Quality Systems And Regulatory Affairs

Quality systems development and administration and regulatory affairs go hand in hand with each other and with engineering design. Once you are past the proof-of-concept phase, you’ll be focusing on rigorously documenting the design, identifying the standards to test against, and verifying the regulatory route to market. That last step is often one of the most time-consuming and vital steps of the entire development process. Verifying the class of the device and the type of filing you will need with the regulatory body (i.e., the FDA) will determine many of the requirements the device must meet. Don’t be surprised if this information changes which features you’ll include in the device’s first generation.

Many developers do not plan nearly enough time for quality and regulatory processes. As a result, they may find themselves going back to the design phase too often or falling severely behind in manufacturing, sterilization, packaging, and marketing phases. The best recommendation is to work with device development experts who have walked in your shoes and take their advice on planning timeframes.

Manufacturing

Although detailed manufacturing choices may feel far off when you’re celebrating your proof of concept, development will go much faster and much more smoothly if you incorporate manufacturing at the beginning of the design phase. In short, designing for manufacture will cut down significantly on your design iterations and eliminate surprises along the way.

To think with this “end” in mind, start by determining the volume you anticipate manufacturing the first five years of production. This one factor will greatly affect device design. For example, in Year One, if you think you will manufacture 100 units, you’ll likely want to consider 3D printing or an aluminum injection molding tool for plastic parts. But if you’re planning on a run of 100,000 devices the first year, you may find that a steel family mold is a better choice – and entails a very different design.

Budgeting And Manpower Decisions

One of the biggest factors in device development, of course, is funding. How much you have and want to invest up front will drive many of your design, manufacturing, and even regulatory decisions. The best strategy – and one that many developers overlook – may be to get a minimal viable product with core features at lower volumes up, running, and into the field. Then you can go to work on higher production and more features once you have user feedback and some revenue coming in.

Concurrent with monetary investment is the issue of manpower and expertise. Will you develop the device by bringing in internal resources or outsourcing some areas? Internal resources can be costly, given the wide range of expertise required. On the other hand, outsourcing comes with the challenges of managing and coordinating outside vendors. Deciding on the right balance and finding the right people will depend in large part on the vision and makeup of your organization.

Working through these decisions immediately after proof of concept will dramatically up your chances of a successful market introduction. Take the time for careful thought and planning to figure out all resources you’ll need and the cost/benefit of staying in-house or utilizing consulting or contract expertise for each need. For example, if you want to do the engineering in-house, you will need a quality employee (or team) to aid in the design controls, including device risk management and determination of require validation testing. You’ll also need an engineer (or team) to actually design the device, which may call for electronics, optical, plastic injection molding, enclosure, and testing expertise. Be sure to consider the hiring environment and labor market in your area, as it may be difficult to create the team you need.

You’re (Not) Almost There

A functioning proof-of-concept device can fool developers into thinking they are “almost there.” In reality, it’s just one – albeit a major one – milestone to cross in getting a device to market. Once you have demonstrated proof of concept, you’ll face many decisions about the device and the structure of your business. And in almost every case, expect it to take longer and cost more to take a proof of concept to market than you originally planned.

The development process can sometimes be as much of a mental one as it is a design, quality, regulatory, and manufacturing one. Keeping perspective and continually planning for the next phase will best help you stay on track for market introduction.

About the Author:

Peggy Fasano is Chief Operating Officer at Boulder iQ. She is an expert in product development, project management, and engineering within the medical device and biotech industries. She has held the positions of senior consultant with Deloitte Consulting, managing director of the Deming Center Venture Fund, product development and engineer consultant for Boulder BioMed, and project manager and mechanical engineer for Sophono, Inc. She also has worked as a mechanical engineer and project manager at Polestar Technologies. Fasano holds a BS in mechanical engineering from Tufts University and an MBA from the University of Colorado. She can be reached at peggy.fasano@boulderiq.com or on LinkedIn.