Mikron’s VX high-precision rotary transfer machine is a flexible production system for cost-efficient manufacturing of various batch sizes. The machine can pre-machine directly on wire or bar stock before cut-off and subsequently clamp on pre-machined surfaces. Subsequent operations can then be performed unattended, producing ready-to- assemble components. Maximum workpiece dimensions are 40mm x 40mm x 80mm (40mm x 40mm x 160mm, optional).
EOS Additive Minds Manager Fabian Alefeld says the first prototype with its smart knee-joint monitoring shows the potential of combining AM with sensors and connectivity.
Photo: EOS & Blackbox Solutions GmbH
A smart knee prosthetic containing embedded sensors and connectivity allows doctors to analyze data in real-time, potentially speeding patient recovery. Additive manufacturing (AM) company EOS and Blockbox Solutions combined their respective expertise in 3D printing and sensor technology to create the customizable orthosis.
EOS officials say the full potential of Internet of Things (IoT) comes from leveraging AM, a technology that makes it easier to integrate intelligent and connected components. The combination of sensor technology, connectivity, and AM could expand digitization to new applications and business cases.
A recurring challenge
Torn ligaments, typically caused by wrong movements and excessive physical pressure on the knee, are one of the most common knee injuries and usually require a long recovery period with a risk of long-term disabilities. Recovery periods vary heavily based on the patient’s movement behavior. Putting too heavy a load on the knee too early can prolong recovery, as can not moving often enough. However, most patients don’t know what’s too much and what’s not enough. Feedback from a smart device could prevent overexertion or needless restrictions.
EOS Additive Minds specialists developed a knee orthosis to provide that feedback, working with sensor technology experts from Blackbox.
“We created a 3D-printed orthosis which can be customized and has integrated sensors and actuator,” explains EOS Additive Minds Manager Fabian Alefeld. “The orthosis, connected to a smartphone app, can now give live feedback via vibration actuator.”
A buzz warns patients when they are overexerting themselves, and the app stores the data, allowing patients to share recovery information with their doctors to guide treatment. Patients gain instant feedback when engaging in activities that could harm rehabilitation progress.
AM smart orthosis
Combining mechanical design elements with embedded electronics – microcontrollers, sensors, radio frequency (RF) connectivity – forms smart parts that could enable customized products. AM smart parts could enable:
Precision designs
Full customization
Integrated sensors for rapid production
Optimized end-user functionality
Rapid time-to-market
Fast ramp-up of small serial production
Agile production
The proof-of-concept, 3D-printed knee orthosis with integrated sensors, data processing capabilities, and RF connectivity demonstrates how stakeholders in a product’s ecosystem can gain real-time insight and benefits from sensor data.
“We measured the angular position of the orthosis joint,” Alefeld explains. “This can also easily be transferred into the total number of movements a day and therefore activity. In future developments, a load sensor or even an accelerometer would add additional significant data points.”
Initial system requirements came from interviews with direct and indirect orthosis users – patients, doctors, and end-equipment manufacturers. Users told developers what data and/or information would be helpful to improve patient experience and doctors’ ability to provide real-time care.
PHOTO: EOS & Blackbox Solutions GmbH
Feedback, security, recovery
The prototype led to an embedded solution that can retrofit legacy orthosis by printing customized housing replacements with designed-in sensors. Sensors that measure angle and force combine high precision with a contactless approach, simplifying integration. WiFi and Bluetooth Low Energy (BLE) communication empowers real-time monitoring and can be controlled by connecting the device to computer networks. A personal mobile device acts as a user interface and controller.
Data analysis on remote, secure servers accessed with a mobile app or directly on the device leverages the integrated embedded computer. Sensitive data can be securely processed locally to protect user privacy and data security. Information collected can be accessed, analyzed, and secured via interfaces tailored for different users.
With Blackbox Solutions’ embedded electronics and user-interface prototype, the EOS team is investigating customized design requirements to retrofit sensor housings to add functionality to legacy orthoses.
Battery powered sensor technology and connected software will let patients and doctors monitor progress in real-time and guide rehabilitation to individual patients. Ongoing data collection will provide equipment manufacturers with user insights and product performance data, allowing refinement and advancement of future designs.
Conclusion
This illustrates AM’s benefits to design, functional sensor integration, and rapid production of customized parts while optimizing functionality for users.
Grabbing defeat from the jaws of victory is something we see often in medtech. Every time it happens, it befuddles us as it’s usually avoidable.
The No. 1 culprit seems to be a lack of situational intelligence by very smart people who simply don’t understand their situation correctly, haven’t done enough preparation for their audience or engaged in enough active listening to properly read the room. Our goal, whether it’s within your own company or between your company and another company, should be a win-win scenario, an outcome that creates the best opportunity for long-term relationships that create the most value.
Scenarios that require situational intelligence include:
Negotiation for a new job or promotion
Sales opportunities with a new or existing customer
Understanding your leverage when selling your company or buying someone else’s company
One example of a scenario that required situational intelligence was:
A bright engineering executive from a U.S. company went to China hoping to develop a new product for a Chinese company. The Chinese company (after 10 minutes of introductions on both sides) asked if the engineering executive’s company could provide a product to demanding specifications. The executive simply said “no, we can’t do that.”
There was stunned silence in the room, and the Chinese team looked at their watches and started to wonder why they were having this meeting. After flying approximately 7,000 miles (and taking almost two days of travel) to get to this meeting (which had taken almost 6 months for the company’s Asia sales team to arrange) the meeting was almost over within 15 minutes. How does a smart person let that happen? Our executive (in this example) is a very smart man, and although he was right on the specific answer to their question, the way he responded was about to end the meeting.
Fortunately, someone on his Asian sales team quickly understood the gravity of the situation and asked the Chinese company “what are you trying to achieve?” When the Chinese company explained what it was that they were seeking to do with their future pipeline of products, the lightbulb went on for the smart engineering executive.
He then spent the next hour at the whiteboard, explaining brilliant ideas to achieve the vision.
With a little applied situational intelligence, the situation was turned from a losing outcome for both parties to a win-win scenario.
This is one of many examples we have experienced and we can share many more. As you go about your business, think about how often you and your team use situational intelligence without really thinking about it. If situational intelligence is considered and understood throughout your organization, then your company will have more long-term success.
Feel free to contact us if you would like to understand more about the appropriate skills required for situational intelligence in this interesting MedTech Global world. And, as always, we welcome any discussion on the topic.
About the authors: CEO Florence Joffroy-Black is a long-time medtech M&A and marketing expert. She can be reached at florencejblack@medworldadvisors.com. Managing Director Dave Sheppard is a former medical OEM Fortune 500 executive. He can be reached at davesheppard@medworldadvisors.com.
5 tips to EU MDR compliance
Features - MDR
European Medical Device Regulation (EU MDR) brings significant changes to the medical device industry, with new classification rules topping the list.
It is less than one year until the end of the European Medical Device Regulation’s (EU MDR) transition period – May 26, 2020 – and Class I manufacturers cannot afford to fall behind on compliance. Now is the time to act and comply with the new regulation to ensure proper certifications are issued to continue to sell products in the EU market.
Lack of urgency in complying with the new regulation may be due to manufacturers’ misperceptions, such as the assumption that only industry competitors manufacturing high-risk devices are required to conform with the EU MDR. Dispelling this myth could not be more crucial.
The new EU MDR brings significant changes to the medical device industry, with new classification rules being one of the most important. For Class I manufacturers to face the impending challenges, the following points help provide a clear pathway to compliance.
1.Take a close look
Publication of the MDR in 2017 opened a new chapter for manufacturers trading in the EU market. The MDR establishes that within the three-year transition period, all manufacturers will have to fall under one of three obligations to continue trading products in the EU. Manufacturers can re-certify under the Medical Devices Directive (MDD) or self-certify under the new requirements of the MDR, while manufacturers producing up-classified devices will need notified body review before the deadline. The first obligation states that if a product is recertified under the MDD (before May 25, 2020) manufacturers can take advantage of an extended transition period until May 2024. However, Class I devices have no EU certificate so there is no extended transition period and all new MDR requirements apply immediately on May 26, 2020.
Another change that Class I manufacturers need to consider is that regulations previously didn’t require a formal Quality Management System (QMS) under MDD, but starting on May 26, 2020, all manufacturers will require a formal QMS as per MDR Article 10, paragraph 9, best served by implementing EN ISO 13485:2016.
2. Self-certification: MDD vs MDR
MDD and the MDR present significant differences that Class I manufacturers should not overlook. Under the MDD, non-sterile Class I products without a measuring function can obtain CE-marking through self-certification in accordance with Annex VII.
Although Class I manufacturers can certify conformity of their own products through the EU declaration of conformity (MDR Article 19), they will still need to provide a comprehensive and detailed technical file. Self-certification conditions within the MDR are well defined; if the device doesn’t require a classification change and stays a Class I product, manufacturers can then continue to self-certify as long as they fulfill MDR requirements. The accuracy of their technical documentation must meet these requirements in time for the deadline, as well as self-declare the conformity of the devices with the requirements and register those details on the EUDAMED database.
3. New classifications, rules
The MDR increases classifications from 18 to 22 – new regulations establish new classifications – and includes important changes to current rules. Reusable surgical instruments are a prime example. Although they are already Class I and don’t require notified body review, they will fall under a new classification of Class I devices – Class Ir (reusable surgical instruments) – and this classification requires a notified body to look at cleaning, repackaging, and reprocessing elements.
To have a clear idea of where new classifications apply and how new conformity assessment routes are changing, manufacturers need to fully understand MDR Annex VIII. Devices that have been up classified to Class IIa or IIb, Class III, or any subsection of Class I, will have to seek notified body review for certification. It’s fundamental that Class I manufacturers don’t underestimate the required additional input, time, preparation, and resources required to demonstrate total EU MDR compliance.
4. Early notified body engagement
Be aware of the significant deficiency of notified bodies across Europe, causing a shortage of regulatory expertise. Manufacturers failing to act now risk not knowing if their device has been up classified, subsequently risking their notified body already operating at full capacity and unable to review their technical documentation in time for the deadline.
5. Clinical evidence
The EU MDR does not allow for grandfathering products. Even if a device has been on the market for two decades it requires a new CE mark to comply with the MDR. While manufacturers wait for notified bodies to be designated under the MDR, they should be working on sourcing the appropriate clinical evidence for their devices to be CE marked. If devices do not meet compliance standards by May 25, 2020, they will be removed from the market and manufacturers won’t be able to gather the appropriate clinical evidence the MDR requires.
Additionally, Class I manufacturers will need to draw up a formal Post Market Surveillance (PMS) report and include it in their QMS. Once the PMS has been put together it’s the manufacturer’s responsibility to keep it up to date with the latest clinical evidence. Acting now means that already available post-market clinical data can be used; moreover, a post-market study can be performed and submitted as clinical evidence within the technical documentation.
MDR compliance needs to be at the top of manufacturers’ priorities, otherwise they face being locked out of the EU market, risking cash-flow repercussions and business reputations. The clock is ticking and the advantages of early compliance to the EU MDR should not be underestimated by Class I manufacturers.
TFX front turning carbide inserts (wiper style available) with up to 0.197" depth of cut in a single pass, incorporate a special chip-breaker with sharp cutting edge for chip control and surface finishes. TFT series holders have rigid side screw clamping for stable turning, preventing insert movement from Z-directional cutting forces. Pair the TFX inserts with a coolant-through holder (TFT...-OH2) to improve chip evacuation, surface finish, part tolerance, and tool life. The -OH2 style holders are compatible with new coolant-through gangs (Citizen L20 & D25 CNC machines).
TFX inserts are available in DM4, for titanium, cobalt chrome, heat resistant alloys, stainless steels, and now in ST4, a super- tough PVD-coated carbide grade. The CrAlN coating provides high hardness and resists oxidation, solving issues related to machining materials such as 304SS, 17-4PH, and Nitinol.
The Kentucky-built VCN-570C various range spindle options, allows shops to balance speed and torque for machining needs and workpiece materials. A 1,659ipm traverse rate in the X-, Y-, and Z-axis also improves productivity. A servo-driven automatic tool changer can be combined with an optional 60-tool magazine to deliver more part-processing versatility through reduced tool setups and more spindle uptime.
ShopFloorConnect OEE and Shop Floor Data Collection software gather data from every machine in a manufacturing operation, displaying results in real-time for detailed overall equipment efficiency (OEE) reports in a variety of formats. Identifying and quantifying excessive production losses and bottlenecks can reduce machine downtime by 70%.
ShopFloorConnect Version 6.0 offers dashboard customization, flexible scheduling capabilities, and machine interface enhancements. Users can improve machine OEE by tracking reasons for scrap, and Version 6.0 allows users to manually enter good and bad part count data.
Posted by Elizabeth Engler Modic
