Robotics and IoT Communities 
Quarterly Newsletter  |  Q2 2018
April 4, 2018 - In This Issue:
Hello MassTLC Robotics/IoT Community Members,

We held our first community meeting of the year at the UMass Lowell iHub and heard from our new members and startups as well as students in the DifferenceMaker Program at the University. You can find a recap here. Thanks to Boston Engineering who hosted a Beer & Bots networking session. 
 
It's not too late to register for the Boston NewCo festival hosted at innovative companies around the Boston area.  On April 11th and 12th, you can pick and choose who to visit over a two-day period. 

MassTLC Awards nominations will be open on April 30th. Last year Robotics and IoT companies were represented as finalists in many categories including Company of the Year, CTO of the year, Consumer Innovative Tech, and Emerging Executive of the Year.

We have a terrific opportunity to showcase the Robotics & IoT community at Boston TechJam. We've dedicated a large area specific to robotics and IoT companies.

Several of our MassTLC community members have been in the news recently! See our news section below. If you have industry news, are interested in contributing to upcoming content and programming, or know speakers you would like to invite to a Robotics/IoT cluster meeting, please let me know.


Joyce Sidopoulos
Roboitcs/IoT Community Manager
 

 

Robotics/IoT Cluster Sponsors
 



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Cluster Co-Chairs


Ted Acworth
Founder & CEO

Executive Director

Professor of Computer Science
Director
NERVE Center & Founder
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Get Involved!

Join our Robotics cluster email list

 

Submit content ideas or speakers

 

Engage in sponsorship opportunities

 

 

 

 

 

 

 

 

 

 

2018 Calendar

    

* April 10-12th - NewCo Boston

* May 16th - Redev B0st0n
* June 14th, Boston TechJam

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NewCo 2018 - There's Still Time to Register!

NewCo Boston by MassTLC lets you meet company founders and  leaders inside their offices. Over 70 companies are opening their office doors for one hour sessions. Join this open-house tour festival to learn, connect, and celebrate! Learn more and register here.
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Boston TechJam

BTJ is the perfect place to exhibit and showcase your success and momentum - and show support for the local ecosystem. Offer a fun street fair/carnival game in your tent to engage the crowd and have fun talking about what you do. Meet people who could become part of your company, or local service providers, or partner with promising young local startups. Bring members of your team and wear branded gear to show your company pride! Check out the Boston TechJam site here !

New at Boston TechJam is a Robotics IoT space dedicated to showcasing our dominance!  If you're interested in showing off your bots or your new IoT innovation contact sponsorship@bostontechjam.org.

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Our Companies In the News

Congrats to many of our companies for making great strides, expansions, acquisitions and awards!
  • Robotics sector thrives in Massachusetts as automation firms add to their ranks - Read more here.
  • Corindus raises $25M to commercialize CorPath GRX surgical robot - Read more here.
  • NextShift celebrates move to Lowell  - Read more here.
  • Humatics accelerates microlocation innovation with acquisition of 5D robotics and time domain - Read more here.
  • Boston Robotics Companies are Getting Serious VC Love - Read more here.
  • The Flying Farmhand: This agricultural drone requires no human supervision at all - Read more here.
  • Baker Announces $2.5M in Expansion Funds for MassRobotics - Read more here.
     
More cluster company news can be found on the MassTLC Robotics Cluster page here .
 
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IntelĀ® Industrial IoT Workshop from our New Community Sponsor
Registration is now open for this upcoming IntelĀ® IoT Developer Workshop. Over the two days you will learn through a combination of lectures, demos and hands-on exercises the standards and technologies that Intel uses to integrate industry and Internet to extract new value from Industry 4.0 processes. 

Topics covered include an introduction to the concepts of cyber-physical modeling, industrial standards in real-time communications protocols, sensors, automation, security, and analytics. Both greenfield and brownfield deployments will be discussed. They will lay foundations of how next generation computer vision systems and deep learning will continue to improve worker safety, reduce downtimes and product defects and provide new revenue streams and increased ROI through real time data.

April 26-27, 9:00 a.m. - 5:00 p.m. hosted at the UMass Lowell Innovation Hub
  • Register for this free event here.
  • Intel will provide the necessary hardware and software for the workshop.
  • Please bring your own Windows, Mac, or Linux laptop with at least two USB Ports.
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A Note From Finnegan our Community Sponsor
Government Regulation of Nanorobots in Medicine: A Two-Part Series
PART I: The FDA's Consideration of Nanorobots

By: Jessica L.A. Marks and Shana K. Cyr, Ph.D.

Nanorobots in medicine are a fascinating development and growing industry. As of 2014, over 200 companies were pursuing commercial efforts in nanomedicine, with at least 23 in advanced development stages. The nanorobots market is expected to grow more than 6% each year until at least 2020, with the primary driver being medical use.

In Part I, we discuss regulations and guidance by the U.S. Food and Drug Administration (FDA) for moving medical nanorobot products from the laboratory to the market. In Part II, we will explore the challenges nanorobot inventions face when seeking protection at the U.S. Patent and Trademark Office (PTO).

Nanorobots and the FDA

Nanorobots are classified by the FDA based on whether the product is mechanical, chemical, or biological. The classification will determine which FDA center has jurisdiction over the product. Medical devices, having a mechanical mode of action, are regulated by the FDA's Center for Devices and Radiological Health (CDRH). Drugs, having a chemical mode of action, are regulated by the Center for Drug Evaluation and Research (CDER). And biologics, having a biological mode of action, are regulated by the Center for Biologics Evaluation and Research (CBER). If a product has more than one mode of action, it is considered a combination product, and one center is assigned primary jurisdiction for the product's review based on the product's primary mode of action. For many nanorobots, the primary mode of action may be mechanical, and the product would be regulated by the CDRH.

The problem with this schema for nanotechnologies is that they do not fit neatly into these three categories. New product sponsors can seek clarity by requesting a classification of the product by the FDA. Sponsors may increase the chances of classification in a desired category by describing the product in a manner that influences the conclusion. Once a nanorobot is classified and assigned to a lead center, its review will likely be similar to the review of any other medical product at that center.

In December 2017, the FDA released its first draft guidance that could relate to regulation of nanorobots (hereinafter, "Draft Guidance"). The Draft Guidance, released by the CDER and CBER, is directed to drug and biological products that contain nanomaterials; whether it applies to nanorobots is unclear. The Draft Guidance recognizes that the FDA does not have established definitions for the terms "nanotechnology," "nanomaterial," or "nanoscale," much less "nanorobots," and specifically avoids creating definitions. The focus of CDRH's nanotechnology program is on understanding the physico-chemical interactions of nanomaterials and on appropriately characterizing nanomaterials. Notably, the CDRH, which regulates medical devices, was not involved and has not issued any guidance documents on what is required or expected for the review of nanorobots. Information on how the CDRH will treat (or potentially is treating) such products is not available. 

The Draft Guidance primarily provides a list of considerations for the evaluation of nanoscale products, but there is little in the way of hard-and-fast rules or requirements. Thus, regardless of categorization, applicants will need to consult closely with the FDA regarding the data required to obtain approval for their nanorobots.

In Part II, we'll discuss how the PTO handles these nanorobot technologies.

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