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Articles from 2017 In August


FDA Fast Tracks New Blood Filtration System

EXTHERA FDA Fast Tracks New Blood Filtration System
FDA granted ExThera's request to put its Seraph microbind affinity blood filter through the agency's Expedited Access Pathway program.

ExThera Medical, a developer of blood filtration systems and biotechnologies, has received Expedited Access Pathway (EAP) designation from FDA for its latest technology, the Seraph 100 blood filter. The EAP designation indicates that the use for the technology will be an adjunctive treatment for bacteremia, in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin-binding bacteria.

ExThera applied for the EAP designation in June, and the company said FDA granted the designation within an accelerated timeframe. The company said its technology differs from other blood filter systems by removing a variety of different pathogens simultaneously by using a blood-contacting surface which does not harm the blood.

The new filter was designed to quickly treat bloodstream infections, preventing them from becoming potentially life-threatening infections. Robert Ward, ExThera president and CEO, said that when it comes to bloodstream infections, time is a very critical factor.

"It has been said that 'speed is life' in the effective treatment of bloodstream infections," Ward said. "Seraph can potentially save thousands of lives now lost to infection for which there are no available drugs."

The functionality of the device is actually quite unique. As a patient's blood flows through the Seraph microbind affinity blood filter, it passes over microspheres coated with molecular receptor sites that can mimic the receptors on human cells that pathogens use to invade the body. Harmful substances are quickly captured and absorbed onto the surface where they can be removed from the bloodstream without adding anything to the blood, allowing the blood to flow back into the patient with all healthy blood cells intact.

The company said the technology can even be configured with optional supplemental absorbents to remove other toxins or evolved pathogens. Researchers were able to showcase this by adding endotoxin binding to Seraph 100, making the technology particularly useful for certain bloodstream infections that progress to endotoxemia. The Seraph filters also have a blood-contacting surface that is anti-thrombogenic and anti-inflammatory to help reduce the risk of other harmful complications.

With new technologies like liquid biopsies and advanced blood tests for blood diseases, it's no wonder that researchers are finding a myriad of different ways to detect anomalies in the bloodstream. With Seraph's broad spectrum ability to remove pathogens without harming the the patient's blood, the company has begun evaluating the use of the technology in a dialysis-like extracorporeal circuit that can treat patients with both drug-resistant and drug-susceptible bloodstream infections.

Recently the company began exploring the technology's potential use in blood banking, as a simple pathogen reduction technology for treating individual units of blood -- indicating that there truly could be a broad range of applications for this budding technology.

"ExThera Medical is focused on developing simple devices for the rapid treatment of bloodstream infections, especially in the face of rising incidence rates, and the worldwide spread of drug-resistant pathogens," Ward said. "Effective treatments for potentially lethal bloodstream infections are also needed for members of our military for whom the risk of exposure is significant."

Kristopher Sturgis is a contributor to Qmed.

[Image credit: Pixabay and ExThera Medical]

X Marks the Spot for Medtronic-Mazor Agreement

Mazor X System
Mazor said it entered the next phase of its partnership with Medtronic earlier than planned after both companies hit certain sales and marketing milestones early and achieved higher than expected global market acceptance and demand for the Mazor X system (shown).

The partnership between Medtronic and Mazor Robotics seems to be going even better than expected. The companies entered the next phase of their agreement this week, a move that was triggered by the early achievement of certain sales and marketing milestones and by higher than expected global market acceptance and demand for the Mazor X system.

Medtronic assumed the exclusive worldwide distribution of the Mazor X system and made a $40 million third tranche investment in the company. This brings Medtronic's total investment in Mazor to $72 million, representing roughly 11.9% of the outstanding shares post investment and10.6% of the fully diluted shares outstanding post investment.

The pair originally entered into a strategic agreement in May 2016. Mazor will issue to Medtronic warrants to purchase an additional 1.21 million of American Depository Shares at $44.23 a pop, representing a 15% premium over the share price for the $40 million equity investment. The warrants expire after 18 months. If Medtronic exercises the warrants in full, it will bring its investment in Mazor to $125 million and its ownership could reach 14.2% based on the current number of shares outstanding on a fully diluted basis.

Ori Hadomi, CEO of Mazor, said the company reached the desired outcome of the first phase of its Medtronic partnership "well ahead" of schedule. "I believe that the move to this next phase reinforces our significant leadership position in the growing market for surgical guidance systems for spine procedures. Our strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers."

Hadomi said the partnership has already resulted in 59 Mazor X system orders since the system was launched in October 2016, which he said reflects an accelerated sales cycle due to customers' eagerness to adopt the technology for the spine market.

"Now, as commercial responsibility for the Mazor X in the spine market shifts to Medtronic, the annual minimums for sale of Mazor X systems agreed to by the two companies are expected to drive substantial improvement in Mazor's financial results during the next several years," Hadomi said.

The partnership will allow the companies to advance the jointly-developed product pipeline for the spine market, Hadomi said, while also giving Mazor the opportunity to pursue new applications of its technologies for other medical needs.

Mazor will continue to manufacture and recognize revenues for Mazor X system sales, disposable kits, and service fees, all of which will be sold at contractual pricing agreed with Medtronic.

The second phase of the agreement appears to be a win-win for Medtronic and Mazor, but it does add competitive pressure to spine companies that don't have a robotic system, like NuVasive.

Mike Matson, an analyst with Needham & Co., said he believes NuVasive plans to counter robotics with its LessRay system. But that technology doesn't provide all the advantages of robotics and probably lacks the patient marketing benefit provided by robotics, Matson said.

LessRay is an image enhancement platform designed to take low-quality, low-dose images and improve them to look like conventional full-dose images.

Amanda Pedersen is Qmed's news editor. Contact her at amanda.pedersen@ubm.com.

Supplier Stories for the Week of August 27

Here’s what was new in the world of medical device suppliers during the week of August 27.This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to marie.thibault@ubm.com with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Here’s what was new in the world of medical device suppliers during the week of August 27.

This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to marie.thibault@ubm.com with the subject line “Supplier Stories.”

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Your Source for Medtech Supplier Connections Is Getting Even Better

Qmed is joining forces with MD+DI to become a one-stop shop to keep you up to date on the latest medtech news and connect you with suppliers and service providers.

Qmed has been connecting you with medtech suppliers and keeping you informed about the latest industry news since 2010, and now your favorite resource is getting even better. Qmed is joining forces with Medical Device and Diagnostic Industry (MD+DI) to become a one-stop shop for staying up to date on industry trends and connecting with trusted partners to speed medical device and diagnostic innovations to market.

You will still be able to access the Qmed Directory to discover qualified suppliers and service providers ranging from components makers to contract manufacturers, but starting September 7 Qmed's powerful search tool will be housed with MD+DI's award-winning editorial content. In addition to the daily news and supplier information you've come to rely on, you'll now have access to technical articles and analysis written by leading experts in the industry. Bookmark www.mddionline.com and check back daily to ensure you don't miss a beat. Current subscribers will continue to receive their Qmed & MD+DI Daily or Qmed & MD+DI Daily Europe e-mail newsletters as usual. And if you haven't already, be sure to sign up to get them delivered straight to your inbox each day.

We appreciate that you trust Qmed to connect you with trusted partners to bring your medical device and diagnostic innovations to life, and we can't wait to enhance your experience with the move to www.mddionline.com. Along with our associated MD&M and BIOMEDevice live events, the newly combined MD+DI and Qmed site will provide the information and connections medtech professionals like you need to design, develop, and manufacture products that save and improve lives.  

Jamie Hartford is editor-in-chief of MD+DI and director of content for medtech brands in UBM's Advanced Manufacturing Group. Reach her at jamie.hartford@ubm.com.

Selecting Adhesives for Medical Devices

Selecting Adhesives for Medical Devices

Selection of a suitable adhesive for a medical device is challenging because of the wide variety of adhesive types, performance characteristics, and an ever-expanding range of use scenarios.  

Jeff Cafmeyer

It is nearly impossible to find an example of a medical device that does not incorporate at least one adhesive joining different materials or components. The adhesive provides a critical role--it is literally the glue that holds a device together so it can perform its function.

However, the selection process for an adhesive does not always incorporate the complex demands that are placed on it. This can lead to durability issues and failures. 

The selection of an adhesive should consider the substrate materials being bonded, the fabrication process, and should contemplate the total use scenario to ensure that the adhesive is appropriate. The process for selecting an adhesive should involve more than consulting the manufacturer's product datasheets, which typically provide guidance with general performance data for the material. Although the process typically begins there, the datasheets cannot be expected to be specific for the conditions and adhesive use situation relevant for the current device.

Register for the MD&M Minneapolis Conference & Expo, November 8-9, 2017.

Even past performance or experience may not provide all the relevant details for the current use scenario. For medical devices, bonding dissimilar materials often with low surface energies, specific manufacturing assembly requirements, and product sterilization all present challenges for creating durable adhesive bonds. 

The effects of sterilization are often overlooked or considered simply in regard to material compatibility instead of the broader system impact. Sterilization--whether steam autoclave, ethylene oxide, radiation, or chemical treatments--is an aggressive exposure condition for a medical device and its constituent materials that is typically harsher than the general use and exposure conditions of the device. Sterilization can be extremely demanding of the adhesives and their function, especially if the device is reusable and will experience the cumulative effect of multiple sterilization cycles over the course of its life.

Sterilization not only tests the integrity of the adhesive material, which can degrade chemically and in performance on an individual basis, it also challenges each of the material interfaces and all the process steps leading to the finished device. Imperfections and deficiencies of the material, interfaces, or processes can lead to these latent issues becoming exacerbated by sterilization and then realized as failures under the stresses of use. 

For medical devices, adhesive materials need to perform reliably even after being subjected to relatively extreme conditions, including sterilization. However, the adhesive performance is dependent on the numerous decisions and steps taken to create the bond, each of which have the potential to be the weak link in the chain.

With various types and performance characteristics of adhesives and an ever-expanding range of use scenarios, selection of a suitable adhesive will continue to be challenging. Carefully considering the conditions and exposures is a key aspect of the adhesive option selection process, ultimately contributing to the total performance of the device.

Jeff Cafmeyer is a senior research scientist in Advanced Materials at Battelle.

[Image courtesy of SAMARTTIW/FREEDIGITALPHOTOS.NET]

Exhibiting at MD&M Minneapolis? Nominate Your Company for the Medtech Innovation Tour

Exhibiting at MD&M Minneapolis? Nominate Your Company for the Medtech Innovation Tour

If you'll be exhibiting at the upcoming Medical Design & Manufacturing Minneapolis expo November 8-9 (or at any of its co-located shows), we invite you to submit any new and innovative products or services you'll be showcasing for possible inclusion in our Medtech Innovation Tour on the show floor. Entries are due September 15, 2017, and there is no charge for a submission.

The MD&M Minneapolis Medtech Innovation Tour is a program highlighting the most innovative products, services, and technologies developed in recent years by exhibitors at the expo. 

The MD+DI editorial team will select five submissions to be honored at the show as well as on UBM's industry-leading media brand MDDIonline.com. These exhibitors will be included in an Innovation tour at MD&M Minneapolis, and they will receive a sign to display in their booths showcasing that they are the MD+DI Editors' Choice Medtech Innovation Tour participant at the show.

This is a chance to showcase the best your company has to offer in the design and manufacturing of medical devices and get public recognition for it.

To enter, please complete this form by 5 p.m. Pacific time on Friday, September 15, 2017.

Eligibility and Requirements for Participation

Interested companies must:

  • Be a 2017 MD&M Minneapolis exhibitor (or an exhibitor at any of its co-located shows).
  • Have company operations in the United States or Canada.
  • Answer the required questions in the form below. Make sure to adequately state your case as to why your product, service, or technology is truly innovative, and to include an image (ideally less than 1 MB in size) and, if available, a video showing how the product works. (Note that the media you submit could be used in a future news story or marketing materials.)
  • Be willing to have your technology featured in an Innovation Tour at 2017 MD&M Minneapolis exhibitor, where a group of attendees stops by the booth to learn more about the relevant technology.

To enter, please complete this form by 5 p.m. Pacific time on Friday, September 15, 2017.

Questions? Please contact Daphne Allen at daphne.allen@ubm.com. Allen is executive editor of PMP News and a contributor to MD+DI and Qmed.

Will New DCB Indication Prove Bard's Worth?

C.R. Bard Lutonix 035
FDA approved C.R. Bard's Lutonix 035 drug-coated balloon catheter for the treatment of patients with dysfunctional AV fistulae.

C.R. Bard delivered on its promise to cast a wider net with the Lutonix 035 drug-coated balloon (DCB) catheter that FDA originally approved in October 2014 for patients with peripheral artery disease. The company told shareholders last year that new indications were in the works and, sure enough, the device just received FDA approval for end stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae. Previously, the device was limited to the treatment of superficial femoral artery and popliteal artery disease.

Lutonix was the first DCB approved by FDA. The latest nod should help the company maintain share in an increasingly competitive market. Medtronic won FDA approval of its IN.PACT Admiral balloon in January 2015, and the agency also recently approved Spectranetics' highly-anticipated Stellarex DCB.

The new Lutonix approval is also good news for Becton, Dickinson and Company (BD), which has agreed to shell out a whopping $24 billion to acquire Bard. That price represents a 25% premium over Bard's last closing stock price prior to the companies going public with the deal. Some BD shareholders seemed to have a case of sticker shock at the time, but the company's management team painted a fairly interesting picture of the long-term value of the combined entity.

FDA approval for the AV fistulae indication was supported by clinical trial follow-up results from randomized patients who were treated with the device. Compared to uncoated balloons, the Lutonix 035 DCB catheter demonstrated safety, as well as a sustained clinical benefit compared to conventional angioplasty through 12 months. 

Amanda Pedersen is Qmed's news editor. Contact her at amanda.pedersen@ubm.com.

[Image credit: C.R. Bard Inc.]

Avoid the Consequences of an Experiment Gone Wrong

Avoid the Consequences of an Experiment Gone Wrong

Linking the experimental process to the design controls defined by FDA can help ensure an effective and efficient new product development effort, as well as a competitive market advantage.

Perry Parendo

FDA guidelines exist for two key purposes. First, to ensure a product performs as expected, and second, to ensure that products can deliver the therapy required to treat the patient condition.

The tests to provide this evidence are the final confirmation tests and part of the validation effort. Prior to taking this final exam it is wise to do your homework. Failure to perform appropriate characterization testing can disrupt development schedules with validation delays, and create big questions in the minds at FDA. The following are examples of "experiments gone wrong" that could have been avoided with proper test planning and set up.

Smart Design Inputs

The only way to know a test is successful is to know that you have met the product requirements. It is far too common to fail a validation and find out the original product requirements (FDA calls this Design Inputs) were not correct. Changing requirements to pass a validation is heavily frowned upon by FDA.

The solution? Ensure you spend the time up front to understand the source of requirements. Do a quick confirmation test prior to final validation to ensure critical-to-therapy requirements are going to pass. The consequences are either a long story to explain sloppy requirements development, or a redesign to pass an unnecessary specification that is not benefiting the patient.

Hear more from Parendo during his session, "Aligning Design of Experiments," at the MD&M Minneapolis Conference & Expo, November 8-9, 2017.

Firm Design Freeze

Definitive proof of meeting requirements is required for validation. New functions need to be evaluated during characterization, and the earlier, the better.

On one project, an electrical instability was determined after design freeze. Additional components were needed to address this issue. The consequences? A new component needed to be sourced through procurement. This component needed manufacturing evaluation for process compatibility. The circuit board layout needed to be changed, making prior process characterization work suspect. It changed the testing fixture and test process.

Even though only one design requirement was being reviewed, nearly every manufacturing step was being questioned. The solution here is performing design characterization work early and in depth. Going beyond the design freeze led to a need for reworking and a risk of failing the validation.

Start the Clock

Every company faces the rush to FDA submission. Validating a design that needs further changes prior to market launch creates a quandary. Do we start the clock, knowing that many questions will need to be resolved? Or do we delay our submission and clean up the design to a level we plan to release?

My preference is to clean up the design first. Ultimately, this saves FDA review effort and will likely speed the final approval date. Companies need to focus on what gets approval fastest, not how to get something in front of FDA fastest.

One implantable project was able to get FDA approval a year faster than a competitor. Our focus was on a clear and compelling story, and it showed in the questions we received and our ability to address those questions within 24 hours. Think about starting the clock for acceptance of your application. The consequence can be endless questions from FDA as they find holes in your story.

Questions to Answer

Validation testing needs to be done to answer expected and potential questions from FDA. Did we include enough depth in our characterization testing? Did we make assumptions that we are certain of and have proof of? Is there a use condition that has been ignored or overlooked?

Using Design of Experiment methods can ensure the ability to cover a wide range of input variables, as well as customer use conditions. Seeing this comprehensive testing builds confidence with FDA, compared to a test that tries to slip through with minimum effort to attempt to reduce the validation schedule. The consequence here is delays during FDA review. They are likely to dig deeper in all areas when they do not get a positive first impression.

Do Your Homework

When we are not clear about our requirements, do not understand or acknowledge project risks (different than product risks), or have a comprehensive test strategy, we are destined to create a situation where the project can go off the tracks. Linking your experimental process to the design controls defined by FDA can help you ensure an effective and efficient new product development effort.

Done right, it can create a competitive advantage in product performance and in overall speed to market.

Perry Parendo is the founder and president of Perry's Solutions, Inc., a consultancy focused on Design of Experiment methods and new product development.

[Image courtesy of PHOTOSTOCK/FREEDIGITALPHOTOS.NET]

Soft Robotics Bring Increased Dexterity to Surgery

Harvard University Rigid Soft Robotic Arm Harvard University
A photo of the soft pop-up arm performing tissue countertraction during an ex-vivo test on a porcine stomach.  

When it comes to developing endoscopic technologies, size, flexibility, and rigidity are all difficult concepts to marry. Endoscopes must be small and flexible to navigate the narrow passages of the body, but also need to be rigid enough to manipulate and remove tissue once they arrive at the surgical site. A new technology developed at Harvard's Wyss Institute may offer a solution that checks all three boxes, taking endoscopic surgery to the next level.

Thanks to soft robotic technologies, researchers have developed a new hybrid-rigid soft robotic arm for endoscopes that aims to integrate sensing technologies with unprecedented flexibility and precision. The new device was actually built using a manufacturing model based on pop-up fabrication and soft lithography, meaning that the soft robotic arm lies flat on an endoscope until it arrives at the desired location, where it can pop up to assist in surgical procedures.

Sheila Russo, PhD, postdoctoral fellow at the Wyss Institute and lead author on the work, told university news that integrating soft robotics into the pop-up structures will provide surgeons with the force output and control necessary for delicate endoscopic procedures.

"We found that by integrating soft fluidic microactuators into the rigid pop-up structures, we could create soft pop-up mechanisms that increased the performance of the actuators in terms of the force output and the predictability and controllability of the motion," she said. "The idea behind this technology is basically to obtain the best of both worlds by combining soft robotic technologies with origami-inspired rigid structures. Using this fabrication method, we were able to design a device that can lie flat when the endoscope is navigating to the surgical area, and when the surgeon reaches the area they want to operate on, they can deploy a soft system that can safely and effectively interact with tissue."

A diagram depicting the hybrid soft pop-up actuators. The image is colored to differentiate between the soft (yellow) structures and the rigid (blue) structures. 

Russo and her team actually designed the soft actuators to be powered by water, and they connect to the rigid components through an irreversible chemical bond, meaning they don't require any adhesive. They also integrated simple capacitive sensing technologies that can be used to measure the force applied to the surrounding tissue, providing surgeons with an improved sense of where the arm is and how it's moving inside the body.

Of course, all materials used to create the arm are completely biocompatible, and the arm itself comes equipped with a suction cup--inspired by octopus tentacles--to help surgeons safely interact with tissue. The technology was even designed to allow for mass manufacturing, making the new arm both accessible and cost effective.

The team of researchers demonstrated that the device could be scaled down to as small as one millimeter, which would allow for use in the smallest endoscopic procedures, such as lung and brain procedures. The hope is that with this kind of size flexibility, the technology can have a broader impact across a wide range of endoscopic procedures.

As the group moves forward, they hope to begin testing the device in vivo, and believe that the new robotic arm could be among the first to pave the way for smaller, smarter soft robotic technologies.

Kristopher Sturgis is a contributor to Qmed.

[Top image courtesy of HARVARD UNIVERSITY; Second image courtesy of WYSS INSTITUTE AT HARVARD UNIVERSITY]

Innovating Regulation: FDA's PreCert Pilot Program

Innovating Regulation: FDA's PreCert Pilot Program

The global market for mobile medical apps designed for healthcare professionals is expected to reach $14 billion by 2020 according to Global Industry Analysts. Consumer demand and shifts toward value-based care and mobile health have helped fuel wider adoption of health apps, remote monitoring, and Software as a Medical Device (SaMD).

FDA takes a "hands off" approach toward lower-risk digital health technology (a fitness tracker or an educational resource, for example). However, it has faced challenges in how to best regulate what it considers SaMD.  

As a step toward an efficient process for SaMD regulation that ensures patient safety without hampering innovation, FDA recently launched its Software Precertification (PreCert) Pilot Program.

The program's goals are threefold: to streamline pre- and postmarket obligations for software regulated as a medical device; to ensure quality products throughout their lifecycles; and to adapt to the needs of developers. The pilot program is part of FDA's Digital Health Innovation Plan, which focuses on fostering digital health innovation while continuing to protect and promote public health.

"Our goal is to create a program that is aligned with how products are being developed and how quickly they come to market, as well as one that's aligned internationally with other regulators," said FDA associate director for digital health Bakul Patel. "This is about creating a new paradigm."

Medtech and FDA, Working Together

FDA will select only nine companies, from small startups to large companies, and both traditional and nontraditional medical device manufacturers. FDA and pilot participants will work together closely to develop the program.

"This is an experiential pilot," said Zach Rothstein, associate vice president, technology and regulatory affairs for Advanced Medical Technology Association (AdvaMed). "They're taking concepts talked about in theory and figuring out how to apply them in the real world."

FDA will meet with pilot participants to learn about their respective companies and specific use cases. Ongoing discussion will help FDA determine steps for getting products to market, data collection, and other processes through the product lifecycle.

The pilot program will also involve public input. "Once we understand what the components of the paradigm will look like, we will have a larger discussion with the public in early 2018," said Patel.

Because the PreCert Pilot Program is such a work in progress, FDA has no firm timeline for the pilot program's duration. The nine companies selected for the pilot will have a rare opportunity to shape what will be a new initiative for FDA.

For information on the FDA PreCert Pilot Program and how to apply, visit FDA's FAQ page. To find out if your company meets the criteria, read the Federal Register notice.

AdvaMed; which, along with the Medical Imaging & Technology Alliance (MITA), worked with FDA on developing the concepts of what a pre-cert program would look like, said its member companies support the program and are excited to possibly participate and work hand-in-hand with a governmental agency.

"The immediate results of participating in the pilot is building trust and good will with FDA at this stage," said Rothstein. "The participating companies will also learn a lot. It's like having FDA as a member of their team."

Kalle Soderholm, chairman of Health Invest, a Finland-based healthcare firm that developed My+Care(TM), an end-to-end, cloud-based elder care system, views the PreCert Pilot Program as a positive forward move. "The intent to leverage stakeholders across the healthcare environment will create a well-balanced program with more practical and comprehensive outcomes," he said. "FDA has taken a good first step toward the creation of a long-term, standardized digital health regulatory pathway."

It will take time and legislative and regulatory changes to get a permanent pre-certification program in place. In theory, however, the program lessens the regulatory burden for SaMD companies while adhering to the overall goal of patient safety.

"I think companies will get a better experience if they're part of the pre-cert program," said Patel. "We expect pre-market review to be more streamlined as we move forward. We also expect more transparency and clarity in terms of what people need to do as they engage in their regulatory systems."

Patel said pre-certified companies developing low-risk products may not need to file a 510(k). "Being pre-certified, low-risk products could potentially go straight to market if we have a full understanding of the type of company that's making that product," he said.

"We would welcome the opportunity to enter into a permanent pre-certification process within a Software as a Medical Device (SaMD) program," said Soderholm. "Such a program provides the opportunity to give feedback through our system, whether to regulatory bodies, end users, or clinicians. Anything to support transparency, clinical outcomes, and usability is exciting to us."

When in Doubt, Apply

Patel said FDA plans to start the pilot program in early September, even if it hasn't selected all nine participants. He encourages companies to apply up to and even after September 1. For one, FDA may still have openings. Second, it gives FDA important feedback.

"It tells me people are willing to help us, and we may take that help at any point during the pilot program, even if we're beyond the nine participants," Patel said. "We want to consider everybody's perspective in this phase because it's important for us to get it right."

Heather R. Johnson is a freelance writer based in Oakland, California. 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]