If you make the selection just on cost, in about a year, you may be very sorry about the decision you made, began Mark Rutkiewicz, VP, Quality at Innovize.
His was a really solid talk. I'll share the first of his five questions here. You can find the rest on the 10x Medical Device Conference blog. It includes his slides and talk transcript.
Or watch the video below.
Is the contract manufacturer even asking for the right things?
Far and away, if your prospective medical device contract manufacturer doesn't ask you the right questions up front, you know you're in trouble.
So what should he ask for?
- Your Device Master Record (DMR). They need to know: Your bill of materials, your suppliers, your manufacturing work instructions. If you're manufacturing for the first time, they have to work these out with you.
- Your process validations. Otherwise, how will they know if they're doing it right?
- Your design requirements. Might they change some elements to scale manufacturability for higher yields? They can't make those suggestions without your requirements.
- Your availability to see his manufacturing facility. Mark's had cases where the contractor wouldn't let him on the floor. That's a quick way to lose an engagement. What are they hiding? Are you going to be partners or not?
Action Item: If you manufacture medical devices, do yourself a favor and download all of Mark's questions.
May 15-16 in San Diego: The 10x Medical Device Conference
10x is a cross-functional event. We invite experts from the entire medical device ecosystem to give you a one-stop shop to answer all your questions about how to:
- Design and develop your medical device;
- Submit applications to regulatory bodies domestically and abroad;
- Improve operational excellence across your entire enterprise;
- Gain market access through reimbursement, with an understanding of health economics and value analysis committees;
- Market and sell your devices to hospitals, primary care, direct-to-consumer, government, and more.
Here's the whole point of the Medical Devices Group and why you should attend 10x:
The Medical Devices Group can answer all your medical device-related questions.
We have a huge network and believe in the power of community and superlative attention to your needs.
We're building this site, MedicalDevicesGroup.net, to be the world's most useful website serving the medical device industry.
Similarly, 10x events are designed to be the world's most useful medical device conferences – bringing all players together for the industry – to help our community do their best work, with the smartest resources, and a group of people who genuinely care about relationships and doing good work together. Plus, we make it fun, with ice cream, videos, music, and camaraderie.
If you haven't yet attended a 10x event, make 2019 the year you do.
We expect a completed agenda in a matter of weeks. Visit the 10x Medical Device Conference site for information and I hope to see you in May.
The Medical Devices Group Job Board
How many medical device sales jobs do you think we presently have on the board?
Fact is, there are thousands of medical device jobs featured on our board, like this one:
So, if you're looking for work, let me help.
And if you're looking for candidates, email me back. Let's talk about prominently featuring your jobs on the board, on this website, and in newsletters.
Let's get those jobs filled with qualified candidates, right here among our Medical Devices Group friends.
What We're Talking About This Week
Cheryl Schaaf from Resolution Bioscience is looking for Medical Device PLM recommendations. She got some suggestions. Do you have others?
Michelle Lott has a warning about your notified body.
Got a question or need votes on a survey? Ask the community!
Thank you for being part of our Medical Devices Group community!
Make it a great week.
Medical Devices Group Leader
P.S. For those of you celebrating, a safe and blessed 🦃 Thanksgiving weekend 🦃 to you.
I’m currently a student at the University of North Carolina at Chapel Hill, studying economics. I am taking an Entrepreneurship class, where we must create a venture in relation to health care.
My group has come up with an idea to create wristbands that monitor the four major vital signs – blood pressure, body temperature, pulse, and respiration rate – while patients are waiting to receive care in the emergency room.
The band would send the measurements to an accessible system, allowing physicians and nurses to have access to the health information of waiting patients.
Please let us know what you think about the product, including its usefulness, practicality, problems, etc. Thanks in advance for the input!!!
Then how about Carsten Horn, the business development manager for maxon precision motors? Carsten gave a 10x Medical Device talk on product design and manufacturing considerations when you miniaturize your medical device.
I made the replay, slides, and transcript available for you: Click here.Of course, miniaturization is one of the major trends in medical devices. Miniaturization, along with digitization, is a central theme ResMed's go-to-market strategy. (See ResMed CEO Mick Farrell's 10x keynote presentation.)
Why is miniaturization so big?
You see what I did there? 😄
Because, as Carsten notes, "The major driver is the patient. Smaller devices, especially ambulatory devices (drug pumps, patches, etc.), shouldn't bother you to wear."
"To make them comfortable, you need to make them extremely small," he continued. "We are working on micro robots and miniature robots that work within the body and doing the surgery, not from the outside anymore. That will be the future, and you need to miniaturize for that."
So if you might miniaturize, or just wish to stay current on this hot trend, give our summary a look.
#HumbleBraggingExample: It was an honor to host so many thought-provoking speakers and guests at last week's 10x for Design and Manufacturing event. Another: I don't know what it is about 10x Medical Device Conferences. Alumni come again and again, saying 10x delivers so much value in terms of content and connections. In other words... First up: 10x for SALES and MARKETING (call for speakers) on January 29 and 30 in Florida. (Early bird pricing now available.) Then: The 10x Medical Device Conference (call for speakers) on May 15-16 in San Diego. Then: 10x for Design and Manufacturing (call for speakers) in October in Minneapolis. So, possible? I'm giving you a whole year of notice – and before you've set your annual budget. Please, join us. You'll see why I guarantee your satisfaction and offer the industry's most generous return policy. +++
Two Free Webinars!Since I already know who you are, all you have to do to register for these webinars is click the links. Easy! 😊 • Live FDA announcement. Thursday, October 18, 11:45 Eastern Daylight time (EDT). FDA will discuss new draft guidance, entitled "Computer Software Assurance for Manufacturing, Operations, and Quality System Software." Yes, sign me up for that. • Workshop: How to prepare a 510(k) submission. Thursday, October 25, noon EDT. Yes, we do FDA submissions. I'm interested. As always, if you can't make the live events, we'll send you the recordings and slides afterward.
+++Project Manager, Medical Device Product Development, Mansfield, MA • Entry Level Medical Device Sales Representative, Fort Dix, NJ • Director of R&D, Natick, MA Hiring managers, list your opportunities for just $39 at https://medgroup.biz/jobs anytime this month (promo code OCTOBER). Candidates, search medical device jobs and sign up for job alerts at https://medgroup.biz/jobs. +++
Discussions You May Have MissedAsk your question at medicaldevicesgroup.net/question/add.
- Barbara Duffy, Chief Operations Officer for Healthcare Innovations Institute, has a question about "How else to use medical models?"
- Jackie Jaskula, Regulatory Manager at OrthoPediatrics , asks, "Why is FDA accepting 510(k) for implants with no usability or biocompatibility?"
Thank you for being part of our Medical Devices Group community!
Make it a great week.
Medical Devices Group Leader
Dear colleagues, what are your "tips and tricks" to limit the number of article codes for your finished products?
How do you manage the different power cords, languages for software interface, languages for IFU, duration for authorization time, labeling differences, and more?
Thanks in advance, and best regards.
There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.
Let’s say I am designing a PCB and have to write a protocol to test it. I would include measuring voltages and current at different stages.
But there is much more to consider, even before I plug in the device (like shorts and loose solder connections). Many companies have a team to take care of this, but in a start-up that may not be practical.
My question: What's a good approach when just starting out in protocol design?
Polyolefins have been shown to be safe alternatives to PVC's widely reported risks.
However Polyolefin films make up only a small percentage of liquid tight medical bags in the US with shapes and fitments.
Is it because of the sizable investments already made, or not knowing how to make with Polyolefins in scale?
Designing delightful and robust user experiences is not an art. It is science. And it is business.
These are the questions you should ask yourself - and the tools to get you started: http://bit.ly/product-love
Do you ask yourself these questions? If not, why? (I am genuinely interested in your perspective, so please comment)
All the best, Kasper
I'm trying to put together a very high level view of medical device development for novice (meaning no prior experience in the industry, not just this is their first invention) inventors.
I am interested to hear from others what (if any) role they have seen research play in the process of developing a new medical device, including at what point in the process the research occurred. Did most of the research occur pre-IP? Pre-POC? Did any occur after the design process (user requirements, design inputs, V&V plan, etc.) got underway?
P.S. Does anyone here has been involved in medical device development at a medical device company think that a data collection activity (bench testing, clinical trial) done to verify or validate the design could appropriately be described as "research?"
I am interested to learn about the fabric/textile products people are using in their medical-related work.
I am particularly interested to learn what problems could be helped with new or improved fabric/textile products. Thanks!
Having no references to similar devices, I find it difficult to find the way to be able to license it when it is in the prototype phase.
Anyone here have answers for, or maybe just some thoughts on, any of these questions?
Application-wise, right now I am looking for a material with similar strength and fatigue properties as titanium that may be easier to use in manufacturing, potentially injection molding.
5 Tips for Medical Device Engineers on FDA Design Controls
If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a majo
Quantities? Parameters ? Forms ? How many batches ?
In theory you can create a design plan and any other missing documents from your DHF retroactively, but that only helps you with compliance during an FDA inspection. The purpose of a design plan is to make sure that you conduct all the necessary steps required to design and develop a medical device, and to make sure that you have adequate resources. For example, how did you make sure that all the required tests were performed that are required for a 510(k) submission?
Verification tests are the tests you perform prior to a 510(k) submission in order to make sure that your design outputs (also known as drawings and specifications) meet the design inputs. Both the outputs and the inputs must be reviewed and approved. Ideally, every requirement you document in a drawing or material specification should have a purpose and the purpose is to ensure that the medical device will pass your verification testing. For example, you might specify a specific brand and quantity of adhesive to be applied to two plastic parts in order to bond them together. The purpose (i.e., “User Need”) is to ensure that the product is biocompatible and the adhesive bond is strong enough that it won’t break during use.
Biocompatibility should have a specific set of design inputs based upon a recognized standard--ISO 10993-1. Compatibility with the manufacturing process is verified by performing process validation. There should be a protocol and report for the cleaning validation and for the steam sterilization. Steam sterilization also has a recognized standard--ISO 17665. You also need to make sure the final assembly is strong enough. This could be done several ways. Ideally, you will use a combination of design verification and design validation. If appropriate, you might use an ASTM standard for a tensile test to verify the assembly is strong enough. The ASTM standard would be a design input, and the testing would be design verification. You might also test the device in simulated use. In this case, you would write a protocol for design validation.
Your initial design plan might only specify that you will have four design reviews: 1) review and approval of design inputs, 2) review and approval of design outputs (i.e., design freeze), 3) review and approval of verification/validation testing for your 510(k) submission, and 4) review and approval of product launch--pending 510(k) clearance. As your project progresses, you need to update your design plan. You need to identify and document potential hazards--a required element of a risk management file. You need to use these potential hazards as inputs into your design process, by identifying design inputs to verify that each potential hazard has been evaluated.
Unfortunately, if you wait until after you submit your 510(k) to write your design plan then you may not have all the required tests identified. If you forgot to test for the strength of an adhesive bond between two parts during design verification and validation, the best-case scenario is that the FDA reviewer will place your 510(k) submission on hold and request testing data. The worst-case scenario is that your product will malfunction in the field and you will have to recall product, redesign the product and submit a new 510(k) for the device modification.
I started asking myself why, and came up with what I think are the top 5 reasons it is important for us to use in med device. For the sake of brevity, I will just list them without much explanation:
1. THE USER CENTRIC NATURE OF DESIGN. This can be the key to beating the competition.
2. VERIFICATION TESTING. Early design research informs more formative work, freeing people up to be more creative.
3. CROSS FUNCTIONAL COORDINATION. This can help reduce delays from missed expectations.
4. DESIGN FOR MANUFACTURING. Done early with design thinking makes engineering down the road easier, not harder.
5. POSITIVELY IMPACTING LIVES. The contribution to the improvement of people who need help is immeasurable.
So what are YOU waiting for? The cost to create great innovative devices has been optimized, and the tools to make it happen have never been more accessible and available.
I’d love to know – does your company use design thinking yet? Why or why not? Do you think design thinking really works to create acceptability for medical devices? Why or why not?
FYI, the picture I used at the top of this post is from a device we created for a Minneapolis-based medical device company, NxThera. (video link below) If you have a picture or video of a project of your own, or a link to one you like, please share in the comments! Would love to see other examples!
Unusual surgical device video: http://www.nxthera.com/rezum/the-rezum-system/
All changes must be reviewed and approved, but how much control is necessary prior to verification and validation. During the verification and validation activities there is a cost to your business, but there is no impact on safety or efficacy. However, once a product is released to market more stringent change control is necessary. The best design procedures articulate these important differences as a risk-based control of design changes. How do you plan to update your design control procedures for compliance with ISO 13485:2016, Clause 7.3.9?
Please share what you think are the best approaches to address this dilemma.
Here's a way to save you money: Educate you how to avoid the penalties associated with cracks in your environmental compliance procedures.
And it's free for group members: http://medgroup.biz/RoHS
Anne Barr from The Compliance Map will give us an update on the current outlook of material compliance and product stewardship such as RoHS, REACH, and Prop65. We'll learn what to look out for as a medical device producer from a risk and enforcement perspective.
• Global RoHS update (Restriction of Hazardous Substances)
• REACH update (Registration, Evaluation, Authorization, Restriction of Chemicals)
• Prop65 (a politically controversial law because it puts the burden of proof on business instead of government)
• Product Stewardship (over electronic equipment, batteries, sharps)
The live webinar will be Thursday, April 28 at 12 p.m. New York time. All who register (even if you can't make the live event) will get the slides, replay, and transcript.
That link again: http://medgroup.biz/RoHS
Will you be going to 10x in San Diego? I teaching a couple of workshops on 510(k) submissions and CE Marking. The event is May 2-4. I hope to see you there.
On April 28 there will be a new live webinar on the best practices for controlling Design Changes. If you are interested in the webinar, please visit this page to learn more: