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Medical device companies play a critical role in advancing healthcare as their ability to diagnose, monitor, and treat medical conditions allow patients like you and I the opportunity to recover and live longer.  Device companies carry a heavy burden on our behalf and that burden starts with product risk.
 
One of the biggest challenges an OEM medical device organization will be faced with is managing risk, especially during the early stages of product development.
 
The integration of risk management into design control (ISO 14971) is essential for identifying, assessing, and mitigating potential risks associated with the design and development of a medical device. Given risk management is a part of nearly every development process, and is a primary focus of all regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), why is it then so many medical device companies struggle with sound risk management strategies?
 
The failure to address risks adequately can lead to a whole host of problems ranging from regulatory non-compliance, compromised patient safety, financial setbacks, and in severe situations criminal prosecution of executives.  Needless to say, understanding why medical device companies come up short with their risk management strategy and how you can avoid that for yourself is key to your future success. In this article, we will explore some of the key reasons behind risk management failure.
 
Most Common Risk Failure Factor - Inadequate Understanding of Regulatory Requirements:
One of the primary reasons for failure in risk management is an insufficient understanding of the complex and evolving regulatory landscape. Medical device companies must navigate a web of regulations, standards, and guidelines to ensure compliance. Failing to keep abreast of these requirements can result in flawed risk assessments, inadequate risk mitigation measures, and ultimately, regulatory sanctions.
 
Poor Integration of Risk Management into Product Development:
Successful risk management should be an integral part of the product development lifecycle. However, some companies make the mistake of treating it as a standalone process rather than integrating it seamlessly into every stage of development. When risk management is an afterthought, essential risks may be overlooked, leading to suboptimal product designs, increased failure rates, and compromised patient outcomes.
 
Lack of Cross-Functional Collaboration:
Effective risk management requires collaboration across various departments, including research and development, regulatory affairs, quality assurance, and manufacturing. Failure to establish clear communication channels and encourage cross-functional collaboration can result in siloed decision-making. This lack of coordination can lead to critical risks being underestimated or missed entirely.
 
Insufficient Resources and Expertise:
Some medical device companies fail in risk management due to resource constraints and a shortage of expertise. This can manifest in inadequate training for personnel responsible for risk management, insufficient allocation of time and budget, and a lack of access to external expertise. Without the necessary resources, companies may struggle to conduct comprehensive risk assessments and implement effective risk mitigation strategies.
 
Overemphasis on Short-Term Goals:
Pressure to meet short-term financial goals can sometimes lead companies to prioritize speed to market over thorough risk analysis. This can result in hasty decision-making and inadequate risk identification and mitigation. Companies need to strike a balance between meeting market demands and ensuring the safety and efficacy of their medical devices in the long run.
 
Failure to Learn from Industry Incidents:
The medical device industry has witnessed several high-profile incidents related to product failures and patient harm. Failure to learn from these incidents and implement lessons learned into future risk management strategies can perpetuate the same mistakes. Companies must actively analyze industry incidents, update risk management processes accordingly, and continuously improve their practices.
 
Ineffective Communication with Stakeholders:
Communication is crucial in risk management, both internally and externally. Companies that fail to communicate effectively with their stakeholders, including regulatory bodies, healthcare professionals, and patients, may face increased scrutiny and regulatory challenges. Transparency and open communication are essential for building trust and demonstrating commitment to patient safety.
 
In the highly regulated and dynamic field of medical devices, effective risk management is not just a regulatory requirement - it is a fundamental aspect of ensuring patient safety and the success of a company. Understanding the pitfalls that lead to failures in risk management can help medical device companies proactively address these challenges. By prioritizing compliance, integrating risk management into every stage of product development, fostering cross-functional collaboration, and learning from industry incidents, companies can enhance their risk management strategies and contribute to the advancement of healthcare with safe and reliable medical devices.

We're breaking the mold!

Medtech Snapshot returns with an enticing debate as #RAQA medtech industry experts Stephanie Rallis-Daw, RAC, CQE, CMDA and Robert Lahaderne, MBA spar on the topic of "When starting a new job/ project, what is the most common medtech compliance shortfall you can expect to encounter at your new company?"

New to Medtech Snapshot? Check out our archive of past episodes at https://www.sqr1services.com/white-papers/category/snapshot covering topics in R&D, Quality, Clinical and Manufacturing. Honey for your eyes and ears, friends.

#medtech #snapshot #podcast #medicaldevice #compliance #quality #regulatory #documentation #training

​One of the biggest challenges professionals face when starting a new job is how they navigate ingratiating themselves into the new company and culture they’re now surrounded by.  No two companies are alike, which also means practices, processes and procedures can vary wildly from one company to another.  How a new employee, including new management, sorts through this can make or break their ability to be received well by their fellow colleagues while having a good career at their new employer.

Imagine you’re in your second week of employment and you begin to uncover a variety of compliance issues like a lack of regulatory understanding throughout the company, poor or missing documentation, insufficient training, little to no post-market surveillance processes or a dinosaur quality management system (QMS) that’s holding the company back.  Any of these shortcomings can be problematic for an operation, but the presence of several can be detrimental to the company’s short- and long-term success.

It can be a precarious situation to come in as the new ‘gal or guy’ and start changing things right away.  In fact, this typically doesn’t bode well for those who take the scorched earth strategy making big changes right out the ‘new hire’ gates, regardless of those changes being warranted.

So the question begs to be asked – what do you do if you start a new job and quickly uncover problems within the company’s operations, especially if those problems are compliance related?
Taking a measured and strategic approach to your new job and how you will handle the current business practice issues you are experiencing is key to your success.  Consider the following process:

1. Observe and Assess: In your initial weeks at the job, focus on observing and gathering information. Pay attention to the processes, procedures, and behaviors that seem problematic or inefficient. This will help you form a clear understanding of the issues.
2. Seek Clarification: If you come across practices that seem questionable or inefficient, seek clarification from your boss or colleagues. Ask questions in a non-confrontational and open manner to understand why things are done the way they are. Avoid being judgmental or critical at this stage as this is the time to ‘seek to understand’.
3. Listen and Learn: Be open to feedback and learn from your colleagues' experiences. They may have valuable insights into the company culture and the reasons behind certain practices. Engage in conversations to gain a better understanding of the organization's dynamics.
4. Document Your Observations: Keep a record of the practices or processes that you find problematic. Note down specific examples, their impact on the organization, and potential improvements. This documentation will be valuable if you decide to address these issues later.
5. Build Relationships: Establish positive relationships with your colleagues and supervisors. Building trust and rapport with your team will make it easier to communicate your concerns later on.
6. Propose Solutions: Once you have a good grasp of the issues, focus on proposing constructive solutions. Instead of merely pointing out problems, offer suggestions for improvements. Data is key at this phase to support your ideas while bringing a clear vision for the business case behind why such changed is needed.
7. Choose the Right Time: Timing is crucial when discussing concerns about poor practices in a company. Pick an appropriate moment when you have your boss’ or team's full attention and can have a productive conversation without interruptions.
8. Use Constructive Communication: When addressing the issues, use a diplomatic and constructive approach. Express your concerns calmly and professionally, focusing on the impact of the practices on the team or the company's objectives. Avoid blaming or accusing anyone.
9. Collaborate: Encourage a collaborative approach by inviting input and feedback from your colleagues. This can help create a sense of ownership and a shared commitment to implementing changes.
10. Choose Your Battles: Not all poor practices may be worth addressing immediately. Prioritize the issues that have the most significant impact on your work and the organization as a whole.
11. Be Patient: Change in organizations can be slow, especially when it involves changing established practices. Be patient and persistent in your efforts to improve things.
12. Consider Your Long-Term Goals: Evaluate whether the poor practices at your new job are something you can tolerate in the long run. If they are deeply ingrained and negatively affect your job satisfaction, it may be worth exploring other career opportunities, regardless of how long you have worked with your new employer.  Sadly, some ships just can’t be saved and are destined for the bottom of the sea, no matter how hard you may work to save them.

 
Remember that every organization is different, and your approach to addressing poor practices will depend on the specific circumstances. Your ultimate goal should be to contribute positively to the organization's growth and improvement while maintaining your professionalism and integrity.

The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering.  Learn more about how we can solve your technical work and project problems today to get you back on track.​

​In most regulated industries remediation is a cost of doing business.  Unfortunately the medical device industry is no different.  While remediation won’t hit every business, the fact of the matter is as regulations continue to change and or grow more companies will find themselves in a spot where they are having to change their processes and procedures in order to remain in compliance.
 
In 2021 we wrote about the keys to success, identifying six (6) key areas of focus to help one get through remediation and come out on the other end still in tact and moving forward.
 
As the medical device industry continues to evolve, so must our approach to solving problems we face.  As such, understanding the reasons why a device company may experience failure as they go through remediation is key to learning from others mistakes so we don’t repeat them when it comes our turn.
 
WHY THINGS GO SIDEWAYS
the top 11 reasons why remediation goes wrong for medical device OEMs:
 

1. ROOT CAUSE: failing to fully understand the root cause of the issue and or not adequately addressing all aspects of the problem
2. PREVENTION: neglecting to update or improve processes to prevent future issues
3. REGULATORY COLLABORATION: insufficient communication and partnering with regulatory agencies
4. BIG PICTURE: focusing on short-term fixes rather than solving the longer-term problem
5. RESOURCES & TIME: underestimating the resources and time required for remediation
6. TRAINING: neglecting to train employees on new or improved processes
7. CROSS FUNCTIONAL IMPACT: not considering potential effects on other departments or products.
8. STAKEHOLDERS: not sufficiently involving all relevant stakeholders in the remediation process.
9. END USER: Taking shortcuts or making compromises which endanger patient safety.
10. DOCUMENTATION: lack of adequate documentation, record keeping and associated outcomes
11. VALIDATION: failing to thoroughly validate the effectiveness of the remediation

 
When looking at this list the biggest take away is the starting point.  Once it has been determined remediation is necessary, whether through regulatory intervention or internal, understanding what occurred to get us there in the first place is critical.  If we misdiagnose the root cause of the problem within our operations our ability to successfully navigate through the rest of remediation is be hampered significantly.  For this reason its wise to spend as much time as possible sorting through the cause and effects of your operation to accurately determine the root cause leading to remediation.  Rushing this process will inevitably cause unnecessary challenges on the back end.
 
SOLVING THE PROBLEM
The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering.  Learn more about how we can solve your compliance problems while besting your remediation beast!

​On January 6, 2023 the European Commission, a political and regulatory steering committee consisting of a group of 27 Commissioners, known as 'the College', adopted a proposal to give more time to device OEMs to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal, which now needs to be adopted by the European Parliament, could push out MDR requirements several years.  Higher risk devices such as pacemakers and joint implants would have a shorter transition period till December 2027, whereas lower risk devices, such as syringes or reusable surgical instruments wouldn't be until December 2028.

Regardless of EU Parliament's decision to potentially extend MDR, device OEMs should consider the following as we hedge through 2023:
1. Strategies for US product approval and or commercialization will continue to increase as OEMs seek alternative pathways to potentially avoid EU MDR compliance.

2. As a result of #1, support to aide OEMs in their go-to-market strategy will intensify causing a shortage for resources, while potentially lengthening the process to get to approvals (supply & demand constraints - notified bodies and consulting firms experience increases in demand causing support shortages).  This will be especially true with remediation work.

3. The idea of putting off or slowing MDR related efforts in the interim to re-focus on other activities may provide momentary relief, however it also creates a long-term liability in the business.  This liability comes with a variety of future unknowns: regulatory landscape, inflation, cost of resources, CRO and notified body constraints, etc.  If you must achieve MDR compliance our recommendation is to get it done and over with in the present. 
​
4. Work associated with achieving MDR compliance can be easily underestimated, especially if you have legacy product where your CE mark was granted pre mid 2000s.  The burden to meet MDR requirements may be steep, which is all the more reason to avoid procrastinating said efforts as outlined in #4. 

​The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering.  Learn more about how we can solve your compliance problems while besting your EU MDR beast!

Learn about Square-1 Engineering's mission and what it means to be fearless!

Orange County unemployment rate is 2.9 percent as of July, 2022, as such the talent scarcity is creating gaps between the supply and demand of skilled MedTech professionals.  Given these challenges we’re all facing we recently asked the online community the following question:

Which part of your business has the hardest time finding and hiring talent?

I suppose EU MDR is to blame for this as the majority of respondents indicated RA QA personnel are the hardest to find.

There’s another distinction worth noting that’s adding fuel to the fire.  The cost of living (COLA) in Orange County is 54% higher than the national average.  As a result, this has a direct impact on the sheer number of people who can afford to live in OC, which decreases the size of the employment pool.  Add into the mix issues the overall State is experiencing like a 250k net migration loss along with relatively new industry regulations like EU MDR and you have a perfect storm where demand is grossly outpacing supply.
​
Pete Nalbach, GM of SeaSpine in Irvine, CA shared some interesting insights about the present hiring, employment and talent situation:

​Pete indicated and I’m paraphrasing a bit “…candidates have options.  This means they only accept jobs they really want which in turn gets a higher engaged employee for the company in the long term”
 
What’s your solution to the talent shortage?

Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.

The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing  locations domestically.  As you can guess our clients’ situation was dire due to several implant failures in the field.

We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.

EU MDR got you down? Is the mountain of compliance work you have in front of you taking away from other projects?

It's time you got some help! Learn more HERE

#compliance #consulting #qualityengineering #regulatoryaffairs

​Want to get through your remediation project successfully?  Doing these two things helps dramatically increase your chances of success.

#fearlessmedtech #remediation #fda #medicaldevice #medtech #quality #compliance #QMS