Tips and Tricks to Bring Your Medical Device to Market
The advancement of medical technology has been nothing short of revolutionary. In the past few decades, we have seen the development of new drugs, surgical procedures, and medical devices that have saved millions of lives and improved the quality of life for countless others. The global pandemic brought revolutionary ideas to life, including the increase in telehealth that allows you to do things like have a doctor’s visit in the comfort of your home.
What is a Medical Device?
One of the most exciting areas of medical technology development is in the field of medical devices. Medical devices are any product used to diagnose, treat, or prevent disease. They range from simple tools like tongue depressors and bandages to complex machines like pacemakers and MRI scanners.
Why are so many medical devices being developed?
Despite the challenges, the development of new medical devices is accelerating. This is due to a number of factors, including:
- The increasing availability of funding for medical research
- The growing number of talented engineers and scientists working in the field of medical technology
- The rapid pace of technological innovation in other industries, such as electronics and computing
As a result of these factors, we are seeing a constant stream of new and innovative medical devices being developed. Some of the most promising new medical devices in development include:
- Artificial organs and tissues
- Implantable devices that can monitor and treat diseases in real time
- Robotic surgery systems that are more precise and less invasive than traditional surgery
- 3D-printed medical devices that can be customized to the individual patient
These new medical devices have the potential to revolutionize the way we diagnose, treat, and prevent disease. They could save lives, improve quality of life, and greatly reduce the cost of healthcare.
What are the steps in developing a medical device?
Developing a medical device is a complex and challenging process that requires a deep understanding of human anatomy and physiology, and the latest advances in engineering and materials science. It also requires extensive testing and regulatory approval processes, which can take years to complete. Here, we’ve outlined the steps needed to ensure your medical device goes to market quickly and is a beaming success.
1. Identify the Need for your Medical Device
This is the initial stage in any new product development. You need to figure out what problem your new product will solve. Is this something that can already be purchased? If so, how can your product improve what’s already on the market? You should do ample amounts of market research to find if there is a need for your medical device, and who benefits from using it. You will need to learn about potential competitors already having a leg up on the market.
2. Design and Develop with DFM in Mind
This is one of the most painstaking steps in designing and developing any new product, but it’s especially true in medical devices. This step involves taking all your ideas and designing your product, then moving it into development. You must ensure your medical device is designed with all the strict regulatory requirements already in place. If this is missed, you could fail required tests, which takes you back to the drawing board. This is one of the most overlooked steps, yet it saves much-needed time and money. If you’re unsure of your medical device’s requirements, enlisting the knowledge of a product design firm that’s well-versed in medical device design is best.
If you plan to create a product that will be available to large quantities of people, you will also need to design your product with manufacturing in mind. This ensures a faster time to market by providing an efficient assembly process and taking advantage of price breaks by ordering large quantities of materials.
3. Perform Comprehensive Testing Before Production Runs
Just as designing your medical device with the mandatory requirements is important, we will now test the design. Medical devices are under much stricter standards, therefore, a documented design process is often required to ensure safety and effectiveness. You should complete several test runs with your product to ensure all possible outcomes before mass production. This will also give great feedback on your product’s user experience, leading to greater market success and adoptability.
4. Certification and Regulatory Requirements
Once you have finalized your design and have a working prototype, now comes the process of obtaining the proper certifications for your medical device. Depending on the use of your device, there are several standards and certifications that must be passed before your product can go to market. In addition to various ISO certifications, the country to which you are selling your product might have additional regulatory requirements that must be obtained.
5. Manufacturing and Assembly of your Final Product
After passing all the required certifications, you are now ready to manufacture your final product. Most medical devices must be manufactured in an ISO-certified or FDA-registered facility. If you do not already have access to one of these manufacturing sites, partner with a company with vast medical device manufacturing experience. Establishing good manufacturing and assembly processes will ensure a faster time to market for your medical device.
Where your product is manufactured is an often-overlooked element of the product development process. If you do choose to partner with an experienced manufacturing firm, they should have full transparency in their manufacturing processes and allow you access to their facility when needed to ensure your product is on schedule.
What challenges could I face when developing a medical device?
You will face several hurdles when developing a new medical device, or any medical technology for that matter. These range from regulatory compliance, clinical trials, risk management, design and technical complications, resource constraints, market competition, and cultural differences. All of these and more can stop development in its tracks. Each of these can take valuable time to solve, which puts your product at risk of being late to market.
Partnering with a Product Development Company to Increase Your Product’s Success
The fastest and most reliable way to shorten the time to market for new medical devices is to partner with a company specializing in medical device design and manufacturing. These companies will already have the experience and can lead you through the process. This can significantly shorten the time to market for new medical devices, giving companies a competitive advantage.
Here are some of the benefits of partnering with an experienced medical device design company can bring:
- Speed: These companies already have the expertise and resources to design and manufacture medical devices that meet all regulatory requirements quickly and efficiently.
- Cost: Design companies can often manufacture medical devices at a lower cost than in-house manufacturing since they already have the skills and workforce. This can save companies money, which can be reinvested in research and development.
- Quality: Design service companies have a track record of manufacturing high-quality medical devices that meet all regulatory requirements. This can give companies peace of mind knowing their products are safe and effective. They also know all the hurdles to the development process, and most companies have an in-house quality and regulatory compliance team.
By partnering with a medical device design and manufacturing company, you can focus on what you do best – developing innovative medical devices that can save lives and improve the quality of life for millions of people. You will also gain access to new technologies and manufacturing processes that may not be available to in-house manufacturing. This can give companies a competitive edge in the marketplace.
Pivot International has over 50 years of experience designing, developing, and manufacturing a range of products, including medical devices. We have global teams of over 150 multi-disciplined engineers working together to bring our customers’ ideas to life. Once design is complete, we offer 300,000 square feet of manufacturing space spread across three continents. Whether your needs are developing a prototype or having access to scalable production runs, Pivot can be the answer to your product development needs. Contact our team to learn more about our teams and capabilities.
Top Medtech Development Challenges and Solutions
Developing any complex product comes with challenges, but one can argue that medtech takes these challenges to their limit. And understandably. Few other product categories face stakes measured not only in market metrics but in human lives. By definition, medtech occupies an intersection of opposing tensions (this vs. that questions) that represent uniquely formidable obstacles to successful development. The key to success lies in taking an integrative, whole-systems approach to reconciling these tensions.
Top Medtech Challenges
Hand in hand with digital health, medtech is the fastest-growing healthcare sector. The race is on to capitalize on mushrooming market opportunity. Companies will have to successfully solve the following challenges to be among the first to cross the finish line.
Product Solution and Use-Case Challenges
Wireless and cellular medtech applications (product solutions) are shaping the future of healthcare. These applications include WiFi 6, LoRa, Bluetooth, NB-IoT, CAT-M, and sensor technologies. Each product solution has strengths and limitations regarding connectivity range, device size, weight, and power consumption.
Reconciling the tensions between various product solutions is difficult, but it’s only the beginning. Design and engineering teams must also reconcile tensions between device applications, networks, and specific product use-case, making the equation dizzyingly complex. At Pivot, our design and engineering teams are masters of discerning the strategic tradeoffs that must be made between these variables to control costs — all without deviating from safety standards and product requirements or compromising functionality, performance, and UX.
Ecosystem Visibility Challenges
Solving the technology and use-case challenges discussed above begins with deep insight into the broader product ecosystem in which a medtech device will be deployed. Development teams that lack this “X-ray vision” stand no chance of creating a device that interfaces seamlessly with complementary devices, patient-care practices, and business processes and systems. Taken as a whole, these challenges make it imperative for development teams to work closely with key stakeholders. At Pivot, our highly collaborative approach to product development ensures the high levels of ecosystemic visibility and coordination required for developing successful medtech.
Supply Chain, Manufacturing, and Innovation Challenges
Although supply chain and manufacturing challenges are not unique to medtech, they are currently among the thorniest. This makes DFM (Design For Manufacture) one of the most sought-after capabilities in medtech development. DFM is a specialized area of expertise that integrates supply chain and manufacturing considerations into the broader product development process.
DFM begins medtech design with a survey of the supply chain landscape to determine which parts, components, and materials are readily available, functionally ideal, and cost-effective for the device in question. When desired parts, components, and materials are found to be unavailable, in short supply, or too expensive to procure, DFM actively seeks to reconfigure product parameters to accommodate alternative supply chain solutions. At Pivot, our DFM teams can solve a significant percentage of problems using this strategy.
DFM also approaches device development to the limitations of manufacturing methods and technology. This prevents the development of devices that meet product requirements, perform flawlessly, and are UX-optimized but cost-prohibitive to manufacture at scale.
Last, in a highly competitive and increasingly crowded market space full of would-be copycats, DFM delivers a crucial advantage that extends beyond supply chain and manufacturing benefits. By narrowing the field of available product options, DFM teams place themselves in what is essentially an innovation incubator. This forces them to devise novel solutions that result in superior products and heightened brand differentiation.
Preparing to Launch a Successful Medtech Innovation?
At Pivot International, we are the proven one-source partner behind some of the world’s most innovative and award-winning medtech. For more than 50 years, our integrative approach to NPD has provided leading-edge solutions for medical, industrial, and consumer products. With FDA registration and multiple ISO and IEC certifications (ISO 9001:2015, ISO 13485:2016, ISO 80079-34, and IEC 60601-1), we are the go-to partner for medtech design, engineering, and manufacture. With advanced DFM expertise and 320,000 square feet of company-owned global and domestic manufacturing capacity, we drive results that position our partners for market leadership.
If you’re seeking a US-based global leader with extensive medtech experience and all the right certifications, Pivot is the partner you’ve been looking for. To learn more about how we will help you successfully scale, contact us today.
Why Medtech Companies are Increasing Their Investment in Digital Marketing
All businesses know that marketing is essential for solving their larger product-success puzzle. For medtech innovations, digital marketing plays a distinctly important role in ROI for reasons not readily apparent to most companies.
Why is digital marketing such a powerful tool for medtech developers? And what are the most profitable areas to allocate digital marketing dollars? Let’s take a look.
Why Medtech Companies are Increasing Their Investment in Digital Marketing
The shift to remote work and the rise of telehealth have impacted the larger ecosystem in which medtech innovations are delivered, leads generated, and customers served. On the side of healthcare providers (HCPs) it has changed their communication needs, preferences, and expectations for how they interact with medtech companies and salespeople. On the side of medtech companies, it has increased awareness of the optimality of digital marketing efforts across three areas: 1) penetrating their target market 2), engaging their customer base (HCPs), and 3) increasing the return on their marketing investment.
These variables are driving a trend in medtech toward greater investment in digital marketing. Taking their cues from the commercial sector, companies rely on tactics that include social listening, email and social media campaigns, SEO and SEM (search engine marketing), and digital-channel and app management.
At Pivot International, we help companies capitalize on market opportunities with medtech innovations designed and developed at the cusp of digital evolution. With fifty years of proven NPD experience, in-house DFM expertise, FDA-Registered facilities, and multiple ISO certifications, we are powerfully positioned to meet medtech companies’ unique needs.
Our understanding of the medtech market makes it clear to us and our clients the role that digital marketing is increasingly coming to play in market success. What follows are the top areas in which we’re seeing our clients get the most bang for their digital marketing buck.
Target Market Penetration
With HCPs needing (and in many cases, preferring) digital communication, medtech companies are leveraging digital marketing to penetrate their target market and generate leads. About half of companies using this approach say that email campaigns are the most effective digital tactic, while the other half report gaining significant traction via social media campaigns. To effectively personalize messaging and tailor engagement (both pre-and post-purchase), companies can benefit greatly from the practice of creating customer personas — fictional characters that represent different types of buyers within their target market.
Hybrid Product Launches
During the height of the global pandemic, product launches shifted almost exclusively to digital channels with companies reporting success via email and social media campaigns and online conferences. Even with the lifting of lockdown restrictions and the return to traditional launch events, many medtech companies recognize the value of a hybrid approach. While non-virtual events will almost always be the most compelling context for product launch, their success depends more than ever on strategic digital marketing efforts before, during, and after launch.
Improved Value Prop Positioning
To compete in the current market, it’s no longer enough for a company to deliver a successful product. Instead, they have to successfully position themselves as purveyors of an entire portfolio of solutions. Digital analytics are indispensable in identifying opportunities where customers are primed for the introduction of additional product solutions. These solutions can be best positioned as complements to existing purchases that add value to customers’ businesses while also enabling them to better serve patients.
Sales Empowerment and Account Management
Medtech companies whose target market and customer base include more sophisticated or institutional players are relying on machine learning to provide salespeople and account managers with the data to effectively segment, prioritize, and care for each account. By integrating digital marketing with other marketing and sales channels, higher degrees of coordination and more consistent messaging are achieved to prime potential buyers for purchase. By taking an omnichannel approach informed by analytics, medtech companies can ensure they’re engaging their target market and customer base — online and in-person — at the right time and in the right way.
Looking to Launch a Successful Medtech Innovation?
If you’re looking to launch a successful medtech innovation, Pivot will work closely with your team to make your product vision a winning reality. Our industry-leading reputation, track record of success, and extensive portfolio of award-winning medtech devices assures you’re in good hands. (ISO 9001:2015, ISO 13485:2016, ISO 80079-34, and IEC 60601-1) If you’d like to learn more about how we can help you scale, contact us today.
The Rise of Telehealth: New Market Opportunities for Medtech Companies
Before 2020, demand for telehealth services and home-care medical devices was already on the rise. But the global pandemic has driven exponential consumer adoption and skyrocketed market demand for these services and products, and Mckinsey & Company estimates the potential market for them at $250 billion in US healthcare spending.
With market opportunities for medtech companies exponentially increasing and the race for first-to-market advantage accelerating, the need for proven supply partners has perhaps never been so critical.
At Pivot International, our advanced supply chain solutions and extensive medtech expertise are behind some of the most successful consumer and clinical medtech on the market. Pivot’s portfolio of medtech products includes the N-Tidal Personal Capnometer, winner of the European Product Design Award, the Zibrio SmartScale, an Honoree of the CES Innovation Award, a state-of-the-art mobile phone ophthalmoscope, and much more.
As medtech leaders mobilize to capitalize on mounting market opportunities, here are some key considerations.
Be Aware of Regulatory Changes
COVID-19 and ongoing trade tensions have precipitated a trend toward regional protectionism, resulting in regulatory changes for security-sensitive and critical components. For many medtech companies, this will necessitate a move away from China-based manufacturing and a search for proven supply partners with cost-effective alternatives. Pivot’s company-owned facilities in the Philippines and global sourcing network can help companies reconfigure, optimize, and secure their supply chain to comply with new regulations. What’s more, Pivot’s integrative solutions ensure a seamless product development process and expedite time-to-market.
Innovate New Markets
The rising demand for telehealth and new medtech is not just about filling existing gaps with new products but also about the opportunity to innovate new markets. Medtech leaders need to think bigger and reconceive telehealth as more than just a replacement or at-home supplement to clinical visits.
Cast a wider net by envisioning possibilities for broader applications and deploy strategies to drive growth in new markets and diverse patient populations. Segment patient populations (for example, acute care, chronic care, drug and alcohol treatment, etc.) and identify opportunities to scale virtual interactions with IoT at-home medical devices.
Cast a Wider Net
When approaching medtech design, keep your ear to the ground for changing consumer trends and look for opportunities in adjacent markets. Not only has the global pandemic forever changed the face of healthcare, but it has also driven a dramatic spike in demand for remote solutions to wellness, personal fitness training, sports training, and more. Significant areas of overlap may exist between the consumer medtech market and other industries. Pivot’s expertise spans twelve industries, including sports and fitness, and our teams can help your company identify potential opportunities for product expansion into adjacent markets.
With nearly fifty years of expertise in integrative product development (including concept, prototyping, engineering, design, DFM, manufacturing, and distribution), Pivot helps companies worldwide defy disruption and bring medtech innovations to market. We provide more than 200,000 square feet of manufacturing capability across three continents to serve Asia, Europe, and US markets. Our FDA-registration and multiple ISE and ISO certifications (ISO 9001:2015, ISO 13485:2016, ISO 80079-34, and IEC 60601-1) ensure strict quality control and regulatory adherence. Contact us today and learn more about how a partnership with Pivot can help your company lead the way into a new future.
How Medical Device Software is Changing
In order to optimize the patient experience, it’s important that the medical industry is user-centric rather than tech-centric. Gone are the days when each part of the medical device design process took place in a silo. In order to provide the best patient care, all components of the device development team (medical, software, electrical, mechanical) need to work together. This means a number of people will be coming together from different backgrounds, mainly programming and medical.
Programmers are changing the way they do things when it comes to developing a software product with the end goal of providing the ultimate user experience. They are working more closely with medical teams and becoming more aware of how they can impact patients by doing so. The main changes include:
- continuous integration
- use of appropriate language
- change management
Continuous Integration
When you have a team of experts in the software development field working with experts in the medical field, you may end up with specialists who know a lot about their own field but next to nothing about the other field. Here’s where continuous integration comes in.
Continuous integration is the process of merging everybody’s work frequently and conducting tests to ensure things are going as planned. When it comes to software development projects, it’s highly recommended that there is a controlled version of the source code so changes and progress can be monitored accurately.
Use Appropriate Language
Language is another area where all parties on the medical device software development team may not have the same knowledge. Programming language might not mean anything to medical experts and medical language may not mean anything to programmers. It’s important that everyone working on the project use language that is easily understood by other team members.
In addition to using language, everyone on the software development team can understand, it’s also important to explain why you are doing certain things so all team members are kept informed and can vary any actions they may take in response to new developments.
Product Data Management
When there are multiple people working on a software development project, it’s extremely important to monitor and control changes so the reported results are accurate. This includes things like analyzing necessary changes, announcing when a change will be made, giving the change a name so it’s easy to track, and recording any feedback as a result of the change. This can be accomplished most effectively through a product data management system.
In order for medical device software companies to be competitive, they will need to provide the ultimate patient experience. It’s important that medical device software development teams consist of both programming and medical experts. By using language all team members understand, continually integrating processes, and managing change in a way that allows the team to be prepared for and accurately track changes, medical device software development teams will ensure their software provides the best patient experience.
Pivot International is a product design, development, and manufacturing firm with specializations in software development, electrical engineering, mechanical engineering, and industrial design. To learn more about our custom software development services and how we can help you with your medical device software, contact us today.
Developing a Medical Device: A Process Overview
Thanks to the explosion in available technology and a more intense emphasis on patient-focused care, the medical device industry is fast becoming one of the fastest-growing business sectors in the country.
Because of the – literally – life-and-death power these devices may hold, the process of designing, developing, and getting one of these devices out into the marketplace is lengthy and complicated. In order to become approved, a medical device goes through painstaking, rigorous testing throughout its life cycle.
Here’s just a glimpse of what one of those devices goes through in the design phase.
An overview of the process
When a company is developing a new medical device, designers will use a set of practices and procedures that are interrelated. The procedures that are incorporated must be documented during the development process, and throughout the process, a company will do several things.
- Identify what their potential customer needs.
- Explore what similar, competing products look like.
- Embark on the actual design process, figuring out how to create their own high-quality product.
- And finally, they can establish the process for making that product.
Design planning
A medical device company must establish a design plan that describes both the end goal and the development process, with each team member’s individual responsibilities during the design. There should be consistent reviews, updates, and approvals for the plan until the design has been completed, validated and verified.
Design input & output
A company must combine standards of safety, risk management, regulatory requirements, economics and performance to properly design a new medical device, and to do that, they often seek input from doctors, nurses and other medical clinicians, whether through surveys or direct interviews.
Design outputs include the proper function of the device, the users manual, results of any clinical studies or other trials, and other technical aspects of the device.
Review
In order to detect any sort of deficiencies in the product during the design phase, companies conduct two types of analysis: hazard analysis and failure mode & effect analysis. These review processes are done by all personnel from every area involved in the device’s design, along with someone who has no direct link to the product for objectivity’s sake.
Verification & Validation
During this concluding phase, the device’s design is confirmed through extensive examination of both the device itself and the objective evidence that exists about the device. The results of these examinations must be documented during the verification process.
During the validation process, it must be confirmed that the final output of the device consistently meets the specifications for its intended use. Validation takes place through lab testing and clinical evaluations and trials.
Again, it’s important to remember that this refers to a single phase of medical device’s life. Does that sound like something your company can handle alone? If not, Pivot International can help. Take a look at our portfolio of medical devices here.
4 Trends Impacting Medical Device Manufacturing
The medical device manufacturing industry plays an incredibly important role in society. It is because of this industry that we have amazing new medical technologies that save lives and improve our quality of life. There are a number of trends impacting medical device manufacturing as medical technology evolves with great speed. The medical device manufacturing industry has adapted to meet new clinical standards as well as respond to shifts in the economy.
Over the last two decades, there have been a number of trends in the medical device manufacturing industry that have consistently impacted the industry and will continue to do so in the future. These include the use of smaller devices, more specialized contractors, improved distribution processes, and more frequent and large-scale mergers. Let’s examine each of these in more detail.
Miniaturization
Medical devices get smaller and smaller every year. It’s predicted that minimally invasive device technology will be worth $50 billion by the end of this decade. Medical procedures are making the move to more laparoscopic and catheter-based technology which means medical device designers and manufacturers are going to need to continue improving the functionality of the technology used in smaller devices as well as design new miniature technology.
Trusted Partners
The role of contract manufacturers in the medical device industry has shifted over the last ten years from simply being told what to produce and how much to acting more like a trusted partner in the medical device production process. This trend will continue with manufacturers broadening the scope of their work to include things like concept design and product delivery in addition to specialized manufacturing services.
Distribution Sophistication
With the increase in responsibility going to contract manufacturers, distribution of medical devices has become more sophisticated as well. Distributors are no longer just suppliers to hospitals. They have become all-encompassing, and this is another trend that will continue to impact the industry. Distributors are creating niches as supply chain and healthcare solutions providers.
Larger Mergers
The medical device manufacturing industry has seen plenty of mergers in the past. Companies merge in order to combine skills and gain market share. This allows them to offer a full range of services from concept design to product development, manufacturing, and distribution. Successful mergers allow companies that offer a wide array of skills to become fully integrated in order to provide a powerhouse of offerings to their customers.
This industry will continue to evolve as new discoveries are made and improved technologies are developed. The trends discussed above will only help improve the industry in order to bring the best technologies to the end user. Be prepared for more mergers, improved distribution offerings, more trusted partners that can help with all areas of medical device manufacturing, and smaller devices that can do more than their larger predecessors.
At Pivot International, we pride ourselves on designing, developing, and manufacturing the best medical devices possible which is why we are excited to have acquired Wide Blue, a Glasgow based firm designing Class 1 and Class 2 medical devices. To learn more about our medical device design and manufacturing services, contact us today.
5 Amazing New Medical Technologies We Love
Medical technology is one of the most important and fastest-evolving fields in the manufacturing industry. Seemingly every day, companies are producing new innovations in an area that could literally save people’s lives.
Many industries thrive on innovation and improvement, but there are few where the stakes are as high as in medtech. Luckily, there’s no shortage of either on the horizon, and there are many new developments in the field to be excited about.
Here are a few new products and concepts in medtech that could change the world for the better over the next few years, with some details about what makes each of them so special.
Optical scanning for melanoma
Melanoma is the most common, most deadly form of skin cancer, and it’s also one of the most difficult to spot with the naked eye. It’s currently impossible to confirm without invasive surgery. But there’s a new handheld tool on the market that’s recently been approved by the FDA that allows for multi-spectral analysis of tissue by dermatologists.
It’s not as definitive as a surgical biopsy, but can provide the vital information a doctor needs to figure out whether or not to perform the biopsy, potentially spotting something that couldn’t be spotted before.
Interestingly enough, the scanner’s technology is based on navigation technology developed and paid for by the Department Of Defense and used for missiles.
Electronic aspirin
Many people all over the world suffer from debilitating migraines and cluster headaches and other types of head pain, and the need for quicker relief from that excruciating pain is obviously very important.
There’s currently a new form of technology being developed that allows a patient to immediately block these headaches at the first sign of pain.We wrote about this technology about a year ago, when we attended the 2016 MD&M conference.
The tech involves the implant of a device that stimulates the nerves on the side of the head most commonly affected by the headaches. Using a small remote control that the patient can attach to their cheek, and the signal blocks the pain transmitters from the brain.
Needle-less diabetes treatment
One of the most taxing parts of suffering from diabetes is the treatment process, especially the glucose testing and the need for constant shots of insulin. There have certainly been improvements in the treatment process, including glucose monitors and pumps that provide insulin. But that hasn’t completely eliminated the need to use needles. But there’s company in Philadelphia that’s working on a technology that would be able to replace the needle with a patch. In simple terms, the patch functions as a sensor that analyzes blood through the skin without having to actually draw blood.
Automated check-ups
There are new medical robots being put before the FDA right now that will, in theory, ultimately be able to do some of the more basic tasks that human doctors do now, including checking in on patients and monitoring, managing individual charts and monitoring vital signs.
This automated technology will involve a two-way video screen and equipment designed to move through the sometimes chaotic and crowded confines of a hospital or doctor’s office.
A life-changing aortic valve
There’s a new aortic valve on the market that is providing a different options for patients whose previous only choice was open-heart surgery. There are many people who aren’t in the condition to handle the rigors of the open-heart procedure, and the valve can be inserted through a small incision in the chest that’s far less invasive.
In addition to being a less dangerous procedure, the patient’s hospital stay would be shortened dramatically, as would the cost with or without insurance. It’s difficult to imagine three better reasons for getting behind a new technology than less pain, less precious time spent in a hospital and less cost.
Pivot International isproud to be part of the medical technology community, and we’re happy to introduce new ideas and innovations regardless of the field they’re in. To read more about innovations in medical technology, read our post “4 Tips for Developing Medical Products.”
How Does Iris Scanning Technology Work?
At Pivot, our product design teams have worked on some really fascinating technology.
Take the home sleep recorder, for example. Created for physicians to offer their sleep lab patients, this recorder allows patients to record their own sleep events using patented palatal snoring analysis.
Then there’s the electric fish skinner, a consumer product that we helped two fisherman develop. Called the Skinzit, the device removes the rib bones and skin from fish, producing a clean fillet in a matter of seconds.
And then there’s the iris recognition device we helped an established research and design company develop. This biometric security device just might be one of our favorites from over the past few years.
How does iris scanning work?
Iris scans are essentially pictures of a person’s iris taken by an extremely high-powered digital camera.
The camera, or scanner, takes a picture of the eye using both regular and infrared light. This allows the scanner to see darker features that aren’t clearly visible in regular light.
The two pictures, one with ordinary light and one with infrared light, are then analyzed by a special computer program that can remove unnecessary, distracting features, and identify 240 unique features. It’s these features that are then used to identify each enrolled user.
This scan contains roughly five times more unique identifiers than a fingerprint, making it far more accurate and difficult to replicate.
After these initial pictures are taken – a process called enrollment – the data is stored within a database. Subsequent scans simply take another photograph of your eye and match it to the stored image.
Why is iris recognition so secure?
Iris recognition is highly secure for a number of reasons.
The first is that unlike a fingerprint, which does, in fact, change to a certain degree over a person’s lifetime, irises do not change.
A person’s unique iris pattern is formed by 10 months of age, and remains stable throughout a person’s life. Additionally, it’s nearly impossible that any two people will have the same iris pattern – especially since the scanners that identify a person’s iris use 240 distinct features to create the image.
Finally, biometric security experts generally agree that iris recognition is the most accurate method of identifying individuals, compared to other methods like retinal scanning, fingerprinting, facial recognition, or vocal analysis.
Advantages of the portable iris recognition system
The iris recognition device that we at Pivot helped develop was designed to be rugged, portable, and easy to use, so that it would offer some strong advantages to other devices on the market.
Perhaps one of the most important features of the device is that it works from a distance of up to 18 inches. This allows the scanner to maintain a comfortable distance from the person being scanned, unlike retinal scanning, which is highly intrusive.
The design is ambidextrous and easily portable. It costs less than other similar devices, has WiFi, 3G, and USB connectivity, and can even withstand temperatures below zero degrees Fahrenheit, for easy use in the field.
Identification can be performed in less than a second, and the scanner captures more than just a single iris. Instead, the scanner is capable of taking digital, dual-iris and facial images at once.
We were able to bring the product to market quickly, delivering production units in just four months by working closely with the client’s design team.
Biometric security measures, like the handheld iris scanner, can offer organizations many advantages:
- Quick – usually within one or two seconds – and accurate identification
- No physical contact required
- Extremely difficult or impossible to replicate
- Databases are kept highly secure
- Simple to install and cost-effective to use
To learn more about how biometrics are being used, check out our infographic, “The Advantages of Biometric Security,” and read our post “Medicine in the Age of Predictive Biometrics.”
4 Tips for Developing Medical Products
This post is part of our product development series, where we share tips and ideas for developing products in various industries.
Developing medical products and devices can be a tricky proposition. Navigating regulatory agencies, testing your device, and finally getting it into the right hands makes the development process a complex one. We at Pivot know this from experience, as we have several medical products in our own portfolio throughout our history.
Our products have a wide range of forms and functions. For example, we created a home sleep recording device that offers an alternative to sleep lab testing. We have also worked on a medical drill driver, which we both developed and manufacture, and an endoscopic camera that allows data sharing and image and video transmission, connecting doctor and patient anytime, anywhere.
In the course of our work in the medical product industry, we’ve picked up a few pointers on ways to make the process less onerous and more efficient. A few are listed below.
- Have a clear, yet flexible definition of your medical product’s requirements. It’s not always certain what the end user requirements will be when developing a new medical product. Since, often, multiple teams are working on a device together, there can be varying ideas of how the device should behave and function. This is especially true for electronic or touchscreen devices—you may end up finding that the device is most useful when it can perform more functions, or fewer functions, than you originally intended.
- Use a risk-based development approach. A risk-based development approach means that focus is placed on the most critical parts of the design, with testing early on. This increases the chance of product success, as it prevents the developers from continuing the development process with faulty or problematic design elements. When using this approach, product developers create prototypes at various stages in the process, testing each along the way.
- Work closely with your manufacturer. If you can select a manufacturer very early in your product development process, do so. This will allow you to work with them throughout the process, taking advantage of their input and expertise on materials, reliability, and other elements of the development and manufacture process.
- Make sure your device is user friendly. Even though the product you’re creating is designed for a very specific purpose for specific individuals to use, it’s still important that the end result is user-friendly if you want the product to succeed. There’s plenty of competition in the medical industry, so if your creation isn’t easy to understand and use, your target audience may go somewhere else. This can mean huge losses if you’re marketing your products to large hospital systems, which have major buying power.
To avoid any confusion throughout the development process, make sure to have a document where you list the functions and requirements of your device, along with any revisions or changes. As you continue through the process, it will become more and more clear exactly what your product needs to do and how it needs to do it.
This risk-based approach is utilized in many industries and agencies—in fact, the FDA, which may well be regulating your new product, uses a risk-based approach for regulation.
The U.S. is currently the largest manufacturer of medical devices in the world, so there is plenty of domestic expertise to draw from. You could, of course, also choose to work with a global manufacturing company, either finding them yourself or working through another organization. Pivot offers manufacturing services that range from full-service, contract manufacturing to electronic manufacturing and global manufacturing.
Are you working on a medical device that you need some help getting off the ground? Pivot International can help you, no matter where you are in the process: product design, prototyping, manufacturing, or even setting up a business. Contact us today!
