12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

How will COVID-19, new regulatory programs and changes, and technological advancements impact your medical device company in 2021? With much uncertainty still on the horizon, how can you plan for the future, while remaining nimble enough to pivot when unforeseen challenges arise?

On December 8-9, 2020, Greenlight Guru will host the 2021 State of Medical Device Virtual Summit, a must-attend virtual event for quality, regulatory, and product development professionals to get answers to these questions and learn how to stay ahead in the ever-evolving world of the medical device industry. Don't miss out — get your free ticket to the 2021 State of Medical Device Virtual Summit now!

This two-day digital event will feature more than twenty of the industry's top experts as they share their knowledgeable perspectives, predictions, and experiences through live presentations on various trending topics.

Twelve medical device expert from this 2021 Virtual Summit event wanted to share some additional nuggets of wisdom with the medical device community. We've gathered their responses to four questions that many industry professionals are seeking answers to as the new year approaches. Let's take a look at their best tips for how you can succeed in 2021:

BONUS OFFER: Click here to download a free PDF of Greenlight Guru’s 2021 State of Medical Device Survey Results Sneak Peek.

2021 VS Expert Roundup blog - Q1

 

What are the biggest technological shifts and trends that will emerge in 2021 for the medical device industry?

 

Expert Tip #1

 
 

As COVID-19 continues throughout 2021, demand and use of telemedicine and no-contact medical devices (where the healthcare provider is able to assist the patient remotely) will continue to surge, and much of those gains will be permanent.

Both trends increase the attack surface of medical devices, and because of our current situation these devices are being rushed to the market with a higher potential for inadequate or non-existent security mitigations, which is absolutely unsustainable except as a temporary emergency measure.

To counter this trend, we must be extra diligent in widespread adoption and performance of the secure development lifecycle as well as implementing secure field upgradability in all devices to be able to patch the vulnerabilities we will inevitably discover in the near future.

chris-gates-vs Christopher Gates | Principal Systems Security Architect | Velentium

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #2

 
 

Ongoing move to connected Medical Devices combined with high profile breaches will mean a focus on points of weakness in the system. Potential for smaller medical devices to be an unanticipated point of entry.

shane-keating-vs Shane Keating | Cybersecurity Engineering and Project Manager | ICS

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #3

 
 

The traditional stand-alone medical device is transforming into the concept of a “medical device ecosystem.” The ecosystem incorporates the conventional physical device – the “appliance” that is implanted or worn by the patient – and also includes supporting components including a mobile app and cloud connectivity.

It will become increasingly important in 2021 that these components – appliance, app, cloud – work in concert to the patient’s ease-of-use and health benefit.

chris-dupont-vs Chris DuPont | CEO | Galen Data

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #4

 
 

More "personalized" diagnostics and treatments and less of the traditional "one size fits all" approach - at least I hope so!

mike-drues-vsMichael Drues, Ph.D. | President | Vascular Sciences

Attend this expert's talk: FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will Change?

 

 

Expert Tip #5

 
 

In the regulatory arena, medical device manufacturers will see a continual migration through 2021 toward more product information being required to be reported in electronic, structured format and the use of more data standards.

Medical device clinical trials, marketing applications, product registrations and listings, product Unique Device Identification (UDI) reporting, postmarket surveillance, adverse event reporting, etc. all are moving toward increased use of standardized digital technologies.

The desired benefits include faster product approval, more accurate product management through the supply chain, less clinical errors, and enhanced market analysis with the overall goal of improving the patient’s experience.

gary-saner-vs Gary Saner | Sr. Manager, Information Solutions Life Sciences | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #6

 
 

Continued expansion of global UDI database submission requirements.

john-lorenc-vs John Lorenc | Director of Product Management, Medical Devices | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #7

 
 
With COVID-19 in our life disrupting the normal and setting a new normal, I expect bigger shifts to occur in the next couple of years, especially around digital health, Patient Data Management, Remote healthcare services, prescriptions, and digitizing many patient/data transactions, including visits.

pooja-kartik-vs Pooja Kartik | Sr. Director Quality & Regulatory | Triple Ring Technologies

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #8

 
 

For Med Dev technology shifts - increased movement toward remote treatment and care. Enabling patients with not just remote visits but remote treatment and monitoring.

For Med Dev Companies internal business practices - eQMS will be standard operations, remote audits, share supplier audits.

nicolle-cannon-vs Nicolle Cannon | Founder & CEO | Cannon Quality Group

Attend this expert's talk: Audits: Let’s get back to Auditing, REMOTELY!

 

 

Expert Tip #9

 
 

Medical devices that are designed and implemented to resolve the challenge of clinical resource constraints (e.g. personnel, cost, reimbursement...etc) will become more attractive to stakeholders. For instance, clinical decision support softwares are being leveraged more frequently during this pandemic.

andrew-wu-vs Andrew Wu | Branch Manager & Software Consultant | Rook Quality Systems

Attend this expert's talk: Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond

 

 

Expert Tip #10

 
 

In 2021 we will see an increase in mobile diagnostic testing devices, especially for COVID and other diseases detectable with DNA target amplification technology. RND Group is currently working on 2 mobile (handheld) COVID diagnostic instruments that deliver results within 60 minutes or less in a field setting with the same accuracy as large laboratory instruments. We will also see the continued use of the cloud for medical devices.

cathy-wilburn-vs Cathy Wilburn | Director of Quality Assurance & Compliance | The RND Group

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #11

 
 

Due to Coronavirus, more remote technologies will be created. Having the possibility to control devices from afar.

monir-el-azzouzi-vs Monir El Azzouzi | Founder & CEO | Easy Medical Device

Attend this expert's talk: Impact of Brexit, Swixit, Turkxit for the European Medical Device Market

 

 

Expert Tip #12

 
 

With the emergence of EU MDR (and all the recent global regulation updates in recent years), attempting to manage QMS without an intentional, intelligent software platform is going to be problematic for companies who do not make the shift.

While not technological per se, we are also seeing more positive movements towards global harmonization with respect to QMS expectations from regulatory bodies.
Also not a technological shift and important: Risk management remains a big weakness for the medical device industry. With the emergence of ISO 14971:2019 and EU MDR and IVDR (among others), the messages should be very clear to industry. We have to embrace risk-based methodologies. We have to manage product risks throughout the entire product lifecycle.

jon-speer-vs Jon Speer | Founder | Greenlight Guru

Attend this expert's talk: Behind the Stats: 2021 Medical Device Product Development & Quality Management Benchmark Survey


track 1-question-2 (V2)

 

2021 VS Expert Roundup blog - Q2

 

What advice would you give to medical device companies to be successful in 2021?

 

Expert Tip #1

 
 

The FDA’s level of insight into the potential for vulnerabilities in a medical device has greatly improved, as has their awareness of current threats.

As an example, if your device utilizes Bluetooth Low Energy, you will be asked about some of the current disclosed vulnerabilities, such as Sweyntooth. So why wait for the questions to be asked? Speed up your presubmission process by addressing these topics head-on in the original submission! This also demonstrates to the reviewer that you are at least aware of the potential security risks.

Also, the FDA has suggested that manufacturers request a pre-submission meeting if they are concerned about their current security activities for their new medical device. This is an excellent suggestion that too few manufacturers take advantage of. The agency will work with you to help secure your device and decrease the time for approval.

chris-gates-vs Christopher Gates | Principal Systems Security Architect | Velentium

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #2

 
 

Design in cybersecurity from the start.

shane-keating-vs Shane Keating | Cybersecurity Engineering and Project Manager | ICS

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #3

 
 

Think early in the product development lifecycle of how a mobile app and cloud connectivity add value to your medical device and how they facilitate and benefit your eventual market deployment. What is the patient benefit? How will they support clinical workflow? What new business opportunities do they present?

chris-dupont-vs Chris DuPont | CEO | Galen Data

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #4

 
 

Stop ticking boxes and do what makes sense!

mike-drues-vsMichael Drues, Ph.D. | President | Vascular Sciences

Attend this expert's talk: FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will Change?

 

 

Expert Tip #5

 
 

Medical device manufacturers expend a massive amount of effort and resources in developing and bringing a product to market. Sometimes regulatory approval and compliance are low on the list and result in delays in introducing a product or gaps in distribution that can significantly decrease business revenue.

In 2021 many regulatory authorities are layering on new Unique Device Identification (UDI) product requirements. To be successful in 2021 medical device manufacturers need to research the regulations, plan their approach, and execute a comprehensive UDI implementation in their efforts to meet the new UDI challenges.

gary-saner-vs Gary Saner | Sr. Manager, Information Solutions Life Sciences | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #6

 
 

Stay connected to industry sources focused on new and evolving regulatory developments - this is an ongoing need, as requirements and milestones can change, as we have seen occur on numerous occasions in the UDI space during 2020.

john-lorenc-vs John Lorenc | Director of Product Management, Medical Devices | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #7

 
 

My advice is to stay vigilant and flexible with the regulatory changes, and life changes that are happening around us to help bring the medical devices and technology that people need. Cybersecurity risk, just like any other risk, needs to be managed to ensure benefits outweigh the risk both pre-market and post market. Practically speaking every coin has two sides to it and that is when its real. Check out the Cybersecurity-related guidance for medical devices for EU MDR/IVDR if you haven't already.

pooja-kartik-vs Pooja Kartik | Sr. Director Quality & Regulatory | Triple Ring Technologies

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #8

 
 

Continue to take stock of your process and iterate them to keep up with the changes as a result of the times we are in and the goals of the organization. We are in an unknown time, and need to continue to think outside the box and iterate, not only in our technology solutions but internally in the organization.

nicolle-cannon-vs Nicolle Cannon | Founder & CEO | Cannon Quality Group

Attend this expert's talk: Audits: Let’s get back to Auditing, REMOTELY!

 

 

Expert Tip #9

 
 

Keep in mind that users must have complete confidence in the device throughout its lifecycle. Quality and reliability must be the highest priorities among all other agendas.

andrew-wu-vs Andrew Wu | Branch Manager & Software Consultant | Rook Quality Systems

Attend this expert's talk: Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond

 

 

Expert Tip #10

 
 

Seek out the best in the industry in each area of medical device development – mechanical, electrical, software, regulatory. 2020 has exposed the need for flexibility and the ability to move quickly.

Having persons with specific expertise on your team is critical to being able to pivot quickly. Additionally, through this pandemic we have learned that we can effectively manage and work with disparate teams.

cathy-wilburn-vs Cathy Wilburn | Director of Quality Assurance & Compliance | The RND Group

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #11

 
 

To move toward digitalization.

monir-el-azzouzi-vs Monir El Azzouzi | Founder & CEO | Easy Medical Device

Attend this expert's talk: Impact of Brexit, Swixit, Turkxit for the European Medical Device Market

 

 

Expert Tip #12

 
 

Assess your risk management practices to ensure you are handling the total product lifecycle. Chances are, you are not and need to revise your approaches.
Make sure your QMS platform is architected intentionally and specifically to address the ever-changing medical device industry needs and regulations.

jon-speer-vs Jon Speer | Founder | Greenlight Guru

Attend this expert's talk: Behind the Stats: 2021 Medical Device Product Development & Quality Management Benchmark Survey


2021 VS Expert Roundup blog - Q3

What are your biggest learnings from 2020 that medical device companies should consider going into 2021?

 

Expert Tip #1

 
 

We already see it happening: the FDA has ramped up their cybersecurity oversight efforts. Where previously we would see 1-6 questions asked as part of the premarket submission process, we are now seeing dozens of cybersecurity questions being asked.

Get ahead of the process. Start your cybersecurity process on the first day of development. There are three places in the development lifecycle where vulnerabilities are introduced: Design Phase, Implementation Phase, and the use of third party software components (AKA TPSC, or SOUP). Do your due diligence, perform your testing, create SBOMs, and scan for disclosed vulnerabilities on any of the third party software components.

There are going to be a lot of improvements to medical device regulations for cybersecurity in 2021; get started now! Read the October 2018 draft guidance for premarket cybersecurity; those were the FDA’s expectations as of 2 and even 3 years ago! They haven’t “retreated” from any of those expectations, and have added a few new ones as well.

And bear in mind that the FDA’s expectations for new medical devices are not the “high bar” to achieve - it is the minimum security standard that you should set for your company. Remember, regulators are only concerned with security measures insofar as security impacts the patient. Meeting regulations alone will not shield manufacturers against threats to their business model.

chris-gates-vs Christopher Gates | Principal Systems Security Architect | Velentium

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #2

 
 

Honestly assess existing products with regards to cybersecurity weakness. Weigh up cost of adding protection vs cost of potential breach.

shane-keating-vs Shane Keating | Cybersecurity Engineering and Project Manager | ICS

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #3

 
 

Nearly all medical device companies understand the need for cloud connectivity. However, in 2020 we saw many develop a custom solution, with the perceived benefit of controlling its functionality.

These companies usually underestimate the complexity and cost of designing, building, and maintaining cloud security and regulatory compliance for the cloud component—factors typically included in a third-party, turnkey cloud solution.

chris-dupont-vs Chris DuPont | CEO | Galen Data

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #4

 
 

That many companies and the people in them continue to do stupid things. If you don't know what you are doing, either get some on your team who does or get out of the game!

mike-drues-vsMichael Drues, Ph.D. | President | Vascular Sciences

Attend this expert's talk: FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will Change?

 

 

Expert Tip #5

 
 

The COVID-19 pandemic forced many companies to implement a remote IT infrastructure and virtual operations model in 2020. For the most part the transition was successful and continues to improve. This now-proven, virtual business model will accelerate earlier trends in this direction.

Medical device regulatory activities are well suited for this remote approach and, as such, policies, procedures, technology improvements, etc. related to the regulatory environment should strongly consider the advantages of a remote approach.

gary-saner-vs Gary Saner | Sr. Manager, Information Solutions Life Sciences | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #6

 
 

Consider your team's ability to adjust to change in the industry, especially from a regulatory requirement perspective.

john-lorenc-vs John Lorenc | Director of Product Management, Medical Devices | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #7

 
 

I think all of us have learned a lot in 2020 unexpectedly and how industry and regulatory bodies have shifted priorities to meet the COVID-19 related demands. My biggest takeaway is, technology has disrupted its own world in the sense that it has enabled all of us to operate seamlessly from the safety of our homes, and with this benefit comes the cybersecurity threat at many levels.

The concept of device has expanded to software only medical devices, network connected technologies, patient data and real time treatments and diagnostics, and all of it is helpful to manage our health, and keeping these options safe is what our job is.

pooja-kartik-vs Pooja Kartik | Sr. Director Quality & Regulatory | Triple Ring Technologies

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #8

 
 

Get off of paper-based systems! Help your teams navigate the remote world, bring them together and continue to build their relationships in order for them to function well as a team that needs to come together to solve problems for patients.

nicolle-cannon-vs Nicolle Cannon | Founder & CEO | Cannon Quality Group

Attend this expert's talk: Audits: Let’s get back to Auditing, REMOTELY!

 

 

Expert Tip #9

 
 

Many opportunities and challenges in the current healthcare paradigm.

andrew-wu-vs Andrew Wu | Branch Manager & Software Consultant | Rook Quality Systems

Attend this expert's talk: Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond

 

 

Expert Tip #10

 
 

Participate in information sharing, like FDA town halls and company-sponsored conferences.

cathy-wilburn-vs Cathy Wilburn | Director of Quality Assurance & Compliance | The RND Group

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #11

 
 

A lot of regulations are changing. Training on these regulations through e-learning will be key.

monir-el-azzouzi-vs Monir El Azzouzi | Founder & CEO | Easy Medical Device

Attend this expert's talk: Impact of Brexit, Swixit, Turkxit for the European Medical Device Market

 

 

Expert Tip #12

 
 

COVID-19, while important to pay attention to, should not put your medical device initiatives on the back-burner. Patients need your products and technologies to improve their quality of life. We have to get back to these key missions.

jon-speer-vs Jon Speer | Founder | Greenlight Guru

Attend this expert's talk: Behind the Stats: 2021 Medical Device Product Development & Quality Management Benchmark Survey


 

2021 VS Expert Roundup blog - Q4

 

What should medical device companies be thinking about as they plan for 2021?

 

Expert Tip #1

 
 
There is a long list of questions that you should be pursuing, such as:
      • Are my existing medical devices insecure?
      • Which legacy devices should be re-designed and replaced?
      • Do we have asymmetric processes in place to monitor the SBOM for the supported life of the medical device?
      • Do we have alternatives to recalls when we become aware of a critical vulnerability in our devices? (recalls are expensive; field upgradability is not!)
      • Do we have a security event handling process in place, staffed, trained, and tested?
      • How do we engage with “Security Researchers” who contact us?
      • Are we monitoring and enforcing the cybersecurity performance of our suppliers (communicating vulnerabilities, notification of breaches, timely patches & workaround, etc.) by maintaining and regularly updating their “Trust Status” on our Approved Supplier List (ASL)?
      • What is our plan for closer engagements with the Healthcare Delivery Organizations (HDOs) that enables enhanced communications and better support for HDO security concerns and events? (If you think the FDA’s expectations are high, wait until you see some of the emerging HDO contract language about medical device cybersecurity).
      • Do we have MDS2s and SBOMs ready to distribute to the HDOs when they ask for them? Or will our competitors differentiate themselves by being able to supply these for their medical devices?
      • Is my development staff trained in how to design and implement embedded security in a fashion that aligns with all our other goals for the device, such as cost per unit, battery life, physical form factor, user burden, etc.? (The answer is almost always: “No they are not!”)

chris-gates-vs Christopher Gates | Principal Systems Security Architect | Velentium

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #2

 
 

We all want to see the benefits of Connected Healthcare - how is that balanced with security.

shane-keating-vs Shane Keating | Cybersecurity Engineering and Project Manager | ICS

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #3

 
 

Developing a working medical device solution can be overwhelming from an engineering and medical science viewpoint. But don’t underestimate the value of addressing issues such as cloud connectivity (including security and compliance), quality management, and contract manufacturing early in the process.

The sooner these issues are considered and factored into the design and development process, the more cost-effective their implementation in terms of both time and money. Identify and align with companies providing these areas of expertise—especially those who partner with one another.

chris-dupont-vs Chris DuPont | CEO | Galen Data

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #4

 
 

What did Einstein say about insanity again? Enough said. 😀

mike-drues-vs  Michael Drues, Ph.D. | President | Vascular Sciences

Attend this expert's talk: FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will Change?

 

 

Expert Tip #5

 
 

As medical device manufacturers continue to tighten their financial belts, trim budgets, and decrease staff, they should strongly consider opportunities to increase productivity by using modern technology solutions.

The emphasis should be placed on implementing single global solutions that support remote users and are flexible to address local/regional regulatory authorities, manufacturing, and distribution requirements.

In addition, efficiencies can be achieved by replacing multiple silo repositories with consolidated systems that are cloud based. Minimal improvement will be realized if the new systems simply electrify or automate the previous manual system – quantum gains are realized by redefining the needs and building a more efficient approach.

For long term advantages, this new strategy should emphasize structured data management as the core foundation and not be centered on the generated files and documents that have on-going changes.

gary-saner-vs Gary Saner | Sr. Manager, Information Solutions Life Sciences | Reed Tech

Attend this expert's talk: Implementing a Global Unique Device Identification (UDI) Solution: Regional Update and Requirements

 

 

Expert Tip #6

 
 

With regards to Cybersecurity and planning for 2021, I think it is essential to design for safety, inherently just like any other design for safety. So bring the cybersecurity aspect to the "Risk Management" early in the product design and development, and stay ahead of the hackers.

You know your device better, so manage the vulnerabilities before the product hits the market, because it's costly once it's in the market!

pooja-kartik-vs Pooja Kartik | Sr. Director Quality & Regulatory | Triple Ring Technologies

Attend this expert's talk: Strategies for Improving Medical Device Software and Cybersecurity

 

 

Expert Tip #7

 
 

I think the industry has done a great job pivoting and innovating through 2020 and I look forward to seeing that continue in 2021. Plan for more pivots and changes.

nicolle-cannon-vs Nicolle Cannon | Founder & CEO | Cannon Quality Group

Attend this expert's talk: Audits: Let’s get back to Auditing, REMOTELY!

 

 

Expert Tip #8

 
 

Think about the positive impact your device will have on patients and providers when your device becomes available on the market.

andrew-wu-vs Andrew Wu | Branch Manager & Software Consultant | Rook Quality Systems

Attend this expert's talk: Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond


BONUS OFFER: Click here to download a free PDF of Greenlight Guru’s 2021 State of Medical Device Survey Results Sneak Peek.

Visit https://2021md.greenlight.guru/ to learn more about the 2021 State of Medical Device Virtual Summit, see the full schedule of presentation talks, and to register for free.

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