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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.

What we know to be true is root cause analysis (RCA) plays a vital role in the development, manufacturing, and use of medical devices. When we are able to successfully identify and address the underlying causes of failures or errors, using RCA as a tool in your operation helps to improve the safety, reliability, and effectiveness of medical devices. 

When done correctly, RCA has a significant impact on medical devices by enhancing patient safety, improving design and manufacturing processes, ensuring regulatory compliance, driving product improvement and iteration, mitigating risks, and supporting post-market surveillance efforts.  While all of this may sound common sense, what's most important is when RCA is used and done correctly.  

​In this episode of Medtech Snapshot we're joined by Quality Executive Robert Lahaderne to talk Root Cause Analysis (RCA)!  Hear how Robert shares his perspective on the impact Root Cause makes to a medical device organization when it is done correct versus when it is done incorrectly and how rushing through FMEAs and hazard analysis creating unnecessary challenges down the road.

#rootcauseanalysis #rootcause #medicaldevice #medtech #fmea #hazardanalysis #patientsafety #riskmanagement

​​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 work and project problems today to get you back on track!

What’s the difference between a great leader and an average one?

​I’ve had the opportunity to observe dozens of leaders in my career.  Some were exceptional, most barely passed for average.  I’ve spent many hours tossing and turning on the idea of what makes for an exceptional leader, what makes them great.  I’ve read books, had discussions with colleagues, watched videos and talked with people who are far smarter and experienced than myself.

After all of this wonderful introspection and discovery one characteristic continues to pop up which defines great leadership over average leadership.  It’s a mindset, a willingness to do what others often won’t.

What makes great leaders is their ability and willingness to use ‘managerial courage’.
Managerial courage is the linchpin, the cornerstone, the apex for all things related to leading successfully.  The word courage is of itself is an incredibly powerful word.  The late John McCain had described courage as “that rare moment of unity between conscience, fear, and action, when something deep within us strikes the flint of love, of honor, of duty, to make the spark that fires our resolve.”  

Bill George, former CEO of Medtronic and best selling author is quoted as saying “Courage is the quality that distinguishes great leaders from excellent managers.”

George also said, “courageous leaders take risks that go against the grain of their organizations. They make decisions with the potential for revolutionary change in their markets. Their boldness inspires their teams, energizes customers, and positions their companies as leaders in societal change.”
If we apply George’s and McCain’s definitions of courage we can surmise that ‘managerial courage’ is the willingness to make decisions which we believe to be in the best interest or our employees or company, regardless of the popularity or risks involved.

A deeper look into managerial courage and we find that it can be further described as a set of actions and beliefs a leader possesses which define who they are and how they go about leading and inspiring others.  These actions and beliefs include:

1. Courage to lead by your ‘True North’, your authentic self (compliments again of Bill George)
2. Courage to face the truth and to openly express it
3. Courage to act as a servant to your employees
4. Courage to rely on others, while stepping aside to allow those around you a chance to lead
5. Courage to listen and not always be heard
6. Courage to make the right decisions in risky or uncertain situations
7. Courage to give praise for a job well done while taking blame when the house of cards collapses
8. Courage to work outside our comfort zone
9. Courage to impose rigorous standards and hold people accountable

There’s no other word I can think of other than ‘courage’ to appropriately define good leadership.  Primarily because it is so easy to not do the things listed above, especially when times are tough, yet to do them consistently it takes great discipline and resolve.  It also means we will inevitably make decisions which don’t favor ourselves yet position our employees or company for better opportunities.

Here’s what managerial courage looks like in real life.

Scenario: A CEO of ABC company is pressing his VP of Sales to reach revenue targets by year end in order for the company to hit its financial goals.  The VP of Sales has one sales rep in particular who singlehandedly drives 30% of the company’s revenue, consistently coming in as the #1 producer in the company, year after year.  The company relies on this sales rep heavily to produce and as such the company has benefited handsomely.  Unfortunately this same sales rep also causes a lot of problems within the company.  He’s had several complaints against him by other employees, has a bad attitude, disregards company policy, has even been caught using his company expense account for personal purchases.  If that wasn’t enough our lovely sales rep has also caused two other employees within the company to quit.  Even though this sales rep is a cancer to his company, the company overlooks his problems because he’s a top performer.  They’ve swept the issues under the rug hoping things will miraculously improve by themselves.  Let’s face it, he makes the company a lot of money, how can they walk away from that.

Does this scenario sound similar to you?

Managerial courage in the above scenario would look like this.  The VP of Sales provides a variety of opportunities for the sales rep to improve while demonstrating the employee is acting in accordance with company standards and the VP’s expectations. In the event these opportunities to improve and or employment warnings are not adhered to the VP of Sales must make a tough and unpopular decision to fire the sales rep.  It’s a tough decision indeed because the VP of Sales knows she very well may lose her own job because she just went against the CEO and fired an employee that represents 30% of the company’s annual revenue intake.

In this scenario, our VP of Sales chose an unpopular decision because it’s what was truly best for the company and its employees, despite what her boss the CEO had advised.  The VP of Sales fired an employee who is a cancer to those around him.  Ultimately it doesn’t matter how good the sales rep is at their job, if they are causing issues and aren’t able to adjust accordingly after receiving feedback they don’t belong there in the first place.

This is managerial courage.  The willingness to make a decision to do what’s right even when the outcome may be unpopular or damaging.

It takes great tenacity, strength, fortitude, mental determination and care to be a leader and do so successfully.  Sure, anyone can be a leader, but those who do it successfully stand head and shoulders above their counterparts when they utilize managerial courage.  The characteristic of courage is the very essence of what leadership is all about.

Key Take Away:
Standing up for what’s right and having the willingness to make tough decisions is key to being a great leader, even if the outcome may be viewed as unpopular.

Action Item:
Read the book ‘True North’ by Bill George.  It’s an incredibly well written book that teaches people who to be themselves while acting and making decisions which are in accordance with your beliefs.