Regulatory approval is just the beginning of your medical device journey

Attention MedTech Innovators and Entrepreneurs

 

Regulatory approval is just the beginning of your journey to market success!

One of the greatest misconceptions in the world of MedTech is the singular focus on regulatory approval. While crucial, it’s merely the starting line, not the finish. Let’s debunk some common myths together:

💡 **510(k) Shortcut? Not Always!**
While the 510(k) route may seem like the easiest and cheapest path, especially for “me too” devices, remember, convincing end-users to switch requires evidence. Medical providers are understandably hesitant to change when they already have functioning solutions.

💡 **Breakthrough Designation: Not a Magic Bullet!**
Attaining Breakthrough Designation isn’t a guaranteed shortcut either. Truly novel devices may lack existing reimbursement codes, necessitating clinical data for gaining reimbursement status. Quick doesn’t always mean easy.

💡 **Exit Strategy Fallacy!**
Thinking only about positioning for an exit overlooks the crucial aspect of long-term viability. Investors and Strategics seek devices with the highest potential for commercial success. Market access alone isn’t enough.

This tunnel vision has led many promising companies to fall short of their goals.

THE BIG IDEA
Identify and follow the regulatory path that aligns best with your company’s goals (not your predicate). Embrace clinical studies; they’re not as daunting as they seem! Craft a commercial plan that’s proactive, far-sighted, and tailored specifically to your product.

🚀Let’s reshape the narrative and shift to comprehensive success. 🚀

3 Quick Tips to Nail that Clinical Study the First Time

Clinical data is the gateway to achieving market access and market adoption for medical device and drug innovations.

With increasing complexities and costs associated with leading a biotech organization, solid clinical strategy and accurate regulatory plans have become the key players to realizing such success.

The goal for startups, small, or emerging biotech companies is to get it right the first time to avoid sacrificing funds, time to market, and credibility within industry.

Recommendations:

Do the “right” study: Design the protocol with endpoints that will unambiguously target the objective/hypothesis/purpose for the investigational product. Refrain from the cut and paste method. One size no longer fits all.

Do the study “right”: Align the study execution with ICH-GCP. Use ISO 14155 for medical device investigations. The FDA advises these guidelines and conducts inspections accordingly. This avoids questionable data quality.

Embrace patient centricity: No device or drug trial can work without patients. Leverage a clinical diversity plan to support your enrollment targets. Use patient-friendly informed consent forms and recruitment methods to foster comfortability and trust with subjects. This helps with patient retention, thus stronger real-world outcomes.

Bottomline:

Invest in the success of your company and product viability by taking a moment to get the scientific rigor and operational structure right, the first time. It is also prudent to evaluate your ongoing plans.

Commericalization GPS

roads representing-commercialization-gps

Envision taking a road trip to an unfamiliar state, navigating solely by your instincts and without a GPS.

Yeah, you may eventually figure it out but at what cost?

This is exactly what many of startups do, and wonder where they went wrong. It sounds blunt but it’s just a fact…

75% of MedTech startups fail!

When launching a new MedTech company or new medical device, make sure you have a GPS. Your commercialization strategy is not accurate if it doesn’t include a comprehensive clinical and regulatory roadmap.

Speed means nothing if you don’t know where you’re going and how you’re getting there.

Medical Device Commercial Path

medical-device-commercial path-infographic

Launching a medical device in the next 1-3 years?

Seeking funding for your medtech startup?
Investing in a startup company?

Here are pivotal milestones and their significance.

  1. Commerical due diligence is essential at this stage to clearly prepare for accurate funding and resources. Sadly, many companies encounter funding challenges by milestone
  2. Reg and Clinical strategies are key by this stage as they are critical to be prepared for FDA pre-submissions and mitigate any potential risks.
  3. Engaging investigators and proactively gathering all required data are vital as FDA negotiations and site selections can consume up to a year.
  4. Be ready to kick off your clinical study as soon as receiving the FDA (or ethics committee) greenlight.

Lesson I Learned About Clinical Research

Lesson-learned-about-clinical-research-post-image

“I don’t trust people who have never failed at something.”

That’s what my friend said yesterday, and I agree! With that, I’d like to share another lesson learned from my repertoire of how I became a clinical research expert…

The study initially recruited 10 sites, with 2 expected to be leading sites due to their larger patient pool and faster enrollment capabilities. However, after a few months, the leading sites significantly underperformed.

I couldn’t figure out how could this happen there. I conducted a root-cause analysis and discovered that the sites were in a predominantly Spanish-speaking area, and the informed consent forms were only available in English. This language barrier hindered patient comfort, despite some site coordinators being bilingual.

Ramifications:
  • Had to hire a translation service to produce new ICFs in Spanish
  • Lost a few months of the study timeline, missed out on great patients
  • Unexpected increase to budget
  • Had to amend the protocol, obtain additional IRB approval (which incurred more time and money)
Lessons Learned:

Selecting investigators and sites demands thorough diligence and strategic planning. Always factor in external considerations when assessing study sites.

The foundation of any study is its patients. Construct your clinical study with a patient-centric approach, or there won’t be a study.

Successful clinical research is relational and not transactional.

I wouldn’t have known this had I not experienced it.

What Medical Device Companies Should Know about the MDR Extension – It’s Time!

european-union-medical-device-regulation
The European Union (EU) adopted the Commission’s proposal to extend the Medical Device Regulation (MDR). The amendment was published in the Official Journal (OJEU) on 15 Mar 2023.¹ What does this mean for U.S. manufacturers? Here is a clinical perspective snapshot.

Medical devices marketed in Europe, prior to 2021, were approved (received CE Mark) by way of the EU Medical Device Directive (MDD). In May 2021, the European Commission (EC) enacted the MDR, a more stringent regulation that requires extensive clinical evidence on devices to validate safety and efficacy. Manufacturers pursuing a new device approval must have robust and specific clinical evidence on its device at the time of the CE Mark application to be considered for market clearance. For legacy devices, products that were already on the EU market, were given until May 2024 to satisfactorily transition from MDD to MDR.

SITUATION

For most MedTech companies, transitioning from MDD to MDR forced manufacturers to conduct new clinical trials on their devices to generate “sufficient” evidence that would satisfy the MDR’s safety and efficacy standards. For the last seven years, manufacturers have been burdened by the lack of existing clinical data, overwhelming costs associated with developing/executing new trials, and shortages of resources to execute studies – all to be complete and approved by 2024. If a manufacturer is unable to meet that deadline, their device(s) will be removed from the EU market; consequently, disrupting the EU healthcare systems and patients access to critical medical products. Unfortunately, this trend and trajectory quickly proved not to be enough time!
With this extension, the MDR transition period was extended from 26 May 2024 to:

  • May 2026 for custom-made implantable devices
  • Dec 2027 for all implantables and all class IIb devices
  • Dec 2028 for class I devices

But let’s not get too excited…

PROBLEM

The new extension does not grant manufacturers more time! The extension permits the Notifying Body (NB) additional time to review documentations and issue MDR certificates, as they remain severely backlogged since 2019. Therefore, manufacturers must keep the same energy, pace, and persistence to obtain sufficient clinical data and prepare submissions as soon as possible. According to the EC, as of June 2023, a total of 13,177 MDR applications were received by NBs and only 3,899 certifications have been issued.² Overall, more than 85% of the 500,000+ devices on the EU market have not yet transitioned to the MDR.³ For further perspective, it takes 13-18 months on average for a NB to review and issue an MDR certificate – after the application enters queue. So, a manufacturer should begin the data collection (clinical study) and analysis process at least 2-3 years prior to the device’s MDD expiration date.
For some of us clinical and regulatory leaders, the race to MDR has been ongoing since 2016 and it has not gotten easier. The key issues have been (1) manufacturers are not prepared with “sufficient” clinical data for the lifetime of the device and (2) the NBs have not provided a clear definition of sufficient or lifetime, and (3) the NBs have not been equipped/staffed/certified to handle the overwhelming number of submissions. There’s still a great deal of interpretation and lessons learned to be had, such that U.S. manufacturers can truly be MDR-ready! What becomes the mitigation path?

SUGGESTIONS

To position your company for a timely and successful approach to MDR, check out the following lessons learned:

  • Given that sufficient and lifetime clinical evidence continues to be chief barriers to MDR-readiness, manufacturers will want to be more innovative in how data is collected. It is a fact that conducting traditional clinical trials on every product within the transition timeframe has not been financially or operationally feasible for companies, even for blue chip giants. Manufacturers should be aware of the various alternative and innovative clinical strategies that can accelerate data gathering and try taking the least burdensome approach for patients.
  • Manufacturers should submit applications with a Clinical Evaluation Report (CER) or technical file (TF) that is fully vetted and pressure tested by an expert. The NB will provide up to three rounds of deficiency responses and opportunities for conformity before removing your submission from queue – thereafter you will be required to start a new submission and subjected to another 13-18 month average process.
  • Be prepared by submitting quality clinical data, which is classified as ISO 14155 and GCP compliant. Ensure there is confidence in knowing your evidence and operation, such that you are in a strong position to negotiate and defend your safety and efficacy profile with the NB. Also, have your post-market clinical follow-up plan (PMCF) protocol in place and ready to execute.
  • Lastly, this extension does not give the manufacturer more time – so keep going!
    While the EU MDR journey has been considered disruptive, the updated regulation has set a path for more patient-centered healthcare where transparency and patients’ choice are a priority, and where patients can benefit from high-performing devices and new therapies.⁴
    That said, MDR is not a moment in time, we should fully accept that this is the new norm for marketing devices on the European market.

References:
1. European Commission – Council Vote on the Medical Device Regulation Extension (07 March 2023). https://ec.europa.eu/commission/presscorner/detail/en/statement_23_1504
2. European Commission – Notified Bodies Survey on certifications and applications (MDR/IVDR) (25 October 2023). https://health.ec.europa.eu/latest-updates/notified-bodies-survey-certifications-and-applications-2022-10-26_en
3. MedTech Europe Survey Report analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation (14 July 2022). https://www.medtecheurope.org/wp-content/uploads/2022/07/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation.pdf
4. European Commission – What is the Medical Devices Regulation about? (accessed 10 Mar 2023). https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24

Is it Okay to Copy a Clinical Design?

I’m considering using a similar study design from another company to expedite the regulatory clearance process for my new device. Can’t I just copy that company’s study design since our devices are similar?
No, No, and No ❌

Ok fine, while it might save time, there are important drawbacks to consider:

  • Missed opportunity to showcase the novelty of your invention
  • Overlooked gaps in the original design, that wasn’t public information
  • Legal, ethical, or compliance issues you may not be aware of from the original design – or implications that could impact your company

Going to market with a “me-too” product could significantly reduce the chances of market success.

It’s crucial to carefully weigh the pros and cons of copying a clinical trial design.

The era of one-size-fits-all is over!

Complex Landscape of MedTech Startups

medtech-ecosytem-diagram

Let’s delve into the intricate landscape of MedTech startups.

Research indicates a daunting reality, with a staggering 75% of medical device startups in the United States meeting failure. Looking deeper into this statistic, a substantial 30% experience setbacks in their second year, while an even higher 50% succumb to challenges in their fifth year.

The journey of bringing a new medical device to market spans an average of 3-7 years, contingent upon device classification. Key milestones unfold in a strategic sequence over this period…

  • Year 1 – focuses on formation, market and risk analysis, along with fundraising efforts.
  • Year 2 – sees critical developments such as hiring key personnel, product engineering, and additional fundraising initiatives.
  • Years 3 & 4 – involve product validation, commercial strategizing, and Yep, continued fundraising.
  • Years 5 – and beyond, the spotlight shifts to clinical studies and securing FDA approval for market launch.
  • The final phase – encompasses manufacturing and full-scale commercialization.

Contrary to common belief, the primary culprit behind these
failures isn’t the innovation itself, but rather the challenge lies in assembling
the right team with the requisite expertise to navigate the intricate
processes. Issues also arise when funds deplete precisely during clinical execution or due to the failure to construct a robust study, leading to costly rework.

The key takeaway is a recommendation to allocate THREE MONTHS in the second or third year of operation for meticulous strategizing and planning, particularly in the realms of clinical and regulatory considerations for commercial launch.

This proactive investment proves to be invaluable, ensuring a smoother trajectory for startups in the complex medtech ecosystem.

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Overview

Sure, the technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Tenet has remained constant: we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Problems

Sure, the technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Challenge

Technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Solution

Technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Ongo Homes of your back office systems provides 10,000 homes for people

Overview

Sure, the technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Tenet has remained constant: we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Problems

Sure, the technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Challenge

Technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.

Solution

Technology has come a long way since then, and the variety of the information objects we’re managing has changed a lot, but one tenet has remained constant we’ve always focused on the intersection of people, processes, and information. As the Association for Intelligent Information Management, we help organizations put their information to work.