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We’re all trying to provide our customers with more feedback and diagnostic information to continuously improve patient outcomes. One way we can add that functionality and capability to our products is by adding microscopically small sensors or Microelectro mechanical Systems (MEMS) that can be fabricated using silicon wafer etching technology to our devices.
Previously, I’ve discussed the advantages of incorporating MEMS into your medical devices.This article will go into more specifics about how to work with an open-use National Nanotechnology Coordinated Infrastructure (NNCI) facility in order to microfabricate sensors. I’ll provide details on the various facilities and step-by-step instructions on how to set up a use agreement.
Starting at a Facility
All of the facilities follow approximately the same procedure for new users to get involved. The steps outlined below were pulled mainly from Cornell University’s website and an interview with Dr. Michael Khbeis, Acting Director for the University of Washington Nanofabrication Facility, but the advice is consistent with what other facilities recommend.
- The first step is to contact the user program manager for the facility. I recommend initiating contact via email and arranging for a teleconference with the user program manager. If feasible, visit the facility for introductions and a tour. There is usually a fee per person for a tour, as it will require gowning up and entering the cleanroom.
- You will then write up a brief project proposal (1-2 pages) and an application to use the facility. If confidentiality is a concern, this can be preceded by establishing nondisclosure agreements.
- I highly recommend having a design review and project feasibility meeting at the facility. In addition to allowing for a more detailed presentation of your project, the facility will arrange to have all their subject matter experts present to formulate a design and fabrication plan to meet your needs. This also creates a preliminary equipment and lab use training plan for you, should you intend to do the fabrication yourself.
- To get established at the lab, you will need to obtain a user ID, access cards and safety training. This can take a couple of weeks to complete, so plan ahead and be proactive about doing all training, tests and paperwork required.
- You will also need to set up a purchase order that the facility can bill against.
- If you are going to have someone travel to work on-site, most facilities can arrange for campus housing (especially during the summer). Remaining travel and lodging arrangements are up to you, but the facilities can provide advice to assist you.
- When you arrive at the facility, you will be assigned a staff person to mentor your project, particularly in the early phases. They will help arrange for your training and will be your main contact throughout the project. They will also help you define what you need, create a process flow document, purchase supplies and subcontract with outside vendors for certain aspects of your project.
- If you are a short-term user, you will likely work in a shared office space, which is generally first-come/first-served. For longer-term users, you may have a designated space. Either way, expect to bring your laptop with you each day. Other supplies and equipment can be stored in lockers or cleanroom lockers. There are rules about what you must wear under your cleanroom suit; usually a long-sleeved shirt, long pants and shoes that fully cover your feet. Hair must be tied back.
- Remember to be flexible in your approach. As you learn more about your design, the facility and the possible fabrication options, your design and process flow document is likely to change.
Locations of the Open Use Facilities
The National Nanotechnology Coordinated Infrastructure (NNCI) consists of 16 primary sites distributed across the U.S. Of these, two are specialized research facilities; the rest are open use facilities that welcome users.
University | Partner
University of Washington | Oregon State University
Montana State University | Carlton College
Arizona State University | Maricopa County Community College & Science Foundation Arizona
University of Minnesota at Twin Cities | North Dakota State University
Northwestern University | University of Chicago
University of Louisville | University of Kentucky
Georgia Institute of Technology | North Carolina A&T University & University of North Carolina at Greensboro
Virginia Tech | Pacific Northwest National Laboratory
Protecting Your Intellectual Property
Although housed at universities, the NNCI facilities are open use and the universities will not make any claims of ownership on your intellectual property. Essentially, you are renting time in their facilities. As with anything, don’t disclose what you don’t want people to know. For those aspects you need to disclose, have a nondisclosure agreement in place with the facility.
If new IP for your project is developed while using a facility, even if with the help of staff, it belongs to you. In the extremely rare instance that a new fabrication technology is developed by staff for use on your project, then that fabrication technology would be available to other users. However, your use of that technology would not be disclosed.
Identifying Assistance with Your Project
Each facility typically has a small set of experienced users who are available as independent contractors on a short- or long-term basis. These “contractors” do not work for the facility, but are available for private hire. This can shorten the learning curve and provide additional intellectual property isolation within the facility.
You may also do a sponsored research program. Companies may establish such a program with any faculty member to gain access to that faculty member’s expertise. This is typically a longer-term collaboration that doesn’t involve specific deliverables. Agreements on intellectual property are between the company and the faculty member. The faculty member will also have experienced students who can be hired to assist with your project at rates that are often more cost effective than using independent contractors. The facility has essentially no part in arrangements with faculty members.
Determining Your Costs
The facilities are set up to offer affordable access to university facilities with leading-edge tools, training and expertise in all disciplines of nanoscale science, engineering and technology to academic, government and industrial researchers, along with hands-on education and outreach events for novice users.
According to Dr. Khbeis, for the most part, the facilities all operate the same. He says the equipment is 90% the same, in terms of types of capabilities, with 10% niche specialized equipment. The Washington Nanofabrication Facility is more industry-centric, but other facilities are interested in expanding their industry clientele and have programs to encourage this.
For example, Cornell University is open 24 hours a day and provides an interactive learning and practicing environment critical to successful cutting-edge research. External users typically spend a week or two at their facility to complete work with strong staff support, but many projects can be accomplished remotely. Cornell has the CNF Foundry Partners program, which is designed to help launch new companies and create high tech jobs. They have cost reductions available to help companies establish new fabrication capabilities as well.
Taking the Next Step
Do you have a design that would benefit from sensors providing diagnostics and operator feedback? Are you looking for ways to enhance your products to be at the forefront of this paradigm shift in the orthopaedic industry? If so, now is the time to learn how to incorporate MEMS into your next big design idea. This is an exciting time in orthopaedics, as new technologies regularly become accessible for us to use in our products. MEMS is one tool that can bring increased functionality and capability to our designs, thus providing more diagnostic information and hopefully improving patient outcomes.
Dr. Deborah Munro is the President of Munro Medical, a biomedical research and consulting firm in Portland, Oregon. She has worked in the orthopaedic medical device field for almost 20 years and holds numerous patents, mostly in the area of spinal fusion. She taught mechanical and biomedical engineering at the University of Portland for eight years, where she also founded a Master’s in Biomedical Engineering program. Her current interests include developing new medical device solutions for companies and assisting them in their regulatory compliance efforts. She can be reached by email.
