Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasiveness and sedation involved, preparing for a colonoscopy is something most patients dread and try to avoid. Fortunately, clinicians and patients can look forward to colonoscopy and colon cancer screening modalities that require no preparation. Today’s guest is Alex Ovadia, CEO of Check-Cap. The company is developing a capsule called, C-Scan, for colon cancer screening, and a U.S. clinical trial has begun. Some of the highlights of the show include: ● Alex describes the motivation behind Check-Cap’s capsule and meeting a need for no-prep to detect polyps from inside the body. ● Check-Cap’s capsule avoids sedation and insertion of a colonoscope in the patient’s body. ● Check-Cap’s capsule modality is simply “swallow and forget.” The capsule uses an algorithm that runs scanning throughout the colon. ● There’s a lot of room for error for patients who have a colonoscopy. Decision intelligence is being developed to prevent human errors that impact patients. ● Alex shares Check-Cap’s current stage of commercialization and upcoming milestones for its capsule. IRB approval has been received. ● Each year, about 880,000 deaths worldwide are due to colon cancer. Check-Cap’s capsule strives to make sure people have better and healthier lives. ● Quality is critical when it comes to the progression of commercializing. Alex describes efforts to maintain safety and compliance with Check-Cap’s capsule.

Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers, as well. The lack of innovative medical devices with intelligent software following cardiothoracic surgery provided an opportunity for one MedTech company in particular. Today’s guest is Evan Luxon, co-founder and CEO at Centese. The early stage company achieved 510(k) clearance from the FDA for its intelligent surgical drainage product called, Thoraguard. Centese followed a deliberate and diligent approach to design and development, while right-sizing its quality management system (QMS). Listen to the full episode as this MedTech executive shares key insights, tips and best practices to help other MedTech leaders achieve similar success. Some of the episode highlights include: - Proactive vs. Reactive: Thoraguard’s core principles are safety, intelligence, and efficacy. - No Rest for the Weary: Thoraguard automatically monitors patients without needing to rely on nurses to routinely check on patients. - MedTech Space: Start by addressing a clinical problem that people are willing to pay for to solve clinical needs. - Proof of Concept Prototypes: Reach out to as many surgeons and others early on to optimize lean launchpad methodology for relevant and reliable feedback. - Quality Role and Regulations: Feedback helps medical device companies avoid feature creep and change scope to meet fundamental and required functionality. - How to right-size your QMS: Build out the QMS as the project and company progress by knowing what’s needed at each phase of development.

In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative, or falsely positive. More than 350 breast cancer cases evade early detection because of misdiagnosis. Many of those errors can be avoided. There's one company in particular that is leading the charge with a truly innovative solution to this problem, Koios Medical. Koios is proprietary software that has the power to meaningfully elevate the quality of medical care and support accurate decision-making by ‘seeing’ what humans can’t. Koios Medical offers accurate ultrasound results through artificial intelligence (AI) and machine learning (ML) algorithms that patients need and physicians find valuable to support early detection and accurate treatment of breast cancer and other diseases. Today’s episode features three guests from Koios Medical offering valuable insight to listeners on how they've been successful in imagining, implementing and innovating a true quality medical device that aims to redefine cancer diagnosis as we know it today, and how other medical device professionals can follow in their footsteps. Some of the highlights of the show include: ● Word Origin and Why: Koios is Titan God of Wisdom, Foresight, and Intellect. ● Regulatory Success: Koios Medical’s DS Breast 2.0 received FDA clearance to assist physicians with AI-based software. ● Koios engineers started using AI/ML algorithms to do face-recognition work for a U.S. defense contractor, and transitioned to adapt AI/ML to do more global good. ● Why now? AI has existed for decades, but only recently has computing power allowed massive amounts of data to become useable in a practical sense. ● Competitive Edge: Koios is doing everything possible to maintain its market lead by building an efficient and expedient processing engine and software. ● Design and Development Direction: Koios’ path to clearance commercialization involves behavioral, technical, and financial challenges/opportunities. ● Reason for Regulations: Koios’ mission is to improve decision making for diagnosing cancer and Reason for Regulations: Quality makes us better.

Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality Program and CMMI Institute’s Medical Device Discovery Appraisal Program (MDDAP). Today’s guest is Becky Fitzgerald, principal and co-founder of Two Harbors Consulting. She’s passionate about her involvement with Case for Quality and being a lead appraiser for MDDAP. In this episode, Becky gives listeners an inside look into her instrumental work and involvement with FDA's Case for Quality and MDDAP programs, including how these initiatives were started and have evolved since, as well as lessons learned along the way. ● Case for Quality: Originated due to auditing issue that revealed problems with the quality of medical devices from fully vs. non-fully compliant organizations. ● Capability Maturity Model Integration (CMMI): FDA selected model to help companies improve the quality of medical devices without more regulations. ● Multiple medical device entities produced proof of concept and pilot program to show benefits, effectiveness, and value of Case for Quality and MDDAP. ● Compliance vs. Quality: Medical device industry’s checkbox and compliance mindset can create direct and indirect impact on quality. ● MDDAP focuses on conversations with people; the intent and goals for documenting or recording are different. ● Processes vs. Attributes: Is there a way to predict if a project will succeed? ● Lessons Learned: Medical device industry isn’t great at estimating work, project management, and handling changes to non-functional requirements. ● Minor Changes, Major Impact: Ask for input, receive it, and make changes to build momentum for quality.

If you or your child have ever experienced ear infections, you know how difficult (and painful) they can be to diagnose and treat with prescribed medicines and procedures. Today’s guest is Ryan Shelton, CEO and founder of PhotoniCare, whose team has developed TOMi Scope, a non-invasive handheld imaging platform that uses light to see through ear tissue. PhotoniCare’s TOMi Scope looks directly at the disease, not the eardrum. Some of the highlights of the show include: ● Middle ear infection is the leading cause of hearing loss, surgeries, and antibiotic use, especially in children. ● Traditionally, an otoscope is used that results in a 50% misdiagnosis rate. ● TOMi Scope looks like the otoscope, but optical coherence tomography (OCT) images of middle ear increase accuracy, eliminate subjectivity and speculation. ● TOMi Scope is simple to use by nurse practitioners, physician’s assistants, and technicians. It’s not anymore complicated than a flashlight or magnifying glass. ● Parents and patients feel helpless due to limitations of standard care for middle ear disease. ● MedTech startups experience challenges, obstacles, successes, and barriers with fundraising, compliance, regulatory, quality, design, and testing. ● Trying to avoid being on FDA’s radar? Embrace the regulatory landscape. ● A picture is worth a thousand words, a prototype is worth a thousand pictures.

Is creating a culture of quality a top priority at your MedTech company? But you’re not sure how or when to start? Today’s guest is Devon Campbell, founder of Prodct LLC, a MedTech company helping to establish and implement holistic, efficient, and practical product development and manufacturing strategies. In this episode, Devon shares valuable insight with listeners on the topic of quality culture within companies. His proven approach has helped a wide range of medical device professionals achieve success, from both a cultural and product development standpoint. Some of the highlights of the show include: ● When: Sooner than later, start a culture of quality to accelerate clinical/regulatory approval and achieve market success for your company. ● How: Devon helps companies create a culture of quality by aligning their systems and processes to meet future goals and objectives. ● Devon works with all staff, teams, and departments involved to better understand challenges and changes with a company’s quality management system (QMS). ● Culture of Quality: Start small and early on with the end result in mind to address compliance and quality related to product development. ● Compliance vs. True Quality: Purposefully and consciously develop and deliver a quality product and data to meet the needs of those who benefit from the device. ● Exciting events and exits are not all about making money by being acquired by companies, but receiving acknowledgement and appreciation from them. ● NanoView is a perfect example of how to build a culture of quality by going above and beyond, even overboard, by implementing and using a QMS. ● Document control is more important than you realize. Approach it in a phase-savvy way; pause and push yourself to document early and revise often.

The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's leading that charge is Schelte Post. He’s a quality manager at MR Coils, a company that has successfully developed specialized and innovative Magnetic Resonance Coils for MRI systems. In this episode of MedTech True Quality Stories, Schelte Post shares the fascinating story of MR Coils’ journey in discovering powerful new MRI visible biomarkers, a non-invasive technology can be developed for dynamically mapping biochemical processes in the whole human body. Through their innovative work in detecting metabolic biomarkers, MR Coils is advancing MRI technology as we know it today. Some of the highlights of the show include: ● At MR Coils, Schelte enjoys using his background in quality and process improvement to help improve quality of life and make a difference. ● MR Coils has grown quickly. Schelte describes the company’s journey due to less competition and innovation for accessory parts for MRI scanners. ● Initially, MR Coils underestimated the amount of regulations, standards, and effort needed for compliance and to put a medical device in the marketplace. ● The biggest challenges the company has faced include setting up a design history file for each prototype and making sure changes are processed properly. ● MR Coils recently achieved the milestone of ISO 13485:2016 certification with the help of QMS software from Greenlight Guru. The company had some prior QMS experience to help prepare for an audit. ● Company’s mindset and culture of quality improves every day. Processes have been enhanced, and everyone knows what’s expected to manage risk. ● Audit: Practice what you preach and have evidence to back it up. Always have a healthy level of fear and anxiety, but be prepared and do business as usual.

Within the medical device industry, there’s a right way and a wrong way to address quality and compliance. Today, our guest is Daniel Powell, CEO of Spark Biomedical, a startup building non-invasive neurostimulation systems. Daniel’s been working in the medical device industry for almost 20 years and shares stories that led him to shift his mindset and focus more on quality. Some of the highlights of the show include: - From FDA warning letters to lots of changes, companies face challenges when trying to fix their quality management system (QMS). - From such experiences, Daniel developed a higher quality IQ on what can go wrong and how critical thinking skills put a QMS back on the right track. - Believe that it will happen someday. FDA does an inspection and gives you a warning letter, which is disruptive, stops everything, and takes years to resolve. - You may get a 483 observation; you’re one-and-only chance to prevent a warning letter. Take it seriously, provide a response, and learn from it. - There’s a difference between being compliance vs. true quality focused. Don’t use your own terminology and reduce engineers’ cognitive load. - FDA submission, audit, complaint, and other items always come back to risk. Implement a risk management system that works. - Trying to manage risk can get out of control. Embrace spirit and definition of 14971, and understand the patient perspective to use it as your guiding force. - You have a responsibility to improve quality of life. Do the right thing as you design and develop. Also, learn from others and refresh your knowledge.

How do medical device companies approach the “scaries” related to quality and guidance regulations without breaking the bank? Today’s guest is David Narrow, CEO and founder of Sonavex, a medical device company that offers automated ultrasound solutions. David played a key role in helping Sonavex grow by going from a startup to developing an idea to launching a product in just three years. David shares how to successfully fundraise for seed and Series A rounds, implement a quality management system (QMS), and achieve regulatory pre-submission and 510(k) clearance. Some of the highlights of the show include: - Cost-effective and efficient options: Bring in somebody to set up paper-based QMS or select electronic QMS with expert guidance on implementation and maintenance procedures. - Sonavex sought buy-in from FDA early on and put together a thorough pre-submission package to gain confidence and move forward with its product. - Pre-submission process is a time-intensive but worthwhile paperwork burden. The information gathered is imperative and prepares you for 510(k) submission. - Once on the 510(k) path, you’re usually committed to various activities, including expensive verification testing. Pre-submission can prevent need for re-testing. - Sonavex and TMCx strive to understand reimbursement, healthcare economics, and other key facets. Do good and help each other through resources. - David’s Advice: Identify what you don’t know, get support from resources/experts, obtain experience, take calculated risks, etc. - When fundraising, figure out and find an investor who is the right fit based on the purpose and stage of your company. - David describes what to look forward to at Sonavex, such as starting a limited release of its first product and pursuing initial market applications.

Premature birth is the number one cause of infant mortality in the United States. Improving the quality of life matters, especially from the moment the most delicate patient is born. Today’s guest is Dr. Amir Fassihi, CEO and founder of Amnion Life. He has been spearheading the company's efforts in developing AmnioBed, a True Quality medical device that aims to save the lives of thousands preterm babies born every year and. Some of the highlights of the show include: - Any minor insult or trauma from the environment that a baby born early suffers from could have devastatingly decades-long consequences to the human body. - To help prevent complications, Amir dreamt that preemies should be in synthetic amniotic fluid called, Amnion. He started Amnion Life to turn a dream into reality. - Due to the cost and complexity of developing the AmnioBed medical device, Amnion Life selected to work on it with qualified Serbian engineers. - In 2019, Amnion Life plans to do testing and verification of AmnioBed. In 2020, it will begin conducting clinical trials. - Amir hasn’t faced typical issues that founders of startups experience. He doesn’t need to take salary from the company, works remotely, and has flexible hours. - Why didn’t anybody develop such a medical device sooner? Proper guidelines and standards didn’t exist years ago to know how to build a safe device. - Amnion Life creates the same content of a womb’s amniotic fluid, but purifies it by filtering out toxins and other substances to become dialysis-grade water. - Be patient and take things in stride. Startup founders/CEOs don’t need to be an expert on everything; surround yourself with the right people.