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Global Medical Device Podcast powered by Greenlight Guru

greenlight.guru's Jon Speer + Medical Device Entre

7
Followers
6
Plays
Global Medical Device Podcast powered by Greenlight Guru
Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru

greenlight.guru's Jon Speer + Medical Device Entre

7
Followers
6
Plays
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About Us

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Latest Episodes

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP). Requirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities. Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how this new program may be applicable to your medical device and design efforts. Some of the highlights of the show include: ● The main difference is that STeP’s focus is on improving safety; BDP’s emphasis is on efficacy side of devices for more serious diseases, injuries, or conditions. ● BDP vs. STeP: Which is a better option, and why? Programs should have been combined because there’s a need to offer incentives for safety and effectiveness. ● STeP Eligibility Criteria: ○ If device o...

33 MIN5 d ago
Comments
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How do you navigate, capture, and document when and what to do? In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss FDA’s two, new guidance documents that provide additional transparency, consistency, and objectivity regarding benefit-risk determinations. Some of the highlights of the show include: ● Differences between Documents: Under what circumstances that pose a greater risk are acceptable for product submissions vs. appendices related to ISO 14971. ● New nine-page benefit-risk assessment worksheet is oversimplified and presents a non-traditional instead of analytical approach to determining benefit-risk. ● New guidance documents don’t mention 510(k) device, but why? People should already know about uncertainty and risk of 510(k) medical devices via predicates. ● Higher risk is acceptable in various classifications of medical devices, including PMAs and BDPs, and when dealing with small populations. ● Adding to the complexity of medical devices, the guidance documents now include low-, medium-, and high-risk categories and criteria of uncertainty. ● Pay attention to patient’s perspective of uncertainty when available. Are patients willing to truly accept risks and uncertainty to achieve unmet clinical need? ● Mitigate uncertainty in other ways, such as through labeling, degree of need, and clinical evidence/market data of product. ● Probable Benefit of HDE: Efficacy at a lower statistical power may diminish uncertainty due to giving patients early access to a medical device.

36 MIN2 w ago
Comments
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Do you know everything there is to know about prototyping, product iteration, and manufacturing to get your medical device to market? In this episode, Greg Paulsen, the Director of Application Engineering at Xometry, describes nuances to consider and how to leverage technology and rapid prototyping methodologies. Specifically, Greg shares Xometry’s different procurement and fulfilment strategies and options that help simplify and speed up the medical device process. Some of the highlights of the show include: ● Procurement Problems: Xometry makes and fulfills on-demand custom manufactured parts for medical devices. ● Prototyping: When to start? What types to create? What are verification and validation requirements? Why consider past, present, and future iterations? ● Today’s Trends: Greg describes the evolution of materials, functions, and technologies (i.e., 3D printing, injection molding, and urethane casting). ● What problem will the medical device solve? Prototyping helps identify and define user needs, materials, form-fit-function requirements, and human factors. ● Agile/Iterative Product Development: Start early to make modifications and iterations to be flexible and leverage prototype for verification and validation. ● Material Selection: Prototyping identifies advantages and disadvantages of trying different materials to determine which to use for medical devices. ● A rapid prototype can be used for verification, if a rapid type of material can function and perform during testing and performance. ● Rapid prototyping can be used for first-run production, depending on market size. Consider low-volume vs. mass production tool due to cost and possible changes.

39 MIN3 w ago
Comments
Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. This is especially true when quality engineers limit their testing activities to only take place during the research and development (R&D) process. In this episode, Mike Drues of Vascular Sciences joins me to discuss the nuances of design verification, as it relates to quality and design controls. Some of the highlights of the show include: ● The difference between design verification and design validation is whether you designed the product correctly vs. you designed the correct product. ● Conduct research prior to design verification to determine which questions to ask and tests to perform to solve the right problems. ● Trust but Verify: Never assume that users know what they really need. They may think they know the best solution, but that’s not always true. ● No-thought fallback position is testing according to standards or guidance documents as a design verification strategy. ● Present testing matrix as part of FDA pre-submission process. Avoid making design verification an afterthought. ● Plan, be proactive, and collaborate with regulatory bodies to prevent delayed product launches and loss of revenue. ● Quality engineers in R&D need to participate, prototype, iterate, and demonstrate/prove concepts before design verification to discover bad decisions.

40 MINSEP 12
Comments
Why Design Verification Matters in Medical Device Design and Development

Implementing Changes to SaMD under New EU MDR

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty. In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert. Some of the highlights of the show include: ● Most noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state. ● SaMD classification changes are drastic but vague following MDR implementation. ● Gap analysis should be performed to identify changes that companies need to make to conform with changes. ● Groups that will most likely experience the greatest impact due to classification and qualification changes: ○ Products on market in EU as Class I software will be uplisted as Class IIa. ○ Products that provide clinical information for informed clinical decisions. ● Timeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020. ● Plan, prioritize, and understand your regulatory conformance strategy going forward. ● Compare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.

37 MINSEP 5
Comments
Implementing Changes to SaMD under New EU MDR

Career Tips for QA/RA Professionals in the Medical Device Industry

Medical device quality and regulatory professionals face changes, challenges, requirements, standards, and so much more. It’s a challenge for them to keep up. In this episode, Mitch Robbins, founder and managing director of The Anthony Michael Group, offers tips for Quality Assurance and Regulatory Affairs (QA/RA) professionals on how to prepare for such a career. Some of the highlights of the show include: ● The Anthony Michael Group is executive search firm that focuses on the medical device industry and places regulatory and quality leadership talent. ● Common quality and regulatory themes impacting the medical device industry include expediting time to market and keeping up with post-market changes. ● Regulatory and quality professionals help companies overcome obstacles to get things done and accomplish product development goals. ● Mindsets and Skill Sets: Differentiate low and high performers by understanding how their function and responsibilities fit with other pieces of the business. ● Market changes and expectations have evolved from must-have to integrated and cross-functional approach with increased respect. ● In the future, Mitch expects the “gig” economy to continue to grow with a contingent and consultant workforce. ● Build employee value proposition (EVP), candidate value proposition (CDP), and your brand and portfolio of expertise, recognition, and outcomes. ● Network, get certified, be resourceful, and add value by taking risks, volunteering for projects, and putting yourself in uncomfortable situations.

30 MINAUG 29
Comments
Career Tips for QA/RA Professionals in the Medical Device Industry

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of your medical device company? How do you know if it is or isn't? If it is wrong-sized, what can you do to correct it? Today’s guest, Mike Drues of Vascular Sciences, and I discuss this topic through the lenses of regulatory and quality factors to share with listeners the best ways to approach and succeed in right-sizing your QMS. Some of the highlights of the show include: ● QMS: Policies and procedures in place to meet regulatory requirements and define design, development, manufacturing, and servicing of medical devices. ● Two Extremes: Company’s QMS is too light because of vague and ambiguous verbiage, or too weighted with burdensome specifics; neither of which is a right-sized QMS. ● Company Pulse: To effectively right-size your QMS, you must understand who your company is, where you are, what stage you’re at in the process, and who’s involved. ● Perform a gap analysis, on-site visit, and internal audit to evaluate existing procedures and adjust as necessary. ● Companies that don’t follow their own procedures create regulatory, quality, and product liability problems. ● If you can’t measure it, you can’t improve it: Achieve consistent, repeatable, and reproducible outcomes. ● The difference between compliance and true quality, and why it’s important: Improve quality of life and provide the best possible outcome for patients. ● Are rules meant to be broken? Don’t follow rules blindly, especially if they don’t make sense. Be practical and pragmatic.

38 MINAUG 22
Comments
Right-sizing your QMS

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices. In this episode, Mike Drues of Vascular Sciences, and I discuss the lack of availability for such devices and prescription drugs, specifically with children in mind. Some of the highlights of the show include: ● Smaller versions of adult medical devices and drugs for pediatric population may not be the best solution or solve the problem. ● Lack of availability is due to lack of market. Drugs approved by the FDA for adults are relabeled for kids. ● Two-thirds of all drugs prescribed to children have not been studied or labeled specifically for them, and 90% of the drugs given to newborns are off-label. ● Physicians modify and improvise: Technical challenges include designing and developing pediatric-specific products that change and grow as the child does. ● How can industry get companies to focus on life-sustaining/life-saving devices and drugs for pediatric market? Clinical trials, informed consent, and 3D printing. ● Most medical products are required to show safety and efficacy; HDE only requires probable benefit. ● Real world evidence needed to support pediatric medical device submissions. ● Necessity is the Mother of Invention: Doctors retrofitted breathing tube for Saybie, a micro preemie the size of an apple.

31 MINAUG 15
Comments
Challenges with Pediatric Medical Devices

When Should You Start a QMS?

Early-stage startups often wonder when the right time is to consider a quality management system (QMS)? Is it ever too soon to start a QMS? Today’s guest is Devon Campbell, founder of Prodct LLC, which helps establish and implement holistic, efficient, and practical product development and manufacturing strategies. Devon and Jon Speer discuss the importance of timing when starting a QMS for medical device companies to ensure future product success.. Some of the highlights of the show include: ● Emerging Trend: Almost all of Devon’s clients have no QMS, or have what they consider a QMS, but isn’t in reality. ● Mentor for MassChallenge: The global, zero-equity startup accelerator has helped more than 1,900 startups and raise more than $4.3 billion in funding. ● Hungry for Knowledge: What’s your core technology? Commercialization strategy? Development strategy? What do you need to do to take it to market? ● Lack of Appreciation: Startups should think through QMS and design control opportunities, strategies, and implementation sooner than later. ● Start Early with End in Mind: Make it easy to pivot later. If you don’t go through the effort that it takes, it’s difficult to backtrack. ● Best Practices: Look far forward and obtain external help and guidance from quality experts. ● Bigger Picture: Work with everyone involved to better understand challenges and changes with a company’s QMS, as it evolves and matures in real time. ● Patients who depend on your medical technology will appreciate your focus on true quality.

30 MINAUG 8
Comments
When Should You Start a QMS?

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical devices, general wellness devices, or both? In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products. Some of the highlights of the show include: ● FDA does not regulate or classify general wellness devices that don’t diagnose, treat, or prevent a disease, injury, or condition. ● General wellness devices are required to do what they claim to do through prudent engineering. ● A general wellness device can still be considered a medical device, which creates confusion and false claims. ● Should manufacturers take the wellness or regulated route? Try both by putting versions of the same device on the market at the same time. ● Dumbed-down vs...

34 MINAUG 1
Comments
How General Wellness Devices Have Opened a Pandora's Box of Confusion

Latest Episodes

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP). Requirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities. Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how this new program may be applicable to your medical device and design efforts. Some of the highlights of the show include: ● The main difference is that STeP’s focus is on improving safety; BDP’s emphasis is on efficacy side of devices for more serious diseases, injuries, or conditions. ● BDP vs. STeP: Which is a better option, and why? Programs should have been combined because there’s a need to offer incentives for safety and effectiveness. ● STeP Eligibility Criteria: ○ If device o...

33 MIN5 d ago
Comments
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How do you navigate, capture, and document when and what to do? In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss FDA’s two, new guidance documents that provide additional transparency, consistency, and objectivity regarding benefit-risk determinations. Some of the highlights of the show include: ● Differences between Documents: Under what circumstances that pose a greater risk are acceptable for product submissions vs. appendices related to ISO 14971. ● New nine-page benefit-risk assessment worksheet is oversimplified and presents a non-traditional instead of analytical approach to determining benefit-risk. ● New guidance documents don’t mention 510(k) device, but why? People should already know about uncertainty and risk of 510(k) medical devices via predicates. ● Higher risk is acceptable in various classifications of medical devices, including PMAs and BDPs, and when dealing with small populations. ● Adding to the complexity of medical devices, the guidance documents now include low-, medium-, and high-risk categories and criteria of uncertainty. ● Pay attention to patient’s perspective of uncertainty when available. Are patients willing to truly accept risks and uncertainty to achieve unmet clinical need? ● Mitigate uncertainty in other ways, such as through labeling, degree of need, and clinical evidence/market data of product. ● Probable Benefit of HDE: Efficacy at a lower statistical power may diminish uncertainty due to giving patients early access to a medical device.

36 MIN2 w ago
Comments
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Do you know everything there is to know about prototyping, product iteration, and manufacturing to get your medical device to market? In this episode, Greg Paulsen, the Director of Application Engineering at Xometry, describes nuances to consider and how to leverage technology and rapid prototyping methodologies. Specifically, Greg shares Xometry’s different procurement and fulfilment strategies and options that help simplify and speed up the medical device process. Some of the highlights of the show include: ● Procurement Problems: Xometry makes and fulfills on-demand custom manufactured parts for medical devices. ● Prototyping: When to start? What types to create? What are verification and validation requirements? Why consider past, present, and future iterations? ● Today’s Trends: Greg describes the evolution of materials, functions, and technologies (i.e., 3D printing, injection molding, and urethane casting). ● What problem will the medical device solve? Prototyping helps identify and define user needs, materials, form-fit-function requirements, and human factors. ● Agile/Iterative Product Development: Start early to make modifications and iterations to be flexible and leverage prototype for verification and validation. ● Material Selection: Prototyping identifies advantages and disadvantages of trying different materials to determine which to use for medical devices. ● A rapid prototype can be used for verification, if a rapid type of material can function and perform during testing and performance. ● Rapid prototyping can be used for first-run production, depending on market size. Consider low-volume vs. mass production tool due to cost and possible changes.

39 MIN3 w ago
Comments
Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. This is especially true when quality engineers limit their testing activities to only take place during the research and development (R&D) process. In this episode, Mike Drues of Vascular Sciences joins me to discuss the nuances of design verification, as it relates to quality and design controls. Some of the highlights of the show include: ● The difference between design verification and design validation is whether you designed the product correctly vs. you designed the correct product. ● Conduct research prior to design verification to determine which questions to ask and tests to perform to solve the right problems. ● Trust but Verify: Never assume that users know what they really need. They may think they know the best solution, but that’s not always true. ● No-thought fallback position is testing according to standards or guidance documents as a design verification strategy. ● Present testing matrix as part of FDA pre-submission process. Avoid making design verification an afterthought. ● Plan, be proactive, and collaborate with regulatory bodies to prevent delayed product launches and loss of revenue. ● Quality engineers in R&D need to participate, prototype, iterate, and demonstrate/prove concepts before design verification to discover bad decisions.

40 MINSEP 12
Comments
Why Design Verification Matters in Medical Device Design and Development

Implementing Changes to SaMD under New EU MDR

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty. In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert. Some of the highlights of the show include: ● Most noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state. ● SaMD classification changes are drastic but vague following MDR implementation. ● Gap analysis should be performed to identify changes that companies need to make to conform with changes. ● Groups that will most likely experience the greatest impact due to classification and qualification changes: ○ Products on market in EU as Class I software will be uplisted as Class IIa. ○ Products that provide clinical information for informed clinical decisions. ● Timeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020. ● Plan, prioritize, and understand your regulatory conformance strategy going forward. ● Compare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.

37 MINSEP 5
Comments
Implementing Changes to SaMD under New EU MDR

Career Tips for QA/RA Professionals in the Medical Device Industry

Medical device quality and regulatory professionals face changes, challenges, requirements, standards, and so much more. It’s a challenge for them to keep up. In this episode, Mitch Robbins, founder and managing director of The Anthony Michael Group, offers tips for Quality Assurance and Regulatory Affairs (QA/RA) professionals on how to prepare for such a career. Some of the highlights of the show include: ● The Anthony Michael Group is executive search firm that focuses on the medical device industry and places regulatory and quality leadership talent. ● Common quality and regulatory themes impacting the medical device industry include expediting time to market and keeping up with post-market changes. ● Regulatory and quality professionals help companies overcome obstacles to get things done and accomplish product development goals. ● Mindsets and Skill Sets: Differentiate low and high performers by understanding how their function and responsibilities fit with other pieces of the business. ● Market changes and expectations have evolved from must-have to integrated and cross-functional approach with increased respect. ● In the future, Mitch expects the “gig” economy to continue to grow with a contingent and consultant workforce. ● Build employee value proposition (EVP), candidate value proposition (CDP), and your brand and portfolio of expertise, recognition, and outcomes. ● Network, get certified, be resourceful, and add value by taking risks, volunteering for projects, and putting yourself in uncomfortable situations.

30 MINAUG 29
Comments
Career Tips for QA/RA Professionals in the Medical Device Industry

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of your medical device company? How do you know if it is or isn't? If it is wrong-sized, what can you do to correct it? Today’s guest, Mike Drues of Vascular Sciences, and I discuss this topic through the lenses of regulatory and quality factors to share with listeners the best ways to approach and succeed in right-sizing your QMS. Some of the highlights of the show include: ● QMS: Policies and procedures in place to meet regulatory requirements and define design, development, manufacturing, and servicing of medical devices. ● Two Extremes: Company’s QMS is too light because of vague and ambiguous verbiage, or too weighted with burdensome specifics; neither of which is a right-sized QMS. ● Company Pulse: To effectively right-size your QMS, you must understand who your company is, where you are, what stage you’re at in the process, and who’s involved. ● Perform a gap analysis, on-site visit, and internal audit to evaluate existing procedures and adjust as necessary. ● Companies that don’t follow their own procedures create regulatory, quality, and product liability problems. ● If you can’t measure it, you can’t improve it: Achieve consistent, repeatable, and reproducible outcomes. ● The difference between compliance and true quality, and why it’s important: Improve quality of life and provide the best possible outcome for patients. ● Are rules meant to be broken? Don’t follow rules blindly, especially if they don’t make sense. Be practical and pragmatic.

38 MINAUG 22
Comments
Right-sizing your QMS

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices. In this episode, Mike Drues of Vascular Sciences, and I discuss the lack of availability for such devices and prescription drugs, specifically with children in mind. Some of the highlights of the show include: ● Smaller versions of adult medical devices and drugs for pediatric population may not be the best solution or solve the problem. ● Lack of availability is due to lack of market. Drugs approved by the FDA for adults are relabeled for kids. ● Two-thirds of all drugs prescribed to children have not been studied or labeled specifically for them, and 90% of the drugs given to newborns are off-label. ● Physicians modify and improvise: Technical challenges include designing and developing pediatric-specific products that change and grow as the child does. ● How can industry get companies to focus on life-sustaining/life-saving devices and drugs for pediatric market? Clinical trials, informed consent, and 3D printing. ● Most medical products are required to show safety and efficacy; HDE only requires probable benefit. ● Real world evidence needed to support pediatric medical device submissions. ● Necessity is the Mother of Invention: Doctors retrofitted breathing tube for Saybie, a micro preemie the size of an apple.

31 MINAUG 15
Comments
Challenges with Pediatric Medical Devices

When Should You Start a QMS?

Early-stage startups often wonder when the right time is to consider a quality management system (QMS)? Is it ever too soon to start a QMS? Today’s guest is Devon Campbell, founder of Prodct LLC, which helps establish and implement holistic, efficient, and practical product development and manufacturing strategies. Devon and Jon Speer discuss the importance of timing when starting a QMS for medical device companies to ensure future product success.. Some of the highlights of the show include: ● Emerging Trend: Almost all of Devon’s clients have no QMS, or have what they consider a QMS, but isn’t in reality. ● Mentor for MassChallenge: The global, zero-equity startup accelerator has helped more than 1,900 startups and raise more than $4.3 billion in funding. ● Hungry for Knowledge: What’s your core technology? Commercialization strategy? Development strategy? What do you need to do to take it to market? ● Lack of Appreciation: Startups should think through QMS and design control opportunities, strategies, and implementation sooner than later. ● Start Early with End in Mind: Make it easy to pivot later. If you don’t go through the effort that it takes, it’s difficult to backtrack. ● Best Practices: Look far forward and obtain external help and guidance from quality experts. ● Bigger Picture: Work with everyone involved to better understand challenges and changes with a company’s QMS, as it evolves and matures in real time. ● Patients who depend on your medical technology will appreciate your focus on true quality.

30 MINAUG 8
Comments
When Should You Start a QMS?

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical devices, general wellness devices, or both? In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products. Some of the highlights of the show include: ● FDA does not regulate or classify general wellness devices that don’t diagnose, treat, or prevent a disease, injury, or condition. ● General wellness devices are required to do what they claim to do through prudent engineering. ● A general wellness device can still be considered a medical device, which creates confusion and false claims. ● Should manufacturers take the wellness or regulated route? Try both by putting versions of the same device on the market at the same time. ● Dumbed-down vs...

34 MINAUG 1
Comments
How General Wellness Devices Have Opened a Pandora's Box of Confusion