An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures.
The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told MassDevice.com via email.
Bayard Design consultant Matthew De Remer designed the ventilator system for the OCS Lung.
Bayard Design is very excited for the team at ecobee. After much hard work the ecobee4 has been released for sale. Consultant Matthew De Remer helped integrate the microphones and speaker into the ecobee4 to provide the full Alexa experience and assisted in transitioning the unit to off shore manufacture.
Dr. Waleed Hassanein is being honored for developing the Organ Care System (OCS), a technique for preserving human organs outside the body three times longer than traditional cold storage. Dr. Hassanein originally developed the technique to store human hearts at Georgetown University by focusing on using warm environments and surrounding the heart with nutrient-rich blood. Implemented clinically in 2007, OCS is now used for human lung and kidney storage as well.
The additional time that an organ remains viable due to OCS presents a significant breakthrough for transplants. With a longer duration of viability outside the human body, organs can now be transported further and doctors can now accurately assess the suitability of a new organ before re-implantation. Today, Dr. Hassanein is the CEO, President, and Director of TransMedics, the company he founded to commercialize the concept of “living organ transplants” for the improvement of clinical practice.
I Will What I Want: Women, Design, and Empowerment explores the complex and sometimes-contradictory role that design has played from the mid-Twentieth Century, through second wave feminism, to present non-binary intersections in the pursuit of gender expression and equality for those who have uteruses, menstruate, and/or identify as women.
The exhibition features objects, interfaces, and clothing that have sought to enable those who have uteruses, menstruate, or embrace womanhood as independent and creative subjects in a material world largely designed by and for men but consumed by those who identify as women.
Design’s relationship with the individual and with societies is rarely uncomplicated. With the introduction of the contraceptive pill came the rise of laws designed to constrict reproductive rights for people with uteruses; for every breast pump that facilitates new parents’ choices about work and nutrition, there exists a poorly designed familial leave policy; and so many designs “for her,” even for very young girls, come with the baggage of implicit and explicit expectations about class, race, gender performance, labor, and sexuality.
To keep pace with the growth of Bayard Design’s customer base and workforce we are moving to a multi-office suite in North Cambridge. Our new offices have on-site guest parking (rear of the building), easy access to the Red Line (10 minute walk to Davis Square or 20 minute walk to Alewife), easy access to the Fitchburg Commuter Rail (20 minute walk to Porter Square), easy access to bicycling infrastructure (adjacent to Alewife Linear Park) and easy access to route 2 and route 93.
Great post on the bolt blog talking about how hardware start ups fail. It really hits the nail right on the head with a couple quotes and graphics namely “There’s a valley of death for hardware startups. Ironically, it occurs when companies start selling their product.”
This really speaks to the transition stage between being a start up (hey let’s make 10 or 100) and being a real product company (let’s make 50k). This gulf can be huge. Anyone can make it through 100 unit pilot run with a litany of problems, but once you have to make 50k or 200 a day (over a 250 day work year) all the problems have to be gone or you’re simply not going to make your cost, profit or timing goals. Likewise beta testers and kickstarter backers will be tolerant. Walmart/Best Buy/regular consumers will not be.
How does a start up make it through this “valley of death”?
The original post had some good suggestions that I’d sum up as understand your pricing fully: sell price, make price and make price changes with volume changes.
Solid funding that anticipates this period not just the first phase. This is easier said than done, but it comes down to understanding the funding you need to be successful and working to get to that level.
Skilled employees and consultants to quickly mitigate problems, sell your product and get you through to the 50k order as quickly as possible. This is where spending money on superstars is better than just checking the box. If you increase your burn rate by 150%, but only burn for 6 months, its better than a slow burn for 24 months of misery and failure.
This last point is where Bayard Design shines. Trust us to make your product production ready for effortless scaling on a tight schedule.
Last fall Bayard Design consultant Matthew De Remer participated in a weekend long event at the MIT Media Lab dedicated to improving breast pump technology for nursing mothers. The “Make the Breast Pump Not Suck” Hackathon was a multi-disciplined event encompassing engineers, designers, lactation consultants, nursing mothers and other interested parties. Matt’s team ultimately won “Most Outstanding User Focused Design”.
Matt hacking a manual expression concept
Footage from the event was made into a short documentary that has now been uploaded to YouTube documenting the experience.
Inventors are often very concerned that their great ideas could be usurped. After all if you came up with a great idea couldn’t someone else? If you tell someone about it could they steal it? These are not invalid concerns, but I would caution against spending a great deal of money up front on patent protection to the detriment of actually getting your ideas to market. You’ll have a patent and no product and no money.
There is another option though – a provisional patent or more formally a provisional application for a patent. They can be completed without an attorney and filed for only $130. Only a minimal level of information is required:
a written description of the invention
any drawings necessary to understand the invention,
However a provisional patent puts your project on a tight timeline. A ‘real’ patent application must be filed within 12 months with the requisite attorney fees, search fees, etc likely totally from $5 to $30k+.
Although offering much less protection your idea can be protected by non-disclosure agreements or confidentiality agreements. NDAs are pretty typical nowadays and create an exception that your ideas will not be shared with third parties. After all in the early stages you’ll be discussing your ideas with professionals who’s job it is to realize inventor’s dreams not steal them.
So in summary don’t spend all your money on patents until the time is right.
Disclaimer: No attorneys were consulted for this blog post. This a layman’s interpretation of the applicable laws and regulations and does not substitute for the advise of the good patent attorney. Patent protection is an important part of any business plan.
According to Design News the DoD put down some big money to help develop Digital Manufacturing.
As part of President Obama’s promise to invest in innovation in American manufacturing, the US Department of Defense has awarded Chicago-based UI Labs $70 million to open the Digital Lab for Manufacturing, a research and commercialization institution for the development of new processes and strategies to promote digital manufacturing.
Given how much you can get for $200 or $2300 or $20,000 it will be interesting to see what they come up with.
Yes, because in the right (or wrong) circumstances, any device which contains a relatively high speed clock (above the low kHz range) stands to possibly produce unwanted interference to other local devices. Devices which do not use radio transmitters are referred to as “unintentional radiators”, and the testing bar is lower for them than it is for intentional radiators. Thus, all devices which cannot be exempted must obtain FCC authorization prior to being marketed in the US.
In other words many devices that contain no radio or wireless functionality will require approval as an unintentional radiator. Does your device contain a processor? Then the odds are very high that it will need approval.
How much does it cost to obtain authorization under the FCC rules?
That depends on your device. Devices which require Verification or a Declaration of Conformity- which is to say, unintentional radiators- can be tested for about $1000. There is usually an additional fee of around $500 for a report which may or may not be needed. For intentional radiators, the Certification cost is more like $10,000-$12,000, unless an approved module is used. It may be that you will fail, of course, which will require retesting.
These estimates are consistent with our experiences.
Are their exemptions for small runs or small businesses? No. Though there are exceptions for experimental devices.
Amazon has taken a calculated risk in heavily advertising their new Kindle Fire tablets without FCC approval. This will most likely pay off given that they got to announce a week before Apple’s possible iPad press event and that they are unlikely not be approved by the FCC. Moreover given the timing Amazon is likely already tooling for their November 20 ship date, so they must anticipate passing with little or no changes to their design.
Partnering with a design firm that can write comprehensive test plans, including all regulatory testing and product requirements testing, is critical to product success. Bayard Design uses the Design for Six Sigma methodology to ensure every key product requirement flows down to its test plan, component specifications and process specifications.
I am pleased to share some exciting news with you. Today we announced that RedEye’s parent company, Stratasys, and Objet have reached an agreement to merge, creating an even stronger company better positioned for growth.
As you may know, Objet is a leading manufacturer of 3D printers for rapid prototyping. Founded in 1998, the company developed its proprietary inkjet-based 3D printing technology, and today has more than 2,800 customers worldwide, including several of the Fortune 100 and Fortune 500 companies. Objet is headquartered in Rehovot, Israel and has more than 430 employees.
We are confident that this combination will enhance our ability to serve you by bringing together two companies with customer-focused, differentiated capabilities and a shared commitment to excellence. We believe that together we will offer you, a broader range of rapid prototyping and direct digital manufacturing services and an exciting roadmap for future product services. We hope you share our excitement.
The combined company will continue to operate under the Stratasys name and will have dual headquarters in Eden Prairie, Minnesota and Rehovot, Israel. As we work towards completing the combination and following the combination, there will be no changes in your relationship with RedEye or Stratasys, and your day-to-day contacts will remain the same. In short, it is business as usual for customers of RedEye. We will continue to deliver the same great on-demand services you have come to expect. As always, if you have any questions, please feel free to call your RedEye Account Manager or email firstname.lastname@example.org.
The transaction is expected to be completed in the third quarter of this year. Until then, both Stratasys and Objet will continue to operate as separate companies. Given the complementary nature of our technology portfolios and our shared commitment to innovation and service, we anticipate a seamless integration.
We appreciate your business and thank you for your continued support.
Chief Executive Officer and Chairman
Although SLA samples are generally regarded as not biologically compatible, DSM has successfully tested 2 of their resins to USP IV.
Somos® WaterShed XC 11122 resin – a clear, durable, water resistant material – has been tested and approved for USP Class VI in biomedical and skin contact applications.
DSM reports that the ABS-like material passed ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization, ISO 10993-10 Irritation certified and was USP Class VI approved. Reading ISO 10993-1 that would make it good enough for Surface Devices: Skin Contact. Likewise that gets it most of the way there for other applications too.
The final step in any product development cycle is validation of the product design and manufacturing process. The ability to meet a life target is normally one of the most important attributes. This data can also be used to estimate warranty costs and repair or replacement revenue.
The challenge is how does one test a product that is used continously for a number of years? No one wants to test a 10 year expected life by testing samples for 10 years.
It is universally accepted that under certain circumstances accelerated life testing will reliability predict product performance. MDDI had a great article explaining use of the Arrhenius reaction rate function to perform accelerated shelf life testing at elevated temperatures allowing months of shelf life to be simulated in hours. Likewise MIL-STD-202G, Method 10 describes methods for testing PCBs via thermal shocks to simulated years of use in hours.
Accelerated life testing in critical to quickly finding persistent failure modes and estimating product life before warranty returns and customer complaints start pouring in.
There was a great article in Design News this month on the importance of mold design as it relates to part design and quality:
The four simple rules are:
Establish nominal wall thickness.
Allow draft to make it possible to easily remove the part from the mold cavity.
Watch rib-to-wall ratio. The section where a rib joins a nominal wall should not be more than two thirds of the nominal wall. Drop that to 50 percent on crystalline resins, such as polypropylene or nylon, because of greater shrinkage rates. Make sure radii do not cause sink or inhibit part ejection.
Ok, its almost 2012, but I realized I never commented on the color of the year for 2011. It’s Honeysuckle. Yes, honeysuckle. It looks pink. Probably not the right choice for every product, but for some it could work.
Reuters has collected some great quotes from leading designers in regards to Steve Jobs legacy. Here are a few:
“Many credit Apple as probably the best advertisement for professional design and the role of design that we have ever seen”
“Steve Jobs has shown that breakthrough products come from taking intuitive risks, not from listening to focus groups. He was a master of semiotic design,”
Although it had become a running joke with clients that we should “make their product look like an iPhone” or that a proposed design “looks like an iPod” there is quite a bit of seriousness to this remark.
When I saw the iPod in the Smithsonian’s Cooper Hewitt I was initially taken aback. It was too commonplace, too mainstream to be in a design museum, but there it was. Then it hit me. The iPod/iPhone is the most well designed, successful, mass market product of modern times. Its clean, simple, elegant design has been copied by many, but emulated by few.
Steve Jobs has shown us that good design doesn’t have to be a niche market and that the public will pay for it.
1) The Law of Leadership: Executive level support (Board, CEO and his/her direct reports) is critical for an organization that wants to have innovation at is core…
2) The Law of Culture: Establishing and nurturing an innovation culture sets the foundation for the organization…
People: Every person feels ownership of the innovation agenda and is quipped and skilled to have impact.
Ideas: Ideas are actively solicited from all sources and valued and nurtured not criticized or minimized.
Alignment: All resources are aligned against the innovation agenda to ensure everyone is pulling the same direction.
Communication: Communication that is clear, honest, respectful and transparent is essential for teamwork and establishing trust within the organization.
3) The Law of Resources: Innovation requires a committed level of resources (people, money, time, equipment) over an extended period of time…
4) The Law of Patience: Innovation takes time. More time than is expected…
5) The Law of Process: To succeed at innovation, organizations need an innovation process that fits and works within their organization and culture…
6) The Law Of BHAG: What is a BHAG? A BHAG is “Big Hairy Audacious Goal”. It’s what leadership lays out as the innovation agenda. The BHAG sets a clear and compelling target…
7) The Law Of Execution: The ability to execute on the both the innovation agenda and the quarterly objectives of the operating business is a key skill that the organization needs to have. Focusing on only one area of execution leaves the other to flounder. Segmenting the execution roles into separate silos works against the Law of Culture.
I buy into these with some caveats. I’ve seen worthwhile projects fail to succeed due to violations of one or more of these laws. However, in regards to rules 4 through 7, projects must achieve reasonable milestones to continue. In this business climate no one is going to pay for innovation for the sake of innovation. Having said that killing projects too early (rule 4) will never lead to commerical success.
As reported in the Boston Phoenix presidential hopefuls for 2012 are being asked to sign a pledge to “to attend two days of training on the Lean Six Sigma method . . . prior to…inauguration.” There is apparently more attached to the pledge than that and considering that the vast majority of Lean Six Sigma training is paid this is quite the marketing coup. Despite these cynical aspects of the pledge promoting the wider use of Six Sigma is a good thing.
Those that thought Six Sigma was a fad in the 90’s that would go the way of TPM et al and fizzle after a few years have been proven incorrect. The power of Six Sigma is that its not a gimmick, but a methodology largely based on simple statistics and methodologies that have been validated since the 1950’s.
Used properly Six Sigma can reduce defects, improve productivity and reduce costs. What company can’t use increased efficiency and a higher quality product?
In my last post I lamented that one of the biggest barriers to inventors and entrepreneurs is the sometimes high cost of tooling and how Kickstarter.com and crowd sourcing could be the answer. No sooner had I write that then Proto Labs, the parent of Protomold and Firstcut CNC, dropped this e-mail into my inbox.
Cool Idea! Program to Award $100,000 in Proto Labs Services
Do you or someone you know have a cool idea for a brilliant new product? If so, we want to hear from you, and help turn that idea into a reality. We’re excited to announce the launch of our Cool Idea! Award*, a new program created to give product designers the opportunity to bring innovative products to life.
In 2011, we’ll grant award winners an aggregate of up to $100,000 in Firstcut CNC machining services and/or Protomold injection molding services. Unlike other awards that recognize products or innovative design after the product has already been created, the Cool Idea! program supports products in the idea stage, and helps move them from pie-in-the-sky to product-on-the-shelf. Winners can use their fully functional Firstcut and Protomold parts for prototyping, design iterations, testing, or even an initial production run.
KickStarter has emerged as an awesome way to validate product ideas and get the capital to launch those ideas. One of my friends, who works in the non-profit realm, first brought KickStarter to my attention as a new form of crowd charitable giving. I tucked the site into my bookmark list as a potential way to do a new product pre-sale or method of raising capital.
These ideas were realized and then some by the Glif phenonmon. A pair of independent designers raised/sold $137,417 worth of iPhone 4 tripod mounts in 60 days! This was repeated just recently by the Waldok, which raised/sold $76,491. In this case people effectively pre-purchased an innovative iPod speaker/dock. In both cases the inventors got more than enough money to meet their capital needs and produce the promised number of units.
One of the biggest fears of the innovator is whether enough people will actually buy his or her great idea. Kickstarter can easily answer that question and also answer the next nagging question — where do I get the $10 to $100k to design, tool, test and produce my product?
A recent study by the Aberdeen Group shows that “best in class” users of simulation pay 14% less for product development than “worst in class” implementers. Warranty costs, number of physical prototypes and number of change orders all follow a similar trend.
Bayard Design is proud to offer FEA and CFD services to customers. This allows smaller companies, who can not justify software licensing and training for their stable of products, to achieve “best in class” simulation implementation.
Here’s an interesting post about using social media as a tool in product development.
To many, the process of developing a successful product can be a mystery. Sometimes companies will spend months of development time to create a product that doesn’t reflect the needs or the scope of its intended market…
After we have used our monitoring tools to identify trends and audiences, we now begin to monitor scope and direction. Understanding how your target audience is using products is important in your planning process…
Although the example is a video software tool one could argue that the same techniques could be used for any product.
Although not explicitly mentioned in the post this got me thinking about a great hypoethical use. For example if you’re thinking about adding a new feature to an existing product you could see how many people are searching for that new product on Google via a Google Adwords tool.
And of course Google is a great tool to see what the competitve market place looks like. Although these techiques can never replace a large user survey they are much less expensive and could perhaps vet multiple options at an early stage.
I buy into the argument made by a new white paper by Blue Ridge Numerics that doing a CFD can save tens of thousands of dollars. Even if proof of concept units work well a thermal or structural failure can occur during more rigorous alpha or beta testing potentially wasting the cost of those units or the cost of replacing components or subassemblies.
CFD analysis can answer many questions. Some of the common ones are wind loading, thermal management of electronics enclosure and thermal safety of devices.
I would suggest that this arguments apply to FEA analysis for strength as well.
Rigorous expensive analysis is not required for each and every project though. A skilled engineer knows when rule of thumb or paper analysis has reached its limits and a more through analysis is required.
There was a great article in last month’s Wired Magazine. It celebrates the power that the individual inventor has in today’s world to develop and sell his or her invention independent of a large corporation. One might think that this would threaten a firm like Bayard Design.
On the contrary these same forces ultimately lower development costs for us and our customers thereby increasing our potential customer base due to lower start up costs. I would suggest that Bayard Design would have a role to play in the process as a trusted adviser whether it be an engineered solution to a problem or a go-between to find a reliable supplier in China. I would further suggest a slightly difference development path than shown in Wired:
From Wired Magazine Jan 2010
1. INVENT – The inventor comes up with their cutting edge idea.
2. DESIGN – Bayard Design designs and engineers your product with your input and knowledge.
3. PROTOTYPE – Costs to prototype parts have gone down substantially in the last 10 years making lots of 1 to 10 parts well within the reach of the individual inventor. Bayard Design has a database of vendors who use various processes to produce professional level prototypes.
4. MANUFACTURE – Costs to tool and produce parts in China have drastically reduced the start up costs for a typical consumer product. Bayard Design also has a number of Chinese vendors that we have worked with previously to successfully make and assemble products at extremely low cost. We also have a database of US suppliers that can make and assemble products that may not have the volumes to justify a move to China.
5. SELL – Market the product yourself or market it through an established on-line distributor or through a box store. Although box stores have been decried as destroying small businesses if you get into one it guarantees moderate sales volumes just to stock all their shelves. Selling on Amazon or Sparkfun or another established website can also supply a good amount of traffic to guarantee a minimal amount of sales.
Please ask your senator and representative to remove the proposed medical device tax from their chamber’s respective health care reform bills.
We had taken a neutral view towards the proposed tax in order to allow the facts and details to come out. Now that they have, in among other places MD+DI magazine, it clearly and unfairly affects medical device start ups. This is not in the best interests of anyone that could benefit from new medical device technology and furthermore would put US firms at a competitive disadvantage to competitors in Europe and Hong Kong.
With steady sales throughout the holiday season, The Beatles: Rock Band has sold over one million copies worldwide. News of the sales milestone comes via both Gamespot and Industry Gamers,according to information they obtained from a Harmonix spokesperson. The wider Rock Band franchise also recently hit another major milestone, as its downloadable catalog for Rock Band/Rock Band 2 exceeded 1000 songs.
Its great to see a worthwhile, life saving product in use — especially one you had a hand in developing. Although not visible in the trailer or other clips available currently on-line, the QinetiQ North America PSM and Solider Tracker (Locator) system were on display for about 20 minutes of the episode when a Special Forces candidate inexplicably stopped moving during an all-night land navigation exercise. Using the PSM system the Cadre were able to tell that the soldier’s vital signs were normal. Using the Tracker system the Cadre were able to quickly find the soldier and confirm that he was ok — just sleeping. The Cadre were displeased to say the least.