Origami Leads to New Non-Profit

During the COVID-19 crisis, Archimedic collaborated with hospital-clients and fabrication partners to rapidly develop the Origami Mask.  This mask can be made from a variety of materials without the need for sewing or specialty equipment.  Within a very short period of time, thousands of masks have been deployed to healthcare professionals and vulnerable individuals to help mitigate the spread of the coronavirus. 

As an open-sourced initiative, Archimedic and collaborators have made all design files, material recommendations, and instructional videos available to the public.  Hundreds of individuals from across the globe have downloaded the files, and stories have been pouring-in from individuals building and donating masks to hospitals, nursing homes, and family members.  Furthermore, hundreds of open-source collaborators have joined the initiative to suggest design and manufacturing improvements, provide material and vendor information, and expand raise awareness of the Origami Mask as a source of DIY PPE.

Through this process, the innovators behind the Origami Mask determined that this open-source concept could be extended to address a variety of unmet medical needs.  Team members behind the Origami Mask used this project as launching pad for Open Medical, a non-profit organization focused on open-sourced medical products for patients and providers with urgent, unmet medical needs.

Just as the COVID-19 public health crisis has illuminated unmet medical needs during a time of public health crisis, many other patient populations, such as pediatrics and rare diseases, have been neglected by the medical device industry due to poor financial returns associated with limited markets sizes. The objective of Open Medical is to address these underserved patients by leveraging the talents and resources of the open-source community.

Open Medical is a 501c3 organization (status pending), which relies on the contributions of a broad base of members having clinical, engineering, design, marketing, and other backgrounds.  A robust community has been activated, and additional members are sought to help drive these important initiatives forward.  Please consider getting involved and contributing to the Open Medical Mission.

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Note:  The Origami Mask has been developed rapidly to address the needs of PPE during the COVID-19 crisis.  As a result, extensive testing has not been completed, and the Origami Mask has not been registered with or cleared by the FDA.

 Written by Eric Sugalski

Written by Eric Sugalski

Eric Sugalski is the founder and president of Archimedic, a contract medical device development firm with offices in Boston and Philadelphia. Sugalski has led the development of a novel pediatric life support system, cardiovascular implants, laparoscopic surgical devices, and an array of wearable diagnostics. In addition to his technical background, Eric provides companies with product development strategy that encompasses regulatory, reimbursement, and fundraising requirements. Eric obtained a B.S. in mechanical engineering from the University of Colorado Boulder and an MBA from the MIT Sloan School of Management.

Origami Respirator

FOR MORE INFORMATION ON THIS PROJECT, INCLUDING TEMPLATES AND INSTRUCTIONS, PLEASE VISIT THE FOLLOWING LINK:

Open Medical Website

The Origami Respirator is a concept intended to address the shortage of PPE (Personal Protective Equipment) within hospitals and other care facilities.  

Below is a video showing how to make a respirator using a vacuum cleaning bag, a zip tie, and 2 rubber bands.  The process entails the following steps:

  • Downloading template files for flat pattern (See embedded form)
  • Trace template on single-ply vacuum cleaning bag material
  • Complete the origami fold sequence described in the video
  • Use zip tie to secure respirator together
  • Attach rubber bands for ear clips
  • FOR MORE INFORMATION ON THIS PROJECT, INCLUDING TEMPLATES AND INSTRUCTIONS, PLEASE VISIT THE FOLLOWING LINK:

    (Big thank you to Tony Gnau at T60 Productions for video editing support!)

    The vacuum cleaning bag was chosen due to its sub-micron filtration and high flow rate capabilities. Alternative materials may be suitable for this origami respirator design. Below are a number of materials provided by Smart Air Filters. As illustrated in the chart below, Vacuum Cleaning Bags have 95% effectiveness compared to Surgical Masks at 97% effectiveness against 1-Micron particles.

    As discussed in the video, the Origami Respirator concept has not undergone the extensive safety and efficacy verification that would be required for a regulated medical device. As such, it is not currently approved by FDA or any other regulating body.

    To download the template files, please use the download form embedded within this page. If there are questions or comments, feel free to send us an email. Thank you for helping resolve the PPE shortage through the coronavirus crisis

    FOR MORE INFORMATION ON THIS PROJECT, INCLUDING TEMPLATES AND INSTRUCTIONS, PLEASE VISIT THE FOLLOWING LINK:

     Written by Eric Sugalski

    Written by Eric Sugalski

    Eric Sugalski is the founder and president of Archimedic, a contract medical device development firm with offices in Boston and Philadelphia. Sugalski has led the development of a novel pediatric life support system, cardiovascular implants, laparoscopic surgical devices, and an array of wearable diagnostics. In addition to his technical background, Eric provides companies with product development strategy that encompasses regulatory, reimbursement, and fundraising requirements. Eric obtained a B.S. in mechanical engineering from the University of Colorado Boulder and an MBA from the MIT Sloan School of Management.

    Smithwise + Catapult = Archimedic

    WALTHAM, Mass., May 20, 2019 /PRNewswire/ — After announcing their merger last month, medical product development firms Smithwise and Catapult rolled out their new brand today, Archimedic.

    Eric Sugalski, CEO of the joint entity, explained how they settled on the name. “As we brainstormed a new name, we knew we wanted it to reflect the medical device industry we serve.” Hence the -medic part. “But,” he continued, “we also latched onto this character of Archimedes. He was a truly remarkable figure in ancient history–an engineer, mathematician, inventor, and strategist. Though he discovered solutions to different types of problems in a long-ago era, our team takes inspiration from his creative legacy as we solve modern-day healthcare challenges.”

    The firm’s logo is inspired by the Stomachion of Archimedes, a dissection puzzle wherein pieces are arranged in various configurations to form a square. The Archimedic icon is a section of the best-known Stomachion solution.

    “There are more than 500 ways to assemble the fourteen pieces of the Stomachion puzzle,” said Andy Zielger, COO & CTO of the new firm, “Each solution is challenging and elegant in its own way. To us, this was a clear analogy for what we do here. Many technical, regulatory, clinical, and commercial factors come into play during the medical product development process. At Archimedic, our role is to work alongside clients and determine how these pieces best fit together to uniquely solve their commercialization puzzle.”

    By joining the two firms, Archimedic is able to offer expanded electromechanical, software, systems, and quality engineering and industrial design services to the medtech industry. A larger team of medtech experts means deeper expertise in a number of industry verticals, including diagnostics, drug delivery, and advanced surgical systems.

    “We’re excited about this new brand because it reflects so many of the things that are important to Andy and me about our partnership,” Sugalski added. “More than that, they’re important to the clients we serve and the team we lead. Under Archimedic, we get to bring the best of who we were together into something new. We can’t wait to keep building on this foundation.”

    About Archimedic: Formed in 2019 by the merger of Smithwise and Catapult Product Development, Archimedic is a full-service medical device developer. We help innovators struggling with technical, regulatory, and manufacturing challenges accelerate their next new products along the path to market. Our clients span established medical device manufacturers, top-tier academic hospitals, and venture-backed startups. We specialize in advanced medical systems, including telemedicine and diagnostic platforms, wearables, drug delivery devices, and surgical systems. Our client projects range from proof-of-concept prototypes to high-volume production design and manufacturing transfer. Visit us at www.archimedic.com

    Media Contact:
    Daniel Henrich
    Director of Marketing
    dhenrich@archimedic.com
    (610) 455 4255 x 735

    Written by Daniel Henrich

    Written by Daniel Henrich

    Director of Marketing at Archimedic

    Catapult and Smithwise Announce They’re Combining Teams

    WALTHAM, Mass., Apr. 4, 2019 /PRNewswire/

    Two medical device development firms, Catapult Product Development, Inc. and Smithwise, Inc. announced today they have agreed to a merger in order to offer expanded medical device development capabilities to their clients.

    “I’ve long described us as partner organizations,” said Eric Sugalski, Founder and President of Smithwise, “we share the same values and mission, we serve the same customers, and we offer complementary strengths to device innovators.”Though both firms bring mechanical, electrical, and software engineering capabilities to the medtech industry, they specialize in different areas—the Smithwise team skews towards mechanical engineering and industrial design, while the Catapult team has deeper electrical and software expertise in-house. “Together, we’ll be able to better serve our clients,” said Andy Ziegler, President of Catapult, “instead of regularly bringing the other team in as a subcontractor to supplement existing capabilities, we’ll be able to make immediate decisions on project resourcing and expedite our response for clients. Eric and I began discussions last year after realizing that our clients will appreciate being able to directly leverage our combined expertise.”

    The leaders of both organizations were emphatic about their desire to communicate that this is a partnership of equals. “We’d like our customers and strategic partners to understand this merger is a meeting of the minds, not a case of one firm being absorbed by the other,” said Sugalski. “We also want them to share our confidence that this relationship is already tried and tested—we’ve worked closely together for years across many different projects. In many ways, we’re acknowledging a reality that’s existed for some time and now we’re formalizing it. There will be some new questions to resolve in the coming months but, overall, we’re simplifying things for ourselves and our customers.”

    Both engineers by background, Sugalski will serve the joint enterprise as CEO, while Ziegler fills the COO and CTO roles. The new firm will combine Boston area offices with no staffing changes anticipated for the Boston or Philadelphia teams.

    An announcement regarding the joint firm name will be forthcoming. “Stay tuned,” said Sugalski.

    About Catapult Product Development: Founded in 2012, Catapult is a full-service medical device development firm, specializing in console-based diagnostic and therapeutic systems, minimally-invasive surgical and diagnostic tools, and a wide array of portable and handheld medical equipment. We work extensively with startups to enable their core technologies, as well as supporting leading device manufacturers and academic centers as they accelerate critical device development projects towards commercialization.

    About Smithwise: Founded in 2009 as Boston Device Development, Smithwise is a medical device developer that helps innovators struggling with technical, regulatory, or manufacturing challenges with their next new product. Our clients span top-tier academic hospitals, established medical device manufacturers, and venture-backed startups. We specialize in connected medical devices, wearables, and surgical systems. Our client projects range from proof-of-concept prototypes to high-volume production design and manufacturing transfer.

    Media Contact:
    Daniel Henrich
    Director of Marketing
    dhenrich@smithwise.com
    (610) 455 4255 x 735

    Written by Daniel Henrich

    Written by Daniel Henrich

    Director of Marketing at Archimedic

    Building a Better BOM

    How a detailed bill of materials sets you up for success in manufacturing transfer

    How medical device startups should evaluate contract manufacturers is a topic we frequently address with clients. Selecting a manufacturing partner can be an intimidating process and a lot rides on making the right decision. Developing a detailed bill of materials (BOM) will position you to receive a set of high-quality quotes from prospective manufacturers and conduct an apples-to-apples comparison before moving forward.

    Imagine this (or maybe you don’t have to):

    You’ve invested countless hours and many shekels of hard-won capital refining your medical device design and preparing to move into the manufacturing phase. You’ve been through multiple rounds of prototyping and bench testing. As a next step, you want to obtain production quotes for manufactured units. You call around to industry colleagues and receive some recommendations for contract manufacturing organizations (CMOs). You pair this effort with some independent research to come up with a list of CMOs to approach and find the appropriate point-of-contact for each. You then go through the process of executing confidentiality agreements with each CMO before sending over your engineering data. The whole process of requesting quotes has been much more involved and taken a lot longer than you originally thought. You eagerly await replies from the CMOs, bringing you the numbers that will inform so many of your decisions down the road.

    Over the next several days, instead of quotes, most of your CMO contacts get back to you with a polite “thanks-but-no-thanks” type of reply. The project “isn’t the right fit” or they’re “not set up to meet your specifications at a competitive price point.” The few that do respond take forever to do so and the numbers they give are much higher than you were anticipating. When you ask for details on how they arrived at those figures, they’re elusive and you get the impression they don’t really want you to accept their proposal.

    What went wrong?

    Simply put, the CMOs got the impression this project might be more trouble than it’s worth. Startups are notoriously difficult for CMOs to work with. They come with the same (or higher) sets of management costs as larger, more established clients, but with lower volume production runs and higher associated risks (non-payment, for instance). The manner and content of your request for a quote communicates to the CMO how easy you will be to work with and how likely it is this will be a profitable relationship for them in the long term. The single best thing you can do to position yourself for success in this process is to invest time with your design team in building a comprehensive bill of materials. A complete and detailed BOM will make your life a lot easier in the following areas:

    Procuring Quotes

    Your BOM is like a table of contents for your design transfer package. Along with your toleranced drawings, 3D CAD files, work instructions, and other materials, it telegraphs to a CMO your overall level of organization and professional competency. A detailed BOM (or lack thereof) tells a manufacturer how much “handholding” (i.e. non-billable up-front costs) a client is likely to require during the design transfer and pilot production phases. If you give the impression you’re disorganized or your project has been messy up to this point, you may receive a no-quote or inflated pricing in place of the information you were hoping for. Leading the conversation with a well-constructed BOM improves your chances of favorable responses from CMOs.

    Additionally, procuring component and subassembly quotes and incorporating them into your BOM reduces the amount of legwork required by a CMO, making the prospect of taking you on as a client more palatable.

    (By the way, along with your BOM, you should share details with prospective CMOs that will build your credibility: funding milestones met, management team backgrounds, etc. Think of this as a mini investor pitch–remember, you’re soliciting a strategic partner for your business!)

    Deepening your Understanding of Cost Drivers

    A BOM should be more than a list of components and their respective quantities. It should include part numbers, materials, processes, secondary operations, vendors, costs, and many other details. Supply chains are best built from the bottom up. By requesting production quotations for each custom component and assembly, the design team deepens its understanding of the drivers behind the final price tag on their product. This allows teams to identify and concentrate on the components that can have the greatest impact on their cost of good sold (COGS).

    Identifying cost drivers will foster helpful relationships with specialty suppliers including machine shops, injections molders, and PCB manufacturers. Often, these organizations can provide expert feedback on your design, helping you select components that will not only reduce production costs, but also improve the quality of your product.

    Mitigating Costs of Change

    Hopefully, you’re able to find a single CMO that can meet all your requirements and form a long-term relationship that benefits all parties. However, if a time comes when your CMO relationship isn’t meeting your needs, you’ll have to be able to pivot to working with a new partner (more on that below). If your CMO has compiled and controls the whole BOM–supplier list, component pricing, and other details–your task will be much more difficult. Building a BOM in advance of forming a relationship with a CMO is your insurance policy, in case that relationship doesn’t work out in the long run.

    Reducing Supplier Risk

    Maybe your product contains components requiring specialized materials or processing. The number of potential suppliers for these components may be quite small–exposing risk in your overall design you haven’t yet appreciated. Building a BOM is an exercise that will help you identify and reduce these risks, forming contingency plans to mitigate potential issues. A design team that builds and controls its own BOM is much better positioned to control supplier risk than one whose BOM is assembled for them by their CMO.

    Understanding Scale

    Startups usually begin their product’s production phase with a small number of units. This may require finding a CMO that specializes in launching production with low volume runs. However, that same CMO may be not be set up to produce the same product cost-effectively at scale.

    Horizontally-integrated CMOs have established broad networks of suppliers, assembling the subcontractors they need on a project-by-project basis. Such a CMO might focus solely on assembling the finished product, depending on other organizations for fabrication. These CMOs tend to be on the smaller side, allowing device entrepreneurs direct access to the CMO management team throughout the manufacturing planning process. The per-unit pricing of a horizontally-integrated CMO is usually higher, since it includes the cost of sourcing and managing subcontractors.

    Vertically-integrated CMOs have expansive in-house capabilities, such as injection molding, machining, PCB fabrication, and precision assembly, all in a single location. These are typically large organizations with high minimum order quantities. Usually, this type of CMO won’t be a good fit for a startup just entering into production for the first time. A detailed BOM, including component and assembly pricing information at different volumes, will allow a device startup to understand the point at which it may outgrow its first horizontally-integrated CMO, moving to a vertically-integrated partner for larger runs at lower unit prices.

    In Conclusion

    The points above are laid out to convince you that it’s worth taking the time to build a proper BOM prior to forming manufacturing relationships. They shouldn’t cause you to adopt an overly-defensive posture when interacting with potential CMOs. You’re forming a partnership that can literally make or break the success of your company, so tread carefully and protect your interests, but remember that trust between your organizations will be vital to your success. Developing a BOM isn’t the most exciting part of the product development process but it is a critical one you shouldn’t skip!

    If you need help with your BOM or have other design-for-manufacturing questions about your medtech project, contact our team using the form on this page. We’ll be happy to talk with you.

    About the image above: Exploded view of the DxTER orb from Basil Leaf Technologies. You can learn more about this project here

     Written by Eric Sugalski

    Written by Eric Sugalski

    Eric Sugalski is the founder and president of Archimedic, a contract medical device development firm with offices in Boston and Philadelphia. Sugalski has led the development of a novel pediatric life support system, cardiovascular implants, laparoscopic surgical devices, and an array of wearable diagnostics. In addition to his technical background, Eric provides companies with product development strategy that encompasses regulatory, reimbursement, and fundraising requirements. Eric obtained a B.S. in mechanical engineering from the University of Colorado Boulder and an MBA from the MIT Sloan School of Management.