Thought leadership on medical device customer support

Oct 29, 2015

How can we keep medical device reps out of the operating room, but not out of the picture?

A victim of suboptimal medical device training and supportFred Taylor went in for a routine prostatectomy that was supposed to take five hours using the DaVinci surgical robot. However, the surgery ended up taking 13 hours with severe complications that caused him to be incontinent, leading to kidney/lung damage, sepsis then a stroke. He ultimately died a year later.He was a victim of poor medical device support and training for surgeons that led to suboptimal outcomes and ultimately could have been a factor in his death.Financial gains ahead of patient outcomesThe DaVinci received premarket notification approval without requiring robust safety and efficacy data in exchange for providing detailed data on how surgeons would be trained on the system. Intuitive Surgical provided a 70 question exam and three day hands on training as part of the approval.However, within a year they dropped it down to a 10 question online quiz and one day of training.The surgeon mentioned previously, who used the DaVinci, had never used the system during a surgery without supervision. Intuitive Surgical, the company who markets and trains surgeons on the DaVinci, was called into question on the quality of training and support they provided before surgeons use the system on actual patients. Hospitals are responsible for setting the training requirements in order to be credentialed on using the DaVinci system. Intuitive Surgical sales reps were responsible for pressuring hospitals to reduce the credentialing standards to drive quicker adoption.“Don’t let proctoring or credentialing get in our way” said a Western regional sales manager when an account had only used the system 5 times when their sales target was 36.Salesmen in the operating roomIntuitive Surgical is not alone in the medical device space. New medical device and procedures are launched that require surgeons to learn new methods and techniques. Driven by quarterly sales forecasts however, the sales reps are pressured into reducing the barriers to adoption and meeting revenue targets. And believe it or not, these salesmen are actually present in the operating room.There are an estimated 94,752 medical device sales reps in the U.S. with the majority being in high cost, high touch physician preference item categories.An estimated 31 million procedures (37% of total US procedures) have a sales rep present in the operating room during the procedure. For the DaVinci, the sales reps were physically present to assist new surgeons experiencing technical difficulties with the robot. With this level of access, the sales reps gained access to the surgery schedule and pressured surgeons to use the DaVinci on upcoming procedures and reduce the requirements for new surgeons to use the system.Balance of TrustMedical device companies have evolved the market to require a trusted embedded resource in the operating room that can lead to improved patient outcomes; born was the ‘medical device rep’. Medical device reps are indeed a valuable resource to the healthcare industry. Medical device reps provide critical and timely expert guidance, support management of inventory, repurchasing and invoicing and provide an overall level of ‘comfort and convenience’ to the operating room.But with conflicting objectives, providers and suppliers are at odds with each other in the brave new ‘value-based’ world. On one side, their expertise is valued. On the other side, they can let their quest for profits impact patient safety.How can we keep medical device reps out of the operating room, but not out of the picture?

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Apr 23, 2015

Are repless models the answer to PPI cost management?

Medical device “repless” modelTo reduce the cost of medical devices, particularly costly physician preference items (PPIs), some hospitals are contracting out or training their own staff to provide support in the operating room, replacing the role of a medical device sales representative. BenefitsThe primary benefit for a medical institution going repless is to curb the influence of sales rep upselling in the operating room and reduce the sales, general and administrative (SG&A) costs associated with having in-person rep support. Recent analyses suggests that repless models in Orthopedics and Spinal implant procedures can save up to 50% on the cost of medical devices. In addition to reduced medical device costs, repless models also reduce patient privacy as few patients are aware of the sales rep presence in the operating room.Challenges With value segment in healthcare rapidly growing, ‘repless’ is becoming a common phrase as hospitals look for medical devices that are clinically effective at the lowest price. However, in looking for the lowest price, hospitals will also need to balance the effectiveness and safety associated with these devices. In addition, the lack of an expert from the medical device company could potentially impact patient safety if the hospital staff replacing the rep is not adequately trained on the supplier implant and instruments.Furthermore, physicians who often had a preference for specific items, may be required to use items (sometimes generic) contracted by the hospital at a reduced price.Finally, repless models lack the comfort and convenience of having a rep from the medical device supplier supporting the O.R. staff during the procedure. Some prominent Orthopedic surgeons have expressed their concerns as they feel the rep provides a security blanket and the model may only be applicable in outpatient settings such as ambulatory surgery centers with consistent OR staff requirements. Medical device companies also confirm the importance of having an expert from the supplier in the operating room. The concept has been considered disruptive to the status quo with much conversation on the topic on social media channels.ExamplesInnovative repless models are being championed by both medical device companies and hospitals. On the medical device side, companies such as Smith & Nephew Syncera, Royal Oak Medical Devices, Microport Implant Partners and Cardinal Health Orthopedic Solutions have introduced repless models in order to offer low cost medical devices to hospitals.On the hospital side, institutions such as Loma Linda University Medical Center and Mercy Hospital have implemented supply chain innovation solutions that include repless support that has accounted for up to 50% savings on Orthopedic and Spinal devices. Companies such as Intralign are helping hospitals accomplish this by employing RNs or PAs to take on the role of the rep. OpportunitiesIt is clear that a new model will be required in a value-based healthcare environment. While repless models are an obvious answer to medical institutions, they will need to closely consider patient safety, total cost and outcomes across multiple specialities.One opportunity to improve repless models is through innovative technologies. A technology-enabled medical device support model differs from a repless model by allowing heathcare professionals the ability to connect with medical device suppliers through a secure interface. Technology-enabled medical device modelsEnsure the optimal team is present during a procedure by having an expert from the medical device supplier present for clinical or technical supportProvide physicians the preference of selecting preferred suppliersReduce hospital labor costs by eliminating the need to hire a PA or RN to replace the role of the rep in the operating roomScalable across multiple specialties and physician preference items, not limited to Orthopedic or Spinal proceduresGoing completely repless can be a major jump for medical institutions to take. By enabling a technology-enabled support model, hospitals can still realize medical device cost savings, but still have the comfort and convenience of having an expert rep from the supplier supporting the OR staff.Are you working in a repless institution or have a perspective on the repless topic? We’d love to hear from you.

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Feb 24, 2015

A rapidly evolving new value customer in medical devices

Tighter hospital margins…Lower reimbursements on episodes of care…Payers looking to control costs. These factors are triggering a transformation of how medical devices are purchased and valued.A shift in purchasing power from physicians to ACOs and IDNsPurchasing decisions for physician preference items (PPIs) that used to be made by the physician, are now also made by hospital administrators in large ACOs and IDNs. This broader set of influencers comes with different objectives, specifically a prioritization of cost effectiveness.Medical device markets are maturing causing a shift in valueMajor medical device categories are beginning to mature and are getting crowded with competition as a result. As innovation becomes harder to identify, and price transparency becomes more commonplace, medical device companies with lower cost products and innovative business models are winning more market share.Rise of the “value” customer segmentThese drivers are creating a customer base that look for products that are clinically effective at the lowest price. This “value” customer is growing twice as fast the medical device industry.Few have managed to develop a business around the value segment while protecting their premium offerings. For example, in the stent market, some companies have offered significant discounts without differentiating their premium products, leading to annual declines in pricing.Value customers:Are concerned about priceWeigh price comparatively to safety, effectiveness and supportAre reluctant to pay for additional features or servicesAs cost pressures continue, the value segment will give rise to a ‘tiering’ of products. Value customers are willing to sacrifice a degree of innovation, quality, and service in return for a lower price.Winning the value segment through new business modelsAs medical device companies look to penetrate the increasingly growing value segment, they have to structure a strategy and business model that aligns with the customer demands. Below are two business models that can be leveraged.Streamlined Selling: Least expensive sales model with limited customer support. This model is ideal for medical devices maturing in their lifecycle as new products are introduced such as stents.Reduced Service: By reducing service and support levels in clinical and distribution, medical device manufacturers can offer lower cost products. This model still relies on a sales force to capture new accounts. This model is ideal for medical devices with complex selling cycles, high switching costs and high service level burden such as Orthopedic and Spinal products.Whichever model you choose, a clear strategy is required to ensure you capitalize on the ever growing value customer segment. Early innovators that leverage their existing brand and account relationships will be able to win against new lower cost entrants. In addition, Medical device companies have been slow to adopt digital technologies, and now could be the appropriate time for helping them achieve business models that allow them to streamline their sales and support structure and win in the new value segment.Sources: C. Llewellyn et. al. Capturing the new ‘value’ segment in medical devices. McKinsey. 2015. McLaren et. al. Decision Resources Group. Is Medtech on the Mend? Top Trends and Events that will influence medtech markets in 2014. Feb 2014.

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Nov 26, 2014

Reducing healthcare costs through resource utilization programs

Physician Preference Items (PPI) Overview The Association for Healthcare Resource & Materials Management (AHRMM) predicts that around the year 2020, medical supplies will outpace labor as the biggest expense for hospitals and health systems. The increase of expensive devices, or what’s commonly known as physician preference items (PPIs) has driven this increase. PPIs and Hospital Expenses PPIs now account for 60% of med/surg spend, compared with 40% a decade ago. More than half of orthopedic procedures now use implantable devices, as do more than one-third of cardiac procedures, with the costs of a single device accounting for the majority of total inpatient cost of a surgical procedure. That means PPIs have the single largest impact on supply and procedure costs. Yet, even for hospitals that have a good handle on costs for general supplies, PPIs can be a challenge. The process for acquiring PPIs often bypasses a hospitals usual purchasing process. Hospital Management of PPIs through Resource Utilization Programs 78% of C-suite executives have resource utilization programs in place to better control the use and cost of PPIs. Hospitals typically partner with a third party to manage their PPI expenses through a resource utilization program. These programs typically employ a sourcing event where they invite specific vendors for a particular PPI category and source the best bid based on price, quality and service. These resource utilization programs identify areas where hospitals can maximize their savings by contracting with the best medical device supplier based on data-driven outcomes. Examples of Resource Utilization Programs Many different organizations offer resource utilization programs to help hospitals reduce their costs on PPIs. We’ve identified three categories. Technology Platforms Ariba Medpricer Curvo Labs Group Purchasing Organizations Premier Healthtrust PG MedAssets Consulting Firms Advisory Board Company McKinsey Deloitte Opportunities for Additional Savings Resource utilization platforms help hospitals maximize savings by finding the best contract for a particular PPI category. As these services continue to work with hospitals to maximize savings, they will further discover areas where increased efficiency and reduced cost can be realized. One area of opportunity exists within the Sales, General and Administrative (SG&A) costs associated with PPI customer support. Up to 40-50% of the cost of a PPI can be the medical device representative support in the operating room during the procedure. For hospitals that want the best price, they may start  to source contracts from suppliers that reduce or eliminate the level of support. There are three types of medical device support and the associated savings for each model will vary for each PPI category. In-person support - premium price Technology-enabled support - moderate price Repless support - lowest price Although a repless model may seem apealing to hospitals, costs balance out when having to employ specific individuals to take over the role of the rep for each PPI category. There is also a safety concern that proceeding without a rep may in effect be proceeding without the optimal team present, leading to compromised patient outcomes. Technology-enabled service models may be the most attractive risk and return profile for reducing PPI costs, but maximizing the patient safety and overall outcomes. Technology-enabled models allow hospitals to restrict reps from patient care areas and obtain their support through a secure communication platform. This allows them to obtain support from any supplier, eliminates the burden of hiring their own headcount to replace the rep and maximizes the savings they can obtain from suppliers. There are limited solutions available for providing technology-enabled medical device support. Resource utilization program vendors should identify solutions to recommend to their hospital clients that provide the highest quality experience and are focused exclusively on hospitals and medical device company needs, as opposed to one-size-fits-all remote support solutions. Source: McKesson. How PPIs affect your organization. 2014.

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Aug 20, 2014

Veteran Health Administration: Shortcomings in implant sourcing, tracking and vendor support

The Veterans Health Administration (VHA), part of the Veteran Affairs (VA), is one of the largest purchasers of medical devices. With 152 hospitals across the country, the VHA spent $562M on implants alone in 2012, a 28% increase from 2008. However, the VHA recently came under fire from the Government Accountability Office (GAO) for how they purchase, track and use medical devices. According to the GAO report, the VHA is being investigated on three fronts: 1) Failed to seek most competitive market prices for implants The VHA is paying a higher than normal price for medical devices. Surgeons at VHA usually determine needs for surgical implants, request the implant of their choice for purchase, and perform the clinical procedures to implant the items. While VA has negotiated competitive contracts for a variety of implants, VA medical centers (VAMCs) can purchase a specific surgical implant requested by a clinician from the open market with appropriate clinical justification, rather than purchasing a similar item through a VA-negotiated competitive contract. Lack of VHA oversight and appropriate clinical justification for open market implant purchases has raised concerns. 2) Failed to sufficiently track veterans who receive implants In addition, the VHA is not sufficiently tracking veterans who receive implants, meaning they may not be easily reached in the event of an implant defect or recall. Implant purchases are not being accurately documented, including recording serial and lot numbers, so veterans who have had implants can be easily identified in case of an U.S. Food and Drug Administration recall or other safety issues. As a result, the VHA has limited ability to identify and locate a patient who has received a surgical implant which has potentially significant patient safety and cost implications. 3) Allowed medical device reps to become too involved in patient care Finally, surgical implant vendor reps (medical device reps) are getting too involved in patient care, which goes against industry practices. The GAO has raised concerns that medical device reps were participating in patient surgeries and procedures. The VHA has no documentation on file regarding vendor qualifications, training or other certifications and competencies for the medical device reps present in clinical areas. The report states that medical device reps were directly linked to being involved in patient care at three VAMCs between Feb. 2013 and Jan. 2014. Specifically in question was medical device reps directly applying skin grafts to patient wounds. “As a VA orthopedic surgeon, my primary interest is in safe and efficient care of my veteran patients.  Given the GAO findings, the VA has a duty to improve and take advantage of its competitive purchasing power, improve it’s tracking of prosthetics, and ensure that only licensed and credentialed personnel engage in direct patient care.” - Dr. Nicholas Giori, Orthopedic Surgeon, VA Palo Alto Health Care System   Sources: //; //

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Jul 15, 2014

Medical Device Customer Service Excellence: Beyond Remote Field Support

As we’ve described previously, the role of a medical device rep is complex. Hospitals are increasingly looking for ways to restrict their access to provide a better environment of safety. So, both medical device companies and hospitals are looking at different solutions to address this problem. Consumer products are not secure as companies can face HIPAA violations; and ‘one-size-fits-all’ remote field solutions are only a small portion of the solution. We’ve identified nine services that are required to provide a “total” customer service model excellence approach to connect medical device suppliers and hospitals.   Customer Service Model Excellence in Medical Devices: Product Services & Support 1. Pre-Op Planning 2. Peri-Operative Support 3. Post-Operative Follow-Up 4. Provider to Provider Referrals Training & Education 5. In-Servicing & Training 6. Privileging & Credentialing Product Acquisition & Supply Chain Management 7. RFID Inventory Tracking 8. Case Scheduling Data & Analytics 9. Clinical & Non-Clinical Data and Analytics Medical device companies and hospitals will require a total solution that provides these services in a single mobile platform in order to successfully collaborate in a value-based healthcare environment.

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Jun 5, 2014

Implications of Orthopedic Consolidation on the Customer Support Model

The estimated $45B musculoskeletal market is going through a period of consolidation that will dramatically impact the orthopedic customer support model. Consolidation is primarily being driven by changes being taken to the healthcare system in response to the Affordable Care Act. Recently, Zimmer acquired Biomet for $13.35B which brings them to an estimated 40% market share in the Ortho recon market. They mention that they plan to keep everyone, but it is likely that deep cuts will occur as the acquisition realizes efficiency gains in sales, general and administrative (SG&A). In addition, recent announcements have suggested that Stryker (or Medtronic) may aquire Smith & Nephew at an estimated $19B deal that would bring them to an estimated 35% market share in the Ortho recon market. This would leave Zimmer/Biomet, Stryker/Smith&Nephew and J&J Depuy Synthes as the three top players in the market. There are several general implications to the consolidation of the Ortho industry including: Hospitals will partner with fewer suppliers realizing cost savings Switch in Medtech commercial model from incremental improvements and price increases, to high volume with lower margins Lower implant prices will be compensated for through reduced SG&A and higher volume Expanded customer base beyond the surgeon to other specialists to drive increased volume “With implant pricing remaining under pressure and hospitals continuing to consolidate, medtech companies are looking to gain scale and reduce costs,” - Glenn Novarro, an analyst with RBC Capital Markets In addition, there will be implications to the customer support model: Higher volume will drive increased customer support requirements Reduced SG&A will lead to less medical device reps to support customers As Ortho companies consolidate together to realize efficiency, they will also have to find ways to support the increased volume of procedures. With reduced margins, they can no longer afford to send medical device reps to support every procedure in-person as they have in the past. The higher volume of procedures and reduced SG&A will create a ‘gap’ in customer support that will need to be filled with innovative approaches. As industry consolidation continues, and high volume becomes the new approach,  a new customer support model will be paramount to ensure healthcare professionals get support when they need it and patient outcomes are not compromised.

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May 19, 2014

Considerations when selecting a remote service solution

The medical device industry is beginning to rethink their service model and are looking at remote service solutions to help them better support their customers in the operating room. A number of players are beginning to emerge. We have identified ten categories of key questions to consider when evaluating remote service solutions. 1. Security What level of encryption do they provide? Do they have documentation supporting HIPAA compliance? 2. Accessibility Can they access restrictive hospital networks? Do they provide network diagnostic tools? 3. Mobility Do they have the ability to support mobile to mobile? 4. Functionality Do they have unique features that allow you to support your customers remotely? 5. Simplicity Did they design the solution to be easy to use? 6. Focus Are they focused on your industry and specific needs? 7. Workflow Can they integrate into your customer’s clinical workflow? 8. On-Demand Do they allow you to tailor the call sequence or offer on-demand support? 9. Data & Analytics Do they capture relevant data and analytics that matter to you and your customers? 10. Integration Is their video codec a 3rd party plugin or is it fully integrated? Do they integrate with your existing IT infrastructure? Are they a consumer or enterprise communication platform? Remote video support is a new and innovative market and taking the appropriate steps to find the right solution will allow you to provide better service along with your product.

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Mar 10, 2014

Opportunities and Limitations of Wearable Technology in the Operating Room

Guest commentary from renowned surgeons Dr. Pierre Theodore (UCSF) and Dr. Edward Bender (St. Francis Medical Center). “Using wearables such as Google Glass at the point of care provides a tantalizing view of what future holds. Work still needs to be done in the short-term in order for the technology to be ready for primetime. Enhancements to speech recognition capabilities and more robust image processing will allow for wearable technology like Google Glass to be viable platform that will ultimately improve patient care.” - Dr. Pierre Theodore, UCSF Medical Center Wearable technology presents an opportunity to drive value for surgical procedures by allowing the operating room staff to leverage real time audio visual communications to improve patient care. This is not new. Surgeons are accustomed to wearing head mounted cameras connected to standard video recording and transmission devices, but these have been hampered by supporting only one way communication from inside the operating room to an audience outside the operating room. The technology for the reverse trip back to the surgeon has been either ignored or hacked together using separate and cumbersome technologies such as an intercom, an independent AV feed, or even the telephone with sketchy audio quality. Indeed, surgeons are excited about the possibility of more advanced wearable technologies allowing them to change the way procedures are conducted. Google Glass is the newest and most highly touted of these technological advances. The anticipated benefits include the ability to coordinate care, increase efficiency and provide better patient outcomes by bringing in remote experts on-demand for virtual live-video support. In testing the Google Glass platform in various operative environments with our medical advisors, we’ve identified the following opportunities and limitations with the current state of the Google Glass technology for on-demand support in the operating room leveraging live video streaming. Opportunities Real-time support: Ability for the operative staff to leverage the audio and video communications built into the wearable technology. Hands free: Ability to obtain real-time support and have both hands free for the task at hand. Integrates into workflow: No impedance on the clinical workflow in the operating room. Local visualization: Remote user is able to hear and see exactly what the Glass user is viewing in real-time. Limitations Limited battery life: The battery is limited just with basic use. Add live streaming of real-time communications and the battery life is reduced to a half an hour or less. Ambient noise: Operating rooms are noisy places. Glass has limited audio with a mono and stereo earbuds that do not provide adequate volume in the operative environment. Small screen: The OR staff can have trouble viewing the Glass screen and may require prescription lenses. Limited viewpoint: The operating room staff is unable to view the remote user because it is a “personal” video stream seen only by the wearer. This limits the use in certain applications such as inservicing and other activities where the entire surgical team must be synchronized. High learning curve: Glass is a new interface with different functionality that requires users to learn the hardware and software. We’ve found this to be a relatively high learning curve and not intuitive. Limited use case: In certain cases, surgeons require the use of loupes to provide magnification to the operative field, and the Glass platform may not be easily adaptable to such situations. To address some of the limitations, there is the ability to add a battery pack, include custom headphones, add prescription lenses and provide user training. However, these are temporary fixes that are not sustainable for larger scale adoption. In addition, technology such as Google Glass is still in early beta development under a Google Glass explorer program with commercial release not expected until late 2014. The wearable technology presents an opportunity should the limitations be addressed in future iterations.

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Jan 8, 2014

Aligning medical device suppliers and hospitals in a value-based healthcare environment

The current medical device support model may not be sustainable in a value-based healthcare environment. As the U.S. healthcare system shifts from a volume-based (fee-for-service) to a value-based payment model (pay-for-performance reimbursement, i.e., bundled payments), medical device suppliers will need to find ways to increase efficiency, drive value, reduce cost while becoming an integral component of coordinated care. In this post, we discuss the health care reform factors that are impacting medical device companies, the challenges and recommendations for medical device companies. Bundled Payments are defined as the reimbursement to health care providers on the basis of expected costs for clinically-defined episodes of care. Bundled payments discourage unnecessary care, encourage coordination across providers, potentially improves quality and reduces health care cost. Providers will have to begin to take on the risks associated with managing a patient over his or her lifetime. As a result, this will dramatically impact the way hospitals make purchase decisions. Once driven by individual physicians, purchase decisions will be driven by committees of administrators and purchasing managers equipped with information on product prices. These decisions are being made on the basis of clinical and economic benefit, rather than individual clinician preference. In addition, value-based purchasing will shift where hospital purchasing decisions occur. Specifically, selling that used to occur at a local hospitals will now be made centrally to executives in a large hospital system. Furthermore, another pricing strategy employed by hospitals is capitation. Capitated pricing is a model established that allows healthcare providers to purchase medical products and devices from a variety of companies at set levels based on the level of the product. This requires medical device companies to establish their products to fall into each of these categories (typically three; standard, high and premium) by a certain set of characteristics that make these products “equal” based on value. Then the healthcare provider will pay each medical device company the same amount for any product in each level. Finally, meaningful use is defined as the implementation of electronic medical records (EMR). Achieving different stages of meaningful use qualifies hospitals to receive payments from the government. It also allows hospitals to make data-driven decisions and collect their own outcomes data on specific products. This will likely result in hospitals being equipped with more patient outcomes data on medical devices and limit the number of suppliers they work with based on predictable, quality outcomes that are efficient and low cost. Given these value-based health care initiatives,  we have identified four strategic imperatives for medical device companies: Provide more predictable operating room efficiency Improve operative environment of safety Reduce variability in quality Reduce cost of care In order to drive these imperatives, medical device companies will need transition to becoming ‘healthcare solutions’ companies by aligning their priorities with hospitals and coordinating care for every patient to ensure the best outcomes. Source: BCG. Fixing the Medtech Commercial Model. 2013

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Oct 31, 2013

Making service model excellence a part of your medical device commercial strategy

As we’ve written in the past, the medical device industry spends 300-500% more on SG&A as a percentage of COGS than any other industry. Consequently, these high cost commercial models are becoming ineffective as medical device purchasing decisions shift from individual physicians to value analysis committees armed with transparent information on product prices and outcomes. We’ve seen physician preference decline 10% in past year and it is expected to dip to 20% more in the next two years. To address these issues, medical device companies should start to look for ways to reduce their SG&A in addition to providing value-added services beyond the medical device. Service model excellence is one area where medical device companies have not been innovative and have chosen models similar to those of their competitors. Differentiating the service model can help reduce SG&A costs, provide a competitive advantage by differentiating your total product offering and become a source of additional revenue. What are some examples of innovative service models in the medical device industry? We’d love to hear from you. Source: BCG. Fixing the Medtech Commercial Model. Accessed 10/30/2013. Available from: //

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Oct 2, 2013

A Closer Look at Medical Device Support Models

As the healthcare environment continues to evolve at a rapid pace, the medical device industry will also have to adapt by offering a support model that meets the needs of its customers. Over the past year we’ve been tracking different models employed by major medical device companies and the service model innovations that have been taking place. Although there are many different variations of each model, we’ve outlined four different models. Rep Support - In-person rep support Surgical Assist - Trained hospital staff Remote Support - Remote rep support Repless - No rep support Choosing a specific model will depend on the commercial objectives and priorities of your organization. When deciding on a model, medical device organizations should take the following into consideration: Level of access to hospital operating rooms Who the hospital decision makers are with regards to your device Your SG&A costs in comparison to COGS and net margins Level of support your device requires As medical device companies move away from product business and towards a total solutions business, service model differentiation will be an important factor to consider in order to survive in the rapidly evolving healthcare environment.

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Aug 21, 2013

6 Challenges with Medical Device Reps in the Operating Room

It is no wonder 75% of hospitals are taking steps to restrict medical device rep access in hospitals. Here are six reasons why hospital operating room managers are looking for ways to restrict medical device rep access from the operating room. 1.    Purchasing Influence It is no secret that medical device reps provide updates on new product lines during a procedure while in the OR. This can lead to physicians requesting higher cost devices. However, as hospitals move towards a capitated model, they are looking more and more for cost:benefit when purchasing medical devices – not just physician preference.  “They are really good at having surgeons request products that are more expensive than we’d like to buy.” –OR Director 2.    Reliance on Support The OR team (physician, nurse coordinator and OR scrub tech) have enjoyed the luxury of having an onsite rep from the medical device manufacturer present in the OR during almost every procedure. “I talk with the nurse coordinator…laugh…who is the vendor and who is the physician…feel like the vendors are almost performing the surgeries.” –OR Director   3.    No Control Even with vendor management solutions such as RepTrax and Vendormate, hospital struggle to manage medical device rep foot traffic in and out of the operating room. Some hospitals have gone as far as dedicating a specific individual from procurement to police the ORs and escort out reps that are not not authorized, preventing them from returning for up to a month. “So many (medical device) vendors coming in and out of the OR, very challenging for us to control.” –Nurse Coordinator  4.    Delays in Patient Care With no system or processes in place, having reps from multiple medical device manufacturers coming in and out of the OR is not an efficient process and results in delays. These delays cost time and money for the hospital.  “It is difficult for us to contact the rep for a particular device. Sometimes we can’t get in contact with them for several hours and we can’t start the case without their support.” –Nurse Manager 5.    Infection Risk  Having an additional body in the OR poses additional infection risk. With 10% of the average hospital budget spent on infection related costs, reps in the OR increase this risk.  “There can sometimes be 2-3 reps in the (OR) room. It really is an increased infection risk.” –Orthopedic Surgeon 6.    Privacy Risk Medical device reps are, by definition, considered HIPAA compliant. However, medical device reps are exposed to significantly more patient protected health information (PHI) than they should be while in the operating room. “I can see the patient charts, the records, it’s all readily accessible. I probably see much more (PHI) than I should while I’m in the OR.” –Orthopedic Rep It is clear that these challenges are becoming more top-of-mind to hospitals. Hospitals will need to find a way to more efficiently manage reps in and out of the OR, while balancing the need for the OR team to obtain quality support.

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Jul 30, 2013

A Day in the Life of an Orthopedic Rep—A Real-Life Account

This is the first in our series of “A day in the Life of…” In this months post, we asked an experienced DePuy Orthopedics medtech representative to diarize a their day, describing the activities performed in his own words and giving his own perspective on how the day unfolded. At the end of the post you can see an analysis of how his time was spent. The results may surprise you. [Note: The identity of the representative has been kept anonymous.] A Day in The Life… 6:15 am: Drive to Hospital to support total hip case (45 mins) This hospital is one of my most loyal customers and does one of the largest [product] volumes in my territory. Typically, I use this travel time to catch up on news and make phone calls (e.g. calling the head office in Warsaw, Indiana to answer any questions I may have or clarify anything that wasn’t addressed the day before). Today I simply listened to NPR, drank coffee and arrived just after 7am. 7:00 am: Register with hospital rep tracking system (15 mins) This tends to be different for every account and there is commonly a problem of some sort. It could be with the computer that you need to sign in with, or that you aren’t cleared through this specific hospitals system. To achieve this very simple task often holds a rep up. Also, if you are rushing to arrive for a case this can derail your progress heavily. Often the registration computer isn’t even in the same area as where you are going, sometimes even in a different building a block away. But no problems today. They were able to register me pretty quickly. 7:15 am: Pull implantable devices/instrumentation off the shelf for total hip procedure (15 mins) This is the bulk of the pre-case work that no one else in the hospital knows as clearly as the rep. There are often missing instruments, or the restocks from the cases the day before haven’t arrived yet and you need to get them from the office or hospital receiving. If you are not there this tends to be a major problem. Mundane, but this is key to a smooth start. Today, the staff were able to get most of the trays correct for the first case so there was only one tray that needed to be pulled. 7:30 am: Wait for procedure to begin (5 mins) This is the most wasteful time of the rep’s work-lifecycle. This often can drag on for a number of hours if there is any sort of a hold up—blood work wasn’t done properly, the patient ate, the surgeon isn’t there yet, the patient hasn’t arrived yet, the anesthesia application is difficult, etc. There are many different reasons for a case to be delayed and this time is often wasted time for a rep - downtime when we are just waiting for someone to say, “We are good to go”. Today there was very little wait and we were off and running after 5 minutes or so. 7:35 am: Support OR team for total hip procedure (1 hr 25 mins) Here my main role is to advise the scrub nurse on the use of instruments (as appropriate); hand over packaged implantable devices to the OR nurse (for him/her to open packaging and hand to the surgeon); advise the surgeon as appropriate on the use of the devices. This is where we are an actual asset to the OR team as we can keep the scrub tech ahead of the surgeon so they won’t have to wait for instrument assembly or locating implants. If the surgeon has any operative questions, having an on hand representative is helpful to keep them moving and making the right decisions. Today, the surgeon I worked with was very good and the OR team very experienced, so I did very little during the procedure. The scrub tech got behind a couple of times and I advised her to grab the correct instrumentation a few times. In order to be ahead of the surgeon, I must be paying close attention and anticipating their next move so they have the correct instrumentation ready and waiting for the surgeon. It is a stressful part of the job because if anything goes wrong, you are the first to be blamed as well as the first person everyone looks to, expecting to find the answer. Nothing went wrong today but nonetheless it is stressful until they are closing skin. 9:00 am: Drive to office to pick up implant (15 mins) Typically this time in the day is usually allocated for surgery or office visits, or to grab implants/instrumentation. It is a bit ambiguous because time between cases tends to be where reps complete daily projects/life errands. If you need to visit a surgeon’s office, this is when you tend to get that done. If you need laundry detergent, this is when you tend to grab it. If you are on your way to another surgery, you wouldn’t of course [do personal errands], but otherwise it is at the rep’s discretion as to what needs to be achieved. Today I needed to go to the office and back to grab an implant because my restocks had not come in. I phoned the office on the way and it turned out the office said my fax wasn’t received and therefore the implants were never reordered. I turned the care around and due to heavy traffic, made it back just in time to start the second case. 9:15 am: Pull implantable devices (total hip) off the shelf (15 mins) Today I did this after the last case just to make sure they had all their instruments ready and waiting for their second case. Good thing too, because one of my stem instrument trays was missing and I had to run upstairs to the Central Processing Department in order to get it downstairs and by the OR front door with the other instruments. If I had not done this before going to the office it would have been a major problem and the OR staff would have been calling me on the road to find out where that tray would be. There was a problem because one of the trays, after they opened it, had a foreign object that was left behind from the Central Processing Staff. This deemed the tray unsterile. The OR staff took initiative and were able to re-sterilize the tray without needing much help from me. 9:30 am: Wait for procedure to begin (45 mins) I use this time to complete admin; make phone calls; be available for the less experienced rep on the team who has a case at this time and may need to phone with questions etc. Today this part was quick because I had to run to the office and wasn’t waiting around the hospital for the surgery to start. I didn’t have anyone calling for questions at this point. I arrived back from the office in just enough time to get the implants in the room before they made incision. 10:15 am: Support OR team for total hip procedure (1 hr 30 mins) Today the second case was a little easier than the first one. She was a smaller patient, which means there is less mass to move around. However, the implant sizes are also smaller and were reamed/broached too quickly. We had a back up system ready and waiting because the neck anteversion was abnormal, but we ended up not needing this at all. It ended up being a very straightforward surgery. 11:45 am: Pull implantable devices off the shelf for a total knee revision (15 mins) The last surgery today was a much more complex surgery that required the surgeon and I to discuss at length our approach prior to going into the OR. This was particularly important because the patient was awake for the procedure. We needed to discuss the plan of action and to have Plan B as well as Plan C ready to go. Normally this is discussed beforehand at his office, but during the time we normally meet I had to cover a surgery for a colleague and missed the window of time for the office visit. Thus it was pre-surgery - the day of - when we met. There were two basic plans that the surgeon could do: A) A much more invasive but much more definitive outcome with high levels of success and high levels of pain/rehab necessary, B) A much less invasive procedure and replace just the poly on the tibial size in order to tighten the ligaments in the hope that it would tighten up enough to give the patient stability. After about a 10-minute discussion we came to a joint decision to go with the more conservative method—Plan B. 12:00 am: Wait for procedure to begin (1 hr) Again, I use time to complete admin; make phone calls etc. Today, the anesthetist went on lunch between the second and third case, which means it slows the progress of the day. I went and found lunch myself since there was a little extra time today. After eating quickly I hurried back to the OR fearful they were going to be starting without me, therefore making me be behind the surgeon. I hustled back to the OR after maybe a 15 minute lunch stop and found the patient was just getting into the room. Since we had decided on the more conservative route I didn’t need to set up much for the instrumentation. I went and pulled all of the implants needed, just in case we had to bail out and go with Plan A after all. Even still there was a good 30 minutes of wasted time. One of the most frustrating parts of the job is the all too common “hurry up and wait”. This can really eat at me, although I completely understood today because everyone was being more cautious since this was a revision we were about to do. 1:00 pm: Support OR team for total knee revision procedure (1 hr 15 mins) Plan B was a success and he was able to make this potentially difficult procedure, a quick surgery. The case didn’t need much help but because the surgeon and I went back and forth before the surgery. However, he was asking more than the usual questions today. Therefore I was paying very close attention to what was going on in the surgery. I quickly left the OR, changed out of my scrubs and headed to the carpark to drive to my next appointment. 2:15 pm: Drive to small, rural hospital (30 mins) I needed to review x-rays for a total knee and total shoulder procedure that is taking place later this week. 2:45 pm: Review x-rays (45 mins) I reviewed the x-rays and made an instrument/device list based on what was seen. 3:30 pm: Visit nurse coordinator to confirm case schedule for next week (10 mins) These tend to be in and out calls where I prepare for the coming week. I go through the case schedule with the nurse coordinator and make sure that our schedules are in synch. 3:40 pm: Visit Surgeon office at hospital for sales call (20 mins) Here I discussed our new knee replacement system that will be coming out next month. He was a difficult to see surgeon so I was pleased that I finally managed to get it in front of him. 4:00 pm: Drive to a competitive surgeons office (15 mins) This was another sales call to discuss a meeting coming up in August that he may be interested in. It is an educational meeting that we are sponsoring in the area. 4:15 pm: Sales Call (30 mins) Here I waited for the surgeon to finish up the last of his patients and met briefly after his full clinic day. Typically, this can be quick or really slow depending on your relationship with the surgeon. There are often times they will make you wait in the waiting room for over an hour because you are simply going to try and sell to them and consequently, they would rather not meet with you. Often, even if you have waited for an hour, the surgeon may still only give you 5 minutes of his time. Today wasn’t so bad. He was finishing up his patient clinic and made time to talk with me as soon as his he finished with his last patient. I was discussing the meeting in August and I knew he would have interest in it, so I didn’t BS much and went right to the subject. It worked! He is interested in going to the meeting, which felt good at the end of waiting 30 minutes in his waiting room. 4:45 pm: Drive to my final hospital of the day (40 mins) This was my last windshield time of the day, prior to driving home! It was a significant drive, but I needed to make sure the instruments are ready for tomorrow’s cases. 5:25 pm: Pull implantable devices (15 mins) This is where the office can frequently make a mistake and if it is a hospital that rarely does cases you could be in trouble if you only catch the mistake the day of the surgery. I have learnt from experience that it is always a good move to know the night before that everything is ready for the next day. Today, I had to fight through a lot of traffic in order to get to the last hospital, so it took longer than I was hoping to arrive there. It turned out all the instruments were set up correctly and were ready for the cases tomorrow. It felt good to know that is was complete but I was still frustrated knowing I wasted 45 min traveling through traffic just to make sure everyone else had done their job correctly. But, in the end, that is what we are supposed to do—make sure everything is good for the surgeon to perform the surgery. 5:40 pm: Drive back home (45 mins) At this point in the day, there are no more clinics open, so I headed back through all that traffic to head home. Summary of Day—Time spent on different activities Case Support – 34% Selling – 7% Case Preparation/Admin – 18% Driving/Down Time – 41%

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Jun 12, 2013

Medtech facing strong headwinds—a need for a new support model

The last 5 years haven’t been the easiest for the medical technology (medtech) industry. A time period characterized by flat revenue growth and an unsustainably high cost structure is paving the way for a change in how they sell to and support their customers. The current medtech support model The medical device industry’s sales approach has remained virtually unchanged since almost the beginning of time. It is based around the notion that relationships are the cornerstone of effective selling, and that good relationships are built through regular in-person customer visits. This is sound logic, but what if the healthcare environment had changed when nobody was looking and relationships no longer got you as far as they once did? This is the situation that we are seeing today and it is forcing medtech companies to address the immediate problem of an unsustainably high cost of doing business. An outdated and costly sales and support model We only have to look at the current medtech customer support model to see where the problems lie. Today, the medical device rep is physically present in the operating room (OR) to support the surgeon and his/her OR team as required throughout a surgical procedure.  This is the status quo for the vast majority of surgical procedures that require an implantable medical device. This high-touch sales model is sub optimal for both the hospital and the manufacturer. The manufacturer is hit by an unprecedentedly high SG&A (sales, general and administrative) expense, and the hospital is hit because this expense is essentially passed on to them—baked into the selling price of each device. A recent report by PWC (PricewaterhouseCoopers)1 stated that SG&A (Selling, General & Administrative) has been showing a declining trend in performance between 2005 and 2011, driven for the most part by the implantable medical device segment. The main culprits are cardiothoracic, spinal and orthopedic surgeries, which all involve a significant service component (provided by the medical device rep) to not only support the OR team, but to also maintain large volumes of inventory in the field. In fact, the seven largest orthopedic companies spent more than 43% of the cost of an implant on SG&A expenses, whereas COGS (Cost of Goods Sold) was less than 30%2. This model is costing the device industry “an arm and a leg” (quite literally in the case of orthopedic surgery), with an estimated $35B per year being spent on sales support alone. Compared to other industries, medtech firms can spend up to 500% more on SG&A than the typical high tech or industrial firm, according to a recent BCG report3. Misalignment with hospital purchasing priorities So what has changed between yesterday and today’s model? In a word, the customer. The pressures of healthcare reform have resulted in hospitals taking a far closer look at their margins. Clinical effectiveness is no longer looked at in isolation, but must be delivered economically and in a way that can be quantified. As a result, purchasing decisions fall into the laps of “value analysis committees” instead of physicians, and those devices that don’t make the cut are put out to pasture. We are currently in a time when the medtech industry can no longer get away with significant price increases for products with incremental improvements—this means that medtech companies are struggling more than ever to realize a return on their investment in innovation. Furthermore, “hospital demand letters” are challenging their pricing and forcing them into volume-value deals in order to avoid losing key contracts to competitors. Reinventing the Customer Support Model But there are steps that can be taken. Those companies that will rise to the top will be the forward-thinking medtech companies that realize that the quickest fixes are to spend less and to spend smart. Nurep believes that the medtech industry should focus its attention on the following critical success factors if they are to develop a commercially sustainable customer support model that recognizes the shifts in healthcare that are currently effecting their business: Invest in productivity levers that make customer service and support a differentiator Focus on efficiencies that are effective and sustainable—not just cost cutting measures Effectively demonstrate value to the customer that combines both clinical and economic value Benchmark by looking at success in other industries that have effectively contained SG&A 1 PWC Report: Operating performance in the Medtech industry—Trends and imperatives (Oct, 2012) 2 Orthopedic Network News (July, 2010) 3 BCG press release (Oct 2012)

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Apr 24, 2013

Hospitals taking steps to reduce medical device rep access

Hospitals first restricted the access of pharmaceutical and biotech sales representatives. Now, hospitals are beginning to restrict access of medical device representatives into the operating room. Here are six steps that have been taken to limit medical device rep access in hospitals. 1) Appointment required to gain access 75% of US hospitals require an appointment for a medical device rep to enter the hospital. Physicians now have to plan ahead to ensure their local medical device rep is available, and then ensure the rep has the appropriate hospital approval for access to the operating room. 2) Limited to interactions with purchasing department 53% of US hospitals only allow medical device reps to interact with the purchasing department. This tactic was employed so that hospitals can keep apprised of what companies are trying to sell and limit reps’ interactions with physicians. Hospitals also want to be involved in the decision-making process for new medical devices, whereas the physician has historically held the purchasing power. 3) Track reps by using a monitoring system 49% of US hospitals use a monitoring system to track rep interactions within their hospital. These systems (typically Reptrax or Vendormate), vet medical device reps for credentials and reputation. Each medical device rep typically has to pay ~$200/hospital/yr to receive the necessary training, credentialing and background checks to enter the OR. This expense is either covered by the medical device company or paid directly by the rep. These systems complicate the administrative logistics of having reps support physicians on-site in the OR. 4) No access to C-suite at hospital 33% of US hospitals restrict medical device rep access to the chief officers at the institution. This is another measure taken to reduce medical device companies’ influence over the purchasing decisions.  5) Limited time slots available for rep visits 30% of US hospitals only have specific time slots available for medical device rep access. This can have a negative impact on medical device reps’ ability to provide timely support to physicians in the operating room.  6) Only allow reps that have established relationships with physicians 12% of US hospitals limit access to only medical device reps that have established a relationship with a physician at that medical institution. This measure allows physicians to obtain the guidance and support they need in the operating room while restricting unknown reps from selling new devices.  It is clear that the in-person rep model is on its way out. However, medical device companies will still need to find innovative ways to provide the same quality support to physicians and their staff in the operating room. Doing so will be challenging given the increasing number of access restrictions placed on medical device reps. Mobile health innovations can help companies overcome these challenges by supporting physicians remotely. Source: LEK. Hospitals adopt new strategies to boost profitability, but still face deep challenges: A new imperative for Medtech. 2013.

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Feb 25, 2013

Five opportunities to improve the medical device sales and support model

1) Physicians have challenges identifying new devices and device protocols in real-time. “I don’t even know what new devices are available.” Potential Result: Suboptimal device may be used and/or improper use of appropriate device. Potential Impact: Compromised patient care. Suggestion: Consider providing device-specific information all in a single, easy to access location for physicians. 2) Scheduling cases can be challenging as cases may occur earlier/later than planned. Trauma cases are rarely ever planned. “The entire OR staff is ready to go and we are waiting for the rep to arrive.” Potential Result: Delay in care. Potential Impact: Compromised patient care. Suggestion: Research mobile real-time support platform designed specifically for operating room use. 3) Physicians abandon complicated devices that fail to offer guaranteed support. “We stopped using the device. We are tired of needing an in-person rep for every question or issue that arises.” Potential Result: Frustrated physician and OR staff. Suboptimal device may be used. Potential Impact: Lost device sales and/or customers. Compromised patient care. Suggestion:  Investigate opportunities to provide guaranteed product support in the operating room. 4) Physicians that have to switch a device in the OR can’t obtain the support they need. “I’d consider switching my business to a device that offers guaranteed real-time support.” Potential Result: Delay in care. Suboptimal device may be used. Potential Impact: Lost device sales and/or customers. Compromised patient care. Suggestion:  Investigate opportunities to provide guaranteed product support in the operating room. 5) Phone support takes too long and is insufficient, as the rep cannot see the issue. “Visuals would have solved the issue in secs; on the phone for 30min w/ patient in shock. We wasted two $35K devices” Potential Result: Delay in care. Potential Impact: Expensive devices lost. Compromised patient care. Suggestion: Identify suitable alternatives to traditional phone support when in-person support is not feasible.   Contact us to learn more about these opportunities.

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Jan 25, 2013

Four reasons why not to use Skype (or FaceTime)

A lot of people ask us “Why not just Skype”? There are countless reasons why, but we felt it would be valuable to sum up four of the main reasons. Poor Security: Not HIPAA-compliant: Skype doesn’t meet federal requirements for protecting sensitive healthcare data. Risk of losing or abusing patient data: Skype is a hacker’s delight. Unsafe: More spyware infect computers through Skype than any other way with the exception of music file-sharing. Risk of impersonation: No guarantee on Skype that the person you’re speaking to is who they say they are. Not a Closed Community: Skype is a consumer-based product that is not closely monitored. Without any oversight or database, information is not stored, nor is it effectively managed. Only Single Calls: With Skype and FaceTime, the user must manually select the contacts with whom to connect. Low Grade and Unreliable Connection: Skype adjusts for connection resulting in choppy video/audio and dropped calls. It does not optimize the connection based on available bandwidth and network conditions. It does not monitor live audio and video in real time, nor does it obtain the best possible video experience at speeds as low as 500kbps.

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Jan 15, 2013

Nurep Joins Blueprint Health winter 2013 class

Today, we are excited to announce that we have joined the Blueprint Health winter 2013 class. It is an honor to become part of the Blueprint Health family, which has the largest network of mentors with healthcare experience of any accelerator. Blueprint Health is also a charter member of the Global Accelerator Network, which was started by TechStars. You can see the official press release in TechCrunch. Here are a few (of many) reasons why we are excited about Blueprint Health: Mentors: With over 160 mentors with targeted expertise in different fields including: insurance, hospitals, medicine, healthcare IT, pharmacy, pharmaceutical/biotech, medical device, start-ups and venture capital, becoming part of the Blueprint Health family opens the door to unparalleled advice and resources. Focus: Blueprint Health has a focus on helping start-ups who solve real-world healthcare problems. They look for teams that can articulate the problem their customer faces and have a clear solution to address the problem. Teams: We are proud to be joining ten other great teams in the digital healthcare space. We’ll be sure to learn many valued lessons from them, as well as provide guidance from our own experiences. Looking forward to working next to: ForMD, HealthyOut, iMedicare, Keona Health, Luminate Health, MynewMD, TOUCHsurgery, Intelligent M and PadinMotion. Structure: In the first month, we’ll focus on honing in our business model and go-to-market strategy. In the second month, we’ll look to get our product in front of customers. The third and final month is focused on preparing our pitch to investors for Demo Day on April 4, 2013. Perks: We’ve moved to New York and will be working out of the Blueprint Health office, a 12,000 square foot loft space in the heart of SoHo. The program involves a full schedule of social, educational and team activities. There are also a host of technology, Legal, HR, and other perks. We’re all really excited to become part of the third Blueprint Health class and look forward to sharing our rapid progress as the program progresses! Nurep TeamAdam, Paul & Nick

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Dec 21, 2012

Mobile medical apps & FDA regulation

Over the last six years, there has been significant growth in the health technology sector (e.g. mobile medical apps), driven by advances in technology and an increase in venture capital (VC) funding. VCs have been lured into the space due to the perception of high returns on investment within shorter timeframes versus their traditional life science funds. The significant growth in this market has driven the need for increased scrutiny from the FDA in how these products should be regulated. The FDA has the authority to regulate software if it falls within the broad definition of a “device”. It has further segmented medical devices into three classes; Class I, Class II and Class III. Class I devices don’t require FDA regulatory filing (i.e., 510(K), Premarket Approval Application (PMA)) whereas Class II requires 510(K) and Class III devices require a PMA. The class to which a device is assigned determines the type of premarketing submission/application required for FDA clearance, prior to product launch. While the FDA has had policies in place for many years regarding the regulation of software/computer products, it has historically taken the position not to enforce the regulation unless the product interfaces directly with a medical device. In cases such as these, products have then been subjected to regulation as if they were a medical device. This caused problems for the manufacturers of these devices as there was no structured classification system based on a risk assessment, making it difficult to predict whether a device would end up being a Class I, II or III medical device. Furthermore, the rapid adoption of mobile technology within healthcare meant that there was a pressing need to develop specific guidelines around the regulation of these products also (out of the 14,558 medical apps currently available, only 75 have received clearance from the FDA). In response, the FDA developed two documents to outline how software/mobile technology will be reviewed going forwards. These are referred to as the medical device data systems (MDDS) regulation; and the mobile medical application (MMA) draft guidance. Medical Device Data Systems (MDDS) In 2011 the FDA further developed its regulatory guidelines with the publication of the revised MDDS rule. MDDS devices are defined as those that are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. Within this definition they should perform all intended functions without controlling or altering the function or parameters of any connected medical devices. The revised guidelines reclassified MDDS from Class III to Class I. This ruling has significant implications in that it now reduces the complexity and the speed to which an MDDS device can get to market. Where it was previously subjected to premarket approval prior to launch, it will now have to comply only with general controls (annual device registration and listing, good manufacturing processes (e.g. labeling requirements), adverse event reporting). Mobile Medical Application (MMA) Draft Guidance In July 2011, the FDA published a draft guidance on the regulation of mobile medical applications. This followed the development of the MDDS rule outlined above and served to add clarity around the regulation of software designed specifically for a mobile platform. A mobile medical app is defined as an app that a) meets the definition of a device, and b) is either used as an accessory to a regulated device or transforms a mobile platform into a regulated medical device. Those mobile apps that do not meet the criteria for both “a” and “b” will not be regulated according to the criteria set out for an MMA. While the FDA use the term “draft guidance”, manufacturers of such devices may be held accountable to the guidance outlined, even before the final draft has been approved and made public. The FDA has still to confirm when the final guidance document will be released. However, on November 26th of this year the FDA published a list of all draft and final guidance documents to be published in the next 12 months. Amongst these documents is “Mobile Medical Applications”. Mobile Medical App Manufacturers and Navigation of Evolving FDA Regulations How should mobile medical app manufacturers make sense of the current regulatory landscape? While the boundaries are still somewhat blurry, manufacturers of mobile medical apps should air caution if there is any way their iphone/iPad/BlackBerry/tablet computer can be perceived as being used as an accessory to a medical device, or transforming the mobile platform into a regulated medical device. Manufacturers should first seek to understand if their product falls under the FDA definition of a “mobile medical app”. This requires understanding the intended use of the device. For scenarios where the app will be used for diagnosis of disease or curing a disease or will affect the structure of any function of the body, that app will be classified as a mobile medical app. As the FDA gets its arms around how to keep up with the regulation of apps, manufacturers will need to be more vigilant to ensure they are consistent in how they communicate and position the intended use of their app to stakeholders. As they did with biopharmaceuticals, the FDA will inevitably cast its attention on how such apps are labeled, advertised and sold within the marketplace. Language will be key, with words like “diagnosis” raising immediate red flags. Given current ambiguity in FDA guidelines for such apps, manufacturers should be prepared to engage with the FDA early in the product’s life cycle to avoid unforeseen problems later on.

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