ODT Forum Program Notebook

9 a.m.- 9:45 a.m.

State of the Orthopedic Industry

Speaker: Bryan Hughes, director, P&M Corporate Finance

Other industries have true partnerships, as opposed to orthopedics. Given regulatory, pricing challenges there truly is an opportunity for partnering in the industry.
A lot has changed in orthopedics since 2010. With orthopedics, the unexpected happens, like anything in life. 
Forward-looking perspectives are always (partially) wrong when looking in the rear-view mirror.

Industry snapshot: Industry has transitioned into late-stage industrial segments.Total industry revenue is projected to be $47.1 billion in 2024. Only Wright Medical, Globus are expected to grow more than 5 percent. U.S. population is getting older; in 10 years, population over 65 will be greater than those under 18. With an aging population comes an exponential increase in healthcare spending. More encouraging is within age bands, the utilization of orthopedic procedures has risen dramatically in the last seven years. 
The U.S. is ahead the rest of the world in obesity rates, but the rest of the world is close behind. Research indicates total knee replacement rates could increase 600 percent by 2050. 

Stryker Corp. – Drive market-leading growth and achieve category leadership in MedSurg Equipment, Orthopaedics, and Neurotechnology/Spine. Focus on cost improvement and margin improvements in the supply chain.
Wright Medical – Moving away from definition of orthopedic company to a high growth medtech firm. Significant digital ecosystem, and bringing lots of different technologies and patient data together to improve the patient experience. 
Zimmer – Increase in robotics and ecosystem of connected/digital health to provide best patient experience.

Orthopedic robotics – Spending time at AAOS in past few years there is no way to escape the dominance of robotics on the industry. Competing lead orthopedic players are taking different approaches to marketing the robot and how it fits into their respective portfolios. Zimmer had ROSA everywhere at AAOS 2019 but if you wanted to see the robot DePuy is developing, you had to maneuver your way to the booth and even then was not very visible. Question we keep asking is what is the true market opportunity in orthopedic robotics?
Surgeons feel they are way better in surgery than robots will ever be. How much of the procedure do you want to take out of the surgeon’s hand? With ROSA, there is still manual cutting involved. Do surgeons see a need overall? Will they need robots in their procedures? A RBC Proprietary Surven of U.S. orthopedic surgeons revealed most have been trained on MAKO. 
Purchase of a robot is about $1 million on average. Surgeon is interested in incorporating robotic surgery in their practice, but there better be a cost benefit and clinical value in bringing that robot aboard. 
Healthcare will play a major role in the 2020 election cycle. Increased focus on value-based healthcare will not change much in the future. CMS view – rewards healthcare providers with incentive payments for the quality of care. Three-part aim: Better care for individuals, better health for populations, lower cost. CCJR Bundle – a five-year initiative, bundle all payments, entire episode of care, risk/reward arrangement. In the initial stages, there was little cooperation, but now there is nearly 100 percent cooperation. 

Care delivery is evolving. “Focused on the right care, at the right time in the most appropriate setting.” 
Outpatient Utilization – TKR total cost compared to inpatient procedure – 62 percent lower for outpatient ($19,002 vs. $30,249 for inpatient); THR total cost is 71 percent lower for outpatient compared to inpatient procedure ($22,078 vs. $30,685) – BC/BS data. Estimated 2026 outpatient percentage is 51 percent. 2017 knee outpatient utilization was 17 percent. 

As the delivery landscape changes, it impacts pricing, it impacts margins and suppliers. Given pricing pressures, operating leverage has become the name of the game to continue to deliver double-digit EPS growth. 

Orthopedics lags medtech in R&D spending. But many orthopedic companies are expanding through acquisition – they are driving much of their return from an R&D perspective by investing in technologies that are outside of the organization. 

Orthopedics supply chain is evolving, following the lead of aerospace and automotive industries. But why aren’t orthopedics moving more toward outsourcing like other industries? Reality is there are not enough large suppliers to go to. Medical contract manufacturing – $50 billion market. In 2013, Jabil’s healthcare business was roughly $400 million; today it is $3 billion. Acquirer industries often have lower profitability. 

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9:45 a.m.- 10:30 a.m.

Perfect Storm: Addressing the Changing Face of Regulations in the U.S. and Globally

Speaker: Christine Scifert, co-founder, MRC-X LLC

Everything I tell you right now is subject to change. There’s a lot of uncertainty out there.
What is a medical device? One size does not fit all. Rules and regulations are going to change. Global regulatory requirement significantly impact a healthcare company. Regulatory landscapes are dynamic and the rules are always evolving. Rules vary by country and decisions can lead to delays to market launch. 

You’re going to have to do things in most market these days. What is the easiest/fastest geography to launch a medical device?
Europe? Historically it is true, but is no longer the case. The U.S. will be the easier market in the future – it is a changing world right now in terms of what strategy/approach will be in launching products. Different countries have different things that are sticking point. Class I devices certification is changing; Notified Bodies are taking a long time in Europe these days. Be sure you have the appropriate reviews and documentation. Spinal implants – in U.S., still a class II, but in Europe some of these devices are being upgraded to class III, some are still class IIb. 

Timelines for new regulations:
ISO 13485:2016 – complaince required by March 2019
MDSAP compliance required for Canada in January 2019
MDR Compliance dates and MDD Certificate Expiration

• MDD Cert expires before May 2020 complete renewal, so you obtain a certificate with longer date and therefore a longer transition period (some notified bodies are pushing for renewals by April 2019).
• MDD Cert expiring after May 2020
• Opportunity to have transition between May 2020 and your Certificate expiration date
• Only BSI UK has been certified to audit to MDR

MDR 
Class I, compliance required by May 26, 2020. Product placed “on the market” before that date can be sold until may 26, 2024. New imports into EU must comply after May 2020.
Class Ir (reusable) – required by May 26, 2020. New classification so must comply by May 2020 to keep product on the market.

MDSAP Advantages and Challenges:
MDSAP audits can cover the following regulations: U.S., Canada, Brazil, Japan, Australia (recognizes CE Mark so MDR impacts Australia, too). Not Europe.
Canada requires a MDSAP certificate by January 2019
MDSAP audit scope can be tailored to the countries where sales occur or are planned.

Europe is changing. MDD vs. MDR – it’s more than just initials.
A “directive” is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Came into force in 1993.
Major changes in MDR – changes from a pre-approval approach to a total life-cycle approach.
Greater emphasis on clinical trial data and evaluation on the device, for all indications, and for off-label use. Clinical investigation will be expected for implantable devices. 
Greater supervision of notified bodies, which means less notified bodies will be certified under MDR but more work for notified bodies.
Class III – Technical documentation for every device with expert review.
Class IIb active with drug administration or removal – technical documentation for every device with expert review.

Major changes: Authorized reps (roles expanding), importers, distributors, all have legal liability and defined obligations. 
Reclassification of many medical devices to a higher risk (spine is being affected by this, including cages, disc replacement, facet replacements, etc.)

MDR major changes for clinical evaluation – Need to show product has clinical data – not equivalency, but adequate data to put product on the market. These clinical evaluation reports need to be updated annualy every two or five years depending on use/product. Have to own that data – cannot cite data from other publications – you have to own the data. 
Periodic safety update report – required for many of the class IIa products, every two years. 

Look out for standards updates. MDR will impact labeling – make sure it’s readable by humans. Authorized representative name and address on label (MDD allowed on IFU). Implant card and information to be supplied to the patient with an implanted device. Marketing claims must be one label and substantiated,
EU electronic labeling: if manufacturer has a website, the IFU must be made available and kept up to date on the website.

MDR impact on supply chain: manufacturing process flow identifying all suppliers (first, second tier, etc.) must be mantained by legal manufacturer. Suppliers need to have QMS. Supplier holding an ISO 13485 certification.
Suppliers providing product/services that could impact the safety of the device will need a quality agreement. Includes but not limited to raw material, packaging components, manufacturing, coatings, sterilization services, etc. 

MDR and EU economic operators – importer of device into the EU has responsibility to verify compliance (need copies of Declaration of Conformity). Need to confirm authorized representative is on the labeling and the device is registered…
Authorized representative – held legally liable if the product is found to be non-conforming. Keep previous revisions of technical documentation and declarations of conformity for at least 10 years.

Companies have to have a regulatory compliance role as well. Can be more than one employee but responsibilities must be documented in writing. Small firms can use a consultant if a consultant is permanently available (not sure what that means). 

Brexit is causing more uncertainty with the regulatory changes coming about. Will impact trade agreements, imports/exports, acceptance of MDR. If you have a U.K. notified body, move to a EU located notified body. 

Biocompatibility testing global requirement – testing demonstrating the final packaged device is biocompatible. This is more than assessing the raw material. Need to consider color additives, nickel, phthalates, contaminants, manufacturing residues, product degradation, etc.

U.S. – What is Next?
QMS 21 CFR 820 planning on replacing with ISO 13485:2016. FDA working on proposed rule and expects to issue rule in 2019. Implementation will take several years. Biocompatibility required now (2016 document). Risk management (ISO 14971 is a recognized standard). Full compliance with risk plan and risk report is not currently part of submission planning…
Clinical benefit 510(k) device – clinical data is not typically included in 510(k)s to demonstrate SE. However, FDA issued a guidance in 2018 about clinical data for 510(k) with different technological characteristics.

End Game –
Time and money considerations – does it make sense to invest?
Manufacture or distribute the device?
Specification developer and legal manufacturer?
Sell the rights of the product?

EU MDR Considerations – Cost for: QMS audits, clinical data review, clinical data collection, generating testing to demonstrate device compliance to regulations, submission, authorized representative, liability insurance, UDI, labeling translation, FTE to maintain compliant documentation. There’s a big shift from what everyone is used to. There are a lot of resource issues going on right now with notified bodies.

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11:15 a.m.- 12:15 p.m.

Tech Talk: An Overview of the Growing Role of Additive Manufacturing and Robotic Surgery

Moderator: Dawn A. Lissy, president and founder, Empirical

Panelists: Chuck Hansford, director of Advanced Materials Processing, Tecomet Inc.; Brian R. McLaughlin, founder and CEO, Amplify Inc.; Elise Wolf, senior analyst, Computer-Assisted Surgery, SmartTRAK, Mitch Foster, CEO, Mindset Medical

Lissy: Subtractive vs. additivie manufacturing. What are the similarities, differences?
CH: Similarities in materials. Additive allows you to grow anything you subtract. Differences? Brian can take that one.
BM: Design freedom includes a lot when it comes to orthopedics. Additive manufacturing is very software intensive. Supply chain as a whole (main difference) – you need both. One will not replace the other at the end of the day.
CH: I don’t know of a product today that is manufactured additively that doesn’t have a secondary machine. Will additive replace subtractive? Not in my lifetime, not in next 20 years.

Lissy: What is the advantage of additive manufacturing?
CH: To design items that you previously couldn’t design before. Design freedom is the biggest benefit. Native to that is we don’t have people educated to design to the process.
Lissy: From product development standpoint, one of the benefits of having this technology is you can fail fast.
CH: Technology lends itself to things we’re not accustomed to doing. 
BM: Additive – challenges are sensitivity.
Audience member: Advantages – just in time manufacturing, less inventory, so you are taxed much less – cost savings to your company. 

Lissy: Are there different kinds of additive manufacturing processes?
CH: direct metal laser sintering and electron beam processing. Where do they fit – are they contending technologies or are they similar? Laser gives you finer qualities, can generate near net shape or net shape products. E-beam gives you a rougher surface finish for bone growth, have that ability to create bone growth surface application.
BM: Processing is different. Material properties coming out of e-beam is superior to raw materials. Also a facility difference – laser powder is in a different category than e-beam. I’ve used both technologies for implants and instruments. 

Lissy: What are the access issues in using additive manufacturing both today and in the future?
BM: Understanding the technology, where are the universities setting up, what are students learning? Starting to see more programs at more universities now. 
CH: Universities are actually teaching design process, which will take it to a whole other level. We’ve seen geometries that we’ve never seen before, which is the biggest win for this technology right now. Concern I have is the more machines you put in the market, you have to have better education to support those machines. So many things involved.
BM: Have a lot of suppliers, each offering something very different. A lot of companies are trying to establish education centers and that is helping, but it’s not going to create a component or device.

Lissy: Words of wisdom for product development issues that exist in the industry connected with additive manufacturing? Where do you get the education to design appropriately?
CH: There’s software to change a design by removing material, adding struts, improve strength, etc. 
BM: Additive manufacturing is not just one piece of software. There has to be an understanding of how to design for additive manufacturing…understanding every step of the way and the impact that will have on the product. That comes with experience, and suppliers can help with that experience. 

Lissy: Validated processes – what does a validated process mean when it comes to additive manufacturing?
BM: Traditional validated processes – but there’s the question do I really need it? Idea of validation is a challenging one in general.
CH: With this technology, you are validating against the material. Now that there are standards and guidelines out there, we can get into a lot of detail around validation. Great thing about this technology, once you create that parameter set, you’re gold. 
BM: What does the technology mean for your process, handling your parts? There are challenges – how do companies deal with the FDA?

Lissy: Let’s talk about surgical navigation, robotic systems. I want to build a robot. What do you say to that?
EW: I would say get in line. It’s still an industry that is in its infancy – by 2020, certainly by 2022, the major companies in this space will have a robot. J&J just got CE Mark for ROSA for spine and knee applications. There are a lot of robotic systems coming in and not just with the bigger players. Think Surgical has a robotic platform they are developing, has technology for hips, in the process of applying it to total knees. Want to be robotics provider for companies that don’t have robots.
MF: Why? Why do you want to build a robot and how will that drive patient and clinical value? Lot of questions on where you will focus on clinical and patient value. The key driver is working closely with surgeons and solving the clinical problem but never losing sight of the economics.

Lissy: How many hospitals have robotic systems in place?
EW: It’s a new space in the industry but 10 percent have robotic systems right now. It’s an exciting market – in the 90s, I used to design robots for the Department of Defense and then I switched to medical devices. When the opportunity came up to cover this space, this technology is really cool. There are a lot of exciting technologies coming into this space with augmented reality, AI, so it’s a space that’s going to be changing rapidly. It’s very much an evolving space and there’s a lot of room to grow. 
MF: It’s an exciting space, hospitals are being challenged to adopt technology that allows them to offer economic options to patients and providers.
EW: On spine side, there is a component of practice marketing for robotics. Some doctors have justified bringing robotics in because procedure volume has been declining. Clinical data is key, and Stryker has pretty big advantage on orthopedics side. In the end, we’re looking at clinical benefits for patients.

Lissy: What is a realistic timeline for robotics?
EW: Not as long as it had been in the past. It takes a while to get these things developed. With advances in technology, robotic prototypes are being developed quicker…as the technology expands, we will see more robotics coming into play but it’s going to be tough with major players already having robots.
MF: Critical for anyone diving into robotics that they look at where they are in the market. 

Lissy: This is a paradigm shift. DIfferent companies are taking different approaches to business models. What have you seen in the market?
EW: Over the last six months or so, we’ve seen changes in business models, Globus is focusing on capital equipment sale; companies are focused on getting utilization with robotics. Medtronic for example, had been placing systems, now looking at getting implant commitments. Want to gain share in their implants in addition to offering robotics. Another option for companies is expanding indications to include interbody and other indications – that’s where you’ll see traction. 
MF: Improving outcomes, reducing time for procedure…for a robot, it could become the nucleus of a procedure. Monitoring a patient from a nerve standpoint – there is some great stuff we can do. Excited about the future but we should be grounded in reality.  

Lissy: Where do you think this technology will be in the next 10 years?
MF: I am bullish on it. We are seeing more spine surgery and more access to technology now. We’re going to see a significant adoption of this technology. I’m very bullish on where this technology goes. Just being more efficient in healthcare and making sure we provide that clinical value – the numbers have to jive.
EW: Surgeons have said 40 percent of total knees will be robotically assisted in the next five years or so. It depends on who you talk to – the advocates are really into it, but there are some naysayers. A lot of navigation companies out there – with new technologies – are really excited about the adoption of robotic systems because it lends credibility to the procedure. When I first started covering this space, I was shocked at the number of augmented reality companies developing this technology. I’ve been hearing from a lot of bigger companies that have robotics and navigation technologies that they are interested in augmented reality. Seems like every month something new is coming about in this market. Companies that have robotics outside the orthopedic space is gaining traction. There’s a lot of interest out there. Trend will be to have lower-cost systems, more rapid technology that fits into the workflow for the surgeon. 

Lissy: Why would someone look at having a robotic system? What are the benefits?
MF: Accuracy. As good as surgeons are in spine surgery, when there are adverse events, it’s a big deal. Robotics can remove a lot of issues you deal with in spine surgery. A surgeon in New York said, as good as we are as surgeons, the robot can make us better. 
EW: Radiation reduction. Technology that is capable of doing that is really on the radar. It’s not as far removed as the DaVinci type of robot. 

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1:45p.m.- 2:30 p.m.

Smart Implants: Data and Analytics in Orthopedics

Speakers: Lisa Ferrara, Ph.D., owner and president, OrthoKinetic Technologies/OrthoKinetic Testing Technologies; Sagar Patel, CyberSecurity Lead, Battelle; Dan Sands, CEO, director, AMB Surgical; Alison Sathe, founder, Regulatory Mark

Sands: Common theme – it’s about the data and the next generation of technologies coming into this space. 
Revolutionary aspect of smart implants – Disruption in medical devices happens at a snail’s pace but then all of a sudden…innovators adopt something simply because it is new. Early adopters are often opinion leaders. Categories of smart implants include wearables (prevention, monitoring, treatment of quantified self), smart instruments (timely, accurate and actionable presentation of intraoperative information), smart implants (devices that provide not only therapeutic benefits but also have diagnostic capabilities). 
Challenges are cost pressures, differentiation, improved outcomes, efficient care delivery, individualized care, remote/in-home care delivery. Another challenge is making smart implants pro-active rather than reactive. Is this hype or real? It’s a timing thing. Adoption has its challenges – it must be disruptive and superior technology for maximum value. It must offer a superior solution to patient quality of life (improved outcomes)…
Data and analytics are the differentiator. The integration of smart implants into daily clinical practice has the potential for massive cost savings to the healthcare system. Data from smart implants has led to refinments in implant design, surgical techinque and strategies for postoperative care and rehabilitation. 

Clinical and Regulatory Perspectives
Ferrara: Smart tech definition – systems capable of imitating human intelligence; systems that learn and respond to changing stimuli; systems that provide physical, chemical, and/or mechanical diagnostics. Can we mimic living systems? That’s a big question. Human tissue is the ideal smart system. Physiological systems are highly mapped. We’re on our way for smart measurement systems for detection and response. There’s surface-based technologies and sensor-based technologies. Thinking about diferent ways of detecting certain stimuli and directing certain responses. 

There are still challenges that exist for these systems. The human body can be a very harsh environment – long-term corrosion and degradaton. There is research into coatings. Regulatory pathways for these technologies are still in their infancies. There are not a lot of established testing models. The smart technologies may share same application but vary in the way they make their systems smart. May be more of a customized system for regulatory and test areas. Have to combine critical thinking and creativity – think not only short term but also long-term what happens and how to maintain the technology. 
Evaluating smart tech carries with it a lot of challenges. There is a lack of current test standards and guidelines for these systems. There is also a lack of equipment and resources to evaluate new tech; smart implants with the same indications – may differ in what makes them operate in a smart manner. Have to think out of the box.

Tips for evaluating smart tech – use test standards from other areas as a guideline.
Safety evaluation – provide comprehensive tests for full safety profiles. Use test standards – tailored for the new technology… and know the pitfalls (unrealistic goals and timelines). Other pitfalls: Inexperienced team, inadequate/unrealistic funding (no shortcuts), lack of evidence to support safety and function, inadequate test strategies…

Software in Regulatory Perspectives
Sathe: Evolution vs. revolution – is it something new or is it something that is an add-on to existing tech? There is a lot of new guidance coming out of FDA, right now the statutes haven’t changed. Thus, looking at the same framework – pathways include device listing, 510(k)s, de novo, PMAs. Key is documentation in all these areas. Make sure you have all documentation in order.
To make an existing tech smart – look at labeling changes, technology/engineering/performance changes; and materials change. All class III devices will require a new submission. Any class II device made smart will likely require a new submission.
Evaluating changes to existing tech, consider: does the change significantly affect safety/effectiveness? Conduct a risk-based assessment. What are the unintended consequences of the change? Are there unexpected results encounted during validation and verification? Evaluate all changes separately and in aggregate. Document per your QMS; compare to your previously cleared device. 

Software updates – FDA has a guidance that tackles baseline issues. Is it solely a cybersecurity change> Does the change return the specification to the cleared device? What is the impact to risk and risk controls?

Regulatory considerations in development – Is it a standalone software or part of a system? SaMD – FDA has new policies tailored for SaMD including the pre-cert program, SaMD clinical evaluation, and SaMD guidance.
Smart implants – hardware (device) with software – start early (software development environment description, LoC). Ensure your software documents are captured in your quality plan and project plan. 

Regulatory considerations in testing
Software verification and validation.
Verification – Looks for consistency, completeness, and correctness of the software and its supporting documentation as it is being developed, and provides support…

Principles of Software Validation
Requirements must be clear and well-defined; defect prevention – testing isn’t sufficient to establish the software is a fit; time and effort – begin early, conduct throughout lifecycle; coverage- based on complexity and safety risk; independent review; validate changes for the change and the system…

Cybersecurity considerations
Patel: Features vs. Security issues – Increasing connectivity of smart implants lends them to data analytics, improved decision-making, remote therapy, remote software updates, and easy configuration changes. 
This also introduces potential security risks: Increased number of attack vendors; increased risk of device being hacked; patient data privacy issues; and adjacent risks (safety, regulatory, reputation risks). 
Prevalent security threats: STRIDE (Spoofing, Tampering, Non Repudiation, Information Disclosure, Denial of Service, Elevation of Privilege). 

Key Security Aspects
What can happen if a vulnerability is exploited?
How to minimize risk of being exploited
The technical feasibiity of exploiting a vulnerability (practical vs. theoretical risk)
Long-term fixes for the vulnerabiity through a firmware update
Possible risks associated with software/firmware updates
Weighing the benefits of the device vs. the risks associated with the vulnerability

Total Product Lifecycle Security Risk Management
Pre-market stage: Risk profile assessment; connectivity and date lifecycle strategy; secure architecture; security requirements development; threat modeling; vulnerability assessment. 
Post-market stage: Supply chain validation; coordinated vulnerability disclosure; threat modeling; vulnerability assessment; vulnerability mitigation and patching.

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2:30 p.m.- 3:15 p.m.

Design Innovation: How Human Factors and Industrial Design are Reshaping Orthopedic Design

Speaker: Bryce C. Rutter, Ph.D., founder and CEO, Metaphase Design Group Inc. 

What is the best designed product you own? Your car? Your iPhone? Your Gucci shoes? I’m trying to design products people love to use and be around – that are seamless extensions of their body. Here’s three things I love – I love my nest thermometer. I never thought I’d get so excited about a thermometer that I’d call my wife over and say “You have to see this thermometer I just bought for us!” My Gretsch guitar – I look at it and admire the craftsmanship in it. The Omega Seamaster watch – I could have bought a timex that would have kept just as good time, but when I slip on the Omega Seamaster product, I feel like James Bond. 

How many here own an Apple product? How many have thrown out the box?
Core component of great design – make an emotional connection with the people that make your stuff. There’s something about that favorite product you love – there’s an emotional connection to it. 

You can change perception of taste by the way it’s presented. Scent is one we don’t do much about – the persistence of sensory modalities is very strong. Sound – things can sound cheap, expensive, irritating. There are products that when used, sound cheap. Remember K-cars? Close the doors and it sounds like a tin can. 
Visual signature – The potency in the visual appearance of a product does matter. Medical instruments do matter. For me, one of the most overlooked senses in the design of anything is the sense of touch. Remember the first touch of your baby’s hand…I can still remember sitting on the couch and feeling the warm leather hands of my grandfather. Three most important tools in the design of anything is touch, sound, sight. Brands that offer you more than the basics: amazon, Google, Virgin, SONY, US Airways. The grand masters of our time is Steve Jobs, Walt Disney. Their contemporaries are Elon Musk and Richard Branson.

User centered innovation. The user is the ultimate judge and jury of what you bring to market. But don’t think only of end user, think of everyone who has to touch it. For me, watch and listen. It sounds obvious but few people do it. Everyone has their own set of requirements. The lens you look through is important. Sending a marketing team into the field isn’t a bad idea…
If you sell global products, you better be going global because things change. 
Contextual inquiry – finding out how people use as opposed to what they claim (how it’s used)…
Workflow – look at layout in the room and determine how to make it more time efficient and user-friendly.

Ethnographies – What people say they do and how they behave is always different. 
Usability studies are very important, whether they be in clinical lab or seeing how people interact with instructions for use. 

Personas – There are routinely different types of users, especially with global products. Understand the unique characteristics of all different personas and incorporate them into the final design.

Human Factors design: Use this term so we don’t forget the human part. 
Form involves comfort, surface topology, and physiological mapping. 

One of the most important things in medical products is haptics and dexterity. We all come in different sizes and shapes – how do you design something for one size fits all when a woman’s hand is generally smaller than a man’s? We change across the age spectrum…for all men designing products – go to Walgreens, buy fake fingernails, glue them on and wear them for a day because it changes how you design things, it really does. Hand has 27 bones, 37 muscles; 10 percent of the population is left-handed. Have 31 degrees of freedom in one hand (62 degrees in both hands). Grip architectures – the majority of all grips fall into three categories: power, precision, hook. Depending on task, have to find balance between precision and endurance. Short story on balance – you don’t want it on the tail, don’t want it on the front, you want it straight in the middle. 

Textures are always a challenge, especially in surgical instruments that have to be cleaned. Have to look at force of action you’re going to execute…
Dexterity – how we use our hands. The scalpel is a forged product – forces you to use your whole arm to make cuts that are not straight. Gross motor control. Superfingers – using two dumb finders together to clamp against the heel of the hand. 

Don’t forget about packaging and the instructions for use. Instructions are a band-aid for bad design. There’s a direct coorelation to how many instructional steps there are and how bad the design is. Should you use photos or illustrations for instructions for use? I say use illustrations. Focuses the eyeball on exactly what you want the user to look at. 
When designing products that have a digital interface, the age bracket you are dialing into really does matter. 

We now need to think not only of the hardware but also of the digital footprints and where they are landing. Understanding how we perceive things is something that has been studied since the 1950s. Look at all the dashboards we have now – there is so much digital noise in our lives. The fact we don’t use much of the power we have in our hip pocket is because no one is looking at how we look, feel and behave. Make it simple. The dignity of living is important. 
Person who designed the patient gown never had to wear one (because it ties in back). Walkers that have tennis balls on the bottom? Not a great design. 
There’s a chronic disease in the industrial design community. Designers love to design things you can’t make. 
Human factors is not something you sprinkle on – it really dictates the strategy for conducting user research and it’s the voice of the customer throughout the development of the design. 

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4 p.m.- 5 p.m.

Executive Viewpoint: A Panel Discussion

Moderator: David C. Kelman, president, Kelman & Company Consulting LLC
Panelists: Dean Hughes, vice president Knee Product Development, Smith and Nephew; Scott Shankle, vice president of Operations, MicroPort Orthopedics Inc.; Chris West, president, ZeroTo510 Medical Device Accelerator

Kelman: Hughes said the orthopedic industry is behind in creating partnerships with vendors, design houses like the automotive and aerospace industries.
DH: There’s always ups and downs in the industry. Always looking for new technologies and supplements in the field.
SS: There will certainly be times of insourcing and outsourcing. 
CW: From innovation standpoint, we believe innovation is the great balm that soothes everything. Compromise and price pressures force people to realize the old ways of doing things don’t work anymore. Innovation is the lifeblood of all these organizations.

Kelman: How do you manage risk in large companies?
DH: Big companies are still innovative but still looking for bolt-on tech.
CW: Big pharma doesn’t do lot of reearch anymore, leave it to small labs…there is such a huge crush for reimbursement in pharmaceuticals, that innovation happens outside the big companies. Believe that is where innovation will go in orthopedics as well.
SS: Top down innovation does exist but it’s not enough anymore. What can you sell along with that – robotics, digital tools. Gets into the full support and continuum of care. That’s where I see innovation happening. 

Kelman: Will there be a re-examination of your core competency? What is the true core of the orthopedic industry?
DH: From a core value standpoint, you have to look at the data. And that data translates into the logistics models that are coming. Changed from what it was five years ago.
DK: There’s a perfect storm coming – heard this morning that total knees is going to increase 600 percent by 2050. How do you handle that increase? How do you manage the requirement of being more efficient?
DH: Global capacity is going up, pricing pressures taking place. Take a step back and look at what Smith and Nephew has been doing over the last few years – robotics. That’s what is going to take shape over the next several years.
SS: Any time there’s price pressure and want to keep the same service, there’s a lot there. Companies that focus on value are going to have the best opportunities.

Kelman: Where are the opportunities? In adjacenct technologies?
CW: From our standpoint, we’re lacking the insights into what a company is trying to solve. I would like to see the model bend some – we need to start with where the problem is and then find innovations that can solve those problems to help move projects forward.

Kelman: Can you get government funding:
CW: We are good at scrounging resources, getting grants and we instituted an angel network, raised over $2 million in annual capital for inventors here in Memphis. We’re resourceful in finding ways to help companies. We look for all ways to fund projects when we can.

Kelman: Do you seen 3-D printing as the future? Is this an entry point for startups?
DH: It’s definitely part of the future but we have to be smart about how we implement it. Giving the engineers a different perspective in how to design and what can be done.
SS: There are defined terms on what it can do. Longer-term is hard to predict…different materials may be easier to print. The game is going to change.

Kelman: Regulations – how big a pain is it and will that be a killer?
DH: It’s a tremendous strain for every company. You have to pay attention to it, you can’t ignore it. What it may do globally is drive out some small players.
SS: I think it’s going to put cost pressures on OEMs…cost is not just manufacturing anymore. We have to have regulatory and quality people on board, we can’t keep doing it the way we’ve been doing it. There are automation solutions there – tools like accounts receivable, accounts payable. 
CW: Going to be tremendously difficult. This is going to have a huge shake-up effect; companies are going to have to be more efficient. The changes for MDR will help prepare the industry to better fight off reimbursement challenges.
DH: Selling ideas and getting reimbursement is going to be more difficult. Brexit is coming whether we like it or not, have to deal with that.
SS: Is it possible to see a pullback in regulation when innovation starts to slow? What you can learn from Europe (compared to the United States) – there’s something to be learned from U.S. OEMs and trying to figure out – the U.S. is starting to look like what Europe used to look like.

Kelman: Not one-size fits all solutions in this industry.