White Papers & Articles

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.

Today's Medtech Snapshot episode features Seth A. Kaufman, MSHCA as he shares his insights on the best way to land a great clinical research organization (CRO) partner - before you need their help! Hear how Seth outlines his engagement process, things to watch out for and ways to approach your trials with your new partnership.

Interested in listening to our past episodes of Medtech Snapshot? Check out our growing library archives at https://www.sqr1services.com/white-papers/category/snapshot


#CRO #clinicalresearch #clinical #medicaldevice #medtech #outsourcing #trials #snapshot #partnership

​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.​

At the forefront of the medical device new product development (NPD) process we typically find a list of considerations we’re trying to address within our product all while coming up with a solution which meets marketplace needs. Talk to anyone in R&D, or downstream marketing for that matter, and you’ll commonly hear the list of ‘needs’ for a new product can seem never-ending.
​
What you may find surprising is how often design for manufacturability (DFM) is not considered in the beginning of the development process.  DFM is an important, and often overlooked, part of product development which involves designing a product in a way which makes it easier and more cost-effective to manufacture commercially.

While embedding DFM into the process early seems like a logical part of the process, what plays out in reality is an NPD process that is focused on creativity and validating a technology yet can lack appreciation for the future state of the product and it’s foray into the market.  

So why is it companies may overlook incorporating DFM into the development process?

For starters, many of us who design products on the front end, have little perspective, or perhaps no perspective on what it takes to actually produce a scalable product on the back end.  Unless you’ve worked on a manufacturing floor or you’ve walked through an entire new product introduction (NPI) cycle, it’s easy to misunderstand all which goes into producing a product to bring to market.  

The design process also requires creativity and ingenuity in order to find new approaches, break common perceptions of technology capabilities, etc.  It’s about ideation!  Unfortunately thinking down the road about how it will be built for commercial purposes is “someone else’s problem”. 

To illustrate this point let’s look towards the automotive industry at a product we all know, which also happens to be a heavily regulated industry, like the medical device industry. 

If you have ever been to a large-scale automotive show, like the LA Auto Show in Los Angeles, CA, what you’ll see are concept cars on display to wow the eyes and entice the senses.  Ironically, if those same concept cars ever got to production, you’ll find their characteristics which made the vehicle look incredible are often diluted down to features and benefits which consumers will accept and are cost efficient to produce. 

Case in point, the two images below shows a 2010 Chevy Volt electric vehicle.  

​The top image is the concept vehicle – sleek, sophisticated, sharp lines, aggressive character and eye catching.  Almost resembles a sports car.  The bottom image is the production vehicle – commuter extraordinaire with features which are dull, less angular and more consistent with a car which will be manufactured by the hundreds of thousands. 

Concept vehicles have their place though – mostly to show off a company’s capabilities and satisfy egos.  They just aren’t practical on scale.  The truth is if Chevy produced at volume the concept version the average consumer wouldn’t be able to afford it.  As a result, they round out the features, slap some plastic on it and Walla you’ve got a commuter vehicle fit for the masses at a price point which coincides with high volume sales. 

The medical device industry is no different.  While industrial design is playing a much larger role today with device design, the fact of the matter is our industry struggles at times with over engineering products just like the auto industry.  This can lead to a company losing sight of what the end user needs and wants, as well as if it can actually be manufactured to meet reimbursements.

It’s for these reasons it’s important to consider design for manufacturing from the very beginning of the design process.  If you do so, you stand to experience the following:

1. Cost Reduction: DFM helps identify and eliminate potential manufacturing challenges and inefficiencies early in the design phase. By addressing these issues upfront, you can avoid costly design changes and rework later in the process.
2. Faster Time to Market: Efficient and streamlined manufacturing processes result in quicker production cycles. Considering DFM from the start can help you get your product to market faster, gaining a competitive edge and capturing market opportunities more swiftly.
3. Improved Quality and Reliability: A design optimized for manufacturability tends to produce more consistent and reliable products. Minimizing manufacturing complexities and potential error sources can lead to higher product quality and fewer defects.
4. Prototype Development: Prototyping is a vital step in medical device development. DFM principles can help create prototypes that closely resemble the final manufactured product, allowing for more accurate testing and validation.
5. Better Use of Materials: Designing with manufacturing in mind allows for the efficient use of materials. This can reduce material waste and decrease overall production costs. Additionally, it may have environmental benefits by reducing resource consumption and waste generation.
6. Scalability: If your product design is easily manufacturable, it can be scaled up or down more effectively to meet changes in demand. This flexibility is crucial in today's dynamic business environment.
7. Regulatory Compliance: By considering DFM from the beginning, you can design with these requirements in mind, reducing the risk of compliance issues later on.  (think about standards like ISO 13485, 14001 and 14971
8. Enhanced Innovation: Designing for manufacturability doesn't mean sacrificing innovation. In fact, it can encourage creativity by pushing designers to find innovative solutions that are also efficient and cost-effective to manufacture.
9. Minimizing Risk: Addressing manufacturability issues early reduces the risk of encountering unexpected problems during production, which can lead to delays, increased costs, and potential product recalls.

​
Considering DFM from the beginning of the design process is crucial for optimizing the manufacturing process, reducing costs, improving product quality, and ensuring a smoother path to market. It ultimately results in a more competitive and successful product with potential less risk downstream.

​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 medical device 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 does it really take?

Today's episode of Medtech Snapshot features our managing director Travis N. Smith as he covers the outcome of an online survey we hosted to learn what people thought 'is the most important characteristic a medical device start-up management team needs in order to successfully take a product to market'. So, the question remains - what does it really take for a management team to bring their product to market? Listen in and find out!

If you're enjoying our Medtech Snapshot 3-minute digests be sure to check out our other episodes at https://www.sqr1services.com/white-papers/category/snapshot

#medtech #snapshot #medicaldevice #startup #commercialization #product #marketplace #square1engineering #management

Back to our list of strategies to help you prevent scope creep…

5. Prioritize Requirements
Use techniques like MoSCoW (Must have, Should have, Could have, Won't have), Five Whys or the Analytic Hierarchy Process (AHP) to prioritize project requirements. This helps in focusing on what's essential and avoids unnecessary additions.

6. Track Progress Against Scope
Regularly track project progress against the defined scope. Tools like Microsoft Project which build out real-time Gannt charts are incredibly helpful to visualize tasks and progress.  This also helps identify any deviations early on and allows for timely corrective actions.

7. Communicate to Your Team Consistently & Clearly
Ensuring all team members and stakeholders understand the project's scope and the implications of scope changes is paramount to the success of the project. Effective communication can help prevent misunderstandings that might lead to scope creep.

8. Document Changes to the Project
Keep a detailed record of all changes to the project scope, including their rationale and impact. This documentation helps maintain transparency and accountability.

9. Manage Expectations by Providing Project Updates to Stakeholders
Continuously manage stakeholder expectations by providing regular updates on project status and any changes to the scope. This can help prevent unrealistic demands and last-minute additions.

10. Institute a Review and Approval Process for Scope Change
Institute a formal review and approval process for scope changes. All changes should be evaluated by relevant stakeholders and approved based on their impact.

11. Stay Firm but Flexible
While it's important to resist unnecessary scope changes, be open to valid suggestions or changes that genuinely enhance the project's value. Just ensure that these changes go through the proper evaluation and approval processes.  If you can’t readily identify the ROI of the change it probably isn’t a good change to consider.

12. Conduct Regular Project Reviews
Conduct regular reviews with stakeholders to ensure that the project is meeting their expectations and to address any concerns before they escalate.  When facilitating meetings, try to employ Jeff Bezos’ ‘Two Pizza’ rule when it comes to meeting attendees.

13. Manage Dependencies to Avoid Unintended Cross Functional Impact
Understand and manage dependencies between project tasks and deliverables. Changes in one area can often impact other parts of the project.
​
Remember that while complete prevention of scope creep might be challenging, these strategies can significantly help to reduce its occurrence and impact on your project. Regular vigilance and proactive management are key to avoiding scope creep from taking over your project.