Leveraging DfX To Eliminate Mistakes In Your Product Development
Your guide to strengthen your approach
Chapters
DfX carries a lot of different meanings, and while many recognize the term, few understand the purpose or how to “leverage it effectively.” We have created this guide to help define the critical stages of the product development process to ensure you make the smartest decisions along the way.
Chapter 1: How to leverage DfX for successful product design
While far more than just trendy jargon, “Design for Excellence” (DfX) fulfills two common buzzword criteria:
A lot of people have heard it, but only a fraction of these really understand what it means.
The concept behind it is actually pretty straightforward and based on sound business sense.
More than a checklist
Naturally, within the list there are interdependencies. For instance, all 10 dimensions “design for cost” as they improve margins, reduce financial risks or do both. Furthermore, it is not their individual, but their combined benefits that result in a true design for excellence.
This guide examines the 10 dimensions, their benefits and risks of missing critical considerations at the design stage of a product.
10 Dimensions of Design for Excellence
Design for Manufacturing
Before a device can go to market it has to be produced. That may seem exceedingly obvious, and yet, many designs fail to take this into account at early enough stages. In such cases, a device that looks great on paper may end up being too complicated, too expensive, too slow or downright impossible to produce.
Design for Manufacturing (DFM) ensures feasibility and controls costs from the get-go by optimizing decisions and processes for parts, assembly and tooling.
DFM: Parts
The manufacturability of a product relies heavily on the manufacturability of its parts. If everything else is done correctly, but one part of the device fails, cannot be manufactured or is delayed, the knock-on effects can disrupt the entire process and the device itself.
DFM looks at the specifications, functionality and reliability of each part individually that will be incorporated into the device. If the part is to be manufactured in-house, the design will consider production processes, machines and tooling. If the parts are to be acquired, DFM looks at cost, lead-time, quality and alternative sources in case they become necessary.
DFM: Assembly
Getting design for parts right is crucial. Making sure they work together is just as important. If parts are designed in silos without taking into account how they fit in with all other components the result is, once again, a device that cannot perform.
In the past, assembly was perfected (or reached its best attempt) at the prototype phase. In other words, it depended on costly and time-consuming trial and error. Simulation software now allows for design for assembly to occur at, yes, the design phase. It ensures that the parts, once manufactured, can be put together to make a device of the expected level of quality and performance. The sophistication of this software is such that it can even demonstrate how well assembled pieces withstand stress, extreme temperatures, sound waves and more.
DFM: Tooling
Efficient tooling helps manufacturers to reduce costs, improve production throughput and elevate quality. Sub-par tooling, on the other hand, often leads to higher costs, devices prone to malfunction and wastage as entire batches have to be discarded.
Tooling for medical devices
Even manufacturers who ‘design for tooling’ often fail to take into consideration key elements such as a tool’s expected lifetime and the time required to replace it. A broken tool means production stops and, in medical device manufacturing, you can’t simply acquire a new one. The replacement tool has to go through the entire validation process again.
This can be mitigated at the design phase by:
1. Considering the annual estimated units (EAU) each tool will be required to handle and;
2. Determining proactive maintenance plans for tools to ensure they operate optimally throughout their useful lifetime
Design for Cost
Design for cost overlaps with every dimension of DfX as all have a positive impact on a project’s finances. Design for cost means driving smarter decisions when it comes to device development, materials selection, services, production, packaging and distribution.
Design for cost goes beyond the cost of individual units, it looks at the total cost of ownership (TCO), including bills of material, production costs but also cost of (non)-quality and maintenance costs. By looking at the big picture, design for cost prevents decisions that give short-term returns that are likely to drive up the TCO price tag in the long run. For example, selecting slightly cheaper components that are more likely to break down in favour of more expensive components that guarantee device reliability and vastly reduce risk to your bottom line and reputation.
An experienced DfX team does not restrict itself to the short term and looks at future cost benefits as well. For instance, what it will mean if production volumes go up or if there is a drop in price for your type of product?
Ultimately, design for cost means making the most cost-effective decisions while aligning with product requirements and market expectations. We like to compare it to using a Ferrari to get from point A to point B. Not that there is anything wrong with a Ferrari if you don’t mind paying for a luxury sports car to carry out a task that can be as easily by another vehicle at a fraction of the cost. When it comes to people who will use your medical device, designing for cost reminds you that few will prefer a Ferrari and prevent a project from becoming over engineered and overpriced.
Design for Standardization
Consider basic Lego, where blocks of limited dimensions and colors can be used to build almost anything. Design for standardization follows the same principle: Unique products can be built more quickly, reliably and cost-effectively when the design incorporates readily available components, existing products, proven processes and more.
Let’s look at just a few additional benefits of standardization:
A stronger starting point
Standardization gives you a whole bag of tricks that have already been tested successfully in the field. The competitive advantages of not having to start from scratch cannot be overstated.
Cost and quality
Not only does your ready toolkit make you faster, when a good number of your components and processes have already been verified, it reduces the costs and risks that comes from making something brand new (read: untested).
Simplified customization
A common problem with devices that have been upgraded but never fully redesigned for standardization is that customizing such products can involve several hundreds of different configurations. Standardization makes you more agile by starting you off with products that can easily be configured to fit a customer’s needs.
Buying power
When there are shortages of certain components, suppliers will favour big customers over small. If you standardize designs so multiple devices require the same component or components from the same manufacturer, you become one of the buyer’s suppliers have to please.
A stronger brand
When you standardize your platform, you make global improvements with raise the quality and capabilities of your portfolio. You ensure, for instance, that all connectivity technologies in all products under your name are compliant with privacy laws.
Design for Functionality
A medical device must perform its intended function. Again, this may seem like a glaringly obvious statement, but, again, when DfX work is not conducted, basic functionality may suffer.
Design for functionality takes into account what the user needs and for which pricing. This allows early input to create a design that will work the way it is meant to, when it is needed, and where it will be used. It is the starting point for all other design dimension under the umbrella of designing for quality.
Design for Quality
Quality is the primary strategic goal for any device. If design for functionality asks what a device must do, design for quality ensures it does its job well. No reputable medical device manufacturer would admit to compromising in this particular area. This is an industry in which poor quality can have devastating human repercussions.
It is therefore imperative that quality be addressed as early as the design phase, getting a head start on pouring in the team’s combined experience and intelligence. Design for quality pins quality as a priority from the very start of the design and development process, then uses the blueprint to ensuring all initial criteria are fulfilled.
Because of its importance and reach, quality is somewhat of an umbrella term –safety, reliability and compliance are among dimensions that fit under it, all with their specific tools to ensure their DfX effectiveness.
Quality has to be evidenced with specific documentation. This too starts at the design phase, laying the groundwork for supplemental documentation down the road and quality throughout the production process and device’s lifecycle.
Design for Testing
Medical devices are tested at several points to uncover possible defects and to assure that Critical to Quality (CTQ) parameters are met. If defects are found, production stops until modifications can be made and the product re-tested.
Design for testing takes into account all the ways your product will be assessed for conformance to industry, design and regulatory standards. In addition to preventing interruptions in production, design for testing provides a head start in the lengthy processes of regulatory verification and validation because requirements are spelled out from the earliest stages.
Design for Reliability
Not only does a device have to function as promised, it has to maintain that level of performance for the duration of its lifecycle.
A device that is inconsistent on when and whether it performs to standard is an unreliable device. Instead of making a promise to its users, it offers the odds and consequences of Russian roulette. Take, for instance the pacemaker which was heralded as revolutionary in part because of its long battery life. It promised to last at least 10 years, and lasts as long as 19 years. The device would go on to draw even bigger headlines when the same battery failed after three years, gravely endangering its users.
Design for reliability utilizes simulations and other reliability engineering tools to ensure that the components of a device will not malfunction or degrade before the product’s promised end-of-life. It uses complex calculations to predict the behaviour of a device in its intended environment, virtually “exposing” it to anything from temperatures, pressure, vibrations, chemicals, electrical surges and anything else it may be expected to withstand.
Design for Safety
A non-functional device does not perform as expected and an unreliable device only performs intermittently. Both of these fall under failures of design for safety. In even grimmer cases, a design that has neglected to consider safety hurt the very users they were meant to help.
The impact of not conducting a DfX analysis in medical devices is far greater than for other products. An investigation into medical records in the U.S. from 2008 to 2017 found that medical devices may have caused or contributed to over 80,000 deaths and 1.7 million injuries.
Design for safety means potential hazard identification happens during design and development planning. In order to receive ISO 1385:2016 certification, medical device companies are further required to conduct safety and risk assessments throughout the design cycle: design input, output, review, verification and validation. The better and more thorough the identification and mitigation of risks at the beginning, the less likely there are to be issues to address later in the cycle.
UL Certification
For a device to obtain FDA or CE approval, it first has to comply with UL protocols. The UL (Underwriter Laboratory) mark is internationally recognized as a sign that a product has met the most stringent safety standards. In the medical device industry, certification is earned by passing tests in:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Biological evaluation, microbiological tests and sterilization
- Cybersecurity
- Interoperability
A design for safety is checked for all UL requirements and selected parts must also comply with UL standards.
Design for Usability
In 2016, a Johns Hopkins study created a stir when it estimated that medical errors accounted for a quarter of a million deaths in the United States every year. That is nearly one hundred thousand deaths more than those caused by respiratory disease or accidents, making medical error the third leading cause of death in the U.S. before Covid-19. One estimate suggests that 15 percent (approximately 40,000 per year) are due to a poor device user interface.
In other words, a device does not have to malfunction in order to cause damage. Incorrect usage is just as dangerous.
Manufacturers tend to blame use error on users. However, the case has been made that when a device is used improperly over and over, there is likely a problem with the design, the instructions or the training.
Design for usability, also known as “Human Factor Engineering” (HFE), strives to prevent incorrect usage of a quality product. Only very recently has it received due attention for the medical device industry. As late as 2011, the FDA released Applying Human Factors and Usability Engineering to Medical Devices “to support manufacturers in improving the design of devices to minimize potential use errors and resulting harm.”
HFE looks at the long-term use of a device from the end user’s perspective. Is it the person who needs the device or a carer/healthcare provider? Is the end user likely to have difficulties with coordination, strength or vision? Are daily tasks or behaviours likely to interfere with using the device safely? What is the likely level of user’s technological maturity?
Not considering usability at the design stage means errors are only likely to be caught at human testing phase, when going back to the drawing board has become way too expensive. The result is band-aid solutions that do not address fundamental issues and an unacceptable number of use errors.
Design for Future
Designing for future presents as many challenges as opportunities. It involves accurate forecasting and observation of trends. Designing for future examines multiple scenarios in near, mid- and far horizons. Production-wise, what will happen to per device cost if there is a significant increase or decrease in production volume? What if components become obsolete or unavailable?
What disruptions and changes can you expect in your product’s lifecycle? Deloitte found that 88% of MedTech companies manufacturers consider advances in technology as their top challenge. At the same time, only half of these manufacturers consider cyber-readiness as an immediate priority. A further 20 percent intend to make it a priority sometime in the next five years.
How is consumer behaviour changing? Lockdowns during the first year of the Covid-19 pandemic accelerated a trend for users to keep and operate their own medical devices instead of making regular appointments at health care facilities.
There is also a clear move towards customizing wearable devices to make them more fashion-friendly, thereby reducing the stigma of clinical-looking attachments.
Design for future asks these questions to spearhead innovation, without compromising on the other DfX dimensions.
Why DfX is too complex to go at it alone
A design for excellence moves a device swiftly through the development and production process, avoiding surprises, minimizing issues and staying well within budget. It ensures the device passes tests for quality and fulfils expectations for functionality, timeliness and customer satisfaction. It ends up as a reliable, safe and easy-to-use quality-of-health or even lifesaving solution to the end user.
For the list to achieve result in an excellent product, two things have to happen:
- ALL 10 dimensions have to be covered – it’s an all or nothing deal
- ALL 10 dimensions must be considered at the earliest stages of the development process – nothing should be treated as an afterthought.
If this sounds complicated it’s because it is, and many manufacturers are unequipped to cover all dimensions.
An evolution, not a trend
The tools and thinking behind DfX is the culmination of decades of experience, of keen observation and analysis of mistakes, failures, experiments, insights and successes. The observations come from a range of perspectives and the approach is continuously refined by interdisciplinary teams – both individually and cohesively – to optimize the 10 dimensions of DfX.
Providence Enterprise has expertise in all DfX dimensions, including mechanical, electrical, software and quality engineers. Our extensive supply chain network includes trustworthy and reliable suppliers who work with our in-house team, sharing the most up-to-date trends in product offerings, capabilities and technologies.
DfX is not a one-off exercise, any more than a strong start guarantees you will win a race. While Providence Enterprise applies DfX to ensure that strong start and a clearer path, we also continuously monitor, address challenges and seize opportunities that present themselves throughout the process.
Chapter 2: Determining What Stage of a Product’s Lifecycle To Bring in a CM Partner
Your contract manufacturing partner can have a dramatic effect on the success (or failure) of your project. While an end-to-end CM can come in at any point of your production cycle, bringing them in at exactly the right time enables you to reap the greatest rewards, including:
Lower overall costs for your project
Expedited testing and production
Accurate yield calculations
High product quality assurance
Lower BOM costs
A future proof design
What is the optimal entry point?
As we will see, the most advantageous time to bring in a CM is as early as possible in the design phase. Specifically, when you have your concept and strategy in place.
Why at the start of the preliminary design phase? Because this is the only time it is easy to make corrections and changes. Think of it as the starting line in a race. Except that in this race, if you fall, you can’t just pick yourself up and keep going. You need to go back to the starting line. The further you’ve gone, the longer the journey back and the longer it takes for you to ultimately reach your destination.
In this race, the ‘fall’ is any critical design failure. If the fall happens during the electrical or mechanical design phase you need to take a step back, but it is nowhere as serious as if the flaw is discovered during your first production run. In a worst-case scenario, the flaw reveals itself when your device has already reached the market. Consider that in 2020 alone, the FDA issued more than 30 medical device recalls. By this point it is way too late to start over.
Involving your CM partner at the optimal stage not only ensures that there are no falls in the race, but that the run itself is as fast and smooth as possible.
So why do some OEM’s still put off bringing in their CM partner until later (sometimes much later) in the process? Interestingly, the four most common objections only look at half the story.
Real concerns based on faulty assumptions
Do any of these sound familiar?
1
We can save on CM fees by bringing them in later.
Not if, when your CM finally does come onboard, they find problems that they could have helped you avoid in the first place. Returning to the starting line means paying twice to get to the same point.
2
We already have a lot of our own people providing input and opinions. Bringing in a CM this early will only add more cooks to the crowded kitchen.
Naturally involving more experts means there will be more voices. Design and development is exactly when you want people asking the right questions and making the right suggestions.
3
We don’t have time to engage a CM right now, our senior managers want us to get started as soon as possible.
What matters more, when the project starts or when it is completed? Your CM partner will be extremely careful to ensure that things are done right. This time investment at the start of the project means everything else will go much faster.
4
Why involve someone else when no one knows our business like we do.
When it comes to concept and strategy, there is definitely no one who understands your market better than you do. Your CM partner’s job is to turn your concept into the quality product you envision, reaching the market without cost overruns, with optimal efficiency.
Delaying the engagement of a CM partner boils down to two things: First, looking at immediate ‘wins’, which actually hide the greater, farther reaching benefits. And second, not really understanding the value that an end-to-end CM partner can bring to the table. Especially if brought to the table at the right time.
What Early CM Involvement Gets You
End-to-end expertise
Much like manufacturing itself, a supply chain is made up of many moving parts working in concert. From world-standard production facilities to high-end technology to teams of dedicated professionals, your end-to-end CM partner has all everything ready and working in unison to design, manufacture and even package your product so it is market-ready.
A single ‘control tower’
Any manufacturing project requires a capable project manager to coordinate between the numerous suppliers, engineers, departments and stakeholders, all with their own priorities. It involves a lot of running back and forth, and the more fragments of your project you outsource to different parties, the more difficult your project manager’s job.
On the other hand, when you hand the reins over to an end-to-end CM partner at the start of the design and development phase, there are experts and processes already under your CM’s umbrella. A dedicated team works closely with your people and known suppliers to ensure everyone is aligned in working toward the big picture.
A design that checks all the boxes
A completed design does not necessarily translate into a manufacturable product. When different engineers are involved in doing their best work within their own silos, all sorts of things can go wrong when it all finally comes together. Mechanical engineers may design a circular device with a diameter of 20cm, while the electrical team has designed a PCB that is 50cm long. Both designs fulfil their own requirements, but cannot possibly work together. Or your BOM includes components that are too tough or expensive to procure. Or the design of the component may mean it is likely to get damaged on a conveyor belt. Or scaling up production will greatly increase your cost per unit.
To ensure that your product can be manufactured, your CM runs a full spectrum of ‘design for excellence’ (DfX), including design for manufacturability. Armed with a profound understanding of manufacturing processes and materials, your CM partner will be able to identify and solve any issues early in the design stage.
Optimizing both product and production
Not only will your contract manufacturing partner identify flaws before they become costly headaches, but they can also recommend ways to lower production costs and increase speed to market.
Take your CM’s expertise in material selection, for instance. There are tens of thousands of types of plastic alone, each with a different set of properties that will affect how durable, light, flexible or easy to clean it is, whether it resists heat, pressure or certain chemicals, whether it bonds with other components, how easily it will be assembled. As early as the design stage, your CM partner will be able to recommend materials that will ensure your device meets all requirements for quality, safety and purpose. Other recommendations your CM might make at the design phase:
- Ways to reduce the number of parts in a device, thereby cutting costs
- Design to simplify assembly & verification
- Design to reduce set-up time
- Design to optimize product reliability
- Ways to future proof your device, for example, by keeping it relevant and useful – or easy to upgrade, when new regulations are introduced or different technologies are accepted.
Growth and innovations
The value of a solid relationship with your contract manufacturing partner extends far beyond your current project. Having someone you trust to make recommendations for better designs, materials and processes opens doors for future projects and innovations. Having a partner who can take care of everything from the design phase, through development and production, gives you the added advantage of getting your innovations to market faster than your competitors.
Chapter 3: How CM-Enabled Transparency Reduces Risk and Improves Your Supply Chain
Communication plays a critical role in any partnership. As you consider the conversations with your contract manufacturing (CM) partner, how can you ensure the best communication strategy to exceed your expectations?
At the very least, you need to tell them your product specs and they need to let you know when your product will be ready for market and how much it will cost. The question is, are you satisfied with the very least?
How big are the greatest communicators?
No two contract manufacturers are created equal. For strength in communication, look for a contract manufacturer committed to building a long-term relationship. Beyond that, consider size. Your ideal CM should be large enough to have all the resources required for world-standard end-to-end manufacturing, but not so large that they sometimes ignore your voice (needs) in favor of louder (bigger) clients.
With the right-fit CM partner, there is no one in the company who is out of bounds to you. You can bring your concerns to anyone from any department and all the way up to senior management. That is, if you need to.
Your CM partner will assign a multi-disciplinary core team dedicated to your projects. Whenever you have technical questions, ask your appointed engineer.
How about questions about orders or logistics? Your planner can handle those. Sharing your goal for the timely and successful delivery of a quality product, every person on this team is proactive in recommending design, process and material improvements, as well as highlighting future opportunities.
Lost in translation
As its name indicates, a global supply chain extends over several countries. If your too-large CM assigns work to whoever is available in different offices, there is a high probability that the “team” members have never worked together before. They don’t know you, they don’t know each other and they are still finding out about your business. That’s a lot of stumbling blocks to communication right there.
With an ideal-fit CM, your team is not just investing in your product, but in your long-term goals. The aim of this partnership is that they will work and grow with you, becoming familiar with your business and understanding what is important to you.
To make communication even easier and to ensure nothing gets missed, your key account manager becomes your point person for information sharing. This is who makes sure everyone involved is aware of their responsibilities, including timeline and deliverables. Your account manager effectively creates short lines of communication between team players.
Can you hear me now?
Speed to market depends on collaboration, which in turn depends on the ongoing exchange of information throughout the entire production lifecycle. Any misunderstanding can cause delays, either in the back-and-forth required to get things right, or worse, moving forward with bad information.
Communication is also key to agility. When there are emergencies, escalations, re-in or re-out requests, new opportunities or anything else that requires a quick strategy change, established open channels of communication enable your dedicated team to react like a well-oiled machine. If your partner is already familiar with your company, product and goals, they can immediately move swiftly to adapt plans of action to new circumstances without consulting too many bureaucratic layers.
Verbal communication is one thing…
The human ear is imperfect. Memory is even more so. What you try to convey and what people hear does not always line up. And even if it does, it may not be remembered correctly or could be forgotten altogether. The solution to this, as every school student learns, is to write things down.
Of course, in manufacturing, it is not anywhere as simple as that. There are specific documents with specific formats to ensure every box is checked and no detail goes unmissed. In the complex world of medical device manufacturing, documentation is even more complicated… and all the more necessary.
From the very start of your CM partner’s involvement, you can rest assured that all process participants can consistently refer to the same, complete and most recent information. Likewise, records of progress, changes and meetings will be meticulously kept and easily accessed. Any misunderstandings about scope, deadlines or responsibilities can be cleared up in as little time as it takes to read written agreements.
Verbal communication is one thing…
The human ear is imperfect. Memory is even more so. What you try to convey and what people hear does not always line up. And even if it does, it may not be remembered correctly or could be forgotten altogether. The solution to this, as every school student learns, is to write things down.
Of course, in manufacturing, it is not anywhere as simple as that. There are specific documents with specific formats to ensure every box is checked and no detail goes unmissed. In the complex world of medical device manufacturing, documentation is even more complicated… and all the more necessary.
From the very start of your CM partner’s involvement, you can rest assured that all process participants can consistently refer to the same, complete and most recent information. Likewise, records of progress, changes and meetings will be meticulously kept and easily accessed. Any misunderstandings about scope, deadlines or responsibilities can be cleared up in as little time as it takes to read written agreements.
Transparency and trust
It is tough to hand over your project to a CM if you believe that means losing control over a big chunk of your supply chain. With document-supported communication, your right-fit CM partner will ensure that all processes are so transparent that you’ll likely have even more visibility over the end-to-end design and production process than most manufacturers have when they do things in-house.
Communication is often the unsung hero of an effective supply chain. A contract manufacturer who takes communication seriously can help you avoid costly errors and delays. They improve product quality and speed to market by ensuring your diverse team is always rowing in the same direction. They protect you from reputational damage and fines that result from shoddy or incomplete documentation. They build trust, work with you to find better alternatives and encourage partnership-driven innovations.
Chapter 4: How to win the speed-to-market race amongst the competition
Worth nearly $450 billion in 2019, the global medical device market is expected to break the $670 billion mark by 2027. In spite of such healthy growth, those who want to capture a decent share of the market need to start early and hit the ground running.
What’s the rush?
The market may be huge, but so is the competition. Imagine a race but with a marathon-number of runners. The closer to the front, the greater your market share. Being first also reflects positively on your brand; in any competition everyone remembers the winner and are more likely to bet on them in the future.
If the perks of being first aren’t enough, consider the downside to late market entry. Today’s customers wait for no one. If someone else is offering a similar product – especially one necessary to get well or manage an illness – customers will take what is immediately available. Even if yours has superior features, how likely are customers to ‘trade-up’ on a medical device that serves its purpose?
A market that shrinks progressively the longer you delay means it takes ever longer to achieve your ROI. Note that delays have already added to your sunk costs; the longer your device remains at development stage, the more you are paying for a product that has yet to earn you any money. On top of that, first-to-market manufacturers set the price that everyone else has to match or, more often, beat. The last thing any manufacturer wants is for someone else to control their pricing.
It is no wonder that even the announcement of a product delay has been found to lower shareholder value by 12 percent.
Know where you’re going
Nothing adds time to your journey like a wrong turn… except travelling on for hours before you realise you made a mistake miles back. Make sure you have a solid roadmap with clear signposts along the way so your team knows it is always on track.
Keep products simple
You don’t have to “innovate” the wheel. More than 25 percent (and as much as 45 percent) of money spent on a product provides no value to either the product or the customer. While there may be dozens of features you can add, stick to the ones that fulfil expectations.
Take smart shortcuts
Know how to identify smarter, faster options. For instance, instead of re-designing each part, check whether there are readily available components which can perform the same function.
Know where speed is not the best option
You can compromise on bells and whistles, but never on quality. Cutting corners may get you there faster, but a sub-par product could result in recalls and unrepairable damage to your reputation.
Put the best people in charge of each task
Trained athletes can traverse an extreme obstacle course as quickly as the rest of us can cross a street. The fastest, surest way to speed your product through design and production is for each person on the team to be the best person for the job.
Communicate
There needs to be clear communication at every phase of the product’s lifecycle. If there are any misunderstandings, or if vital information goes unheard, going back to the root of the problem and fixing it can cause major delays.
Collaborate
It is simple physics: Things move faster when all forces pull in the same direction. It takes a big and diverse team to bring a medical device to market. Draw on everyone’s strengths and make sure they all align their efforts toward the ultimate goal.
Document
Medical devices are often held up by lengthy approval processes. By providing detailed records upon request, you make the job easier for regulatory bodies to move things along.
Be nimble
If requirements change, how quickly can your team pivot to find and incorporate the best alternative? If a component suddenly becomes unavailable, what are your options? Will your entire supply chain be held up for months because you can’t procure a one-dollar part?
Bet on a winner
More than half of medical device and pharmaceutical companies in Europe and the US consider speed-to-market a priority. If you do not have all the resources and capabilities to get your product to customers before the market becomes saturated, get assistance from someone who can.
A contract manufacturer (CM) prepares you and the road ahead, removing obstacles that slow other companies down. Want to make sure your design is right from the start? Check with your CM. In need of a supplier or technical expert? Your CM can find them. Can your CM ensure optimal communication and collaboration, help you identify the highest value features for your product and keep records that will hasten the approval process? Yes, yes, and yes.
Your CM’s dedicated team works with you to create a roadmap, keep track of progress and make sure everything is within scope. Your CM partner is as agile as they are experienced – they have contingency plans for any event.
There is a reason medals are only awarded to the first three places. There is also a reason the public only remembers who took the gold. If you are confident you can make it on your own, great. If not, team up with a trusted CM partner who is sure to speed you to the finish line.
Other Featured Resources
About Providence Enterprise
Providence Enterprise is a Hong Kong medical device contract manufacturer of Class I and II medical devices with manufacturing in China & Vietnam. We specialize in electro-mechanical assemblies and high-volume disposables. We are FDA registered and ISO 13485, ISO 14971, ISO 14001, ISO 27001 certified. Our capabilities include fabricating tooling for silicone rubber and injection molded plastics, clean room injection molding, electronics, clean room assembly, and sterilization.