Proscia to Change Cancer Detection Paradigm with AI

Courtesy of Proscia Proscia to Change Cancer Detection Paradigm with AI

Digital pathology specialist, Proscia has raised about $8.3 million of a series A round. The Philadelphia-based company has developed a software that uses artificial intelligence  (AI) to change the way cancer is diagnosed.

Proscia’s digital pathology platform is currently used by thousands of pathologists, scientists, histotechnicians, and lab managers at more than 300 clinical and research facilities worldwide. The cloud-based, modular platform integrates easily with labs’ environments and complex technology ecosystems.

“We’re trying to change the way that pathology is practiced and the way cancer is diagnosed,” David West, Proscia CEO, told MD+DI. “Cancer has been diagnosed pretty much the same for the past 150 years since we started using the microscope to look at human tissue.”

He added, “ultimately, it’s these deeply-rooted archaic systems that cause laboratory medicine or really the business of pathology to be under very intense financial pressure right now. The number of pathologists is decreasing and these labs need to do more with less. When you have volume increasing and fewer [pathologists] to read those slides, there’s a limit to what those human beings can do. That’s where AI can help speed up the process and eliminate that subjectivity problem.”

Proceeds from the financing will be used to expand the deployment of the company’s digital pathology software and accelerate the use of AI applications to drive accuracy and efficiency in cancer diagnosis. The capital raised will fuel the development and commercialization of new, clinical AI-enabled workflows targeting high-volume, high-impact cancers, the first of which will be available later this year.

Proscia said it will also use the funds to ramp up sales and marketing of its existing cloud-based digital pathology platform, which will serve as the foundation for its AI-based applications. Combined, these technologies will redefine the field of pathology and be the impetus that moves human healthcare forward.

The funding was led by Boston-based Flybridge Capital Partners and included Emerald Development Managers, Fusion Fund, Razor’s Edge Ventures, and RobinHood Ventures.

Will Medtronic's New Spine System Be 'Infinitely' Better for Workflow?

Medtronic plc Will Medtronic's New Spine System Be 'Infinitely' Better for Workflow?
Medtronic launched the Infinity Occipitocervical-Upper Thoracic (OCT) System this week at the annual North American Spine Society meeting in Los Angeles.

Medtronic would have been hard pressed to pick a more appropriate name for its new posterior cervical spine surgery system. The company launched the Infinity Occipitocervical-Upper Thoracic (OCT) System this week at the annual North American Spine Society meeting in Los Angeles.

"When we started on this project and in its genesis we had a blank slate and we wanted to not look at the individual gadgets, but really look at the procedure as a whole and how we could streamline and bring efficiencies to the OR, to the surgeon in that procedure," Michelle Thie, a principal product specialist at Medtronic, told MD+DI.

"Posterior cervical is a known treatment option that can bring its challenges. You're working with small anatomy in the cervical spine, there are anatomical landmarks and scenarios that make it really difficult to assemble a construct and to make that surgery go efficiently," Thie said.

"The name of the system says it all," she added. "There are infinite solutions that are provided through the system."

That said, there were some key areas the company focused on in developing the Infinity OCT. For example, the system includes a multi-axial screw with 60 degrees of angulation in any direction, a set screw (locking cap) with a quick-start thread to minimize cross threading, and 3.0mm and 5.5mm diameter screws for expanded patient demographics and clinical applications. The system also has a full spectrum of implant materials and sizes - and when paired with the company's O-arm imaging system and StealthStation navigation system - provides a fully-enabled procedural solution designed to bring efficiency and simplicity to complex posterior cervical procedures.

Bottom line, the Infinity OCT is intended to be a complete procedural solution that integrates navigation with biologics and Medtronic's comprehensive devices and instrumentation to create efficiency in spinal fusion procedure workflow for the upper back and neck.

The Infinity OCT System is indicated for certain conditions including degenerative disc disease, instability or deformity, tumors, and traumatic spinal fractures or traumatic dislocations. Spine trauma can sometimes result in a spinal cord injury. The Infinity OCT System is now available in the United States and is expected to be released in geographies around the world in 2018 and 2019.

Thie said the response the system is receiving at NASS this week has been more than validating.

"There have been pain points, and there have been struggles with post cervical instrumentation in the past, and we are delivering new technology that people are gravitating toward because I think they can quickly and easily see the benefits and the advantages that it's going to provide in those procedures," she said. "We couldn't be more excited about what this is bringing."

Device Cybersecurity: For Better — and Worse? The Very Connected World of Medical Devices

Pixabay Device Cybersecurity: For Better — and Worse?  The Very Connected World of Medical Devices

The Internet of Things is no longer a faraway dream, like jet packs and cities teeming with self-driving cars. IBM predicts that the burgeoning web of hardware, software, electronics, and sensors will encompass 50 billion devices by 2020, more than 60 pieces of connected hardware for every man, woman, and child on Earth. The National Institutes of Health says 40% of IoT-linked devices will be health-related, more than any other category.

If your online privacy is violated — say a credit card account is hacked or your Facebook data is used for nefarious purposes — it will be upsetting and will likely offend your sense of privacy and propriety. But when networked medical devices are compromised, the consequences can be serious and even life-threatening.

Blood analyzers, glucose meters, heart-rate monitors, pacemakers, CPAP machines, and fitness trackers are just a few of the internet-connected medical devices in wide use today. The growing volume of data these devices gather is collected and transmitted using off-the-shelf software that is widely available and, consequently, highly susceptible to tampering for commercial gain or to simply wreak havoc.

It was potential for malicious hacking that prompted doctors for former Vice President Dick Cheney to order that his heart defibrillator’s wireless capability be turned off when the device was replaced in 2007. Cheney’s cardiologist was concerned that a terrorist might access the device and send the vice president’s heart a fatal shock.

Was turning off the implant’s wireless feature prudent precaution, or was it paranoia? It’s hard to say. But in the decade since, the security of networked medical devices has emerged as a serious concern. In 2015, two security researchers demonstrated their ability to remotely hijack a Jeep’s dashboard functions, steering, transmission, and brakes, an event that caused great embarrassment for Jeep parent Chrysler, which subsequently recalled 1.4 million vehicles to fix the vulnerability.

Most hackers, however, are motivated not by a desire to disrupt or harass, but are pursuing financial gain — looking for information they can exploit commercially. For example:

  • Device makers can benefit greatly by accessing performance data on their competitors’ products, using the information to modify their own offerings and exploiting competing products’ shortcomings in their marketing.
  • Information gathered in clinical trials determines the commercial potential of the drugs and devices under study. If that data is hijacked before a treatment reaches the market, sponsors can sustain potentially catastrophic losses.
  • A company whose drugs treat common chronic conditions might learn that a competitor is developing an implantable device that would give patients a concentrated form of treatment that cuts cost by reducing the required dosage. Stolen data about the device could be manipulated to suggest that’s it’s less effective and safe than its developer claims.
  • Networked devices can provide wide-ranging biometric patient information such as blood pressure, respiration, and blood enzyme levels. Companies that issue individual life insurance policies often purchase this information, repackaged by third parties to appear of legitimate origin, to evaluate clients for insurability and to set premiums.

Hacks can affect not just patients with diagnosed medical conditions, but also healthy people using implantable birth control and even users of wearable personal fitness devices like Fitbits. These ubiquitous wearables can produce vast amounts of personal biometric data but are subject to no federal regulation.

While it’s a real possibility, harming patients does not seem (at least yet) to be motivating medical device hackers. There are chilling examples of people using connected devices to harass and intimidate, such as domestic abusers using smartphone apps to turn appliances on and off, ring doorbells, change thermostat settings, and adjust the volume on sound systems. Can attacks on medical devices be far off?

Another growing concern is not hacking, but accidental consequences of our increasingly connected world. Benign and even benevolent sources of radio energy such as WiFi systems and hospital networks have been found to interfere with medical devices.

Regulators respond

FDA has responded to these concerns with formal guidance on medical device cybersecurity specifically related to devices that use off-the-shelf software. The agency’s Center for Devices and Radiological Health declares that “a cybersecurity vulnerability exists whenever (off-the-shelf) software provides the opportunity for unauthorized access to the network or the medical device,” opening the door to “unwanted software changes that may have an effect on the safety and effectiveness of the medical device.”

Because these vulnerabilities are rooted in the commercial software that underpins these devices, the CDRH advises that device makers maintain formal relationships with software vendors to ensure timely receipt of information about software problems and recommended preventive and corrective actions.

Software makers frequently issue cybersecurity patches, so the CDRH recommends that device companies maintain cybersecurity maintenance plans to address compliance with 21 CFR 820, FDA Quality System regulation.

While hospitals and other healthcare facilities play a central role in evaluating network security and protecting their systems, FDA emphasizes that most healthcare organizations lack the detailed design knowledge and technical resources to take primary maintenance responsibility for medical device software. That places responsibility for software maintenance on device makers, with support from user facilities, software vendors, or third parties as conditions require.

A legislative remedy?

Legislation pending in Washington also would formalize protections for medical device data. In 2017, Connecticut Senator Richard Blumenthal introduced the Medical Device Cybersecurity Act of 2017, citing recent high-profile ransomware attacks and large-scale privacy breaches to underscore how vulnerable medical devices are to cyberattack. The legislation is pending.

Device security is becoming a more frequent topic of discussion between sponsors and contract research organizations. For its part, Premier Research actively advises customers on investigating the cybersecurity implications connected with their products, recognizing the likelihood that regulators will raise questions during the product review.

BeBop Sensors Wants to Power the Next Generation of Smart Fabrics

Bebop Sensors Inc. BeBop Sensors Wants to Power the Next Generation of Smart Fabrics
The Forte data glove is just one example of how Bebop Sensors is using its smart fabric sensor technology to change the world of wearable devices. The glove incorporates haptics, wireless technology, and super accurate rapid sensing for gaming and AR/VR environments.

BeBop Sensors, a company that develops smart fabric sensors, aims to change the world of wearable smart devices and fabrics with its new line of sensor technologies that have been specifically designed to bend and stretch while being worn on the body. The company plans to market the sensors for the next generation of wearable devices, including smart clothing, wearable healthcare devices, prosthetics, and athletic equipment.

“We have a number of new sensors, including carbon fibers and silver or copper wires that offer capacitive resistive, optical solar, and other methodologies to sense and base fabrics such as twill, felt, kevlar, Lycra, and artificial silks,” said Sri Peruvemba, vice president of strategy for BeBop. “Bebop starts with a fabric material that is then coated with proprietary nanomaterials that give it the conducting and sensing abilities. This material is thin, light, flexible, and comfortable, and is cut to pretty much any shape and size. The sensor material is usually attached to a plastic/PET/fabric substrate, and the connection from the sensor material to the drive electronics is usually via conductive inks that are printed onto the substrate.”

So far BeBop has already shipped over two million units into the field across various different industries ranging from healthcare devices to robotics. The company is particularly interested in changing the landscape of wearable fabrics following its latest line of sensor technologies that can remain stable despite any bending or stretching of the material.

“Our sensors can bend, flex, stretch, or twist and continue to perform within spec,” Peruvemba said. “That is precisely why they are chosen. If the application cannot accept a rigid sensor or a sensor that does not have high accuracy, then we are a natural choice. Stability is an essential quality of any sensor, and after numerous lab and field tests, our new flexible fabric sensors are proven stable. They are light, flexible, thin, and very versatile. You can cut them into the shape that you want, and still have a high level of accuracy — and since we mass produce them, we are able to achieve very competitive pricing, not only in medical and industrial applications but in commercial applications as well.”

Peruvemba said the market for wearable sensor technologies has been growing steadily over the past few years. And while many sensor technologies have been traditionally rigid, many modern devices now require more fabric-like, flexible sensor technologies that can stretch and bend to accommodate the contours of the human body. BeBop has already begun shipping out their sensor technologies for a variety of different applications within the medtech realm, including hospital beds and gurneys, wheelchairs, braces, and sports medicine devices that can be used in equipment and protective gear. As the sensors become more ubiquitous, the company expects that they’ll make their way into a variety of devices across the commercial and industrial spectrum.

“We’ve already deployed millions of units, but hopefully you will begin to see these sensors in applications where you might not think you even need a fabric sensor,” Peruvemba said. “Our fabric sensors are being shipped into several medical applications, as well as industrial applications like in the automotive industry including car seats for infants and adults. They’re even being used in electronic musical instruments that are now commercially available for purchase.”

As the company continues to explore various avenues for implementation, the flexible sensor technologies continue to rise to the challenge. Every indication seems to be that the sky truly could be the limit for these new sensors,  and it might not be long before your next wearable device is powered by one — and you may not even know it.

Medtech Needs to Get Serious About Investing in Digital Health

Pixabay Medtech Needs to Get Serious About Investing in Digital Health

Nearly a year ago, MD+DI asked the question, is digital health making an impact on healthcare? Now, a report from Ernst & Young titled Pulse of the Industry is answering that question and points out that if medtech companies don’t make significant investments in digital health capabilities then long-term growth could be at risk.

“Incremental innovation and products are just not going to be able to sustain [long-term] growth,” Jim Welch, Life Sciences Advisory Partner, Ernst & Young, told MD+DI. “I think the real opportunity for med-tech companies that are in a position to do this is to capitalize on digital transformation.”

Welch described digital transformation as devices that are increasingly connected. He noted that the consumers and stakeholders these digital devices serve are more connected and demand more visibility and outcomes.

"While the products have historically been the value driver for medtech … and we’re not saying they will go away by any means, but additionally the data and the digital connectivity of those products in and of itself is going to become a value driver,” Welch said.

A Race to Invest

Medtech isn’t yet where it needs to be when it comes down to investing in the digital health space, according to the report. Ernst and Young’s study also shows that outside of cardiovascular and diabetes management solutions, digital deal making was muted in 2017.

The Ernst & Young report goes on to say that US premarket approval trends bolster the notion that medtech companies have yet to fully embrace new digital capabilities: of the 43 PMA accepted by FDA since the beginning of 2017, only 16 include any digital health component.

“If we go back and look at the top 20 medtech companies and look at the 40 or so deals they did over the last few months, of those 40 or only seven were targeted in digital technology or digital health type companies,” Welch said. “We feel like this trend is going to and needs to increase.”

If medtech companies don’t pick up the rate of investment in digital health, then they could lose out on opportunities to larger much more robust technology firms. Already, these technology companies are at an advantage over medical device firms. The technology companies have the expertise in data analytics, customer engagement and service personalization required to deliver more satisfying customer experiences, are increasingly investing in new health offerings.

The report points out these include data-rich platforms that make it easy to share data proactively with consumers and providers to avoid adverse health events and optimize individual care management. What’s more, technology and retail companies have the ability to significantly disrupt the industry through acquisitions or partnerships.

“The competition for [digital health] acquisitions don’t just come from medtech, but also comes from technology companies,” Welch said. “The raw firepower they have from an acquisition standpoint is well beyond what medtech can currently sustain.”

A group of 10 disruptors, some of which have already entered the medical device or health market, possess nearly double the deal-making firepower of the entire US and European medtech industry ($1.9 trillion vs. $990 billion).

One of the 10 disruptors is Apple, which recently captured headlines with its announcement FDA gave a nod for heart monitoring apps for the Watch Series 4. In February the Cupertino, CA-based company announced it wanted to play a bigger role in the healthcare industry through new medical related apps that included its heart monitoring solutions.

Collaborations Are the Future

A saving grace for many medical companies could come from extensive partnerships and collaborations with companies that can provide strong analytics.

Back in 2014, Google began making headlines due to its collaborations that helped reshape healthcare. The company made the perfect partner for medtech firms, offering rich data analytic solutions. Around the same time as Google began its collaborations Samsung partnered with Medtronic to develop diabetes apps for the Minimed Connect.

At the time the industry labeled these companies “unlikely players” in the space, but that’s changing as both Google (through Verily Lifesciences) and Samsung have gone on to form numerous partnerships with medtech companies.

Welch said that medical device companies need to take note and realize collaborations and investments into these unlikely players will ultimately drive growth.

“I think there’s an opportunity for medtech companies to not only build up their own internal capabilities around data, but at the same time to invest in more collaborations with companies that may or may not be historically like them to gain insight into what consumers and patients are looking for,” he said.

How to Get to Market Quickly, Without Driving Your Team Crazy

How to Get to Market Quickly, Without Driving Your Team Crazy

Project engineers often spend weeks, if not months, waiting for management to formally approve a new project. Then, as soon as the green light is on, so is the pressure.

"The minute our executives say go and everyone is excited, a week later they come down and start asking us, 'okay, when are you going to do this? When can we get this product out?''" said Nikhil Murdeshwar, senior principal research engineer at Olympus Surgical Technologies America, referring to past experiences in the industry (not specific to his current company).

Murdeshwar is slated to speak at MD&M Minneapolis about managing a successful project, exceeding sales estimates, meeting launch commitments, innovating for success, and satisfying users.

"In our world of medical devices our intentions are to get these devices to the market quickly, but in doing that our industry forgets that we're working with people, and we're working with the FDA, so we want to make sure we do everything in a responsible way," Murdeshwar told MD+DI.

There are many instances in which once a project is finished, the team members never want to work together again because it was such a bad, and stressful, experience, he said. But there are instances when the opposite is true and the team can't wait to work together again.

"We have to be mindful and appreciate the people we work with ... so that we don't drive people out of the company, or out of the industry," Murdeshwar said.

Murdeshwar's presentation will include five specific tips for managing a successful project. Among them, is the idea that tools do not replace experience. By that, he means the experience gathered in the field during the research phase of a project.

He explained that on the business side of R&D there are a lot of estimations that must be made about the potential market size of the new product, potential sales, etc. In this day and age, it's all too tempting to turn to computer-aided design tools and spreadsheets to turn over those estimations quickly and from the comfort of your own cubical. But what happens when, down the road, you realize there is a huge gap between what you estimated and what you're actually seeing?

Ideally, when an engineer observes a problem, they develop a hypothesis, test it out, and develop a solution, Murdeshwar explained. Then it's time to sit down at the computer and use those tools to present the idea to the rest of the team and your superiors. 

Someone who does not do that diligently would probably observe a problem, then run straight to their tools and present it to the team," he said.

The scary part is, in this fast-paced world of medical innovation, the company leaders may not have the time to question project leaders about how they came up with those estimates and whether or not they actually went out and talked to surgeons to inform the product design, Murdeshwar said. So it's up to the project engineers to ensure that the proper fieldwork has been done so that the company doesn't invest time and money into developing a device that surgeons won't even use.

Can a Device Be Safe and Effective When FDA Recommends to Not Use It?

Can a Device Be Safe and Effective When FDA Recommends to Not Use It?
Image source: Pixabay

Legally marketed medical devices are supposed to be safe and effective in accordance with FDA’s mandates and procedures. Devices that are already being marketed and are then found to not be safe and effective should be the subject of recalls or market withdrawals. Such recalls are common and may be for specific lots or for the device overall. Almost all such actions are “voluntary” on the part of the manufacturer, although FDA does have the authority to order a recall. The potential to rescind a 510(k) or PMA has also been discussed from time to time. FDA can also ban a medical device, something that has apparently been done three times. Yet from time to time FDA recommends that a device or type of device should not be used, but these devices are not recalled and sales and use may continue.

Recently FDA reiterated that misconnections between tubing devices continue to be a cause of injury. This is a longstanding issue that FDA addressed in 2014. In the particular case of enteral feeding connectors, FDA recommended that only connectors compliant with certain voluntary standards should be used. Manufacturers were advised to implement devices using these standards in lieu of those that do not meet the standards. But no action was suggested with regard to the continued existence of connectors that do not meet the standard despite the established risk.

Another connector issue concerned cross contamination with certain connectors that are used in gastrointestinal endoscopy. In this case, FDA noted that it has not received acceptable testing to demonstrate the safe use of these products. In addition, FDA states that 24-hour multiple-patient-use endoscope connectors should not be used because they carry a risk of cross contamination. Yet they remain on the market and are available for use.

In July 2018 FDA announced that it was “aware that certain device manufacturers may be marketing their energy-based medical device for vaginal 'rejuvenation' and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.” FDA further noted that they “have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products.” But no recalls or other follow-up have been reported. Subsequently one manufacturer suspended sales and marketing of a related device but did nothing about those already in the hands of practitioners.

In 2014 FDA announced that it “discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” yet there were no associated recalls. Later there were new contraindications “recommended” for these devices, but it is not clear if any existing labeling was changed or if later releases of these device included this information. There is also the unanswered question of the effectiveness of new labeling, especially on those who already own the device and might have read the old labeling and do not get the new labeling. It is difficult to explain why new customers need warnings that old customers do not.

Some medical devices are seemingly more mundane than others but can still present significant safety issues. The side rails on hospital beds are medical devices either as accessories or as stand-alone products. Bed rails can present an entrapment risk to the bed occupant, which can lead to death when the neck or chest is the entrapped body part. Earlier this decade, FDA organized a Hospital Bed Safety Working Group that eventually produced a guidance on the physical dimensions of bed rails that was intended to reduce entrapments. In doing so, it was concluded that some existing bed rails were hazardous and then bed rails that met the new guidelines were less hazardous. The older hazardous rails were therefore presumably not safe and effective, but no “legacy” rails were recalled as a result of their not meeting the new guidance. In fact, a “no recall” agreement was part of obtaining industry cooperation on the development of the guidance. After the guidance, older designs continued to be used and sold, resold, and rented, and they continued to cause death.

In almost all such communications, FDA does not include its own product codes for the effected devices. This is unfortunate, since product codes are useful in several FDA databases such as MAUDE and recalls.

Safe and effective is a core principle for medical devices and yet remains challenging to define and enforce. However, FDA sometimes decides that a type of device, or a particular device, is in fact unsafe, and it may issue warnings against continued use. Nonethless, such devices may continue to be marketed, and already sold devices may continue to be used, with no associated recalls. As noted in the recent documentary The Bleeding Edge, sometimes it is harder to get a bad device out of the market place than it was to get that device into the marketplace.

Boston Sci’s Eluvia Set to Make Impact in DES Market with PMA

Courtesy of Boston Scientific Boston Sci’s Eluvia Set to Make Impact in DES Market with PMA

Shares of Boston Scientific were slightly up on Monday (about 1.44%), as the Marlborough, Mass.-based company announced it received FDA approval for the Eluvia Drug-Eluting Vascular Stent System. The stent was specifically approved to treat patients suffering from peripheral artery disease (PAD).

Boston Scientific’s Eluvia stent system is built on the Innova Stent System platform, a self-expanding nitinol stent that has been designed for use in the superficial femoral and proximal popliteal arteries, the main arteries that supply blood to the legs. The Eluvia stent system received CE Mark in 2016.

FDA’s approval of Eluvia is based on results from the IMPERIAL trial. Boston Scientific discussed results of the study, which had the Eluvia stent going head-to-head with Cook Medical’s Zilver Ptx, at the Transcatheter Cardiovascular Therapeutics annual conference.

IMPERIAL trial results show that patients treated with the Eluvia stent experienced a significantly greater 12-month primary patency of 88.5%, compared to 79.5% in patients treated with Zilver PTX (p=0.0119). Additional findings show, patients treated with the Eluvia stent experienced half the target lesion revascularization rate of Zilver PTX at 12 months, a 4.5% TLR rate for Eluvia vs. 9% TLR rate for the Zilver PTX cohort.

"In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95% of patients from needing a reintervention after one year," said William Gray, M.D., system chief, Division of Cardiovascular Diseases and president, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, and co-principal investigator of the IMPERIAL trial. "The Eluvia stent is a breakthrough therapy that marks a significant step forward in the treatment of PAD, and now with its approval and commercial availability, it has the potential to make an immediate impact on the quality and value of care that physicians can provide to their patients."

Fired MiMedx Execs Say the Company's Investigation 'Spun Out of Control'

Pixabay Fired MiMedx Execs Say the Company's Investigation 'Spun Out of Control'
MiMedx said its audit committee's internal investigation is ongoing and there may be other actions taken based on information uncovered in the investigation.

For the first time since being terminated from their top positions at MiMedx, former CEO Parker "Pete" Petit and former COO William Taylor spoke out today about the investigation that led to their dismissal earlier this year.

In February, MiMedx postponed the release of its financial results and the filing of its Form 10-K for 2017 and reported that independent legal and accounting advisors were investigating allegations regarding the company's sales and distribution practices. That investigation eventually led to the resignations of Petit and Taylor, as well as the resignations of former CFO Michael Senken, and former corporate controller and treasurer John Cranston. The company also drew the unwanted attention of both the Securities and Exchange Commission and the Department of Justice.

Last week, the company's board announced that these four separations were to be treated as terminations "for cause," and that the former executives would have to forfeit equity and incentive awards they received in connection with their resignations.

"I am extremely disappointed by the company's decision and by the manner in which it was reached," Taylor said in a statement his attorney's office shared with MD+DI on Monday. "The investigators conducted an unfair investigation that has needlessly damaged employee morale, productivity, and shareholder value. Despite today’s announcement, both Pete Petit and I remain immensely proud of our tenure at the helm of one of the fastest-growing public companies in the country. I hope every MiMedx employee shares our pride in having been part of that accomplishment. I thank every employee and am honored to have worked with each of you.”

Petit's comment in the same statement suggests that while he is no longer CEO or a board member, he isn't yet giving up all ties with MiMedx. "I now look forward to joining our shareholders in initiatives that will refocus the company and its fiduciaries on getting back to efficient and effective business management," he said.

Bill Weinreb, an attorney at New York-based law firm Quinn Emanuel, said Petit and Taylor are victims of an "unfortunate practice" among public companies facing government investigations into alleged malfeasance. According to Weinreb, this is the standard playbook among companies in this position: "identify purported 'wrongdoers' among top management,  dismiss them without severance, and then argue that the 'problem' has been fixed and there is nothing more for the government to do."

In the MiMedx case, Weinreb said, the company effectively accused, tried, and convicted Petit and Taylor of "unspecified inappropriate conduct" without first giving them notice of the supposed charges or a fair and meaningful opportunity to respond.

"The internal investigation that led to today's announcement has spun out of control," Weinreb said. "Shareholders should question whether the audit committee, which has led the investigation, is acting in the company's best interests or its own best interests in finding others responsible for accounting matters for which the committee itself bears ultimate responsibility."

MiMedx noted that the audit committee's investigation is ongoing, and there may be other actions taken based on information the investigation uncovers.

"The board is taking the necessary steps to prepare MiMedx for its next chapter and a stronger future," said Charles Evans, chairman of the board. "The board is committed to taking the decisive actions necessary to develop enhanced systems and controls."

Can Cross-Pollination Improve Medtech Manufacturing Processes?

Can Cross-Pollination Improve Medtech Manufacturing Processes?
Image source: Pixabay

In a panel discussion at MD&M Minneapolis, experts will offer their insights on cross pollination, a process whereby those in the manufacturing arena can draw upon another industry’s methods to improve their own. “I would define cross-pollination as using different technologies, solutions, and knowledge from other industries to solve problems in the medical device industry,” panel member Carlos Melendez, cofounder and COO of artificial intelligence and software engineering services firm, Wovenware, told MD+DI.

Melendez will be speaking in the panel discussion, "Using Cross-Pollination to Drive Medtech Smart Manufacturing," on October 31, 8:30 AM - 9:15 AM, at MD&M Minneapolis.

Not surprisingly, based on his expertise in artificial intelligence (AI) and software development, Melendez said: “I think the future of improving the manufacturing process is based on analytics and AI.” He cited an example of similarities in financial service and transactional systems with healthcare insurance systems. “They do have a lot more in common than both industries know, and a lot of them don’t even see the similarities,” he said.

Melendez said that medical device manufacturers should also be looking to the government for ways they could use AI in manufacturing processes. “Right now government is particularly forward thinking, and they are investing a lot into R&D and trying to understand how best they can use AI for different things,” he said.

In his company, Melendez said, some of the trends that they are looking at are all-around analytics and using them to improve processes in the manufacturing to make each plant perform better. “We’ve seen that there’s really little difference in the prices of materials and the prices of basically the production per se, the power, the facilities, per se. The difference comes in the process and in the engineering and how you measure the efficacy of the whole process. So, to improve the manufacturing plants and improve yields and improve performance, we’re really looking to the analytics to see where those opportunities lie,” he said.

Melendez hopes that attendees might learn of something that is done in another industry and then research how to implement it into their own. He said that particularly those in charge of QA and those who have a say in implementing manufacturing processes should attend this session.

Steven Schmidt, CEO of Resolution Medical LLC and Jim Wetzel, interim CEO of the Clean Energy Smart Manufacturing Innovation Institute will round out the panel, which will be moderated by Jon Coons, global black belt—oT/technical solution professional, Microsoft.

Don't miss the panel discussion "Using Cross-Pollination to Drive Medtech Smart Manufacturing," presented on October 31, 8:30 AM - 9:15 AM at MD&M Minneapolis.