A broad range of connectors are available for medical, consumer, industrial, and Internet of Things (IoT) applications in which small size and high-reliability performance are critical.
A broad range of connectors are available for medical, consumer, industrial, and Internet of Things (IoT) applications in which small size and high-reliability performance are critical. Available as a physical sample and an interactive online simulation, the interconnect sample kit consists of a printed circuit board (PCB) loaded with 15 examples of board-to-board, wire-to-board, battery, and pogo pin connectors, including several of the STRIPT UL-approved, insulator-less single contacts.
The physical version of the sample kit features a white lid designed to simulate a replaceable or disposable module, so users can experience how AVX’s vertical-mate battery connectors eliminate angular insertion in pluggable module applications. Also with the lid, users can see how pogo pin contacts mate with modules in cradle and docking applications, where they can function as the charging, data transfer, or programming interface to a portable device.
The virtual interconnect sample kit allows users to navigate the board with their cursor, and provides brief descriptions of each connector category, summary information about each series, and links to each product page.
A digital health revolution is being fueled primarily by the growing use of wearables and consumer devices that gather health metrics. Connected medical devices are not far behind. We have already seen Bluetooth-connected glucose meters, blood pressure equipment, and scales. In the last year, several announcements along these lines have come from traditionally conservative big pharma providers in respiratory diseases. A sudden rush has most major pharmaceutical companies embarking on product development or trials with connected inhalers, racing to launch commercially. While this appears to be a surprise, a closer look indicates a natural evolution.
The healthcare industry is changing in the U.S. and elsewhere. Rising costs have forced governments to take action, payment systems are changing, and payers have increasingly started demanding evidence for therapy and medical procedures. As pressure mounts for the industry to demonstrate cost efficiency and outcome improvements, companies are turning to technology. Given that pharma producers typically take five-to-eight years to bring new inhalers to market, early exploration of new technology and connectivity solutions is required.
Home use medical devices – and to a large extent, clinical use devices – must be designed to accommodate or adapt to changing environments. Picking components and making technology choices for products that will only come to market three-to-five years later – or longer in the case of drugs – pose significant challenges. Where regulation is involved, keeping products relevant and minimizing chances of obsolescence are critical.
Finally, paths to market, target buyers, and revenue models for connected systems may not be the same as before. So, a strong, long-term strategy and solution roadmap should be put in place prior to making platform decisions or embarking on any design/development, and then revisited and updated often.
Identify the value proposition
A connected health solution may not be appropriate for every drug or for every medical device. Identify the right drug candidate or disease state to identify target users, and determine what value you can provide them via a connected health solution. If suitable value cannot be identified for at least two stakeholders within the ecosystem, it’s unlikely the solution will be commercially viable.
The path to revenue will dictate platform architecture, design, and required features. The business model must be constructed and validated early on, and key revenue-generating items must be identified to enable appropriate trade-offs to be made later. Connected systems lend themselves well to service-based revenue models, based on usage as well as analytics. So, the sources of revenue may be indirect and not strictly limited to device sales.
Design the experience
User engagement is governed to a large degree by the user experience and value delivered by the solution. Solutions that require regular interaction must fit seamlessly into people’s lives and should deliver something meaningful. Features in the device, app, or web service must follow a detailed mapping of the user journey with an understanding of what different stakeholders might want from the system. What works for one individual may not work for another.
With smartphones and apps, people have come to expect personalization with everything they use, including healthcare products. Connected health solutions must balance user-driven customization and a sufficiently standard out-of-the-box experience. Designers should consider the target audience, their skill level, dexterity, and tech savviness as well as the amount of time they are likely to spend customizing the device. For example, surgeons who are typically very busy are less likely to commit to designing their own dashboards, compared with family caregivers.
Behavioral economics can guide the design of an appropriate end-to-end solution. A blend of carrot-and-stick approach is known to work better than just the stick, and blatant reminders are less effective than gentle nudges in capturing users’ attention. Frequently evaluating human factors throughout the development process will help confirm that you are on the right track and can increase chances of successful adoption. Formative studies with interim versions of the intended solution can show how users relate to what you are building. Besides, a full human factors analysis for the end-to-end solution (including the app and perhaps even the back end) is required for FDA approval anyway.
Develop the technology
A connected system requires right platform and a robust, scalable architecture for it. Correctly partitioning functionality can simplify the regulatory process as well as future product iterations and upgrades. Make hardware choices considering the long approval cycle and time to market, and consider various strategies to reduce unnecessary churn, including planning for drop-in replacements and choosing reliable suppliers known for long-term support.
If connectivity is being added to an existing approved medical device, determine upfront whether the design will impose constraints that prevent accurate capture of signals or pose challenges for the electronics (and battery) for key features to deliver a good user experience. For handheld wireless devices, power budgets tend to minimize device size (batteries tend to dictate device size), so appropriate choice of technology, components, and low-power electronics design are critical.
A strong, long-term strategy and solution roadmap should be put in place prior to making platform decisions or embarking on any design/development, and then revisited and updated often.
Often, better power consumption can be achieved via smart software design. To ensure communications reliability, pay attention to the antenna design – invest in a custom antenna if size constraints prevent a standard antenna achieving desired performance. Test the performance of body-worn devices in realistic scenarios, not just in free space.
App architecture and design are key aspects of the system – ones that often pose problems because the smartphone platform is not under your control. The radio on a smartphone is controlled by the operating system, so you may not be able to control how it behaves with an app in the background or with other radios running. Especially in the case of iOS, be prepared to compensate for significant constraints.
Finally, request an opinion from regulatory bodies early in the development process on how they will regulate the app. Apps supporting connected drug delivery products are likely to be considered part of the combination product that require development process, verification, and validation.
Partnerships are likely for data infrastructure support. One key decision to be made is selecting between custom development versus an off-the-shelf solution for data handling and service infrastructure. There are pros and cons of both – the right choice for you will depend on your longer-term ambition. Make this decision early and ideally with the help of an independent, well-informed team. Picking the right partners who share your vision and are vested for the long term is key. Access and ownership of data often tends to be a sticking point.
Connected systems will continually evolve. Software and services will need to be iterated even if the device stays the same, so agree on a minimally viable solution, launch as quickly as possible, and learn from real-world experience. Clinical trials and pilots are controlled settings and will never provide real insights that can be gained from market launch, even on a limited scale. Technology will change sooner than you anticipate – plan for it and use it to your advantage.
Connected systems can add a lot of value, improve adherence to therapy, enable better chronic disease management, and improve long-term outcomes. But solutions need to be designed carefully, deployed smartly, and adopted by users and clinicians.
We are seeing signs that patient-generated data (PGD) will soon be accepted within mainstream care. The Office of the National Coordinator for Health Information Technology (ONC) contracted Accenture earlier this year to develop a framework for PGD in care delivery – one that will address issues around testing data reliability, authenticity, etc. Healthcare delivery as we’ve known it will soon change – and connected medical systems will have a big hand in this transformation.
About the author: Vaishali Kamat is the head of digital health at Cambridge Consultants where she focuses on product design and development for the digital side of health. She can be reached at cambridgeconsultants@marchcomms.com.
Speeding development of 3D printed manufacturing tools
Departments - 3D/Additive Manufacturing
The Manufacturing Aids Package for the Fortus 900mc production 3D printer supports custom tools on demand.
Custom 3D-printed jigs and fixtures show how additive manufacturing can augment conventional production environments. Stratasys’ Manufacturing Aids Package includes 40 hours of design work from Stratasys Professional Services to make producing a first tool easy.
To create strong, lightweight tools, the kit includes six canisters of thermoplastic build material and three canisters of support material. Build material includes Nylon 6 – Stratasys’ newest engineering-grade material – as well as PC and ASA plastic. ASA is available in a choice of 10 colors. Also included is Stratasys’ SR-35 advanced soluble support material that offers faster dissolve time and extended bath life compared to SR-30 soluble support material. Additional items include extra extrusion head tips, build sheets, and the option for Fortus 900mc owners to extend their factory warranty by two years. www.stratasys.com
Manufacturing and design technology
Departments - Cover Shots
Indexable milling grade for high temperature materials; Sliding/fixed headstock automatic lathe; GD&T evaluation software, version 4
Indexable milling grade for high temperature materials
Designed for use with titanium, WS40PM is also suitable for high-temp steel alloys, austenitic and PH stainless steels, and nickel-based super alloys such as Hastelloy and Nitronic.
Many of these materials cause tool failure due to built-up edge (BUE), notching at the depth of cut line, cratering, chipping, and extreme heat generation, which in the case of wet-cutting operations leads to cracking. WS40PM’s cobalt-rich substrate provides fatigue resistance and edge integrity, while the multiphase AlTiN-TiN PVD coating reduces wear.
The Traub TNL18 Swiss-style automatic lathes feature enhanced CNC control, axis amplifier, and more dynamic drives for improved accelerations and top speeds. An optimized drivetrain benefits all machines in the Traub sliding/fixed headstock automatic lathe range: the TNL18-7B with seven linear axes and the B-axis on the upper turret; the TNL1-9 with autonomous counter spindle and nine linear NC axes; and the Traub TNL18-9P, optimized for series production.
The machines’ mechanical construction effectively handles accelerations up to 25% faster than the previous TNL18. Better acceleration and optimized NC programs reduce machining times by up to 21% while delivering consistent quality workpieces.
i4.0 ready
The TX8i’s V7 control on the TNL18-7B dynamic and TNL18-9 dynamic offers enhanced performance with more powerful hardware. The TX8i-s V7 comes with features for programming, editing, simulating, setting up, and operating. Designed for Industry 4.0, the controls provide digital information and automation interfaces such as the industrial M2M communication protocol OPC UA to integrate machine into a corporate network.
Version 4 of SmartProfile, Kotem’s 3D geometric dimensioning and tolerancing (GD&T) analysis software provides fast, accurate analysis of measurements compared to a part’s CAD model and can be used to confirm GD&T compliance for shape, form, profile, orientation, and location on any rigid part. SmartProfile complies with current GD&T standards – ASME Y14.5-1994, ASME Y14.5-2009, and ISO 1101 – including multi-tier position and profile tolerances.
SmartProfile works with point cloud data from virtually all coordinate measuring software packages, allowing direct comparison of measurements made using differing techniques or at different points in the manufacturing process in one common format.
OSIC Carbone takes knowledge gained from robotically manufacturing one-of-a-kind orthoses and makes it available for turnkey medical product manufacturing.
It took Yann Paitel, founder of OSIC Carbone (Orthopedic Solutions, Innovative Concept) eight years to master a range of technologies and develop proprietary methodologies that allow the subsidiary of Orthopédie Bontoux to deliver customized foam orthoses to medical providers in just 12 hours. Now, he is promising to deliver these same capabilities to medical service providers and medical products manufacturers internationally in 10 weeks.
Founded in 2008 to explore new digital and robotics technologies that could be employed to reduce lead times and manufacturing costs, the parent company has produced orthotics using labor intensive, time consuming conventional carbon fiber composite manufacturing techniques.
That work led to strategic partnerships with technology providers which OSIC continues to leverage to extend its offerings. Among the most significant of these was the relationship it developed with Robotmaster and Mastercam software from CNC Software Inc., Tolland, Connecticut, to develop its proprietary robot controls and computer aided manufacturing (CAM) capabilities.
Robotic solution
The traditional approach to creating orthotic devices uses plaster strips to make a cast of the body regions and limbs under consideration. The cast is cut away and further refined using files and specialized manual tools. This physical model can then be measured and modeled digitally to create a computer-aided design (CAD) file that serves as the basis for machining the product or mold for making carbon fiber parts.
Paitel and his team developed a modeling solution that can capture a wide range of inputs – hand measurements, photos, X-ray images, body scans – and semi-automatically transform them into the model for an orthopedic appliance within the Solidworks CAD environment. Once this stage in the custom orthotic design workflow was proven, OSIC turned to its own manufacturing processes.
With complex, deeply recessed geometries and a wide range of sizes, Paitel chose a 6-axis, arm-style robot equipped with a milling head and a long cutter to manufacture the orthotic appliances. After studying the marketplace and several trials, OSIC selected Mastercam CAD/CAM software and Robotmaster. Mastercam can seamlessly import and work file types that surgeons and orthotists were likely to send OSIC for manufacturing their custom devices.
Optimized carving robots
Robotmaster quickly generates programs off-line, generating robot control code directly from Mastercam to produce robot trajectories accurately, without the need to teach points. OSIC has developed robot-control and CNC-cutting strategies that reduce programming time and one-off manufacturing cycles.
All parts are carved using a single long cutter, optimized to cut efficiently while reaching all areas of the part. Using-single tool means manufacturing cycles do not have to be interrupted for tool changes. Productivity is further improved by integrating robotic CNC machining programs with additional work stations, allowing a series of parts to be programmed, simulated, and posted to the robot for continuous single-setup manufacturing.
Paitel says, “The robot can carve the entire piece in one setup with three or four rotations around the part. Once it is finished, it moves directly to the new piece. This maximizes spindle uptime because there is no waiting for the next part to be set up. This utility also makes it possible for additional pieces to be carved with the robot unattended at the end of the workday.”
OSIC uses two robots for manufacturing orthotics from blocks of rigid or soft foam, up to 2m high. On a typical day, the company ships about 25 of these appliances to its customers on a 12-hour turnaround basis. Since robotic manufacturing was instituted in 2008, OSIC has produced approximately 2,000 custom orthotics each year. In eight years, more than 18,000 have been delivered to orthopedic service providers and their patients.
Further expansions
Paitel says that OSIC Carbone’s robotic processes give designers flexibility for creating geometrically complex orthotics that give patients greater support in places where it is most needed. The foam designs are more efficient to manufacture than carbon fiber devices.
To get to the point where his company can efficiently manufacture custom orthotics, Paitel has modeled the made-to-measure delivery process from start to finish and has introduced digital technology enhancements along the way. For the past three years, his company has been offering these technology modules as separate pieces to customers who would most benefit from them.
The company’s scanning solutions use software and hardware to automate the geometric data collection from the patient. A Solidworks interface automates the process of creating specific types of orthotic and prosthetic devices. Proprietary utilities within Mastercam and Robotmaster can automatically generate cutting programs based on the model.
Paitel says that OSIC Carbone is also engaged in a number of R&D projects that will further advance its orthotic and prosthetic manufacturing capabilities. These will also be offered to its customers once they become commercially viable.
