For the past 20 years, the Medical Design Excellence Awards have celebrated medical products that improve the quality and accessibility of healthcare. Our finalists this year carry on this tradition, while also keeping in step with today’s high-tech digital and consumer trends.
With the help of our esteemed jurors, we have identified four key trends in this year’s group of finalists: risk reduction; faster, more-efficient healthcare delivery; the influence of the Internet of Things; and the consumerization of healthcare.
We’ve been tracking a few of these trends in past awards programs, so they’re not necessarily new. In fact, when we launched the program in 1998, we noted a trend in the very first group of MDEA finalists toward “meaningful focus on the patient.” This year’s group of finalists are just as focused and may very well be addressing unmet needs in their respective categories. In this article, we cover a few of the trend-setting finalists; for the complete list, click here.
First, Do No Harm
Medical devices enable doctors and nurses to save and sustain lives every day, but invasive procedures can present risks of infection and trauma. Many finalists this year aim to minimize those risks.
A number of devices intended to ease surgical procedures or reduce their risk competed in this year’s ER and OR Tools, Equipment, and Supplies category. The VersaOne Fascial Closure System, for instance, is designed to deliver consistent port-site closure, added procedural efficiency, and ease of use, Medtronic reported in its submission. The system enables the trocar to remain within the patient while closing the defect, allowing for tissue alignment and pneumoperitoneum. MDEA juror Uli Chettipally, physician, researcher, and an innovator with InnovatorMD, called it a “smart and clean solution.”
The CleanCision wound retraction and protection system (below) for use during abdominal surgery aims to consistently and continuously irrigate the wound edge with a surgeon-selected fluid therapy to actively fight and remove the root cause of surgical site infection—wound contamination—without disrupting current surgical practice, Prescient Surgical explained in its submission.
The CleanCision would retraction and protection system. Image courtesy of Prescient Surgical
Ethicon Endo-Surgery’s ENSEAL X1 Large Jaw Tissue Sealer can seal and cut vessels and tissues. Juror Carmen Chacon, medical designer, Chacon Design, noted that “the product focuses on the end user and patient safety.”
The Minne Ties Agile MMF system is a noninvasive alternative to existing wire or hybrid devices for maxilla-mandibular fixation. Jurors found the system to appear “simpler and faster” than the current standard of care. Juror Mary Kay Smith, director of the Michigan State University Learning and Assessment Center, noted its potential to “eliminate ulcerations in the mouth from wires,” while Chacon noted “better stability through use of material to protect doctor and patient comfort.”
To prepare for surgery, patients could use the MediClear PreOp silicone film drape to clean and prepare a site up to seven days before surgery. Using chlorhexidine and silver-embedded silicone adhesive, the drape provides constant broad-spectrum antimicrobial protection, while its transparent polyurethane backing acts as a barrier to external sources of contamination, Covalon Technologies stated in its entry to the OTC and Self-Care Products category. Juror David Copeland, director of human factors industrial design for Ximedica, described it as “a very novel approach that removes the burden of excessive skin prep and cleaning (and effort) from the patient, and in essence, makes it more passive with application of the patch. Addressing the potential non-compliance factor by providing a wear-it-and-forget-it solution simplifies the HCPs job as well.”
Patients face risks outside of surgery, too. For instance, the Flusso bypass adapter aims to prevent patient disconnection from a mechanical ventilator during a circuit change or disconnection of the patient for transport, McArthur Medical Sales reported in its entry into the Nonsurgical Hospital Supplies and Equipment category. Copeland found the solution “very clever and simple,” adding that it “has immediate benefits to patient, user, and hospital by providing a simple, elegant, and safe means to transition from stationary vents to portable vents and vice versus, all the while having a minimum impact to the patient's care.”
Faster, More Efficient Care
Many finalists are attempting to speed up healthcare screening and procedures, which can benefit patients, clinicians, and healthcare systems.
Built on “deep learning,” PowerLook Tomo Detection (below) is designed “to optimize breast tomosynthesis reading efficiency, streamline workflow, and support cancer detection without compromising reading performance or increasing recalls,” iCAD Inc. wrote in its submission to the Radiological, Imaging, and Electromechanical Devices category. Juror Mark Wehde, section head for Mayo Clinic’s Division of Engineering, called it “an impressive addition to the tomosynthesis being sold in the [United States]. Tomosynthesis has been shown in several studies to generate significantly improved results. The system from iCAD adds to the impressive diagnostic ability of this modality with reduced screening time due to its significantly improved detection algorithms and user interface.”
PowerLook Tomo Detection. Image courtesy of iCAD Inc.
For head and neck imaging, the portable OmniTom 16-slice CT scanner could be used by a single operator. Samsung NeuroLogica claims that the system offers rapid scan time and immediate image viewing of high-quality, noncontrast CT angiograph and CT perfusion scans at the point-of-care.
Submitted in the Implant and Tissue-Replacement category, the GRYPHON Anchor with PROKNOT Technology is a pre-tied knot for loading onto the GRYPHON Anchor for shoulder and hip repairs. The product is 64% smaller than traditional arthroscopic knots and is more consistent than arthroscopic knot-tying due to requiring only one half hitch, according to the submission from Johnson & Johnson Medical Devices Companies. “A simple half-hitch stich and anchor combo eliminates steps in a traditional repair procedure,” said Chacon.
The Alinity s Series blood and plasma screening instrument aims to improve the testing efficiency of blood and plasma donations to screen for infectious diseases. Juror Andra Blomkalns, MD, believes it “could allow for the more rapid delivery of pathogen free blood needed for emergent transfusions by rapidly testing samples for disease like HIV and hepatitis.” Blomkalns serves as vice chair of academic affairs and business development, Department of Emergency Medicine; and medical liaison to the Office for Technology Development, UT Southwestern Medical Center.
Submitted in the Cardiovascular Devices category, the HyperView system employs noninvasive, nonionizing hyperspectral imaging technology to assess tissue oxygenation in cases involving local, regional, and systemic flow ischemia. “The device, while utilizing initial tech from 2006, has incorporated the diagnostic benefits of hyperspectral imaging technology into a portable, point-of-care device to determine tissue oxygenation/perfusion,” observed Blomkalns. “Benefits include that it is real-time, non-invasive, and more efficient than existing methods. It has potential use in several specialties, including vascular surgery, podiatry, plastic surgery.”
The AeroForm Tissue Expander System helps patients prepare for breast reconstruction. The patient-controlled needle-free device can be used at home and could reduce time to reconstruction, noted Blomkalns. “AeroForm is a first-of-its-kind, patient-controlled, tissue-expansion system for patients planning reconstructive surgery after mastectomy for breast cancer,” she said. “The product innovation is the patient controlled and gradual tissue expansion decreasing the need for doctor visits and has led to faster tissue re-expansion period by roughly half. The benefit to the patient and healthcare system is substantial.”
The SPEEDTRAP Graft Preparation System (below) for soft-tissue grafts in orthopedic procedures employs a fingertrap needleless technique to compress rather than pierce the graft. Jurors noted that graft preparation time is 77% faster and that it could reduce vascular injury. Chacon called it a “simple device that minimized procedural time [and] increased strength and reliability for the patient and surgical staff.”
The SPEEDTRAP Graft Preparation System. Image courtesy of DePuy Synthes Companies
Submitted in the Drug-Delivery and Combination Products catgeory, SURGICEL Powder Absorbable Hemostat is designed to quickly stop blood flow across broad surfaces and on friable or raw tissue. Johnson & Johnson Medical Devices Companies report that the structure of the powder penetrates the surface of the blood to get to the sources of bleeding and is proven bactericidal against pathogens. Juror Scott Thielman, chief technology officer, Product Creation Studio, described it as a “beneficial delivery form factor and effective homeostasis; this seems like a welcomed product for surgeons.”
Even faster product sterilization times could offer healthcare benefits. The STERRAD VELOCITY is a hydrogen peroxide biological indicator (BI) system that confirms proper sterilization of reprocessed surgical instruments within 30 minutes, reported Advanced Sterilization Products, part of Johnson & Johnson Medical Devices Companies. “Rapid, 30-minute BI readings are a huge win for the hospital system,” said Thielman.
Internet of Things
There’s very little today that hasn’t been influenced by IoT. Juror Stephen Wilcox, PhD, principal and founder of Design Science, noted an acceleration of IoT and connections to the cloud among this year’s finalists. In hospitals, such connectivity may be controlled or locally limited to protect privacy and minimize risks, but there’s a definite trend in medtech toward some level of connection. Somewhat related, juror Lance Black, MD, medical device innovation lead for the TMC Innovation Institute, also observed that the presence of “software as a service is tribute to what is happening in healthcare.”
The StealthStation S8 visualization and surgical navigation system, designed for cranial, spine, and ear-nose-throat procedures, allows users to track several instruments in real time using optical and electromagnetic localization technologies. The system offers wireless connectivity to hospital and medical devices, allowing the import and export of exams from anywhere within the hospital network, Medtronic reports on its Web site. To maintain cybersecurity, users can define the level of security for user authentication, antivirus protection, encryption, and firewall protection.
Offering remote visibility through RFID, the IntelliGuard Linked Visibility Inventory System tracks medication and reconciliation. Wehde called it a “very sophisticated and well-though-out design” that “allows for seamless tracking of items removed from storage without error-prone human intervention. [The device] facilitates organization of needed medications to help minimize user error. Quality improvement advocates will love this system because it helps drive out user error through elegant 5S design and automated tracking.”
A finalist in the Testing and Diagnostic Products and Systems category, the Sofia 2 (below) uses advanced fluorescence detection in a benchtop system that allows clinicians to test for diseases such as influenza, streptococcus, and respiratory syncytial virus in a point-of-care setting. “Portability, connectivity, and simplicity make the Sofia 2 a great choice for point-of-care diagnostic settings,” said Thielman. “The touch-screen and automated reporting connectivity suggest a modern design.”
The Sofia 2. Image courtesy of Quidel Corp.
Devices used outside healthcare settings are increasingly becoming connected. For instance, the MoMe Kardia electrocardiograph monitoring wearable continuously streams data to the cloud. Blomkalns called it a “novel, sleek, heart rhythm monitoring wearable with three modes (Holter, event, and mobile cardiovascular telemetry). Positive attributes include non-intrusive design, ease of use with simple display and sound prompts, [and] wireless transmission of HIPAA compliant cloud based data accessible to care providers remotely.” The system’s design may also help overcome user struggles. Jurors stated that it is “hard to find an easy-to-use monitor for patients—the leads come off.” Such utility could ultimately make a difference, as “Thousands of patients go undiagnosed,” said Wehde.
Entered into the Rehabilitation and Assistive-Technology Products category, the Podimetrics Remote Temperature Monitoring System for monitoring inflammatory foot diseases such as foot ulcers employs a “telemedicine mat” and an online portal for clinical decision support, Podimetrics Inc. stated. The system provides a compliance indicator that lights up and then generates a phone call if needed, jurors observed. The system has a “great form factor and integration of electronics/algorithms,” noted juror Eric Richardson, associate teaching professor at Rice University.
The nfant Feeding Solution from NFANT Labs measures an infant’s tongue movement during feeding. It can turn a baby bottle into a smart bottle to collect and analyze “real-time, reviewable biofeedback” and report it to clinicians, the company reported. Smith said the design appears to be “very easy to use and not obtrusive to feeding of vulnerable infants. Benefits appear most relevant to decrease in healthcare costs as it is more diagnostic in nature.” It appears to bring technology to a previously manual, perhaps subjective evaluation, as Black stated that the “pinky finger is the standard.”
Consumerization of Healthcare
Copeland saw among the finalists evidence of the consumerization of healthcare products in interfaces and touchpoints, while Blomkalns noted a trend toward allowing patient to do things at home.
The injection devices for Eli Lilly and Co.'s Taltz (below) demonstrate such a user-centric direction. Indicated for patients with moderate to severe plaque psoriasis and psoriatic arthritis, the medication is provided in both autoinjector and prefilled-syringe form. The “auditory click is impressive and provides additional layer of reinforcement for patient to verify medication is injected correctly,” noted Smith. “Attention to arthritic patients is also notable given the growth in patients falling within older demographic. Option for users to choose between two devices provides for more flexibility.”
Taltz Injection Devices. Image courtesy of Eli Lilly and Co.
Methofill (methotrexate) utilizes the self-injecting Self Dose, an alternative to standard injectors. A lot of usability data has been collected. “The summative user testing is compelling for the Self Dose,” said Thielman. “It is clear that user needs drove the design.”
Designed for use without a prescription, ZipStitch is an alternative to stitches for minor cuts and lacerations in seconds. Thielman said that “this is a better method for serious cuts versus bandages and stitches. [It] belongs in every hiking, hunting, scouting, and boating first aid kit.”
The Willow Breast Pump is a hands-free pump with few parts to assemble, noted jurors. “I believe design and technology will revolutionize healthcare,” Thielman said. “Willow is confirmation of this. Great design focused on a better outcome for the user.”
To hear the Gold, Silver, and Bronze MDEA winners as well as the Best in Show winner announced, join us June 12 at the Jacob K. Javits Center in New York City. We’ll host a pre-ceremony cocktail reception at 4:00 PM in Room 1E15 - 1E16 and then we’ll start the show! The ceremony is open to all attendees of Medical Design & Manufacturing East, held June 12-14. Click here to register for the show.
Click here for a complete list of all 2018 finalists and images.
For trends among last year's finalists, please see our May 2017 feature, "The 4 Essential Elements of Device Design Today."