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Benefits Of Wearable Technology In The Health Sector

Benefits Of Wearable Technology In The Health Sector | IT Support and Hardware for Clinics | Scoop.it

When most of us consider wearables, we include devices such as Bluetooth headsets. However, in the medical industry, we expect more from our wearables and only include devices that not only provide a specific function but will also store sensor data for later retrieval by healthcare professionals. This data is then analysed to aid medical diagnosis.

 

In a growing telehealth market, it is these sensor-based devices that will improve healthcare services for millions of patients worldwide. Existing forecasts indicate that the global telehealth spend will increase tenfold within five years, rising to $4.5 billion by 2018.

 

Like any new technology, early adoption figures are quite weak but luckily, in Australia, we are always eager to experiment with new innovations. In fact, a 2014 Kronos survey demonstrates that no less than 30 per cent of Australians already use wearable technology, twice that of our U.S. counterparts. In addition, more than 40 per cent use them for work-related tasks. This high adoption rate is encouraging for future increased use of wearables in the health and fitness areas.

 

For this adoption rate to continue, I believe we need our healthcare providers to embrace the use of wearables, as they are best positioned to encourage their patients of wearable benefits, with the most important being improved care monitoring and increased efficiency for early diagnosis of common ailments. When a medical professional recommends a product, people listen. There are several reasons for this but primarily these include:

 

A company with a commercial interest in the product is unlikely to achieve the same positive response level.


Patients trust their doctors to act in their best interest.
By using these technologies themselves, patients are encouraged to take a more proactive approach to their personal health.
Fitness plans were perhaps the first wearable that provided useful data for medical professionals and were primarily used by those in cardiovascular activities such as running and cycling. Like any product type, the features available vary by model and manufacturer but most are capable of acting as a pedometer and can also record pulse and heart rates. The data gathered by the device sensors is then transmitted to your smartphone using Bluetooth or possibly ANT+ for cycling enthusiasts with bicycle computers. This data is often useful to doctors as it can aid diagnostics, surpassing the original plans for the device as a general fitness monitor.

 

Wearables that are specifically designed for the healthcare industry work in an identical manner. Senses are used to gather data, which is then transferred to another device for later analysis. Smartphones are most commonly used, with apps available for several platforms including Apple’s iOS and Google’s Android, but residential users can also use Wi-Fi to transfer data to the cloud or to another monitoring device.

 

In my opinion, as this technology grows, I believe real-time reporting will be possible, where data is displayed on the health professional’s monitor as soon as new data is uploaded. The exact direction this technology will take requires valuable input from knowledgeable medical professionals. That is not to say that the existing range of devices for the medical industry is limited as this is far from the situation. There are several preventative care devices already on the market and these include:

 

Glucose meters that notify clinics of an emergency situation, ideal for remote monitoring of elderly diabetics
Remote monitoring devices that store information such as blood pressure, temperature, ECG data and more. These can save a vast amount of clinic time, allowing healthcare professionals to prioritize according to patient ailment and creating an environment where early diagnosis is certain for many common ailments.
There are several dedicated devices and applications for monitoring diets, all of which act as a virtual personal trainer who recommends a specific diet according to age and cardiovascular status.
The examples listed above are probably the most common but there are many other devices available that monitor specific conditions. All share the same properties, to gather information and to monitor patients in real-time, thereby improving doctor-patient interaction and the healthcare service provided.

 

The use of wearable technology is a win-win for both healthcare professionals and patients and can reduce individual patient costs while also eliminating unnecessary clinic visits for the patient. For example, if you have high blood pressure and are prescribed specific medication to alleviate the condition, you will no doubt have to make several trips to the clinic to verify that the prescribed treatment is actually working. However, with the use of wearable technology, this is no longer necessary, as the data gathered from the device is simply analysed without travelling to the clinic.

 

Australian healthcare professionals need to adopt wearable technology as soon as possible, given that the benefits surpass any possible costs or training headaches. It is a fact but careful selection of wearable devices and software apps can increase the efficiency of any medical practice, whether it is immediate access to patient data from anywhere, guided surgery, health monitoring tasks and more. Early adopters have already discovered that these solutions can reduce the frequency of clinic visits and related clinic hours per patients.

 

Individual patient costs are reduced substantially but this does not mean that clinics will lose revenue, it merely means that available clinic time is spent treating the seriously ill or patients that require emergency care.

 

Mobile devices, remote data access and analysis with the resulting ability to increase early patient diagnosis are the way of the future. It may take some effort to define the correct processes, workflows and procedures but it is clearly worth it. Can you really afford to ignore the benefits of wearable technology?

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The Promising Future For AI In Orthopedics

The Promising Future For AI In Orthopedics | IT Support and Hardware for Clinics | Scoop.it

In their most simple form, AI applications in healthcare consist of a collection of technologies that will enable machines to sense, comprehend, predict, act, and learn. The first application for AI-based machines, as discussed at the World Medical Innovation Forum (held in April 2018), is to execute healthcare administrator and clinical healthcare functions. Current technologies are limited because they are algorithm based. The future of AI will make the leap past algorithm-only tools to become indispensable instruments for patients, providers, physicians, and payers. AI has the potential to truly augment human activity.

 

Why This Is Important
The potential to drive improvements in quality, cost, and access has made AI a notable buzzword in healthcare. The AI health market is growing rapidly and is forecasted to reach $6.6 billion by 20211 (Table 1).

 

AI Applications in Orthopedics
AI has demonstrated high utility in classifying non-medical images. A study2 looked at the feasibility of using AI for skeletal radiographs. The study authors compared an AI program against the radiography gold standard for fractures. They also compared the performance of the AI program with two orthopedic surgeons who reviewed the same images. They found the AI program had an accuracy of at least 90 percent when identifying laterality, body part, and exam view. AI also performed comparably to the senior orthopedic surgeons’ image reviews. The study outcomes support the use of AI in orthopedic radiographs. While the current AI technology does not provide important features surgeons need, such as advanced measurements, classifications, and the ability to combine multiple exam views, these are technical details that can be worked out in future iterations for the orthopedic surgeon community.

 

AI in Computer-Assisted Navigation3
Orthopedic surgeons have had access to robotic technology to help them position screws, prostheses, or tunnels for some time, but AI enhanced applications are in development (Table 2). For example, one device utilizes infrared light to locate bones intraoperatively. Another technology uses a form of AI to mill the canal for a prosthesis based on CT scans. In total hip surgery, computer assistance in placing the cup of the prosthesis is reported to have the same accuracy as with traditional methods. In the realm of knee replacement surgery, AI-supplemented robotics technology assists to align prostheses. In spine surgery, AI-enhanced computer-assisted navigation helps surgeons avoid neurovascular structures, and place thoracic and lumbar pedicle screws accurately. It is reported that the incidence of poorly placed screws has reached 42 percent with conventional surgical techniques, according to some studies, but is as low as 10 percent with AI-based computer assistance.

 

We Have Needed a Tool Like AI for a Long Time
AI will change the way healthcare work is performed. AI will fill the gaps we all know are coming in the future, such as the labor shortage in healthcare (Table 3). Through AI, we will empower clinicians and give workers tools to increase their productivity. Healthcare institutions will need an AI-trained workforce and culture. Think of the value your products will bring with AI and the ability to gain clinician face-time and recognition as they use AI to enhance efficiency, quality, and outcomes.

 

The Medi-Vantage Perspective
In almost every strategy research project we manage, when we look at adjacent technologies in consumer markets, we see AI being utilized again and again. Our strategy research helps clients understand the opportunity to integrate AI technology into their product strategies. Someday, even the most common medical devices will have an AI component.

 

Maria Shepherd has more than 20 years of leadership experience in medical device/life-science marketing in both small startups and top-tier companies. After her industry career, including her role as vice president of marketing for Oridion Medical where she boosted the company valuation prior to its acquisition by Covidien/Medtronic, director of marketing for Philips Medical, and senior management roles at Boston Scientific Corp., she founded Medi-Vantage. Medi-Vantage provides marketing and business strategy as well as innovation research for the medical device industry. The firm quantitatively and qualitatively sizes and segments opportunities, evaluates new technologies, provides marketing services, and assesses prospective acquisitions. Shepherd has taught marketing and product development courses and is a member of the Aligo Medtech Investment Committee (www.msbiv.com). She can be reached at 855-343-3100, ext. 102, or at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.

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Physicians are not Experts, they rely on their Health IT Vendors for Support and Security Guidance 

Physicians are not Experts, they rely on their Health IT Vendors for Support and Security Guidance  | IT Support and Hardware for Clinics | Scoop.it

Medicine has its own version of a digital divide. In terms of cybersecurity accountability, the buck stops with the physician. The problem is that security expertise lies with information technology (IT) vendors who provide software, equipment, training and other services to physician practices. These vendors often speak a different language than the physician, who is well versed in clinical matters but whose tech savvy may end with the cable TV remote.

 

“Physicians are not security experts. It’s not what they went to school for,” said Laura G. Hoffman, assistant director of the AMA’s department of federal affairs, and presenter on two recent AMA cybersecurity training webinars. Because physicians are not experts, they “rely on their health IT vendors for support and security guidance.”

 

A recent AMA-Accenture survey of 1,300 physicians found that more than a quarter of physicians already outsource their security management and an almost equal number are interested in doing so. Many physician practices go it alone—about half of the practices surveyed have an in-house security official—juggling the requirements of various systems and equipment, and relying largely on trust that the products and services they pay for are secure, reliable and work seamlessly together.

 

“Physicians really trust their vendors and that can be good and bad,” Hoffman said. Under the Health Insurance Portability and Accountability Act (HIPAA), she noted, it’s physicians who “are the ones on the hook if anything goes wrong.”

 

Bridging medicine’s cybersecurity digital divide can be an intimidating prospect, especially for smaller practices. How products from various vendors fit together may be unclear. The scope of a physician’s discussion with a vendor will vary greatly by not only by practice size, but by technology choices. For example, a practice with cloud-based records storage will have different concerns to address than one with its own server. Here is what to consider for having a more effective conversations with vendors.

 

Think ePHI and beyond, not just EHR. A medical practice’s starting point for getting a handle on vendors might be the electronic health record (EHR), but cybersecurity preparedness and accountability requires a broader view. In terms of cybersecurity, HIPAA covers any and all electronic protected health information (ePHI). An EHR is sure to contain ePHI, but ePHI is likely to be found throughout the practice. HIPAA requires a security risk analysis and whether done in-house or by a vendor, it is a great starting point for getting an inventory of all the relevant technology and understanding the interactions of the devices involved.

 

The AMA offers a free, one-hour webinar to familiarize physicians and practice managers about how to conduct it. Beyond obvious HIPAA concerns, there is other technology—for example, non-EHR office software and computers—that can play a role in the safe and smooth functioning of the practice. “Identifying the actual technology in your environment is a first step in making sure everyone is at the table when you have these conversations,” said AMA Senior Health IT Consultant Matt Reid, co-presenter with Hoffman in a separate AMA webinar on cybersecurity and patient safety.

 

Practices need to be more assertive. Technology from different vendors may not always smoothly mesh. For example, a larger practice with cloud-based records storage requires an Internet service provider to supply sufficient Internet bandwidth to reliably store and retrieve data.

 

What’s required is a practice cybersecurity and technology “champion,” said Reid. It is that individual—who may well be a practice staff member as opposed to a physician—who can get vendors together, face to face or in a conference call, to have all the practice’s technology work together. According to Reid, the he champion’s message should be: “This is an issue where we all want to row in the same direction, so how are we all going to work together cohesively?”

 

Vendors need to be more forthcoming. When that practice champion gets the conversation going, a top priority is collecting and sharing a complete set of technical information from all of the practice’s health IT vendors. The objective is to find out fully what the practice needs to know about and, critically, what the vendors need to know about each other’s hardware, software and services requirements.

 

Testing is essential. A practice should periodically test the technology it relies on—Hoffman noted one example of an EHR that, unbeknownst to the practice, ran out of storage space—and be aware that technology problems can arise whenever anything new is added to the mix.

 

Looking ahead, the AMA is exploring how practices can be incentivized to work closer with vendors on cybersecurity. Nearly three-quarters of the doctors in the AMA-Accenture survey said they would be willing to pay a vendor to implement a cybersecurity framework if adoption meant that practices would not be subject to random HIPAA audits.

 

Also on the AMA’s advocacy list: safe-harbor exemptions from the Stark Law and Anti-Kickback Statute expanded to allow donation of cybersecurity-related hardware or software to small medical practices from other provider groups. The AMA recently sent a letter to the U.S. Department of Health and Human Services’ Office of Inspector General on the matter.

 

In the letter, the AMA expressed its deep concern that the country’s health care providers have been insufficiently prepared to meet the cybersecurity challenges of an increasingly digital health system. The AMA firmly believes that this is a national priority and that physicians and other health care providers need tools to secure sensitive patient information in the digital sphere.

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Tips To Help Ensure A Successful Surgeon Design Team

Tips To Help Ensure A Successful Surgeon Design Team | IT Support and Hardware for Clinics | Scoop.it

Design surgeons and surgeon design times have been at the core of the significant advances that have occurred in the medical device market in the last few decades. Working with surgeon design teams is inspirational, mentally demanding, and exciting.

 

Let’s assume a new opportunity has been identified that will improve your organization’s financial position. The marketing team has studied the market space—that is, classified at least three types of current and potentially new innovative strategies this opportunity should incorporate (as was described in the March/April 2018 issue of ODT, “Innovation and the Development Engineer”).

 

Once a complete financial plan, which includes cost to develop/introduce, and a sales/marketing plan have both been vetted and approved by the organization’s senior staff, it is time to move ahead to develop the surgeon design team.

 

I have had experience with two different types of surgeon design teams. The first—a “Hub and Spoke” model—was utilized in situations where aligning with a given group of surgeons or an institution would alienate others from using the product once it was released. The second is the more traditional surgeon design team with a group of surgeons selected to work on a project from beginning to end.

 

The Hub and Spoke model concept relies on one or two core key opinion leading (KOL) surgeons to serve as the hub of the wheel. Different surgeons or groups of surgeons meet independently with the KOL surgeon and the development engineering lead at a series of low-key meetings held at various time points to obtain feedback on different aspects of the design. There is a significant amount of reliance placed upon the KOL surgeon as the amount of involvement of the non-KOL surgeons is substantially less than in a traditional surgeon design team model. In this model, the non-KOL surgeons are assisting with validating the market assessments and need requirements, as well as providing market acceptance feedback of the new product later in the process. It is the responsibility of the KOL surgeon and the development staff to turn that information into a viable product.

 

With the more common traditional surgeon design team, assembling a good design team is critical to the success of the endeavor. The product development team needs to work closely with the marketing department in the selection and assembly of the surgeon design team. The selection process is very much like picking players for a team sport. The desire is to pick the most talented team, with personalities that mesh with each other while becoming aligned to win in the same way.

 

The training and clinical experience of the surgeons, the number of surgeons on the team, and their geographic locations are just a few of the important factors to be considered. The surgeon’s CV is a great reference as are their publications to discover where and by whom they were trained, as well as if they have any won any awards or honors. This process helps an organizer begin to understand a surgeon’s philosophy so as to determine if it matches with the objectives of the project. If these elements do not seem to align, it is best to move on. Further, there are other important considerations—is this the first design team the surgeon has been a part of or is it just the most recent? Has he or she been a part of prior design projects, and if so, what has been the success of those products? You need to fully understand the motivation of a surgeon to be a member of a design team.

 

It is critical the surgeons understand the commitment they will need to make to be part of the design team, as there will be meetings and other activities that will take them away from their clinical practice and surgery. Provide an understanding of the duration of the project and the time periods where their involvement will be greater than other periods as the project progresses. For example, one design project required great commitment from the surgeons as it met approximately every two to three weeks and for full weekends. As a result of the commitment from the surgeons and support of the company, a very large implant/instrument project was conceived and introduced in 18 months. Conversely, projects without full commitment from all surgeons has resulted in the opposite effect, significantly delaying the project, and doubling the anticipated time to market. Therefore, if the surgeon is not willing to commit the time, they are not a good candidate.

 

I have had the opportunity to work with a wide group of surgeons from around the world on numerous design teams. All were excellent surgeons, but their interests and how they assisted the design teams varied greatly. There were some true innovators and designers who would design or create their own drawings of new and innovative products. When the product was introduced, they were willing to stand behind the new concept until it was clinically proven, even in the face of being questioned by traditionalists. Others were known for performing clinical studies or understanding the issues surgeons were facing. Still others offered their strengths in addressing the surgical technique. It is crucial to understand the strengths and weaknesses of the members of the design team.

 

Regarding the project itself, it is vital to have the project well-scoped. The scope needs to be flexible in nature but, at the same time, there need to be boundaries in place to avoid creep and to ensure the end results fulfill the original unmet market requirement. What is the new product or service expected to perform and what is it not going to address? What shouldn’t be addressed is, many times, more important than determining what needs to be. Ensure everyone understands the project’s clinical scope, the financial objectives, and the other innovative aspects desired. In order to keep the team focused and grounded as time progresses, it is often necessary to reflect back upon the scope to avoid derailing and delaying the project.

 

Having the development engineer/staff gain the respect of the surgeon design team is also important. The engineer must have a wide base of knowledge to keep multiple elements of the development project within his or her view. As the process progresses, certain elements of the product are being locked down that impact the long-term commercial success, design attributes, manufacturability, inventory costs, marketing/sales, user experience, and clinical outcomes. Throughout the project, subject matter experts (e.g., the surgeons, manufacturing engineers, etc.) will provide input and support, but the development engineer is ultimately the one who must sift through all the information and recommendations to decide which to accept, modify, or reject. As such, the development engineer must be a jack-of-all-trades. Leading a development program should not be handled as if it is a democracy, but rather, as a benevolent dictatorship. The leader must listen, assess the situation, make a decision, and move on. Attempting to satisfy all parties will only cause delays.

 

There are techniques that can be used to help sort through the issues to attempt to make the best decisions. One technique is to note how many times the same concern is raised. If the issue is repeated by numerous surgeons and/or other advisors, it likely requires further exploration. If it is rarely stated or only by one surgeon, it may be safe to consider it a much lower priority. If the factor significantly impacts cost, however, determine how significantly it could impact the marketability of the product.

 

If a new, creative solution is conceived by a surgeon that seems to have originated from out of left field, it should not be automatically dismissed. Instead, challenge the surgeon to “sell” the idea to the rest of the design team. If he or she cannot earn their acceptance, it may be best to move on. This does not mean the concept was not worthy, but perhaps it needs to be sidelined from the current program and examined independently on its own merits at a later time or for a future generation of the product. Some creative solutions may seem like an idea that makes sense, but ultimately, must be considered within the scope definition for the project.

 

When having a design meeting, it is important to know the outcome ahead of time. Since design meetings can sometimes become confrontational, first addressing key topics individually with surgeons to understand their concerns and issues will provide a means to be better prepared for the full meeting and make it more productive. If there are controversial issues to be addressed, have one of the surgeon designers present them, which can also assist in making the meeting more productive.

 

After the concept for the product design has been finalized, enroll a second group of surgeons not part of the original design team to objectively review the new product concept. This can help ensure market acceptance and help identify issues that may have been overlooked. All members of the design team are too close to the project to objectively review the new product. While this review occurs late in the design process, it is still early enough to allow for modifications to be made relativity inexpensively.

 

Surgeon design teams have been and will continue to be a critical element for the advancement of healthcare in the development of new and innovative medical devices. Leading surgeon design teams is a skill a development engineer needs to hone and refine. It involves technical knowledge, psychology, business acumen, and most importantly, strong leadership attributes.

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Why Firms Of All Sizes Need To Outsource? 

Why Firms Of All Sizes Need To Outsource?  | IT Support and Hardware for Clinics | Scoop.it

I was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for devices, but there were holes in the product development cycle thanks to a lack of resources or expertise.

 

That’s when I decided to grab a shovel and start filling some of those holes. First came Empirical Testing Corp. (ETC), which focused on testing devices. It was all we did, so we got good at it over the course of 20 years. Through ETC, we heard from clients who needed small-batch manufacturing and prototyping, so we launched Empirical Machine. Clients came to us for regulatory support through both of those specialty companies, so we added Empirical Consulting to our group of companies. Each branch of our corporate family tree developed as an answer for companies or individual developers lacking a critical in-house resource.

 

For companies large and small, outsourcing specific aspects of device development builds forward momentum and supports the entire industry.

 

Andy Fauth is an engineer by training. For 13 years, he’s worked in a private-equity, privately owned business he says owes its growth to finding the right vendors. He’s now chief technology officer for SMV Scientific, a company that specializes in the bone-implant interface and designs, develops, and manufactures orthopedic devices. The company began as a two-person research and development venture four years ago and has grown into a 17-person business with three devices on the market and six 510(k)s completed.

 

“As an emerging company, we don’t have the capital to have the equipment internally or hire everybody we’d like to hire for the right way to handle this stuff,” he said. “The only way we could incubate this company and grow was to outsource.”

 

Even for larger companies, it often makes sense to outsource specific parts of device development, he said.

 

“There’s always a bottle neck somewhere—that’s why there is an outsource market,” Fauth said. “Some of that stuff is specialty. When you’re going to do it once every couple of years, you don’t want to do that internally. There’s always specialty equipment, whether it’s a test frame or test fixture or experience with a certain protocol you don’t have in-house, or don’t want to invest in having that in-house long-term. You just need to use it once and check the box.”

 

Raymond Cloutier, vice president, Engineering & Development, Advanced Technologies at Exactech, said despite significant resources and commitment to Exactech’s in-house resources, he also turns to outside vendors for specialized support. Sometimes it’s an issue of capacity, but he also appreciates the benefits of outside expertise.

 

“[Outside vendors] are in a somewhat privileged position,” he said. “They’re also doing work for other companies, which helps them know the benchmark or industry standard. Sometimes when we’re in our own world as a company, we don’t have as much understanding of how requirements should be interpreted. An outside consultant may better understand what expectations, for example, the FDA may have. Suppliers generally have seen how multiple companies prepare submissions.”

 

He said bigger companies may, at times, err on the side of being overly cautious.

 

“Oftentimes large companies take very conservative positions because they have a lot at stake,” Cloutier said. “The question is, are they being ‘overly compliant’? Are they doing things more rigidly than what the external regulatory bodies require? Sometimes an outside perspective helps you better know the answer to that.”

 

David Poirier is founder and owner of spinal implant company Presidio Surgical, which has a staff of eight. He keeps quality control, marketing, sales, distribution, and accounting in-house, but the bulk of his device development work depends on outside vendors.

 

“Everything we do, we pay for through sales and distribution of our products,” Poirier said. “They have to be right. There’s really no room for error. We’ve made errors. They hurt.”

 

At first glance, it may appear outsourcing is more expensive than keeping things under your roof. But those numbers can be misleading. You may pay $200 per hour to a single vendor—which is often more than an employee’s hourly wage—but you’re not paying benefits or down time when the employee is not actively engaged on the project, Poirier said. There’s also a matter of prioritizing in-house expertise to make the best use of time and money, he said.

 

“If I take someone in quality engineering and say, ‘I need you to work on this gauge design,’ my project may have a mid-level priority, but I’ve taken them from a much higher-level project; there’s an opportunity cost,” Poirier said. “There’s the cost of the benefits and true cost of employees, then the opportunity cost. It’s a general management issue you have to think about. With consultants, you’re only paying them for what they deliver instead of the full cost (of an employee).”

 

Paying for support a la carte is less expensive than developing that service for your business, Poirier said.

 

“I only pay them for the work they do,” he said. “When you’re outsourcing, it can be a benefit if you have really good experts. You’re paying them for what you want and get what you need. You’re paying for specific service rather than a staff member. It’s hard to find good people.”

 

Working with consultants who are well-known in the industry has its advantages, Fauth said.

 

“Just to get the expertise for third-party validity for our customers, we’d outsource,” he said. “We actually had to challenge and re-invent new standards. We worked with the FDA to develop protocols and standards that didn’t exist at the time. When you have an outsource company that’s done all of that already and has a reputation of being a good firm, it lends a lot of credibility and merit to what you’re trying to do.”

 

Word-of-mouth referrals and networking are solid first steps toward finding the partner.

 

“Reputable is the key,” Cloutier said. “One test that gives me an indication is how careful they are at protecting other companies’ knowledge. If they share confidential information from other companies with you, then they’re probably sharing your confidential information with others. Observing this helps me judge who is a trustworthy supplier to work with and who isn’t.”

 

And even as you consider outsource options for aspects of your project, never forget the big picture, Fauth said.

 

“I look at anybody we interact with as a potential partnership, not just a customer/supplier relationship,” he said. “If something goes bump in the night, I want everyone equally committed to fixing it.
I also want it to be a win for both parties. That’s the right way to do business long-term. It’s not always about price or lead time. Those are factors. It’s also about quality, it’s about trust, it’s about faith they’re going to make it right if something goes wrong and everybody’s going to work for everybody else’s best interest.”

 

Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.

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EMPOWR Porous And Complex Primary Knee Systems

EMPOWR Porous And Complex Primary Knee Systems | IT Support and Hardware for Clinics | Scoop.it

DJO, a provider of medical technologies designed to get and keep people moving, introduced the EMPOWR Porous Knee System and EMPOWR Complex Primary Knee System at the 2018 Annual Meeting of the American Association of Hip and Knee Surgeons (AAHKS). These new additions to the EMPOWR Knee Platform expand one of the industry’s most modern total knee replacement systems, which now offers primary, cementless primary, complex primary, and tibial revision solutions for surgeons and patients.

EMPOWR Porous Knee System is based on two decades of clinical experience and highly porous materials designed to enhance early implant fixation, while creating an ideal environment for both immediate and long-term biologic fixation.1 DJO’s surface coating technologies, including DJO’s proprietary, highly porous coating, P2 aids in bone apposition for superior in-growth performance.1 EMPOWR Porous’ bladed keel has a bone sparing geometry optimized for cementless application.2 The bladed keel of the asymmetric baseplate was developed to provide robust fixation, while the cruciform pegs provide initial component fixation and durable rotational stability.2

EMPOWR Complex Primary Knee System, with the EMPOWR Universal Tibial Baseplate and EMPOWR Varus Valgus Constraint (VVC) Tibial Insert expand the utility of the EMPOWR Knee Platform and provide a wider range of solutions for complex primary and revision knee arthroplasty. These new implant technologies are designed to provide an efficient and seamless transition from standard primary to revision knee procedures, with a minimal number of additional instruments and trays. The EMPOWR Universal Tibial baseplate maintains the EMPOWR System’s characteristic asymmetric footprint which maximizes cortical coverage and prevents component overhang to ensure long-term fixation without tissue irritation4. This baseplate also provides the ability to stem and augment when more supplementary fixation is required. The VVC insert is offered in e+ polyethene, formulated to reduce long-term wear3, while the insert is designed to provide the necessary support and stability in knees with supportive soft tissue deficiencies.

“DJO has a proven record of bringing high-quality products to market with incredible cadence—faster than any other implant company today,” said Dr. Eugene S. Krauss, an orthopedic surgeon with Northwell Health. “In 2018 alone, the EMPOWR Porous Knee and EMPOWR Complex Primary Knee launches have significantly expanded our ability to treat a wide variety of patients in our practices.”

“The efficiency of DJO’s instrument trays and the streamlined instrumentation enables my surgical team and I to perform up to 12 knee replacements in a single day, making the system well-suited for both hospital and ambulatory surgery center environments,” said Dr. Krauss.

Over the past decade, the science of highly porous metals, including DJO’s P2, has significantly advanced, helping to improve implant longevity and ultimately patient outcomes. These scientific advancements coupled with a younger, healthier patient population, have resulted in a resurgence of cementless knee arthroplasty. Therefore, the contemporary design of the EMPOWR Porous Knee, is certain to have a meaningful impact on the market.

“DJO Surgical’s strong growth over the past few years is a reflection of our commitment to developing products and solutions that help improve clinical outcomes and enhance patient experience,” said Jeffery A. McCaulley, Global President of DJO Surgical. “Our continued expansion of the EMPOWR Platform reflects the overwhelmingly positive reaction we’ve received from surgeons and patients since the first EMPOWR Knee System was launched here at AAHKS in 2015.”

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Robotic Arm Offers Self-Help Mobile Rehab For Stroke Patients 

Robotic Arm Offers Self-Help Mobile Rehab For Stroke Patients  | IT Support and Hardware for Clinics | Scoop.it

The Hong Kong Polytechnic University (PolyU) recently developed a robotic arm to facilitate self-help and upper-limb mobile rehabilitation for stroke patients. The lightweight device enables the patients to engage in intensive and effective self-help rehabilitation exercise anywhere, anytime after they are discharged from the hospital. The robotic arm, called “mobile exo-neuro-musculo-skeleton,” is the first-of-its-kind integration of exoskeleton, soft robot, and exo-nerve stimulation technologies.

Stroke is the third leading cause of disability worldwide1. In Hong Kong, there are about 25,000 new incidences of stroke annually in recent years2. Research studies have proven that intensive, repeated and long-term rehabilitation training are critical for enhancing the physical mobility of stroke patients, thus helping to alleviate post-stroke symptoms such as disability. However, access to the outpatient rehabilitation service for stroke patients has been difficult. Due to the overwhelming demand for rehabilitation services, patients have to queue up for a long time to get a slot for rehabilitation training. As such, they can’t get timely support and routine rehabilitation exercises. Stroke patients also find it challenging to travel from home to outpatient clinics.

The “mobile exo-neuro-musculo-skeleton,” developed by Dr. Hu Xiao-ling and her research team in the Department of Biomedical Engineering (BME) of PolyU, features lightweight design (up to 300g for wearable upper limb components, which are fit for different functional training needs), low power demand (12V rechargeable battery supply for 4-hour continuous use), and sportswear features. The robotic arm thus provides a flexible, self-help, easy-to-use, mobile tool for patients to supplement their rehabilitation sessions at the clinic. The innovative training option can effectively enhance the rehabilitation progress.

 

Dr. Hu Xiaoling said development of the novel device was inspired by the feedback of many stroke patients who were discharged from the hospital. They faced problems in having regular and intensive rehabilitation training crucial for limb recovery. “We are confident that with our mobile exo-neuro-musculo-skeleton, stroke patients can conduct rehabilitation training anytime and anywhere, turning the training into part of their daily activities. We hope such flexible self-help training can well supplement traditional outpatient rehabilitation services, helping stroke patients achieve a much better rehabilitation progress.” Her team anticipated that the robotic arm could be commercialized in two years.

The BME innovation integrates exoskeleton and soft robot structural designs—the two technologies commonly adopted in existing upper-limb rehabilitation training devices for stroke patients as well as the PolyU-patented exo-nerve stimulation technology.

Integration of Exoskeleton, Soft Robot, and Exo-Nerve Stimulation Technologies
The working principle of both exoskeleton and soft robot designs is to provide external mechanical forces driven by voluntary muscle signals to assist the patient’s desired joint movement. Conventional exoskeleton structure is mainly constructed by orthotic materials such as metal and plastic, simulating external bones of the patient. Although it is compact, it is heavy and uncomfortable to wear. The soft robot, made of air-filled or liquid-filled pipes to simulate one’s external muscles, is light in weight but very bulky in size. Both types of structures demand high electrical power for driving motors or pumps, thus it is not convenient for patients to use them outside hospitals or rehabilitation centers. Combining the advantages of both structural designs, the BME innovative robotic arm is light in weight, compact in size, fast in response and demands minimal power supply, therefore it is suitable for use in both indoor and outdoor environment.

 

The robotic arm is unique in performing outstanding rehabilitation effect by further integrating the external mechanical force design with the PolyU-patented Neuro-muscular Electrical Stimulation (NMES) technology. Upon detecting the electromyography signals at the user’s muscles, the device will respond by applying NMES to contract the muscles, as well as exerting external mechanical forces to assist the joint’s desired voluntary movement. Research studies found that the combination of muscle strength triggered by NMES and external mechanical forces is 40 percent more effective for stroke rehabilitation than applying external mechanical forces alone.

Rehabilitation Effect Proven in Trials
An initial trial of the robotic arm on 10 stroke patients indicated better muscle coordination, wrist and finger functions, and lower muscle spasticity of all after they have completed 20 two-hour training sessions. Further clinical trials will be carried out in collaboration with hospitals and clinics.

The robotic arm consists of components for wrist/hand, elbow, and fingers which can be worn separately or together for different functional training needs. The sportswear design, using washable fabric with ultraviolet protection and good ventilation, also makes the robotic arm a comfortable wear for the patients.

The device also has a value-added feature of connecting to a mobile application (APP) where users can use the APP interface to control their own training. The APP also records real-time training data for better monitoring of the rehabilitation progress by both healthcare practitioners and the patients themselves. It can also serve as a social network platform for stroke patients to communicate online with each other for mutual support.

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Health Care Providers Face More Direct Billing, More and Tougher Collections

Health Care Providers Face More Direct Billing, More and Tougher Collections | IT Support and Hardware for Clinics | Scoop.it

Opponents figure that they pretty much killed the Affordable Care Act in December when they ended the individual mandate. They may be right. The mandate – the part of the ACA that required Americans to buy health insurance or face a minor penalty – was a key to trying to broaden and deepen the insurance pool, mitigate payers’ risk and, not least, keep premiums at least remotely tethered to people’s ability to pay.

 

Another part of the ACA is also under threat. The law allowed states to agree to an expansion of Medicaid that was meant to help people who couldn’t afford to meet the mandate on their own.  Still another: it also offered subsidies to help payers meet the expenses of covering all the previously untreated people they’d have to insure and of covering everyone’s pre-existing conditions. 

Premiums in fact did not grow as fast in states that accepted the Medicaid expansion during the past three years and as an estimated 40 million more people gained some form of health insurance.

The end of the individual mandate, the junking of one of the subsidies for health insurers and last year’s drastically truncated open enrollment period for the remaining Exchange plans, however, have again started to reduce the number of Americans with health insurance.

 

These changes affect more than practice volume. They impact operations for practices that retain patients, too.

For without increased attention to “revenue cycle,” all health care providers can expect to be doing more direct billing of patients, doing more collections work and assuming more bad debt from people with higher, tougher-to-pay deductibles in the coming months and years.

 

Here’s why: No one yet knows how many people who bought insurance only because they were required to. There’s reason to believe the end of the individual mandate will start making them drop out of all kinds of plans during the next open enrollment period.

A federally truncated open enrollment period October-December, 2017 has already reduced the number of insured people in the nation.  A number of forces are leading fewer people – and fewer younger, healthy people – to buy plans, and some predictions have premiums rising an extra 10 percent this coming year.

 

More shrinkage is coming. Newly permitted work requirements for Medicaid coverage promise to push still more people into the ranks of the uninsured. Kentucky’s new rules, for example, will drive an estimated 40,000 people out of Medicaid coverage during the next five years. As of this writing, nine other states are considering imposing new restrictions on who can qualify for Medicaid coverage.

 

The increase in the numbers of the uninsured obviously has disturbing implications for the nation’s health as a whole. It will also force payers to raise premiums to make up for the rising costs of being able to spread their risk across smaller, riskier customer pools.

 

The uninsured aren’t the only ones threatening practice finances.

Rising premiums, in turn, are leading employers to offer employees more high-deductible health plans. These HDHPs have lower premiums but higher risk for patients, who in addition to their premiums must pay an average of the first $2,400 of their families’ medical bills out of their own pockets. Some plans have deductibles as high as $10,000.

 

The lower premium costs, however, are attracting more and more people.

 

They are also higher risks for physician practices, which have a harder time collecting from patients with HDHPs. Thirty-seven percent of the people working for employers who offered plans in 2017 chose high-deductible plans. That’s up from 28 percent in 2016. The same year, that accounted for 39.3 percent of all Americans on employer-based health plans. All told, up to 37 percent of insured Americans, regardless of where they bought it, were using HDHPs.

 

But there have been dire unintended consequences. With the costs of care so high, 64 percent of those with high-deductible plans say they’ve put off care because they didn’t want to or couldn’t pay the deductible. And 62 percent said that, despite the lower premiums, they end up spending more on health care than under their previous plan.

 

People with the high-deductible plans thus tend to be bigger financial risks for providers.

Of HDHP customers, 15.5 percent reported having trouble paying medical bills in 2016 (versus 10.3 percent of those with “traditional” plans).

 

In sum, this means everyone in health care – providers, hospitals, practices – are going to chance offending more patients by billing them directly and, at minimum, going to have to devote more resources to revenue cycle and collecting what patients owe them.

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Professional Development Advice from Technology Leaders

Professional Development Advice from Technology Leaders | IT Support and Hardware for Clinics | Scoop.it

This edition of AppointmentPlus Radio brings together two industry leaders within the tech sector. Raymond Wiley, a general manager with Sun-Tec America, shares the story of how he landed his current position, as well as the philosophy that shapes his professional interactions. Dhruv Bhate, a senior technologist who works in 3D printing, offers insight into how reflection on your true values can lead to a meaningful work life. The two also discuss:

 

  • The importance of finding your professional “sweet spot”
  • How to understand, and communicate your professional value
  • Why defining what you do also mean defining what you don’t do
  • Plus: 5 must-have personal technology recommendations and 2 must-read books to overhaul your professional mindset

 

 

About Raymond and Dhruv: 

Raymond Wiley is the general manager at Sun-Tec America, LLC where he is responsible for the go-to-market strategies for Sun-Tec’s high precision lamination, labeling, and taping equipment portfolio for the Americas and European markets. He is the primary interface between the customer and the Sun-Tec design engineers located in Japan and is charged with overseeing the entire sales process through every phase of the project. Previously, Raymond spent 21 years at Motorola in the Semiconductor Products Sector serving in a variety of increasingly responsible positions including operations manager for the Small Signal and MEMS Sensor Businesses in Japan.

 

Dhruv Bhate is a Senior Technologist at Phoenix Analysis & Design Technologies, Inc. (PADT) where he leads R&D efforts in Additive Manufacturing, with a focus on high-performance polymers and metals. Prior to joining PADT, Dhruv spent 7 years at Intel Corporation developing laser-based manufacturing processes. Dhruv has a Ph.D. in Mechanical Engineering from Purdue University and a Master’s from the University of Colorado at Boulder, where he developed fracture models for ductile metal alloys and to simulate adhesion in MEMS.

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Online Scheduling Software Is Revolutionizing the Wellness Industry

Online Scheduling Software Is Revolutionizing the Wellness Industry | IT Support and Hardware for Clinics | Scoop.it

Appointment-Plus, the industry leader in online customer self-scheduling software, announced several major additions to its growing wellness and health screening client base. Major program providers such as Lifecare, Inc., which serves more than 4.5 million individuals, have quickly implemented Appointment-Plus web-based scheduling software to solve many of the thorny scheduling issues often associated with corporate wellness and health screening programs. Appointment-Plus seamlessly manages these large appointment volumes by allowing corporate employees and healthcare members to self-schedule via a secure Internet portal.

 

In addition to Lifecare, Appointment-Plus was also recently selected to be the online scheduling solution utilized by Self-Insured Schools of California (SISC), a health insurance group of over 300 school districts in the California education system. SISC will use Appointment-Plus software to allow thousands of school district employees and dependents to schedule health screenings across the State of California. With the integration of both the online self-scheduling software and the call center services offered by Appointment-Plus, SISC will maintain a comprehensive scheduling solution that meets all aspects of the employee and dependent scheduling process.

 

The appointment-plus software offers wellness providers the ability to customize the system to meet very specific scheduling needs, including the option to private label both the member scheduling view and the administrative view of the system. In addition, Appointment-Plus offers an enterprise solution if required for large projects. The enterprise solution allows wellness providers a web services toolkit to interface Appointment-Plus information with other systems.

 

Because Appointment-Plus operates on a software as a service (SaaS) model, wellness providers can implement the system with virtually no up-front or capital costs. In addition, because the member self-scheduling process eliminates much of the traditional manual scheduling process, using Appointment-Plus is a cost-saving measure for programs. Appointment-Plus accounts are scalable to allow scheduling across multiple client-companies and client-locations. With its robust reporting functionality, Appointment-Plus also effectively manages wellness project information needs.

 

“The flexibility and functionality of the Appointment-Plus system have been a key factor in its success for wellness providers,” said Jeff Fleming, Director of Business Development for Appointment-Plus, “Wellness providers, their clients, and their members really appreciate the simplicity of member self-scheduling and the corresponding business efficiency.”

 

Appointment-Plus is a technology firm that specializes in the development of web-based scheduling and appointment software for a wide variety of applications and industries. Appointment-Plus software clients include Fortune 500 companies such as Pepsi and Comcast, federal and local government, universities and schools, and small/medium sized businesses worldwide. In 2007, Microsoft Corp. selected Appointment-Plus software as its referral source for all appointment manager software clients.

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Cloud Computing Supports Telemedicine Growth

Cloud Computing Supports Telemedicine Growth | IT Support and Hardware for Clinics | Scoop.it

Today’s healthcare professionals enjoy convenient access to a multitude of tools that would have amazed previous generations. Unfortunately, lack of awareness or access to technical experts means that many practices are unable or unwilling to take advantage of the latest technological advances, advances that increase efficiency, security and productivity. Others are intimidated by the technical jargon often associated with eHealth. All that is needed to eliminate all these issues is a partnership with a provider that specialises in the health industry, rather than deal with IT companies that are themselves unwilling to recommend healthcare-specific solutions that they are unfamiliar with.

 

Providers of healthcare solutions are familiar with the inner workings of practices and clinics and can easily review existing processes and recommend solutions that will integrate technology in the best possible manner. They will also support any new technological solutions, leaving medical professionals more time for patient care, which will ultimately provide substantial benefits that aid early diagnosis and prolong lives.

 

Providers without healthcare knowledge will recommend solutions that they are familiar with, ones that are normally selected by traditional commercial enterprises. Such solutions are generally unsuitable for healthcare clinics and practices and often require expensive customisation, assuming that they can even be customised sufficiently to meet existing regulations.
Smaller clinics and practices do not have an on-site IT team and often eliminate IT requirements by automating server maintenance, data backups and archiving using a cloud solution. In such a scenario, it is the provider that is responsible for all of these activities.

 

Telemedicine allows easier collaboration and involves the use of mobile or other internet-enabled devices. Advantages include instant videoconferencing, remote consults, immediate access to electronic health records and the elimination of geographical issues, where patients are unable to visit the practice or clinic in person. These collaborative features are used between medical teams in multiple locations, between mobile clinics and their headquarters and of course can be used by any medical professional on the move.

 

When cloud services are used, connectivity is possible from anywhere a broadband signal is present, whether to a PC or portable device. This is ideal for patients in remote are rural areas and eliminates the time and expense necessary to consult with a specialist in the traditional manner. With videoconferencing, for example, no travel is required yet an excellent service is provided by the healthcare professional involved. Even follow-ups are possible online. Security concerns are also eliminated as a travelling professional accesses data remotely and never stores it on their own personal devices.

 

There are additional cloud benefits for healthcare professionals and these include:


• Scalability – you pay for the amount of space you use and it can be increased on demand


• Automatic updates – the provider’s IT team install security patches promptly


• Disaster recovery – automated regular backups take place and are restored when active data is lost


• Redundancy – multiple broadband connections are available. When one fails, another takes over


• Flexibility – if additional bandwidth is needed, it is readily available. This is not possible with traditional networks


• Works from anywhere – an internet-ready device, a 3G or broadband connection and you are good to go


• Collaboration – depending on requirements, there are specific software applications available to aid collaboration between team members and patients


• Document management – a single document repository allows secure and controlled access to confidential information


• Security – the use of the cloud ensures data is never stored in portable devices, given that thousands are lost or stolen every year

 

• Green-tech – the carbon footprint for each practice or clinic is substantially reduced, with cloud servers using less power per client due to virtualisation technology


• Cost savings – every clinic and practice uses the latest in hardware and software technology but without the initial investment. Ongoing IT maintenance costs are also dramatically reduced

 

When it comes to telemedicine, in addition to data management and document control features, there are software applications available that maximise patient turnover per clinic, improve patient care and even improve follow-up treatment and remote monitoring processes.

 

With benefits of this magnitude and with evolving regulations to embrace technological advances in eHealth, clinics need to install a telemedicine solution sooner rather than later or give competitive advantage to those that adopt now. This is especially true if patients and colleagues are in other geographical areas. In fact, government services are already active for eligible aged-care homes and to patients of Aboriginal Medical Services throughout Australia.

 

 

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Medical Device Quality: Why Software Is More Challenging Than Hardware

Medical Device Quality: Why Software Is More Challenging Than Hardware | IT Support and Hardware for Clinics | Scoop.it

The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,” indicate that further guidance is necessary to successfully comply with the regulation. FDA’s guidance document, “General Principles of Software Validation,” is an important first read in that regard, but many medical device manufacturers are not sufficiently familiar with it.

 

It is impossible to imagine the medical device industry today without the software revolution. From defibrillators to infusion pumps and robotic surgical systems, a broad range of devices relies on software to function safely and effectively. At the same time, medical device software has introduced a level of complexity that dwarfs anything seen before in the field. This column addresses some basic facts about medical device software and how quality professionals, together with executive management, can work together to ensure that FDA’s rigorous requirements are satisfied.

 

Note that FDA has separate requirements for medical device software and quality system software. This column addresses only the software that is part of a medical device, such as software that triggers an alarm when a product fails. Other software, such as that used by a medical device manufacturer to manage complaints in its quality system, is outside of the scope of this discussion.

 

In October 2017, FDA released two new final guidance documents on the same day: “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” In other words, medical device software changes have so many unique challenges and risks that they earn a guidance document of their own, separate from all other device changes.


The Problem: Software Is Different from Hardware
Validation is at the heart of device design, and the validation of software design is especially challenging. Even though FDA’s guidance document, “General Principles of Software Validation,” was last updated in January 2002, that guidance is still highly relevant and useful. When a medical device incorporates software, FDA expects the manufacturer to be well-read in the guidance document.

 

Furthermore, FDA does not intend the guidance document on software validation to be read only by software developers or quality engineers, as it states, “Software engineering needs an even greater level of managerial scrutiny and control than hardware engineering.” The guidance is written in laymen’s terms, so executive management is not excused from this responsibility, even when they have limited experience in software development.

To get to the heart of the problem, the guidance document on software validation includes the deceptively simple statement: “Software is different from hardware.” Actually, there are many complex differences between software and hardware, and understanding those differences is key to ensuring that software validation will pass FDA muster. The comparison chart (above and on the previous page) is adapted from, and expands on, the FDA guidance.

 

The Solution: Software Validation Driven by Rigorous Requirements


Both of the last two differences in the chart use the phrase, “a clear set of detailed requirements.” This is the most crucial element for proper software validation, and one that is frequently neglected. The flow chart figure on page 20 illustrates how requirements play an early and crucial role in software development.

 

During the phases that developers are coding and testing the software, the requirements enter a tunnel that is closed to non-developers, and the software emerges from the other side as a complete design. The resulting software can support a safe and effective device only if executive management and other stakeholders have reviewed a detailed and unambiguous set of requirements. Quality and regulatory teams can expedite this crucial phase by ensuring smooth communications between engineering and the rest of the organization.

 

At the far end of the tunnel, quality and regulatory conduct the final stages of user site testing with faithful attention to the original requirements. As noted in the list of differences between software and hardware, “user expectations are often unexpected,” and any expectations that were not properly specified as requirements are likely to emerge as errors during testing.

 

Clearly, the future of medical device development is bound up with new advances in software—wearable devices, remote medicine, algorithmic diagnostics, and robotics. FDA expects that manufacturers’ quality systems and design controls will ensure safety and efficacy, even as the software code at the heart of the device remains opaque to executive management. Software design might be more challenging than hardware, but software validation will keep the differences manageable and the quality undiminished.

 

Dan Goldstein is a manager for Quality Assurance at Musculoskeletal Clinical Regulatory Advisors (MCRA), primarily focusing on quality system requirements for bringing new devices to market and keeping experienced manufacturers in compliance with FDA and Notified Bodies. He provides MCRA clients with gap assessments, mock FDA inspections, Form 483 remediations, Design History Files, Technical Files, Summary Technical Documents, and Clinical Evaluation Reports. A graduate of the University of Maryland University College, Dan has worked since 2002 in quality assurance for medical devices, including autologous blood products for wound healing and computer-aided-detection software for lung diseases. Musculoskeletal Clinical Regulatory Advisers LLC has broad experience in the area of software validation. MCRA’s staff is especially adept at promoting and maintaining the lines of communication that keep executive management, the “voice of the customer,” and software developers on the same page with regard to the detailed requirements that drive the development process. The organization believes in requirements that follow the “four Cs”—clear, concise, correct, and complete.

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Advanced Software Offers Metal Artifact Reduction For Extremities

Advanced Software Offers Metal Artifact Reduction For Extremities | IT Support and Hardware for Clinics | Scoop.it

Carestream Health will demonstrate new optional advanced metal artifact reduction software for its Carestream OnSight 3D Extremity System at the Radiological Society of North America tradeshow (Booth #6713). Carestream’s OnSight 3D Extremity system captures high-quality, low-dose 3D extremity exams. The company’s new metal artifact reduction software is pending FDA 510(k) Clearance.

“Carestream’s second generation of software takes our state-of-the-art original metal reduction software to a new level. It provides enhanced flexibility depending on the metal content present and reduces the visual distortion caused by screws, implants, rods and other metal objects to create improved visibility and diagnostic confidence,” said Helen Titus, Carestream’s worldwide marketing director for ultrasound & CT.

The optional software makes it easier for radiologists and orthopedic surgeons to accurately diagnose a patient’s condition and develop treatment plans. Image processing can be adjusted and optimized according to the amount of metal present.

The software uses information from the original scan to eliminate the need for additional imaging studies, which reduces costs and lowers radiation exposure for patients.

An intuitive touch screen interface allows technologists to adjust for either moderate or complex metal content. The metal artifact reduction software can be activated prior to the scan or it can be applied after the original reconstruction is complete. Both the original and corrected images are always available to view and compare.

The OnSight 3D Extremity System also assists surgeons in detecting occult and non-union bone fractures. Unlike traditional CT systems, this cone beam CT system has a large-area detector that captures a 3D image of the extremity in a single rotation, which takes only 25 seconds. A patient simply places the injured extremity into a donut-shaped opening in the system. Since the patient’s head and body are not confined, patients do not experience the claustrophobia that often occurs with traditional CT systems. Dose is significantly reduced because only the affected body part is imaged.

The compact extremity system can be installed in an exam room and plugs into a standard wall outlet.

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In Situ Cured Silicone Could Enable Personalized Implants

In Situ Cured Silicone Could Enable Personalized Implants | IT Support and Hardware for Clinics | Scoop.it

Medical-grade silicone is a highly valued, versatile biomaterial widely used for medical implants. Often associated with applications such as cardiovascular pacemakers, cochlear implants, hydrocephalus shunts, implantable infusion pumps, and even intraocular lenses, silicones began to be used for a broad range of orthopedic medical applications beginning in the 1960s. The idea of replacing the small joints of the hand with silicone implants was first introduced by Swanson about 50 years ago.1 Since then, medical-grade silicone elastomer implants have become common in the replacement of diseased small joints. Typically, silicone elastomers are used to fabricate components of devices or entire devices, which are then assembled, packaged, and sterilized prior to implantation via surgery. Now, new dispensing technology serves as a means to provide an alternate method of surgical implantation, where uncured pre-sterilized silicone can be provided as a part of the surgical kit and cured in situ during the orthopedic procedure.

 

Benefits and Innovation
Silicone provides a diverse range of characteristics that make it useful, with properties ranging from very sticky to very slippery, and from soft and pliable to stiff or rigid. Consequently, it is very attractive for different medical uses, such as molded parts or lubricious coatings for medical devices; soft silicone adhesives for wound care; soft tissue implants; and even high-modulus tubing.

 

Device manufacturers often choose silicone for its established pedigree of biocompatibility, unique physical properties, and its ability to be altered at the polymer level. This ability to let manufacturers custom-modify material properties to satisfy specific medical device requirements has given silicone a reputation as a high-technology biomaterial that invites innovation.

 

Innovation in silicones, however, is expanding beyond the properties of the biomaterial itself. A new development in sterilizable dispensing systems allows sterile, uncured silicone elastomers to be considered for therapeutic use in orthopedic and other applications where pre-formed silicone implants are traditionally used. By enabling the silicone to be cured to its final form in situ within the specific area in the body receiving the implant, new approaches to orthopedic device design, fabrication, and implantation have the potential to be developed.

 

Medical-Grade Silicones: Value for Implantable Devices
To explore the value of in situ cured silicone elastomers in orthopedic applications, it’s helpful to examine some key traits and performance considerations that make silicone particularly appealing for implants.

 

Biocompatibility: Medical-grade silicones have been proven to be chemically stable for use in long-term implantable devices, with results demonstrating that biocompatible silicones are not harmful to living tissue.

 

The biomaterials supply crisis of the early 1990s presented a significant testing and documentation challenge for medical device manufacturers. There was a need to provide exhaustive safety data to obtain the regulatory approval required to market their products. Silicone especially, as the primary material from which breast implants are made, received intense evaluation. As a result, more than two decades of laboratory and clinical research and experience with silicone-containing medical devices of all types has produced thousands of peer-reviewed articles, as well as carefully considered regulatory decisions. These findings validate the safety and biocompatibility of implantable devices manufactured with silicone.

 

Customization: Silicone-based implanted orthopedic devices have multiple therapeutic applications, whether for finger joints or even spinal repair. Depending upon how it is used, each device has unique physical property requirements, such as firmness, cushioning ability, or flexibility. The advantage of silicone is its ability to be highly customized, so the desired properties such as elasticity, fatigue resistance, and durometer can be formulated for the appropriate functionality in a device.

 

Durability: Cured silicone retains its properties over long periods of time. This is especially useful in applications such as finger joint replacement, where the elasticity of the moving joint is a key characteristic. In long-term implantable applications, whatever balance of elasticity or firmness the device manufacturer specifies needs to be sustained over the life of the implant.

 

Curability: To fully leverage the properties of silicone, the material must be cured to activate these properties and make the material chemically stable. A widely used method for curing silicone is platinum-catalyzed addition cure. With this method, a platinum-based catalyst is included in the silicone formulation to activate crosslinking. Depending upon the final application, the silicone can cure to be relatively flexible or very hard. Platinum-catalyzed, addition cure chemistry is frequently chosen for implanted medical devices because there are no catalyzation byproducts; all formulation components are chemically bonded in the polymer matrix. Another benefit is the platinum catalyzation allows for flexibility in controlling the cure rate over a wide range of time and temperature.

 

Benefits of In Situ Cured Silicones in Orthopedics
The distinctive features of silicone offer tremendous potential value for therapeutic orthopedic applications. For example, they can create a seal, fill a void, provide cushioning, or enable flexibility. These types of applications can perform best when they fit the anatomy of a patient.

 

Until recently, silicone orthopedic devices were typically produced, cured, and sterilized prior to surgical implantation. However, the advent of silicone that can be cured in situ at the site of the implant is appealing for several reasons. In situ curing of medical-grade silicones in the body, rather than fabricating the device outside the body and implanting it, increases the ability to customize the fit of implanted orthopedic devices, since it is more of a “real-time” implant. In fact, research has already been conducted on the use of in situ-cured silicones in spinal applications. In vertebral repair, for example, it is conceivable that in situ-cured silicone could enable a custom-fit device. Using in situ-cured silicone implants also opens possibilities for less invasive implantation procedures. In addition, customization of in situ-cured silicone enables the material properties to be “tuned” in accordance with specific therapeutic requirements. For example, viscosity can be defined to make in situ implantation and curing easier to accomplish. The cure time can be tuned, so that the silicone cures in situ at body temperature. Moreover, the final physical properties of the material can be precisely defined to provide the desired performance, such as a specific level of hardness, if the orthopedic application is to support; or softness, if the orthopedic device is meant to cushion.

 

Sterilizing Silicone for Implants
As the industry reviews the potential for versatility and usefulness of in situ-cured silicone materials for orthopedic implants, another key factor to consider is sterilization. In order to be implanted, devices pre-fabricated with medical-grade silicones must be sterilized—so an efficient and fully verifiable sterilization solution is necessary.

 

The traditional method for producing silicone orthopedic devices uses a multi-step process. Although methods vary between manufacturers, most implants are molded from liquid silicone, which is then cured. This cured, molded part is typically placed along with other devices used for a specific therapeutic application into a single package or tray, which is then sealed and sterilized before it is delivered for use with a patient.

 

A number of processes can be used to sterilize uncured silicone. However, these processes have had challenges in the past with sterilization of platinum-catalyzed, addition cure silicones in their uncured state.

 

  • Gamma and electron-beam irradiation: May cause premature cure
  • Dry heat and autoclave: May be detrimental for heat- or moisture-sensitive formulation ingredients and packaging components

 

Exposing the silicone to ethylene oxide (EtO) gas is a widely used and effective sterilization method when used with compatible packaging to allow for ingress and egress of the sterilant gas. The implant is typically packaged along with the other components in the orthopedic surgical kit and sterilized as a single unit.

This process works for implants that are fabricated and cured prior to implantation. However, a technical challenge often faced by silicone manufacturers is how to package uncured silicones, so they can be sterilized then later used for in situ-cured therapeutic treatments.

 

New Packaging Enables Sterilization
Designed specifically to allow sterilization of uncured medical grade silicones, a new innovation in silicone dispensing systems makes in situ-cured silicone implants for orthopedics possible.

This novel, patented system2 features a dual-cartridge prefilled dispensing system. One cartridge contains the uncured silicone while the other contains the catalyzing agent. Each cartridge has a gas-permeable plunger seal that allows EtO sterilant gas to permeate through the plunger seal to sterilize the contents of the cartridge.


Key features of the packaging system include:

  • Disposable syringes that are available in a variety of sizes—5.0, 10, 25, 50, and 75 mL—which offers choices to help match the needs for the specific quantity of material required
  • One-step sterilization of both the material in the cartridge and the packaging
  • Easily adaptable to a variety of injection technologies
  • Engineered for use in complete surgical kits

 

Testing of this two-part dispensing system demonstrated that, after sterilization, the uncured silicones were fully sterilized, and there was no residual EtO remaining in the material. Equally important, there was minimal change to key silicone physical properties, such as rheology, durometer, modulus, work time, and cure rate.

 

Thus, the highly valued material properties of silicone—and the increased versatility and custom-fit capabilities offered by in situ curing of silicone—are now more viable through a dispensing system that can be efficiently and effectively sterilized prior to the orthopedic procedure.

 

The development of a new patented dual-cartridge prefilled silicone dispensing system makes in situ silicone curing a practical reality, offering the orthopedic community the potential to explore new therapeutic approaches that provide better outcomes to meet the implant needs of patients.

 

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FDA Clears IlluminOss Medical's Bone Stabilization System

FDA Clears IlluminOss Medical's Bone Stabilization System | IT Support and Hardware for Clinics | Scoop.it

IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.

The IlluminOss System incorporates the use of a thin-walled PET balloon that is infused with a liquid monomer and delivered in a minimally invasive fashion into the intramedullary canal of the bone through a small incision.

Once the balloon is infused with monomer, it conforms to the shape of the patient’s specific bone. The surgeon then activates a light source which delivers visible light to the PET balloon, polymerizing the monomer. The cured, hardened implant provides longitudinal strength and rotational stability over the length of the implant, stabilizing the fracture.

The IlluminOss System, which has been commercially available in international markets and been in clinical use since 2010, will now be available to patients in the U.S. for the treatment of pathological fractures of the humerus, radius and ulna.

“The FDA marketing clearance marks a significant milestone for IlluminOss Medical, allowing us to bring our products to the U.S. market,” said Robert Rabiner, chief technology officer, IlluminOss. “The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.”

Surgeons’ experiences with the product in the international markets have reported smaller incisions, shorter procedural times, faster return to patient’s daily living activities, with reduced hospital stays and lower complication rates for patients.

“The IlluminOss System has significantly changed the way we are able to approach the treatment of certain impending and actual pathological fractures resulting from metastatic bone disease,” said Dr. Richard McGough, Department of Orthopaedic Surgery, University of Pittsburgh Medical Center. “We were able to offer patients a quick, reliable surgical option that minimized pain and hospitalization. We were also able to consolidate their treatments; in some cases, we moved from two-day admissions to outpatient surgery, and we were ultimately able to complete radiation much more quickly.”

“I am delighted that we now have an improved option to help patients with metastatic bone disease of the humerus,” said John Healey, Chief of Orthopaedic Surgery, Memorial Sloan Kettering Cancer Center. “Since this device doesn’t violate the rotator cuff and can be inserted with reduced operative time and blood loss, it relieves pain and restores function more effectively than alternative treatments, in my experience. Furthermore, this new technology is versatile, and I anticipate that new applications will follow.”

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Nerve-on-a-Chip Platform Makes Neuroprosthetics More Effective

Nerve-on-a-Chip Platform Makes Neuroprosthetics More Effective | IT Support and Hardware for Clinics | Scoop.it

Neuroprosthetics—implants containing multi-contact electrodes that can substitute certain nerve functionalities—have the potential to work wonders. They may be able to restore amputees' sense of touch, help the paralyzed walk again by stimulating their spinal cords and silence the nerve activity of people suffering from chronic pain. Stimulating nerves at the right place and the right time is essential for implementing effective treatments, but still a challenge due to implants' inability to record neural activity precisely. "Our brain sends and receives millions of nerve impulses, but we typically implant only about a dozen electrodes in patients. This type of interface often doesn't have the resolution necessary to match the complex patterns of information exchange in a patient's nervous system," said Sandra Gribi, a Ph.D. student at the Bertarelli Foundation Chair in Neuroprosthetic Technology.

Replicating—and Improving—How Neuroprosthetics Work
Scientists at the lab run by Dr. Stéphanie Lacour, a professor at EPFL's School of Engineering, have developed a nerve-on-a-chip platform that can stimulate and record from explanted nerve fibers, just as an implanted neuroprosthetic would. Their platform contains microchannels embedded with electrodes and explanted nerve fibers faithfully replicate the architecture, maturity, and functioning of in vivo tissue.

The scientists tested their platform on explanted nerve fibers from rats' spinal cords, trying out various strategies for stimulating and inhibiting neural activity. "In vitro tests are usually carried out on neuron cultures in dishes. But these cultures don't replicate the diversity of neurons, like their different types and diameters, that you would find in vivo. Resulting nerve cells' properties are changed. What's more, the extracellular microelectrode arrays that some scientists use generally can't record all the activity of a single nerve cell in a culture," said Gribi.

The nerve-on-a-chip platform developed at EPFL can be manufactured in a clean room in two days and is able to rapidly record hundreds of nerve responses with a high signal-to-noise ratio. However, what really sets it apart is that it can record the activity of individual nerve cells. The research has just been published in Nature Communications.

Inhibiting the Activity of Specific Neurons
The scientists used their platform to test a photothermic method for inhibiting neural activity. "Neural inhibition could be a way to treat chronic pain like the phantom limb pain that appears after an arm or leg has been amputated, or neuropathic pain," said Lacour.

The scientists deposited a photothermic semiconducting polymer, called P3HT:PCBM, on some of the chip's electrodes. "The polymer heats up when subject to light. Thanks to the sensitivity of our electrodes, we were able to measure a difference in activity between the various explanted nerve fibers. More specifically, the activity of the thinnest fibers was dominantly blocked," said Gribi. And it's precisely those thin fibers that are nociceptors—the sensory neurons that cause pain. The next step will be to use the polymer in an implant placed around a nerve to study the inhibiting effect in vivo.

Distinguishing Between Sensory and Motor Nerve Fibers
The scientists also used their platform to improve the geometry and position of recording electrodes, in order to develop an implant that can regenerate peripheral nerves. By running the measured neural data through a robust algorithm, they will be able to calculate the speed and direction of nerve impulse propagation—and therefore determine whether a given impulse comes from a sensory or motor nerve. "That will enable engineers to develop bidirectional, selective implants allowing for more natural control of artificial limbs such as prosthetic hands," said Lacour.

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'Dual Mobility' Hip Replacement Implant Reduces Risk Of Dislocation

'Dual Mobility' Hip Replacement Implant Reduces Risk Of Dislocation | IT Support and Hardware for Clinics | Scoop.it

Hip replacement surgery is highly successful in relieving pain, restoring mobility, and improving quality of life. More than 330,000 procedures are performed each year in the United States, and that number is expected to almost double by the year 2030.

As with all surgical procedures, the possibility of a complication exists, and dislocation is the most common problem. The risk of dislocation is higher in patients who have had a second hip replacement, known as revision surgery. Some people need revision surgery many years after their first hip replacement when the original implant wears out. Hip instability after joint replacement is another reason a patient might need a revision surgery.

Research conducted by Dr. Geoffrey Westrich and colleagues at Hospital for Special Surgery and other joint replacement centers indicates that a newer type of artificial hip known as a "modular dual mobility" implant could be a good option for patients who need a revision surgery. Their study was presented at the annual meeting of the American Association of Hip and Knee Surgeons in Dallas this month.

"Although the concept of dual mobility was originally developed in France in the 1970s, the technology is relatively new in the United States," said Dr. Westrich, director of research of the Adult Reconstruction and Joint Replacement Service at HSS. "Our study found that the newer technology with modular dual mobility components offered increased stability, lowering the risk of dislocation, without compromising hip range of motion in patients having a revision surgery."

"Dual mobility" refers to the bearing surface of the implant—where the joint surfaces come together to support one's body weight. A hip replacement implant is a ball-in-socket mechanism, designed to simulate a human hip joint. Typical components include a stem that inserts into the femur (thigh bone), a ball that replaces the round head of the thigh bone, and a shell that lines the hip socket.

Modular dual mobility implants provide an additional bearing surface compared to a traditional implant. With the dual mobility hip, a large polyethylene plastic head fits inside a polished metal hip socket component, and an additional smaller metal or ceramic head is snap-fit within the polyethylene head.

"Currently, there are few large-scale outcome studies on the modular dual mobility device in revision hip replacement," Dr. Westrich noted. "We set out to determine the rate of dislocation and the need for another surgery following revision hip replacement using this implant and report on the functional outcomes."

The study included 370 patients who underwent revision hip replacement with the dual mobility implant between April 2011 and April 2017. The average patient age at the time of surgery was 65.8 years. Clinical, radiographic, and patient reported-outcome information was collected.

To be included in the final report, patients needed to be seen for follow-up for at least two years after their surgery, and the average follow-up was 3.3 years. "At the latest follow-up, we found that surgery with the dual mobility implant resulted in a very low rate of instability for the revision patients, namely 2.9 percent, with good functional improvement and a low rate of reoperation," Dr. Westrich noted. "While longer-term follow-up is needed to fully assess the newer device, in our study there was clearly a benefit provided by the dual mobility implant in the first few years following revision surgery."

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4 Industries That Find Blockchain Technology Useful

4 Industries That Find Blockchain Technology Useful | IT Support and Hardware for Clinics | Scoop.it

 

By 2024, the global blockchain market is expected to be worth $20 billion, and according to a recent study by IBM, one-third of C-level executives are considering adopting these technologies. Does that surprise you? Is your organization exploring blockchain or distributed ledger solutions?

 

Recent reports indicate that blockchain has the potential to reduce certain industries’ infrastructure costs by 30 percent. Additionally, there’s a $8-12 billion annual savings for certain industries that use blockchain technology. Let that sink in.

 

Companies of all industry types are using blockchain technology to help them improve transparency, traceability and trust; but here are four industry-specific benefits.

 

  1. Healthcare: Hospitals are now able to seamlessly access patient data shared between member hospitals and participating hospitals.
  2. Banking: Financial institutions are able to simplify and speed up the transfer of funds, while ensuring the identity of the user.
  3. Supply chain: Manufacturers can ensure the authenticity of goods and products with better transparency and accountability.
  4. Insurance: Companies can eliminate common sources of fraud, and use smart contracts to improve efficiency and improve customer experience.

 

With all of these sample use cases, blockchain helps companies increase efficiency and reduce friction. Sirius offers various services to help organizations define and develop their blockchain solution.

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Keep Your Appointments Afloat! 

Keep Your Appointments Afloat!  | IT Support and Hardware for Clinics | Scoop.it

Summer can be a busy time for sailing and boating businesses as people flock to the beach, bays, rivers and lakes for a fun day on the water. Online scheduling software from Appointment-Plus can be the perfect partner for operators looking to spend less time booking reservations and more time on the water with their customers.

 

Used by businesses coast to coast for scheduling sailing lessons and booking boat rental reservations, Appointment-Plus helps these operations automate and streamline their appointment-setting procedures with such functionality as online self-scheduling, which allows customers to view availability and book their lessons and reservations online, 24 hours a day; automated e-mail and text message reminders, which inform customers of their upcoming appointments and reservations; accurate recordkeeping and report-generating features; and e-marketing capabilities for sending current and past customers information on specials, discounts and other news.

 

“Sailing and boating businesses provide fantastic recreational opportunities for individuals and families throughout the nation,” says Jeff Fleming, marketing director at Appointment-Plus. “Our software helps automate and streamline the entire appointment- and reservation-scheduling process, allowing them to spend more time focused on their operations and their customers.”

 

A Software as a Service (SaaS) application, Appointment-Plus is Web-based and accessible from any Internet connection. This gives operators the ability to access their scheduling calendar from outside of their home or office. Additionally, Appointment-Plus does not require a Web site, expensive hardware or time-consuming installations to use. Pricing starts at $39 per month with no long-term contracts and free set-up assistance with a dedicated coach.

 

Businesses that utilize the online self-scheduling feature can expect a significant drop in the number of phone calls from customers looking to book appointments and check availability. This functionality is especially beneficial if the operator does not have an office or receptionist and routinely takes phone calls at the dock or on the water while giving lessons.

 

“Just think of the convenience of allowing your customers to schedule their lessons or reserve their watercraft at any hour of the day and at their own convenience,” Fleming adds. “Plus, you’ll spend less time answering the phone call and returning messages.”

 

Appointment-Plus supplies almost 4,000 clients throughout the United States, Canada and 10 other countries the tools they need to schedule customer and patient appointment times, book rooms, accept registrations and many other services. Geared primarily toward small businesses such as doctors’ offices, spas, health clubs and massage therapists, users of the service also include Fortune 500 companies; colleges and universities; healthcare agencies and facilities; federal and local government; and freight and delivery companies.

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