Design

3 Tips to Keep Your PCB Development on Schedule

“In order to improve your game, you must study the endgame before everything else. For whereas the endings can be studied and mastered by themselves, the middle game and opening must be studied in relation to the end game.” 

—Jose Raul Capablanca, chess master

There has always been pressure on design teams to deliver on schedule. Nothing is more frustrating than pushing your team to release the design on schedule and then to find out that your first prototype build will be delayed due to several common, avoidable errors.

Here are some tips to help manage risk and to avoid unnecessary delays:

TIP #1 – Select a Supplier Early

Engage your potential suppliers early before your design package is ready for a quote. Ask them explicitly what would help them deliver your PCBA on time. By interacting with them early, you’ll get a feel for the level of support you’ll get in the future.

Setup payment in advance

If the supplier offers credit terms, fill out the credit application in advance. Once you have approved credit with the supplier, it will provide the flexibility to make changes quickly without having to re-authorize subsequent credit card charges, provide additional cash deposits, or send multiple wire transfers. And, of course, make sure you pay your invoices on time to prevent delays on subsequent orders that are held up for delinquent payments.

Provide a preferred shipping carrier

If possible, set up your preferred carrier in the supplier’s system. Then there will be no delays waiting for shipping instructions. I know that this seems obvious, but double check that the billing and shipping addresses are entered correctly as well.

TIP #2 – Plan for Parts Management

Long Part Lead Times

During the design phase, it is important to browse online distributors and take a cursory look at the current stock and standard lead times, especially for single-sourced or unique parts. Begin securing parts as soon as the architecture is stable. Don’t wait until the BOM is finalized before ordering parts. Otherwise you may be in for an unpleasant surprise when parts that were available weeks ago will not be back in stock for several months.

Parts Procurement

Clearly, you will want to avoid paying for additional markup on parts if the supplier orders them, right? However, if you decide to manage the parts yourself, realize that you will be paying for shipping twice: once from the distributor and once to your supplier which may actually cost you more in shipping charges for low cost parts. Also, you’ll assume the handling liability if your supplier discovers problems during the incoming inspection and you will be responsible for handling any warranty claims with component vendors. However, most suppliers order parts daily from distributors so they are able to amortize shipping costs among multiple orders and they likely get better pricing than you can due to their order volume. IMHO, the best approach is to have your supplier secure parts so that the liability rests with them.

Permit substitution for common components

Large suppliers have an existing inventory of common parts, especially passives. If you permit them to substitute for common parts you will save additional costs and reduce the risk that your specified parts will delay your build.

Quote PCB fabrication early

Once the layout is mostly complete, prepare a design package for quoting purposes. This enables the PCB supplier to provide preliminary feedback on your the design. This may include highlighting missing information or identifying errors that would hold prevent the supplier from fabricating the PCB. The longer the turnaround time, the less expensive the PCB fabrication should be. If you can plan for a four-week turn PCB fab, you will get the best pricing possible. Also, components can be ordered concurrently so that all the material will arrive at the same time.

TIP #3 – Plan for Test

Except for the first pass PCBs, you will likely want some level of test for subsequent builds to ensure basic quality.

Provide a Basic Test Procedure

Yes, it will cost extra. BUT, how disappointing will it be when you discover that 6 out of 10 boards don’t work! Either you’ll have to debug them yourself or send them back for warranty. Most warranties are only going to cover workmanship defects anyways. However, if you provide a test, you provide the supplier an opportunity to detect defects and possibly rework the PCBs to correct the defects which will yield more working boards delivered to you.

Test Software

If your PCB design has programmable parts, create a basic test firmware image that can be programmed into the unit. The test software should provide a simple indication to the test technician that confirms that the device is operating properly.

Test Equipment

If your device requires specialized test equipment, check if your supplier can rent it for your project. You should only invest in more advanced test strategies such as flying probe, ICT/MDA, and JTAG boundary scan once your design is finalized. Otherwise, you’ll end up paying NREs multiple times which may hundreds or thousands of dollars.

Summary

Remember, that the first build of your design is just the initial step toward the goal of producing a cost-effective, reliable, and quality product.

Don’t be short-sighted and plan ahead for the end game.

IoT Hardware 101 – The Basics

Most of the IoT (“Internet-of-Things”) hype is about a futuristic vision that has billions of devices generating massive data streams that will be fed into advanced machine learning and AI (“Artificial Intelligence”) systems to create enormous business value. However, often overshadowed in these grandiose discussions is the IoT hardware which makes it all possible.

What is IoT?

IoT is a system of sensor devices, servers, and people connected via IP (“Internet Protocol”) networks. Sensor devices capture and process sensor data, transmit the sensor data to servers where the data is stored and processed in conjunction with other data, often historical data, from disparate sources to provide operational visibility and to generate novel insights that can be acted upon by people or by automated systems.

IoT is a paradigm shift away from vertically integrated, standalone monitoring and alarm systems that silo data and that can only provide pre-programmed reports and alerts. While these legacy systems are limited to either 1:1 (one-to-one) or 1:N (one-to-many) communication pathways, IoT systems enable M:N (many-to-many) communications pathways that allow developers to reconfigure existing systems to create new IoT applications that were not previously conceived.

Sensor devices are composed of four key elements: sensors, processors, network interfaces, and power sources.

Sensors

Without sensors, there is no IoT data.

At a basic level, all IoT sensors generate analog electrical signals that are proportional to a physical property. Then, these analog signals are converted to digital data using ADCs (“Analog-to-Digital Converter”).

Sensors can measure simple electrical properties such as voltage, current, resistance, capacitance, inductance, and impedance. They can also measure the strength and direction of electric and magnetic fields, especially changing ones, across the electromagnetic spectrum from radio waves to light to gamma rays.

For sensors that measure non-electrical properties, a transducer converts physical properties into analog electrical signals.

Common physical properties are:

• Spatial parameters such as acceleration, velocity/speed, vibration, and displacement/position/deflection.
• Environmental properties such as temperature and humidity.
• Fluid dynamics of liquids or gases such as sound, pressure, and flow rates.

Sensors may be passive or active. Active sensors emit radio, light, or sound waves into the environment and detect reflections using a receiver that processes them into measurements. Although passive sensors do not emit waves into the environment, this does not imply that passive sensors are unpowered. In fact, many passive sensors generate electric or magnetic fields and detect changes to these fields as a sensing mechanism.

Advanced digital sensors such a GPS, radars, chemical detectors, gyroscopes, or digital cameras use multiple analog sensing elements to take measurements. Then, sophisticated algorithms translate these raw measurements into useful sensor data.

Processors

Once the sensor data is captured it must be processed before transmitting the results to the cloud. The level of processing varies greatly depending upon the complexity of the sensor and the amount of data processing required to generate the resultant sensor data. A simple example is a temperature reading may be a single data value or an average of a set of values over time. A more complex example is a security camera that may not record digital video unless a scene detection algorithm flags an event.

Based on the complexity and processing power required there are four classes of processing platforms for IoT hardware: PC, mobile systems, microprocessor (MPU) based embedded systems, and microcontroller (MCU) based embedded systems.

  PCs Mobile Embedded MPUs Embedded MCU
Processor x86 (32/64) bit Varies (32/64 bit) Varies (32/64 bit) Varies (8/32 bit)
Clock Speed / Cores GHz / Multi-core GHz / Multi-core Varies MHz / Single-core
Memory DRAM (GB) DRAM (GB) DRAM (MB/GB) SRAM (kB/MB)
Storage HDD / SSD (TB) SSD / SD Card (GB) HDD/SSD (GB), Flash (MB), SD Card (GB) NOR/NAND Flash (kB/MB)
Peripheral Bus USB, PCIe USB-OTG USB, TWI, I2C, SPI, USART, Proprietary TWI, I2C, SPI, USART
Avg System Cost $100s to $3,000 $100 to $1,000 Varies $5-$50
Networking Ethernet, WiFi™, Bluetooth™ WiFi™, Bluetooth™, NFC Varies Proprietary RF or BLE™
Graphics Integrated Graphics or Graphics Card Integrated Graphics Varies Simple text or char display
Cooling Active (Fans) Passive Active or Passive Not usually  required
Power Line powered (desktop)

Rechargeable Li-Ion battery (laptop)

 Rechargeable Li-Ion battery Line powered Battery powered

PC Based Systems

The PC is the ultimately configurable platform that enables system integrators to create custom systems easily from inexpensive, widely available off-the-shelf motherboards, processors, memory, power supplies, and cases. Terabyte hard drives or SSDs (“Solid State Drive”) can provide large data storage capacities. Peripherals can be connected via modern standards-based USB (“Universal Serial Bus”) or PCIe (“Peripheral Component Interconnect Express”) buses, and there are still options to support legacy PC peripheral buses such as RS-232/RS-422/RS-485.

Furthermore, there are even expansion processor cards that include DSPs, FPGAs, GPUs, or high speed I/O to address the needs of specialized applications.

While PCs have an excellent price-to-performance ratio, they are based on consumer-grade technology which tends to have short life cycles and may not be suitable for applications outside of the office or home environments.

An alternative to PCs are SBCs (“Single Board Computer”) that are based on PC technology, but designed for embedded applications with robust, industrial components to provide reliable performance in harsh operating environments.

Because SBCs have higher grade components and the production volumes for SBCs are relatively low, they are more expensive than equivalent performance PC based hardware. However, they usually have long lifecycles that can span up to a decade

PC-based systems usually run Windows or Linux operating systems.

Mobile Systems

Mobile systems are a specialized subset of embedded systems that are optimized for tablets and smartphones which are battery-powered devices that require frequent charging. While these inherently personal devices provide high-performance processing capabilities, they also have advanced system power management capabilities that enable them to conserve energy which extends battery life.

Mobile systems typically have many integrated sensors including 1 or 2 digital cameras, a 3D accelerometer, a gyroscope, a touch sensor, a barometer, a proximity sensor, a magnetometer (compass), an ambient light sensor, and a GPS receiver.

Unfortunately, mobile systems have very limited expansion capabilities.

While Android-based systems may allow expansion through USB OTG (“On-The-Go”) devices, Apple based systems only permit approved 3rd party devices through the MFI (“Made-for-iPod”) licensing program.

Mobile systems have a relatively expensive price-to-performance ratio. They are personal devices based on consumer-grade technology with short lifecycles. They are limited to operation in indoor or mild outdoor environments, and they are also relatively fragile and susceptible to drop damage unless enclosed in a 3rd party ruggedized case.

Although there are a few other options, Google’s Android and Apple’s iOS are the most dominant software environments for mobile systems.

Microprocessor (MPU) Based Embedded Systems

MPU based embedded systems provide the widest possible range of performance and capability options that are optimized to address specific product requirements for consumer electronics, industrial controls, medical devices, automotive controls, communication systems, or other vertical market applications.

They are usually based on application specific ICs (“Integrated Circuits”) such as SoCs (“System-on-Chip”) or SIPs (“System-in-Package”) that have integrated chip-level cores that simplify the design effort and provide cost-optimized solutions for specific product niches.

MPU’s typically run general purpose, multi-tasking operating systems or RTOSs (“Real-Time Operating System”) that provide deterministic responses for control-based applications.

While most embedded systems are fully custom designed, some SoCs are available in SOM (“System-on-Module”) form factors with standardized mating connectors. SOMs enable developers to avoid the difficult and time-consuming work to design a custom embedded system from scratch. Instead, the designers can focus on designing carrier PCBs and on developing software to customize their product.

MPU based embedded systems can run Linux or a variety of other commercial RTOSs (“Real-Time Operating System”).

Microcontroller (MCU) Based Embedded Systems

MCU based embedded systems provide very low-cost solutions for applications with limited processing requirements.

However, some advanced microcontrollers embed specialized hardware modules to accelerate image processing or security functions such as cryptographic acceleration for public/private key exchange, hashing, and TRNG (“True Random Number Generation”).

MCU based systems can be very power efficient because they have fine-grained power control of the processor, peripherals, and clocks. With power optimized internal or external wake-up sources, it is possible to create very low power products that can last for many years without requiring a battery charge.

System software may be a simple run-loop plus interrupt handler or it may run a small footprint RTOS.

Network Interface

While some IoT hardware connects via physical networks such as Ethernet, it is much more common to connect to the Internet via wireless networks such as Wi-Fi™ or cellular.

Power vs Range vs Data Rate

The classic design tradeoffs for wireless communication systems are low power, long distance, or high data rate. (Pick two!)

Network Type Range Power Data Rate Licensed Frequencies
Wi-Fi™ (802.11a/b/g/n/ac/ax) Medium High High No 2.4/5 GHz
White-Fi / Super Wi-Fi (802.11af) Long Medium Medium No 54-698 MHz
HaLow (802.11ah) Long Medium Medium No 915 MHz
Bluetooth™ Short Medium Medium No 2.4 GHz
Bluetooth™ Low Energy (BLE) Short Low Low to Medium No 2.4 GHz
802.15.4 / ZigBee™ Medium Low Low No 2.4 GHz
Proprietary RF Varies Varies Varies No 868/915 MHz
LPWAN – SigFox™ Long Very Low Very Low No 868/915 MHz
LPWAN – LoRA™/Symphony Very Long Very Low Low No 433/868/915 MHz
LPWAN – Ingenu Medium to Long Low Low No 2.4 GHz
LPWAN – Weightless Long Low to Medium Low to Medium No 470-790 MHz
Cellular – 2G, 3G, 4G, 5G Long High High Yes 3GPP Regional Bands
Cellular – CAT-1M Long Low Low Yes 3GPP Regional Bands
Cellular – NB-IoT Long Very Low Very Low Yes 3GPP Regional Bands

 Licensed vs Unlicensed Bands

Governmental authorities regulate access to the electromagnetic spectrum. They may grant licenses to people or entities to operate wireless transmitters within a specified frequency band at a maximum power level within a certain geographic region.

Often a wireless network services provider that holds an exclusive frequency license, such as a cellular service provider, will provide access to its network to other users for a fee. In this case, the service provider is responsible for the operation and maintenance of the wireless network.

Access to certain frequency bands is available to users without a license if they use an approved wireless communication system that complies with the regulations necessary for unlicensed operation. These wireless communication systems must have intelligent coexistence mechanisms such as carrier sensing or frequency agility to compensate for in-band interference from other systems that operate concurrently within the same unlicensed bands.

Unlicensed networks, such as Wi-Fi™ networks, are usually operated and maintained by users at their own cost.

Power Source

The simplest power solution for IoT hardware is to use line power from the electric power grid.

However, many emerging IoT applications cannot use line power because it is not readily accessible in the deployment area and it would be prohibitively difficult or expensive to run additional power lines.

Energy Harvesting

For IoT hardware with low power requirements, novel energy harvesting technologies such as piezo-based vibrational, thermopiles, and hydrodynamic or wind turbines can be viable, but solar panels are still the most popular choice. Although it is technically possible to power IoT hardware directly from these energy sources, a better option is to store the energy for later use.

Energy Storage

While esoteric energy storage systems continue to evolve such as banks of supercapacitors or fuel cells, old, but reliable battery technologies are still the most popular energy storage choice for off-grid IoT hardware.

With a variety of chemistries and construction types, batteries offer a broad range of options for package sizes, energy capacities, voltage ranges, and current delivery capabilities. Some even offer specialized features that minimize self-discharge, support high pulse currents, operate at extreme temperatures or provide extended lifecycles of up to a decade or more.

Summary

As you can see, there are a plethora of sensor, processing, networking, and power supply technologies available to create IoT hardware to meet the technical performance requirements for applications in the healthcare, transportation, industrial, automotive, smart cities, and other niche IoT market segments.

The key is to combine the appropriate technologies that meet the essential technical performance requirements while satisfying the necessary business constraints to create a viable IoT solution.

6 Reasons to Use a Design and Manufacturing Services Partner

So you’ve finally decided to explore using an electronic design and manufacturing services partner to develop and build your product.

There are many reasons why this makes sense, but obviously, your product design will benefit from a manufacturing perspective during the design process.

1.  TECHNICAL EXPERTISE AND EXPERIENCE

Certainly the electronic design & manufacturing firm should have the requisite technical design and manufacturing experience to develop and build your product.

Although engineering discipline expertise such as electrical, mechanical, or software is important, it is not sufficient.

Relevant industry experience is vital, particularly for those products that require specific domain knowledge such as defense, aerospace, communications, or medical. Many of these products may have to meet stringent performance standards in harsh environments or they may have onerous regulatory or critical safety requirements.

Depending on your product’s complexity, the development process may require specialized instrumentation, software, simulation tools, or test and measurement equipment; the electronics design and manufacturing provider’s personnel should have the necessary experience. If not, you will be paying them to learn which is neither ideal nor cost-effective.

Some products may require dedicated facilities such as clean rooms for optical and medical devices or anechoic chambers for sophisticated RF systems. While it may be beneficial if the electronics design & manufacturing company has these facilities in-house, you may also be paying more to cover the additional overhead for these facilities instead of paying one-time fees at a local test lab.

If your product will have complex assemblies like those in electro-mechanical or robotic products, the electronic design and manufacturing firm’s assembly and test experience is essential to help you avoid quality issues, inflated costs, and unanticipated schedule delays during the introduction to the manufacturing process.

2.  MANUFACTURING MINDSET

Feedback during the design phase from the manufacturing team members in sourcing, supply chain, and test engineering reduces the risk of unanticipated issues and increases the likelihood of a seamless design transfer to manufacturing.

SOURCING & SUPPLY CHAIN

Because the BOM (“Bill-of-Material”) cost is usually a significant portion of the total product cost, the electronic design and manufacturing provider’s capabilities to effectively reduce these costs should be an important selection criterion.

Since electronic design & manufacturing companies purchase significant quantities of components and material from their suppliers daily, they have the flexibility to aggregate orders from all of their customers to obtain volume discounts and preferred pricing.

Furthermore, large electronics design and manufacturing firms have access to substantial financial credit facilities that enable them to purchase bulk quantities of parts and materials at best possible terms.

The firm’s design team should leverage this sourcing power to select optimal components for your product design based not only on cost, but also based on availability, lifecycle, and lead times.

TEST CONSIDERATIONS

Often product design teams do not develop production test plans until after the product design is already completed. However, a savvy electronics design and manufacturing provider will ensure that a comprehensive test strategy is developed concurrently with the product design. This approach results in a cost-effective test process with the best possible test coverage which greatly reduces the risk of uncovering issues during test process validation before the product is introduced to manufacturing.

3.  3RD PARTY SUPPLIERS

If the electronics design & manufacturing firm will be using 3rd party resources to design your product such as on-site contractors, remote developers, or external suppliers, there are several things to consider.

First, you should ensure that electronic design and manufacturing partner has substantially equivalent confidentiality agreements with its suppliers to protect your information.

Second, the more suppliers that your electronic design & manufacturing partner uses, the greater the risk of miscommunication among your partner, its suppliers, and you.

Third, assuming that the electronics design and manufacturing company selects its own suppliers, it should be solely responsible for their performance. This includes managing them, ensuring the quality of their work, and paying them. And, you should never be involved in any disputes between the company and its suppliers.

Ideally, choose an electronics design & manufacturing partner that can develop your product with the fewest 3rd party resources.

4.  LOCATION, LOCATION, LOCATION

Even though it is much easier today than in the past to do business internationally as well as virtually, the location of the electronic design and manufacturing firm is still an important consideration.

The smaller the geographic range you’re willing to consider, the fewer choices there will be. However, the further away from the electronic design and manufacturing company is from you, the greater the opportunity for potential problems to arise.

WHAT TIME IS IT OVER THERE?

It is unlikely that you will have any communication issues working with a local supplier since you are typically working the same business hours.

Even a couple of time zones difference is usually not a problem.

But as the distance to the electronics design and manufacturing provider increases, the window for daily communication narrows. For example, a provider that is located in a time zone that is 5 or 6 hours ahead or one that is halfway around the world will likely require you to attend early morning or late evening calls.

This situation hinders timely communication between teams that will inevitably contribute to a longer than expected development cycle since issues can’t be discussed until the end of one team’s day and the beginning of the other team’s day.

TRAVEL

Ideally, it would be great to have a local electronic design and manufacturing firm that was only a short car ride away. But, in most cases, this would greatly limit your options.

It’s worthwhile to estimate the anticipated travel costs in advance if you believe that you will need to make many trips to the electronic design and manufacturing company’s location during the product design and manufacturing phase.

If you choose a domestic electronic design & manufacturing company, your travel costs are limited to airfare, ground transportation, meals, and hotels. It’s fairly straightforward to control these costs using online booking services even when booked on relatively short notice.

However, if you choose a foreign electronics design and manufacturing provider, travel costs will likely be higher than for domestic travel. Additionally, intercontinental travel will exponentially increase your travel costs as well as the time investment required per trip.

Furthermore, you and your team members will need to have passports and possibly need to obtain visas. This situation can be further complicated if some members of your team are not citizens such as those with temporary visas, work permits, or permanent resident alien cards.

A final consideration is that unless the electronics design & manufacturing firm is local, it will likely to bill you for travel costs for its product design team members to travel to your location, especially if it requires them to stay overnight.

SHIPPING

While domestic shipping is relatively cost efficient if you can avoid overnight shipping, the cost of international shipping can vary widely based on the destinations, weight, and class of service.

If the package’s size and weight is relatively small, international air shipping can be a reasonable option. But, if the package’s size and weight is substantial, air freight can be prohibitively expensive. While ground or boat shipment will be more cost effective, you will have to plan for longer shipping times.

It is worth noting that incorrectly filled out customs forms may cause delays and unanticipated tariffs or duties can also substantially increase the effective international shipping costs.

Always ensure that the electronic design and manufacturing provider has experience managing international shipping to your location. Otherwise, you risk delays and unplanned costs.

LEGAL CONSIDERATIONS

If the electronic design & manufacturing company is organized in a foreign country, you may not have the same legal protections as you would domestically for contracts, warranties, liability, or intellectually property.

Even if the electronics design and manufacturing firm has a domestic subsidiary you may still be at risk. If the contractual liability resides with the domestic entity, you may have limited legal recourse when an issue arises if the domestic subsidiary doesn’t have the necessary assets or the appropriate and adequate insurance coverage to cover it.

Also, beware of a domestic electronics design & manufacturing provider who offers a “partnership” with an international supplier. These relationships are almost always just informal business agreements to cooperate without any mutual contractual obligations. So when business goes badly, neither party will take responsibility for the problems leaving you to sort them out for yourself.

The best advice if you’re considering an international electronic design and manufacturing company is to consult with a qualified attorney who has the necessary background and experience in international trade and intellectual property protection.

5.  COMPANY STABILITY

Potential customers often ask how long an electronic design & manufacturing firm has been in business. But, in the current business environment, longevity can no longer be a barometer for company stability.

FINANCIAL STRENGTH

Although often overlooked by potential customers, an electronics design and manufacturing provider’s financial condition is a critical factor to consider before committing your business.

If your electronics design & manufacturing partner is not financially strong, the negative impacts can be subtle such as shipping delays due to outstanding past due invoices from a key supplier, credit constraints based on banking covenants, or key personnel leaving, voluntarily or involuntarily, because of payroll cash flow issues.

You can be assured that a fiscally disciplined electronic design and manufacturing company will do some level of financial qualification on you as a new customer, especially if it will be offering you payment terms. You would be wise to do the same.

PERSONNEL TURNOVER

A key reason to select an electronic design & manufacturing firm is that you have access to a seasoned design team that has worked together for many years.

The stability of the design team is critical to the efficient development of your product. If there are many new people and the electronics design and manufacturing provider is not growing its business, this may be an indicator of a high rate of personnel turnover. However, if there are few new people, this may be a strong indication that you are working with a provider whose business is either stagnant or worse, contracting.

Neither extreme is an encouraging sign that your electronics design & manufacturing partner is stable. Search for a partner that has many long-term team members mixed with some new ones.

6.  INTELLECTUAL PROPERTY

Wouldn’t it be great if you could find an electronic design and manufacturing company that had previously designed a similar product?

While at first, this might seem appealing, there are two concerns that should be addressed.

First, you risk one-track thinking by the electronic design & manufacturing firm’s design team that will highly leverage a previous design to reduce the amount of development time and work. Although this approach may reduce development costs and time, it may result in your product design being only slightly adapted for your requirements instead of being optimized for them.

Second, depending on the agreement under which the previous product was developed, there may be IP (“Intellectual Property”) entanglements including joint ownership, 3rd party licensing terms, and other business restrictions that could potentially limit your future product plans.  Additionally, there is a risk of unintentional infringement unless the firm has well-defined processes in place to ensure that people and documentation are segregated among the competitors’ projects.

Lastly, you need an electronics design and manufacturing partner who is trustworthy, who will honor confidentially agreements, and who will not share your product design details with any 3rd parties.

FINAL THOUGHTS

While the list of considerations stated above is not exhaustive, it will help you evaluate potential electronics design & manufacturing companies based not only on their stated capabilities but also based on key attributes that could impact their ability to successfully design and build your product.

Always remember that working with a good electronic design and manufacturing partner should free up your time and resources to allow you focus on core business processes to grow your business

Explore North America’s Largest Annual Medtech Event

What are you doing February 6-8, 2018? How about coming by to visit with people from Creation Technologies manufacturing and design teams at Booth 546 at Medical Design & Manufacturing (MD&M) West ?

It’s going to be quite an event this year, and we’re really looking forward to reconnecting with industry friends as well as meeting new people. MD&M West is always a great place to solve existing challenges and be inspired by everything new in the MedTech industry.

At MD&M West you’ll find the largest showcase of MedTech suppliers in the country, plus a full spectrum of solutions across the advanced design and manufacturing supply chain. Whether you’re interested in product design, new materials, intelligent sensors, testing solutions, components, packaging, or anything else needed to bring your concept to market, you can source from more than 2,000 cutting-edge suppliers in a time-saving format. Free presentations, interactive events, and fun activities throughout the expo make this a can’t-miss event.

Featuring its biggest program yet, the MD&M West conference will deliver four tracks of expert-led MedTech education you won’t find anywhere else — plus additional smart manufacturing and 3D printing programs — all with unlimited track hopping.   This year MD&M offers a full day of conferences focused on Medical Device Security.  This rigorous conference program will address security and privacy challenges for connected healthcare devices.

This is your chance to get up to speed with the strategies and techniques that turn concepts into competitive products. Curated with the help of an expert advisory team, this unmatched program is made by the industry for the industry and packed with information crucial to every stage in the development process.

Learn about Creation Technologies’ flexible model, integrated solutions and dedicated Customer-Focused Teams and how we offer a complete customized solution that delivers what our customers need…their way. Creation’s experience and robust systems help OEMs avoid costly surprises, get to market faster and scalability to achieve your business goals.

We would love to meet you and learn more about how we can help you meet your future goals. Drop by Booth #546 and learn how we do it.

You can use our Promo Code:  Special when registering and receive a free Expo Pass or 20% off Conference Pricing

Hope to see you there!

 

How a VAVE Risk Mitigation Strategy Improves the Bottom Line

A VAVE analysis is considered a game changer to OEMs because of its potential for major cost reductions.

VAVE is not about a quick fix to cut expenses. Good EMS providers can leverage VAVE to improve product quality and lower lifecycle risk. This focus on risk mitigation will translate into long-term savings and greater revenue opportunities for OEMs.

Here are the ways VAVE teams are achieving this.

Entering the Market with Confidence

Being first to market is important, but it is ineffective if you are not priced appropriately. An OEM may have a great product but will fail in the market because of its high unit cost.

If a VAVE analysis is performed during the prototype phase, you will get expert opinions from your EMS partner on pricing strategies. Early supplier and engineering engagement, before the design is finalized, will ensure there is feedback and approval from all stakeholders.

Putting that upfront investment in VAVE will drive the unit cost down and allow you to enter the market at the right price point. You have an opportunity to capture a competitive market share and maximize revenue potential.

Extending your Life Cycle

A thorough EMS partner will put a large emphasis on quality and risk management when conducting a VAVE analysis. They will make sure that the product and all of its components will last the entire product lifecycle. This is usually done during the risk analysis phase, where your partner evaluates your bill of materials (BOM) and identifies areas of improvement to reduce risk within the product lifecycle.

Making sure that the product BOM has longevity will avoid redesign costs in the midst of the products life.

Part of their task is to get as many approved sources in the design as possible (more on that later) so that if one or two sources become obsolete in a few years, you still have a supply chain that won’t cause you shortages.

Experts in the Supply Chain

Mitigating risk is all about being able to foresee barriers and having a contingency plan to address them without missing a beat. OEMs that aren’t prepared will not be able to react quickly if a major quality issue arises.

Almost 93% of critical shortages where delivery is effected is attributed to OEMs single sourcing their components. That means there are other supply chain options available that haven’t been vetted or approved. When your customer wants an extra 10,000 units, a single sourced component on your BOM can cause you to lose revenue if the supply chain can’t react in time.

We often see in startups or smaller companies, a design engineer is simply not looking for multiple component sources under the pressures of a launch schedule. If they are looking, they may not have the supply chain relationships to identify the lowest cost options.

A capable EMS partner can help you design a sustainable supply chain. They can lessen your risk during a VAVE analysis by identifying and qualifying a second or third source for components, so if there are quality issues, you have the flexibility to adapt.

The BOM might start off with 80-90% single sources, but can drop to 20% single sourced after a successful VAVE analysis. This will not only improve the products longevity, but will eliminate unnecessary long-term costs.

 

 

Tips for Engineers to Avoid Hidden Development Costs and Delays

I have yet to meet an engineer who enjoys seeing costs pile up during the design and development process.

And unexpected costs are definitely unwelcome visitors in the drive for product commercialization.

If you’d like some new, actionable ideas for getting a new product to market quickly and without those unexpected, expensive guests, here’s a suggestion for you…

Attend ‘How to Avoid Hidden Costs and Delays in the Product Design-to-Commercialization Cycle’ next week at PCB West in Santa Clara.

How to Avoid Hidden Costs and Delays in the Product Design-to-Commercialization Cycle: Creation Technologies Technical Workshop at PCB West

In this two-hour, technical workshop, Todd Dierking, Creation’s Director of Design Services and Todd Baggett, Creation’s EVP of Integrated Services, will share their engineering and component expertise to help you:

  • Get the right tradeoffs between Time and Money
  • Assess and define requirements to meet design controls, minimize costs, and still bring your creativity to the project
  • Simplify the prototyping process with some cost-effective technical techniques, as well as a checklist for commercial considerations that will help you make the best choice for each stage of prototyping
  • Uncover the ‘hidden costs’ of designing in the wrong materials

While you’re there, drop by Booth #216 and meet a team from Creation–San Jose, our rapid prototyping/manufacturing facility that’s about 10 minutes from the Santa Clara Convention Center.

Hope we’ll see you there!

More information here in our recent press release.

3 Questions Medical Device OEMs (Should) Have for New Contract Design and Manufacturing Partners

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Today, it’s more common than ever for medical device OEMs to outsource significant portions of their design and manufacturing. The medical industry’s many regulations make this process especially complex.

As Director of Regulatory & Quality for Creation Design Services, I’m often asked about our capabilities across the product life cycle from design through after-market support. Here are a few questions I hear often.

 

1. Do You Have Proven Medical Experience?

The bottom line is, medical device OEMs want a partner with experience – especially regulatory experience.

Off the bat, they are probably going to ask about our FDA-registered product portfolio. They want to see that we have experience working with other companies in the industry.  Much of this information is actually public knowledge that can be found on the FDA website.

Medical OEMs are also looking for regulatory expertise that spans the entire product lifecycle – a partner that can take a drawing on a napkin and see it through to manufacturing transfer, all while meeting FDA requirements. That positions them for a successful 510K or PMA submission experience.

 

 2. Can You Provide Manufacturing AND Design Services?

Creation’s customers today want a full turnkey solution. They are looking for support from the minute they walk in the door with an idea, through the shipment of their first manufacturing pallet, to sustaining engineering at a product’s end-of-life.

Why?

  • Flexibility

A design partner offers medical device OEMs an immediate, expert way to supplement their product development teams.

This could mean adding capacity in existing areas to meet time and cost targets.  This could also mean adding functional expertise in product development, test fixture design, test engineering, component obsolescence redesign, value engineering, etc.

  • No Nasty Regulatory or Quality Surprises

Experienced design engineers who understand the regulatory documentation and submission process help make the transition into manufacturing seamless.

Experienced manufacturing teams who understand the regulatory requirements in a volume production environment help keep auditors and end customers satisfied and safe.

When both the design and manufacturing teams are working cohesively and have a standardized process, any issues can be easily and proactively identified, communicated and solved.

  •  Saving Time and Money

An integrated design and manufacturing team streamlines the New Product Introduction process and ensures consistency from cradle to grave.  From accelerated speed-to-market to higher-quality products, this saves medical OEMs both time and money.

 

3. Can You Support My Product Once in the Field?

Attention to a product shouldn’t end when the device leaves the manufacturing floor. Every medical OEM should target EMS providers that offer after-market services like firmware upgrades, repairs, routine calibration and service.

After all in the medical industry, an OEM can’t tell their customer, “Just put it in a box and send it back to us.”

From a regulatory standpoint, the product needs to go back through a formal process. All modifications must be documented in the DHR – Device History Record – and the provider must be able to provide a detailed record of those changes that are traceable, by serial number, back to that device.

After-market and end-of-life support processes must also take health and safety into account. For example, repair or calibration procedures may need to include decontamination or similar elimination of risk – both to the provider’s employees as well as to the ultimate end user.

At the end of the day, medical device OEMs can trust their outsourcing only to an experienced EMS provider that understands the product life cycle requirements of this highly regulated environment. Questions like these help companies qualify new outsourcing partners. 

Lucky for me that in my role at Creation, I get to say ‘Yes’ to all three.

 

To learn more about Creation Technologies, be sure to attend “Getting More Bang for Your Buck: Innovating within Cost Constraints” , at BIOMEDevice in Boston, MA on April 14, 2016.

 

Beyond Design and NPI: Lifecycle Visibility Yields Cost-Savings for Medical Device OEMs

Stethoscope Laying on Stacks of Hundred Dollar Bills with Narrow Depth of Field.

In the medical device industry, there can sometimes be a disconnect in both the priorities and collaborative communication between design engineering and manufacturing operations teams.

This disconnect can be significant to a medical device OEM’s bottom line, especially when time to market is delayed and unnecessary supply chain costs accumulate quickly.

I’ve been fortunate enough to work in both the product design and electronics manufacturing world. I recently had the chance to speak with Editor in Chief of PlasticsToday, Norbert Sparrow, about medical device design strategies that I’ve seen make things much easier for development and commercialization teams, including:

  • Front-loading design work through ‘hobbyist’ platforms
  • Having a structured process in place when working with regulated industries
  • Gaining a thorough understanding of the manufacturing process including supply chain

I’ll be talking more about this at the BIOMEDevice exhibition and conference in Boston on April 14th.

I’d love to hear your ideas to make the commercialization process easier for all involved, and hope to see you there!

 

Read the full PlasticsToday Article

 

3 Areas for Improvement in the Medical Device Industry in 2016

smart medical doctor hand drawing network with operating room as concept

These are exciting times to work in healthcare. With advancements in research and innovation, the medical device industry continues to push the envelope, saving lives and improving the quality of living for people across the globe.

But even with all of the game-changing products that have been recently introduced such as LifeWatch’s Mobile Cardiac Telemetry (MCT) patch, or Medtronic’s new superDimension lung navigation software, there are still many barriers and process inefficiencies that are detrimental to innovation.

As Director of Regulatory & Quality for Creation Design Services, I see both the technical and business challenges of taking new medical products to market every day. As we begin the new year, I’d like to share my view of three ways we can do better.

 

1. Address the High Cost of Regulatory Requirements

Whether we’re talking about medical devices, pharmaceuticals, or veterinary medicine, medical companies are constantly challenged to keep up with the never-ending changes to regulatory requirements. As a quality and regulatory professional, I am constantly thinking about these changes and their impact.

For example, there are costs associated with allocating resources and time to understand any new legislation and standards.

There are costs associated with acquiring new certifications themselves, not to mention all of the preparation, due diligence and training that must come first.

There are costs associated with providing ongoing training for your people.

Depending on the number and type of products produced, and the number of people you employ, these costs are not trivial and can run into the millions.

And passing these costs onto the consumer, or worse, the costs of non-compliance, may take you right out of competition.

How would costs of compliance be altered if softcopy standards were public domain? Or if “eLearning” were entirely non-profit?

 

2. Reduce Lengthy Delays in FDA Premarket Notification / Premarket Approval

There are substantial delays in the process of marketing a medical product in the United States from FDA submission to approval. A device with a predicate, for instance, can take 180 days for the FDA to grant clearance to market. Class 3 devices requiring premarket approval can take even longer.

These delays can result in loss of potential revenue, leading to increased unit costs because of amortization.

And what about the loss of potential benefit to society?

Because of these costs and delays, some innovative products never get to market.  Both startups and Fortune 500s alike elect not to pursue some concepts because of this barrier to market entry.

What would happen if the FDA hired more submission reviewers?  Or if the FDA addressed existing internal administrative hurdles?

 

3. Simplify Complex and Fragmented Global Legislation

There are many quality and regulatory legislative requirements around the globe. Some of these are region-specific.  Some are industry- or product-specific.

As much as the International Organization for Standardization (ISO) advocates a homogeneous approach to regulatory requirements, this harmonization is not yet a reality.

For example, the FDA 21CFR820 regulation versus the ISO 13485 standard. These two requirements are very similar, however will most likely never merge. For those wishing to market in Japan on the other hand, the requirements of the Pharmaceutical and Medical Device Law (PMDL) must be independently met.

Comprehending, executing and sustaining the in-depth requirements of multiple standards is a constant burden.

If a globally harmonized standard existed, how else could these time and resources be spent?

 

Looking Forward in 2016

In conclusion, can the industry be more Lean, while still maintaining public safety and integrity?

How can we apply the Theory of Constraints to the industry as a whole?

Without a doubt, the medical device industry matures each year and while I look forward to the advancements in 2016, there is always room for improvement. Imagine if companies did not have to worry so much about barriers, but rather, focus more time into innovation and collaboration. The possibilities could be limitless.

What are your biggest Medical design and manufacturing headaches?  Drop by our Booth #571 at MD&M West in Anaheim, CA on February 9-11

 

 

Speed and the Bottom Line: Rapid Prototyping is a Fiscal Game Changer

Breadboard and Jumper Cable Wires close up on white background

We have all heard the buzz around 3D printing as a tool for prototyping and low-volume manufacturing. As 3D printing technology progresses and becomes more accessible, demand is expected to jump from $1.3 billion in 2012 to $5.2 billion in 2020.

Being new to Creation Technologies – and the electronics manufacturing industry – I assumed that when our OEM customers mentioned “rapid prototyping”, they meant 3D printing. This isn’t the case.

In our industry, Rapid Prototyping refers to an accelerated product development model, and most of the time it’s done without a 3D printer.

So What is Rapid Prototyping?

Rapid Prototyping is designed to get new products out to market in the quickest and most efficient manner. Companies that offer Rapid Prototyping services, find ways to significantly condense the new product development cycle, through either technology or in-house expertise.

OEMs in the electronics manufacturing industry are typically looking for experienced companies that can assist them with product documentation, complete test strategies, supply chain demand, and DFX services.

When done right, rapid prototyping can increase an OEM’s top-line revenue and extend their product lifecycles by ensuring that their product features at launch are actually the features their customers need.

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Get to Market Faster

“If you are not first you are last.”

This is the reality when it comes to new product introduction. With ramped up competition and technology advancing daily, businesses – both startups and established – need to get their new products to market quicker, smarter and as cost efficiently as possible.

Making good decisions early can create the competitive advantage companies need to maximize revenue opportunities. Rapid prototyping can help.

Look at a company like Xerox. Last year, with printer sales declining, the company adopted a rapid prototyping approach to streamline their production cycle for their value-added services.

Xerox focused on smaller, more customized projects so that they could give (and get) instant feedback early in the process. With the help of this rapid feedback loop, products like the Digital Nurse Assistant were commercialized several months quicker than it would had Xerox opted for a more traditional approach.

Million-Dollar Errors in New Product Development

Regardless of whether they build in-house or outsource, OEMs need to maneuver through industry requirements, eliminate costly design mistakes, and ensure quality early in the process.

Rapid prototyping is a smart option for OEMs looking to do this quickly, especially if they leverage a partner that is rich in end-to-end expertise. (Did I mention that Creation Technologies specializes in end-to-end solutions for OEMs?)

In many situations, prototyping and manufacturing are done in isolation. Not only are opportunities for improvement overlooked, critical information often gets misinterpreted in the process, adding unnecessary costs and time onto the development process.

Creation Technologies’ Business Development Director for Creation Express Services, Michelle Angel, has worked with product innovators in the Bay Area for two decades. Today, she’s focused on creating high-impact solutions for Creation’s rapid prototyping customers. Michelle told me that if a mistake is not identified or fixed at the prototyping stage and moves into production, the simple error could cost a customer hundreds of thousands, maybe even millions of dollars.

Are you making million-dollar errors in a time where every competitive advantage matters?

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