Ensuring the smooth progression of a medical device through product development is more than just having a good idea and the money to back it up. In the ever-evolving landscape of healthcare, the development of cutting-edge medical devices demands a strategic and disciplined approach. At the heart of this process lies several key drivers each with their own distinctive value, yet all of which work in harmony bringing us to the conclusion we are hoping for - getting our products successfully through each phase of product development and eventually out the door to patients in need. This article explores the 'key drivers' which will keep your product development efforts successfully moving forward. Let’s begin with looking at what may very well be an obvious statement – what problem are you trying to solve and is it worth solving in the first place. The second portion of this question is key – is the problem you want to solve, via the technology you intend to develop, actually worth solving. Some advice – not all problems are worth solving, especially in the eyes of investors. It’s going to take deep pockets to build a product, upwards of $100 million on average for a PMA device, which is why its so important to be able to confidently answer this first two-part question: what problem are you trying to solve and is it worth solving in the first place. Once you know your technology front and back, understand the macroeconomics associated with it, it’s time to put a well-crafted plan into place to help keep you on track throughout each phase of the development cycle. Here enters project management. Project management plays a critical role in the success of medical device product development as it holds your team accountable to keeping focused on the key strategies which contribute to a seamless progression from concept to market. This should include: Developing A Clear Project Plan A well-defined roadmap is the cornerstone of any successful project as it delineates tasks, milestones, and dependencies. Roles and responsibilities are outlined, laying the groundwork for a collaborative and efficient work environment. Regular updates and adjustments ensure the plan can accommodate change while staying aligned with the overarching project goals. Timely Decision-Making Delays are costly endeavors. Projects which embrace prompt decision-making empower team members to make informed choices within their spheres of expertise. This can minimize bottlenecks, fostering an environment where decisions were made swiftly, keeping the project on a forward trajectory. Risk Management A robust risk management plan provides continuous assessment of potential challenges. Glen Rabito, COO of Nidus Biomedical, advises “identify the top three (3) risks and go tackle those things first. This will allow us to understand the technical and clinical risks” [associated with the development of your technology]. Effective Communication Clear and transparent communication is the lifeblood of successful projects. Regular team meetings facilitate discussions on progress, challenges, and potential solutions, creating an environment where everyone is well-informed and engaged. Resource Allocation Efficient resource allocation is essential for maintaining momentum throughout the development process. Teams which carefully monitor the allocation of human, financial, and technological resources tend to fare better than those who don’t. Also, what should you keep internally as a core competency versus outsource to someone better set up to facilitate a portion of your work. Adaptability Flexibility in the face of change is a hallmark of successful product development efforts. Project plans should be designed to be adaptable allowing the team to accommodate shifts in scope, requirements, or unforeseen economic challenges. Regulatory Compliance Navigating the complex landscape of medical device development requires a keen understanding of regulatory requirements. Staying informed of regulations and incorporating specific milestones related to regulatory submissions in the project plan is crucial to your success in keeping things moving forward. Prototyping and Iterative Development Teams which embrace an iterative development approach are focused on continuous improvement, allowing the team to make necessary adjustments based on user and stakeholder input. The result is a product which meets regulatory standards AND user needs and expectations. Quality Assurance and Testing Ensuring the highest quality standards is non-negotiable. Thorough quality assurance and testing processes should be integrated at every stage, whereas multiple testing iterations are planned for and issues identified during testing are promptly addressed. Documentation and Traceability Many of us love to gloss over this step – yet doing so is a monstrous mistake. A disciplined approach to documentation is critical for accountability and traceability. A team which maintains accurate and up-to-date documentation throughout the project, establishing clear traceability between milestones, design inputs, and verification/validation activities will be better positioned for success down the road, while mitigating project efforts being put on hold. In the intricate dance of medical device development and effective project management is the guiding force which better positions your team and company for success. The strategies outlined above, from meticulous planning to continuous improvement, collectively contribute to the seamless progression of a product and the overarching project. As the healthcare landscape continues to evolve, these principles will remain essential for navigating the complexities of medical device development and delivering innovations which make a lasting impact on patient care. 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!
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Medtech Snapshot: Forward Progress in Product Development with Glen Rabito, COO of Nidus Biomedical1/10/2024 Medtech Snapshot episode #21 features Nidus Biomedical COO Glen Rabito talking through the five considerations to keep product development moving forward, especially in the early phases of development.
#medtech #snapshot #medicaldevice #productdevelopment #NPD #riskmanagement #userneeds #patientsafety Episode #20 of Medtech Snapshot features Peman Montazemi, CTO of Bright Uro - overcoming some of the biggest software development challenges for medical device applications.
#software #embeddedsystem #medicaldevice #snapshot #medtechsnapshot #medtech #softwaredevelopment #engineering #newproductdevelopment #regulation #cybersecurity #samd #spdf Episode 19 of Medtech Snapshot features Scott Nelson, CEO of FastWave Medical sharing insights on the strategy of operating in stealth mode versus public for a medical device start-up.
Are you liking these Medtech Snapshot digests? Check out our archives for more 3 minutes snip-its at https://lnkd.in/gFwF9GYN #snapshot #medtech #medtechsnapshot #startup #stealth #strategy #medicaldevice The art of attracting talent! Nuvaira, Inc. CEO Dennis Wahr M.D. joins us on Medtech Snapshot to discuss strategies in attracting great talent into a small company, especially how to lure talent away from big businesses. Check out https://lnkd.in/gFwF9GYN for our past episodes of Medtech Snapshot. #medtech #news #strategy #talent #hiring #snapshot #podcast 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! VISIT HERE 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. 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!
Executive Summary
Developing a strategic and consistent process to evaluate and therefore acquire suppliers before you need them is vital to our ability in growing our respective companies. When we utilize a systematic process we eliminate bias and emotion from the decision making process which allows us to make decisions which are capabilities and needs based rather than emotions. Your ‘minimum expectations’ list serves as a road map for decision making and comparison shopping as you engage with each supplier. Developing A Supplier Selection Process The supplier selection process is an important and vital step for any size company. Making the wrong decision leads to countless hours of wasted time and of course money down the drain. A successful supplier selection process is even more important for small and startup based business where financial considerations are at the top of the pecking order. When looking for a new supplier follow these steps to best position yourself and company for success: Know What You Need Before You Need It Two reasons this is important: 1st – if you don’t know what you need how will you be able to explain it to a supplier? When we know what we need and want we are better prepared to explain those needs accordingly while setting expectations for what a successful partnership and outcome looks like. This minimizes miscommunication and opportunity for expectations falling through. 2nd - Waiting till the last minute to find suppliers can lead hasty decision making which may get you out of a jam in the moment but lead to larger problems down the road. For this reason it’s vital you are proactive in establishing relationships with vendors and suppliers so they’re there when you need them. Establish Minimum Expectations for Vetting Suppliers Establishing minimum expectations means that you will vet all potential suppliers with the same list of needs and expectations. This will help to create an even playing field when vetting suppliers and their capabilities. Similar to #1, when you know what you want and have created a way to gather information which allows you to do equal comparisons your chance of making the right decision increases dramatically. Create an SOP or checklist to hold yourself accountable to collect the right information. Be Strategic Once you know what you need from a supplier it is important to think about other associated or cross functional activities which need to be done that could be accomplished by said supplier(s). The ideal situation is you find a supplier that can do more than just one component of your needs, therefore providing more value in the long run. This also saves you time because you have less suppliers and vendors to managed increasing your efficiency and effectiveness. Supplier Identification Referrals, referrals, referrals. Once you know what you need the best approach to finding the right supplier is by reaching out to others in your industry, or industry associations, to learn who they use, and just as important who they don’t use. Take the time to read reviews, gather intel from people you trust before you start calling potential suppliers. While sites like Thomas.net and Google can provide this information, it is likely you will quickly find yourself overwhelmed with information. In the end the most useful data is those which are unbiased or comes from experience -this is best collected from a trusted resource. Outreach and Selection When speaking for the first time with a potential new supplier try to connect with the people you will actually be working with, not just the company’s sales person. This is important because once the relationship is established the majority of your time won’t be spent with their sales people rather those delivering the service or product. What is their communication like? Do they respond quickly and address mistakes immediately? What is their customer retention rate? Find out how long their employees have been with the company too. If the company suffers from consistent turnover that should be a big red flag as you will likely have to be much more involved with this supplier helping coach and direct new employees to ensure the work is done properly. Also, where are you in the pecking order of the level of importance to the supplier? Don’t be fooled not all clients are treated equal, even if they tell you otherwise. When you know where you stand it is easier to build a relationship based on realistic expectations. In the end, supplier selection should come down to three things, in ranked order: 1. Performance 2. Relationship 3. Price Key Takeaway At the end of the day it doesn’t matter how affordable or cost effective a supplier is, or how nice they are as people. If they can’t perform, and do so consistently, the other two don’t matter. I’ve also found that paying a bit more for the right service and relationship often times is worth the investment it in the long run. #whitepaper #supplychain #supplier #vendor #selectionprocess #outsource #square1engineering #medtech #medicaldevice Our most recent Medtech Snapshot features product development executive Barry Fulkerson as he takes us through his strategy of obtaining user needs data on the cheap and how creating a patient advisory board can help get you there.
We have archives! To watch and listen in to our past Medtech Snapshot episodes visit https://www.sqr1services.com/white-papers/category/snapshot #userneeds #medtech #snapshot #medicaldevice #productdevelopment #conceptdevelopment #patient 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 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 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!
About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Categories
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