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
With institutions like Harvard University and MIT in its backyard, the city of Boston has a storied tradition for academic and research excellence. It should come as no surprise that the New England region also possesses a thriving medical technology and manufacturing sector.
Last week, Creation Technologies was one of over 400 suppliers that attended the BIOMEDevice Boston event. For two days, engineers, innovators, and suppliers connected and collaborated on projects that will transcend the health care industry.
For medical device OEMs that attended the show, filtering through the many design firm options can be a daunting task – with cost, quality, experience, and location all considerations.
In order to identify the right fit for your design needs, here are 5 questions you should be asking a potential design partner.
1. Is your process ISO 13485 Registered?
ISO 13485 represents the requirements for a quality management system for the design and manufacturing of medical devices. You should not even consider any supplier that does not have a registered quality system. Many design firms may say that they have compliant processes but have not obtained ISO 13485. While you may plan to execute the design project under your internal quality system, it is still important your partner has experience developing products within the controls of an ISO 13485 quality system. Their estimates will be more accurate, execution will be more efficient, and your design partner maybe able to assist in the continuous improvement of your internal quality system.
2. Who owns the Intellectual Property?
Your IP should be your IP. Many medical device OEMs elect to share their intellectual property with a design firm because the upfront development costs may initially appear to be less.
There are potential risks involved in co-developing your IP with a design partner such as:
The design partner could potentially license that IP to your competitors and charge you an ongoing royalty on your own product.
The design partner could get acquired by another corporation, who might leverage the IP into its products, enabling the competition.
The design partner could extend your joint IP, enabling future generation capability and leveling the playing field with your competitors.
A lack of alignment on the long-term use of the IP can actually delay the development of the IP and the product causing undue risk of missing your market window and costing many times more than the originally perceived potential savings.
It is more beneficial in the long run to own your IP and leverage a design partner to develop and transition your product into volume manufacturing.
3. How do you Approach Unit Costing?
An experienced design partner will identify potential cost implications early in the development process. Many times, inexperienced design firms will adhere to demands to medical device OEMs without assessing the long-term implications. This could drive the unit costs up and delay the development program.
As a result, OEMs find out late in the process that they won’t meet their unit cost targets and their business assumptions were incorrect from the onset. If this is the situation, it is critical it is discovered as early as possible in the development cycle that product strategies can be reassessed and meaningful changes can be made to the project plan.
In order to control unit costs, it is also a good idea to partner with a design partner with strong manufacturing relationships so that accurate estimates of manufacturing costs are established. Many design-only companies struggle in the design to manufacturing transfer process because they don’t have the experience or the sophisticated tools required to execute seamlessly and are surprised when actual manufacturing cost information is available..
4. How Financially Flexible are you?
High upfront costs can be a huge barrier for medical device OEMs. Many design firms may demand full advanced payment of the entire program before starting the development project. This is a red flag because it indicates a lack of trust and financial controls. Additionally, a design partner shouldn’t be using your cash for their operational liquidity needs.
Design firms that are financially strained cannot be relied upon to make your product their priority. There are many projects risk that you and your design partner will need to face together, the risk of insolvency and staffing changes are not risks a design partner should bring to your product development effort.
Partnering up with an established design firm with strong financial footing may afford you better terms and credit, allowing you to be more flexible with your resources. Larger design firms also will have proper insurance and quality processes to support you in the event of a product liability claim.
5. How Far Along can you take us?
There are lots of design firms that will happily enjoy the revenue provided from developing your product for as long as they can. But to ensure program and product success, your partner’s financial motivations must be aligned with yours. If you partner is not capable of supporting your product through transition to production manufacturing and sustaining support, it will be difficult for your organizations to remain aligned. Invest your time with a design partner you can envision building a long-term relationship with. One who will be able to and motivated to serve you throughout the lifecycle of your product.
Find a company that is multi-disciplinary, that can help take your concept from napkin to manufacturing to after-market services.
And lastly, make sure you work with a company and people that you like. There will be times of conflict and challenging situations, so you will want to be with a design partner that will support you and understand your needs.
Let’s be honest, tradeshows can be a bit crazy. With massive exhibition spaces filled with an infinite amount of people, booths and conference sessions over multiple days, it can sometimes be overwhelming to make best use of your time (especially if it’s your first visit to a particular show).
While MD&M West is not as big as a CES or Comic Con, it is one of the largest medical technology tradeshows in the world, attracting more than 20,000 engineers and executives. It’s a great place to be.
Because designing and manufacturing medical devices is a huge part of what Creation does best, we enjoy making the annual trek to Anaheim, CA (really not so much a trek as a hop, skip and a jump from our San Jose location) to exhibit, network and learn about the trends in the industry.
For medical device OEMs planning on attending MD&M this February, we created a guide based on our experience that will help you maximize your time, conserve your energy, and get the most ROI out of your trip.
Do Your Homework
This might seem like common sense, but it is always a good idea to get familiar with the lay of the land ahead of time and start planning.
You wouldn’t go to Disneyland without mapping out which rides or shows to visit first would you?
Save Time, Register in Advance
The first thing you want to do is to preregister for the show. Doing this in advance helps you get set up and ready to go so that you are not spending your first hours standing in lines.
Scout Your Prospects
Next, look at the list of exhibitors on the MD&M West website and determine which booths you want to visit, whether an EMS provider or a plastics manufacturing specialist. You also want to plan your visits based on proximity. Try setting up meetings in advance.
Our suggestion is to visit the websites of the companies that you are interested in. Create a spreadsheet and make notes on each, so you have their basic information (their services, location, clients, etc.) available and you can prepare questions you want to ask. In the spreadsheet, also put down their booth location. Download and print out a floor map as well. The MD&M West team does a great job of making this easy.
Be ‘In The Know’
You also want to go to the conference schedule to see what learning sessions, keynote speeches and networking events are must-dos. With MD&M West, you have the option to export the schedule via email, spreadsheet or print. Remember some sessions are free while other conferences and workshops have fees (for which you might have to register or pay in advance).
Beat the Clock
With multiple things going on simultaneously during an event, time management is crucial if you want to maximize your productivity. Being aware of the schedule and peak times will help eliminate delays, lines and missed opportunities.
Without question, you want to be early every day (especially the first day).
Since MD&M West opens at 10 am, it is best to head to the Anaheim Convention Center before 9 am to beat the rush. The parking lot and late-morning shuttles fill up very quickly. Typically, the first two days are the busiest, while the crowds thin out drastically on Day 3.
The lunch crowds are also large, so unless you consider waiting in a 50-person line a prime networking opportunity (do you want chicken or beef?), you are better off going to the concessions or Starbucks during off-peak hours (example: 11 am or 2 pm).
Remember, MD&M West is a marathon not a sprint. Makes sure to pace yourself for the three days and don’t try to do and see everything. Take breaks during the day, whether that is a walk outside or resting on any free comfortable chair in the hallways.
Dress for Success (and Here We Really Mean Substance over Style)
The most important item you can pack for MD&M West is good walking shoes.
The exhibit floor at the Anaheim Convention Center is over 800,000 sq. feet – so that is a lot of walking!
The majority of people dress in business casual, so unless you have a crucial meeting, you can leave your shiny shoes or heels in the hotel room.
On top of attire, bring a backpack to hold water, snacks, business cards (we know you wouldn’t miss this!), a notebook, and room for all the brochures and free swag you will be collecting at the booths you visit. From laser pens to t-shirts to the candy that keeps you going – collecting free swag is the best part of tradeshows!
Meet and Mingle
Conferences are not solely about fulfilling immediate business goals and closing deals onsite.
Professionals in every industry recognize the value of building relationships and having fun together to recognize alignment and shared vision – at Creation we know the importance of liking the people you do business with, and at events we have the opportunity to share laughs, games, gimmicks, cocktail hours, impersonators and entertainment at booths and on stage.
Again, pace yourself, it is a three-day show.
Educate Yourself: Network and Ask Great Questions
Whether you are in the market for a new EMS provider or need design assistance, make sure you find the company that is right for you to partner with.
Is This a Fit?
When visiting different booths, come prepared. You only discover if a company is a fit if you ask good, relevant questions. The more specific the better.
For example, if you are looking for an EMS partner, you can ask about:
Traceability and Visibility – Do you have a tool that tracks every step of your work?
Design – Are your facilities ISO 13485-certified and FDA-registered?
NPI – How fast can you get a new product out?
Transfer – Do you have experience with Class I, II, or III devices? (domestic and offshore)
Besides booth visits, MD&M West provides a platform to network. There will be opportunities to meet people within your specific industry, and find opportunities to collaborate or share ideas during different networking sessions or workshops. You will also be in contact with a lot of your competitors – which is not necessarily a bad thing. You can learn from what they are doing well as well as identify what areas you need to improve in.
Make sure to be friendly, give and take business cards, and follow up with your new contacts after the show. You never know how those relationships can benefit you down the line.
Fun in the Sun
Although MD&M West may be a business trip, you might as well turn it into a mini-vacation. There aren’t too many places better than Southern California in February.
Plenty of Options
After the show ends on Thursday, you can potentially spend the weekend in one of the several nearby cities like Los Angeles, Palm Springs or San Diego. But perhaps staying local is best. Anaheim is home to Disneyland, which is the happiest place on earth!
So now that you know what to expect from MD&M West, you can now take full advantage of this great opportunity. After your three days, you should go back home with exciting new contacts, new ideas, and a better understanding on what steps you need to take to be a major player in the medical device industry.
If you are lucky, you will also come home with a nice tan.
The start of a new year always brings people a sense of optimism. For those in the medical technology industry, it is the prospect of new innovative devices and solutions that will better humanity.
But for all the good that medical devices bring, the industry itself is complex, filled with many regulatory requirements and barriers. It is also a very competitive field, where every OEM is looking for any advantage to differentiate itself.
In the ever-changing landscape of the medical technology industry, there will always be new threats as well as new opportunities. Being aware, equipped, and adaptable is the key for OEMs to stay ahead of the game.
These 17 medical device trends may give you a glimpse of what to expect in 2017. Which ones have already affected your team or business model?
The Continued Rise of Wearable Tech – Wearable medical devices like glucose monitors and exercise trackers are projected to experience double the revenue growth of the overall device market. The global wearable device market was valued at over $13.2 billion in 2016.
Solving Cybersecurity Threats – The Internet of Things (IoT) has made it possible for medical devices to be smarter and more predictive when it comes down to patient care. The downside to devices connected to the cloud is the possibility of hacking. Expect OEMs to put a higher emphasis on cybersecurity in 2017, especially around HIPAA data protocols and exchange mechanisms.
Mergers Spur Growth – In the past few years, medical device OEMs have used mergers and acquisitions to boost growth. In 2015 and early 2016, there were over 150 major medical device company acquisitions and mergers. Expect that trend to continue in 2017.
The Trump Effect – With the new presidential administration about to begin, there is a lot of speculation on how this will impact the health care industry. Look for the industry to try to work with the new administration to lower medical device user fees (MDUFA) and improve the FDA regulatory process.
Medical Device Impact on Behavioral Health – Hand-in-hand with the Collaborative Care Movement, expect further growth in behavioral health diagnostic tools to help patients self-treat symptoms of conditions like depression, anxiety, and PTSD.
Hospital Consolidation – More than 100 hospital consolidations occurred in the USA alone in the last half decade, leading to fewer buyers. The trend of consolidation is expected to slow down in 2017 due to a tougher consolidation approval process.
Focus on Women’s Health Technologies – More companies and startups are developing innovative products and services to address childbirth, contraception, and medical conditions specific to women.
Don’t Sleep on Sleep Tech –Many of the most inventive and intelligent new gadgets were introduced this month at the Consumer Electronics Show (CES), the biggest consumer technology tradeshow in the world. One of the hottest digital trends was ‘Sleep Tech’, devices and diagnostic tools for sleep and stress reduction.
Cardiovascular Advancements on the Rise – According to a report by GlobalData, cardiovascular innovations are trending upwards. Two specific cardiovascular innovations—coronary bioresorbable vascular scaffolds (BVSs) and peripheral drug-coated balloons (DCBs) have made regulatory progress in the past year.
Larger Presence of 3D Medical Printing – According to the US International Trade Administration, in 2017, 3D medical printing technology is expected play a larger role in the development of innovative new devices, including applications for surgical planning and biomaterials.
Like every year, the medical device sector will experience technological advancements as well as industry challenges. Hopefully when 2017 is all said and done, the innovation and passion within the industry will continue to push the needle forward and make global health care better.
As Director of Regulatory & Quality for Creation Design Services, I continuously ask the question, “Is there value-add with the new UDI System?”
The regulations to make medical devices safer and with the highest possible quality are constantly evolving. A good example of this has been the implementation of the Medical Device UDI System.
The Food and Drug Administration (FDA) UDI System focuses on labeling medical devices with a unique device identifier (UDI) in human and machine-readable format. The legislation came into effect in 2013 and the implementation period continues until 2020. If you’re a regulatory professional in the medical device industry today, most likely UDI compliance is part of your daily conversation.
According to the FDA, a primary initiative behind UDI labeling is to improve device traceability throughout the life of the product in order to:
“Improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation”
However, validating that claim can be challenging.
How can the industry measure the ROI for UDI implementation?
Measuring the Benefits of UDI Labelling
Here are three tangible metrics that can be possibly used to gauge the benefits of UDI labeling:
Adverse Events – a reduction in future Medical Device Reporting (MDR) would suggest problem devices are identified and recalled earlier with UDI tracking.
PMA / 510(k) approval and clearance process time – UDI provides diligent post-market monitoring and analysis of medical device applications to support new uses and new medical benefit claims.
Device Recalls – UDI can quickly track down locations of end users for stop-use/ recall bulletins.
Adding UDI information to a patient’s electronic health record (EHR) may also improve the efficiency of health care insurance claims. In a recent letter from the Centers for Medicare & Medicaid Services (CMS), UDI information may “improve device oversight and monitoring and support more robust research”, however, according to AAMI and the U.S. Department of Health and Human Services, changes in workflow and updates to the billing and claim process would have to be implemented before this could happen. And this is a financial and resource burden the CMS apparently would not be willing to absorb themselves at this time.
Analysis and Prevention: ROI from a Holistic Approach
So will the UDI requirement provide additional patient safety? And is there a monetary benefit to gain as well?
I believe there are clear benefits of the UDI legislation, however, simply placing a new label format on a device will have little effect if the whole global supply chain and healthcare industry miss their cues.
In my mind, there are two key elements.
1. Good data and strong analysis with actionable correction
The onus falls on field reporting. Period.
ROI will only be realized with accurate identification of questionable devices and timely reporting of adverse events.
Traceability, swift recalls, root-cause analysis of failures and unambiguous conclusions are paramount to the success of the UDI program.
2. Harm Reduction as part of the bigger picture
Reducing the number of adverse events can decrease the cost of healthcare for all of us.
When a patient is injured or dies due to product or user negligence, the cost of litigation is passed on to you and me. According to U.S. mortality statistics, preventable medical errors claim 400,000 people each year. It’s one of the top killers in the U.S., third only to heart disease and cancer, costing a staggering $1 trillion each year.
So as a regulatory professional, advocate of the FDA’s UDI vision, and occasional patient, I look forward to finally seeing the benefits of a fully implemented system.
I believe that ROI will come via: faster FDA premarket notification and approval submissions, a reduction in harm from misuse of a medical device, and a reduction in overall healthcare costs.
UPDATE (October 27, 2016):
Creation Technologies recently launched its FDA UDI Compliance Program in their global manufacturing and design operations. In a move to ensure medical product safety and quality, all ten of Creation’s manufacturing locations will now require FDA UDI compliance and labeling for all Class I, Class II, and Class III medical devices.
I had an opportunity to catch up again with Jessica Crawford, President of New York-based MedTech, connecting bioscience, pharmaceutical and medical technology companies. Jessica and I discussed the success of the inaugural New York Medtech Week, the amazing innovation in New York State, and the upcoming MEDTECH 2016 conference.
The Inaugural New York Medtech Week
Janelle Urchenko: Jessica, it’s great to have the chance to catch up with you. I know that the MedTech team has been up to some exciting things lately, like June’s inaugural New York Medtech Week! Tell me more about it. Was it as successful as you’d envisioned?
Jessica Crawford: Absolutely! New York Medtech Week is a week-long initiative highlighting the numerous innovations and medical device companies in New York State that save lives throughout the region and around the world.
In this, the Week’s first year, we were able to share some incredible stories of why MedTech member companies do business in NYS. We also had a social media campaign, highlighting our medical device companies and the economic role the medical device industry plays in the various regions in NYS.
I would love to expand on this more for the 2017 New York Medtech Week and encourage our member companies, and other medical device companies in the state, to celebrate Medtech Week with us.
JU: I know MD&M East played a key role in this year’s New York Medtech Week. The Creation Technologies team and the team from iuvo BioScience, another MedTech member company, had a great time learning and meeting new people in the medical device industry at the conference and enjoyed spending time together in the MedTech booth.
JC: I’m glad to hear that Creation Technologies and iuvo BioScience had such a positive experience at the show! The reception sponsored by the two companies on Tuesday night was a huge success and drew numerous MD&M East attendees to our booth.
For our part, it was a great opportunity for MedTech to work with UBM Americas, the organization that plans all of the MD&M events, on an expanded partnership to launch Medtech Week. UBM has a strong following, so it was very beneficial in pushing the message out about New York Medtech Week and reaching many individuals in the medical device industry, not just our member companies.
Amazing Things for Medical OEMs in New York State
JU: One of the things that struck the Creation Technologies team at this year’s show was the diversity of conference attendees. Since our role in the industry is to design, commercialize and manufacture medical devices for OEMs, we really enjoyed the opportunity to learn first-hand the profound impact these products have for end users – patients, hospital administrators, doctors both in clinical practice and in academia. What is one of your key takeaways from MD&M East?
JC: For us, the key takeaway from this show is how essential the medical device industry is within the healthcare ecosystem. As the eighth largest medical device presence in the nation, the industry in New York State accounts for more than 13,000 jobs and $4.6 billion in overall economic impact. In Upstate NY alone, the medical device industry employs 8,400 residents across 141 business establishments.
While at MD&M East, it was great to see the 900+ companies exhibiting, many of which were from NYS or the Northeastern part of our nation. With so many leading companies under one roof, the networking and collaboration at this is event was palpable and we were so pleased to have supported this event as it helps to continue growing the Bio/Med industry in NYS.
JU: 13,000 jobs and 4.6 billion dollars – that’s a tremendous impact. What is at the core of this expanding New York State bioscience and medical technology market? Where is the energy and passion coming from?
JC: The numerous economic incentive programs in New York State help to maintain New York as a leader in the industry and continue to energize companies across the state. Since 2001, the region has seen strong employment growth in research, testing and medical labs (up 48%) and bioscience-related distribution (up to 9%) that outpaced national growth. The most highly concentrated industry subsector in the state is drugs and pharmaceuticals with a concentration that is 8% greater than that seen nationally.
Women in Leadership – Medical and Beyond
JU: Speaking of government and its strong advocacy for economic growth in the medical sector, it must have been a treat to have Lieutenant Governor Kathy Hochul as part of the New York Medtech Week kick-off. Not only does her participation underscore the importance of the Week and the opportunity for New York to lead the way in medical device innovation, it also highlights the fact that many of the people now leading the way are women. What’s it been like to work with her?
JC: Working with Lieutenant Governor Kathy Hochul is always a great experience.
A Buffalo native, Hochul is a true friend to our state and to MedTech, and we were honored to have her speak at our annual conference, MEDTECH 2015. Hochul and her team work relentlessly with Governor Andrew Cuomo to continue helping medical device companies in the state and improve the overall economy of NYS.
She and her team continue to impress me, specifically with their responsiveness and interest in helping NYS companies. At MD&M East she met with one of our member companies that is interested in expanding in Upstate New York. Hours after she left the event, she followed up with the company interested in setting up a meeting. It’s that level of responsiveness that makes working with her such a great experience.
JU: MEDTECH 2016 is coming up quickly! What can we expect from this year’s annual conference?
JC: That’s right, MEDTECH 2016 is just around the corner, scheduled for September 26-28 at the Albany Hilton in Albany, N.Y. While MEDTECH 2015 focused on the need for industry collaboration and leveraging the strengths of non-traditional partnerships, MEDTECH 2016 will focus on the need for New York State companies to effectively innovate and what the upcoming election means to the Bio/Med industry.
JU: We’re excited to attend again this year, and I know Sean Priddy from Creation Design Services is looking forward to being on one of the panel discussions in the always-interesting Innovation & Technology track.
Last question for you, Jessica. Leaders like Kathy Hochul are having an obvious impact on the growth and success of the medical industry. As the President of MedTech, what has it been like for you personally as a woman in a leadership role in the medical industry? What advice would you offer other woman leaders and entrepreneurs?
JC: My biggest piece of advice for women looking to take on leadership roles in the medical industry is to be passionate about the industry that you work in and continue to grow your professional network. My interest in healthcare and passion for helping our members succeed is what drives me every day. Each week I meet with companies that share the same desire for pursuing medical breakthroughs and improving the health of all. It’s these individuals that motivate me to continue to be my best.
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.
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.
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
In the medical device industry, the reliability of a product is critical for patient safety. If a device has design flaws, missing due diligence documentation, or perceived gaps in compliance, an OEM’s credibility and ability to deliver a high-quality and safe product on deadline comes into question in the marketplace.
At Creation, we understand the importance of our customers’ brand equity. Every day, I get to see the commitment our manufacturing teams have to delivering high-quality products on time. Maybe more importantly in my role as a Director of Quality and Regulatory, I also see how we analyze and provide evidentiary documentation to meet and exceed the compliance standards required in the highly-regulated medical device industry.
I’m very proud that Creation Technologies has achieved our strategic milestone to provide third-party validation of our high-reliability and quality inherent to successful medical device manufacturing and design. Today, I’m excited to say that all Creation global manufacturing and design locations now have ISO 13485 Certification.
The ISO 13485 Certification is an internationally recognized quality standard for medical devices and diagnostics. With this thorough and effective quality management system in place company-wide, I know that our customers can continue to count on us to commercialize their innovative products that have the utmost consideration for long-term patient safety and sustainability in the marketplace.
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.
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.
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