Johner Institute New Zealand Ltd.’s Post

To many medtech start ups and enginners learning regulatory compliance is boring and tedious. For example: Anne Arndt and I spent 2hrs today going over the differences in regulatory pathways to Europe (MDR), Australia (TGA) and America (FDA), the hidden/undisclosed costs and technical loop holes and tricks for each market to make the regulatory process easier and then once in a markets knowing the maintenance and surveillance requirements/costs for each market to sell your medtech. Now that may seem lame to you, but sarting up a medtech company costs millions and millions of dollars. Not having a regulatory plan and strategy to take your device to market can cost you even more money unnecessarily. What I love about regulatory is there are pathways and processes to follow, but it's my job to understand each pathway, ensure we are compliant and the real challenge is to have the added pressure of getting it all right with our team to ensure we don't need to spend extra millions unnecessarily. 😂 No pressure ae. Thankfully we have partnered with the Johner Institute New Zealand Ltd. to ensure we have their team of experts to support us. It also helps that nerds get to nerd out with nerds to be unapologetically nerdy 😎 #MedTech #Startup #RegulatoryNerds Narelle Hepi Tautoko Technology #unapologeticallyMe #UnapologeticallyNerdy

It's exciting being in Tautoko Technology a MedTech start up, focused on developing an easier to use insulin pump with great wrap around support. The thing I currently enjoy the most is the exposure to mana wāhine who are knowledgeable like Dr. Grace Walker and Anne Arndt. These wāhine are both skilled experts within their own fields. I love being a part of this team focused on Regulatory and QMS, while these two focus on our big picture and strategy moving forward, I have the luxury of working in the background (my favourite place) maintaining and developing our QMS. #dreamteam They make it look simple but trust me, these lengthy nerdy conversations will save us big pūtea ($) in the long run and I'm a part of the team who's going to bring this to fruition. Looking forward to the next few years of developing MedTech in Aotearoa to support our people in NZ and then taking it global! Johner Institute New Zealand Ltd.#medtech #startup #Aotearoa #Regulatory #QMS #FDA #MDR #TGA #bestteam #manawahine

Let’s talk about traceability in medical device requirements… When it comes to regulatory submissions, managing a requirements stack across the total product life cycle seems daunting. At Hardian, we've made it easier by organising these requirements into tiers, ensuring clear traceability from user needs to design outputs. This approach helps manage verification, validation, and ongoing maintenance. Getting this right means your technical documentation stays organised and compliant from initial submission to post-market surveillance. If you’d like to learn more about staying compliant throughout the product lifecycle, read our latest blog ➡️ https://lnkd.in/eUEh2uuK Need support optimising your requirements management for medical devices? Contact Hardian today ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

Another great opportunity to learn more about the interface between medical device design & development and regulatory compliance. I’m sure this will book up quickly so register as soon as you can! #medicaldevices #medtech #regulatory #compliance #eumdr #fda

Navigating regulatory compliance is complex, but it doesn’t have to be! Our collaboration with Envisionit Deep AI® demonstrates how our technical and clinical expertise can help to streamline and strengthen regulatory applications, including US FDA. With our guidance, Envisionit successfully established a strong regulatory framework and Quality Management System, crucial for meeting compliance standards. This support refined their evaluation process and market strategy, ensuring their product approval success. We are dedicated to working collaboratively with our clients to navigate regulatory complexities and achieve market readiness. Need support tackling your regulatory challenges? Get in touch ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

**"In a world where speed often trumps quality, are we sacrificing patient safety for the sake of innovation?"** In the HealthTech and BioTech sectors, many startups rush to launch their products, overlooking the critical importance of robust software development. This haste can lead to costly errors, compliance issues, and ultimately, a loss of trust from both patients and investors. **The solution?** - Prioritize a comprehensive software development strategy that emphasizes quality assurance and user-centered design from the outset. - By investing in thorough testing and iterative development, you can ensure that your product not only meets regulatory standards but also genuinely addresses the needs of your users. **The big benefit?** - By committing to quality, you will not only enhance patient safety but also position your startup as a trusted leader in the industry, paving the way for sustainable growth and innovation. #HealthTech #BioTech #MedTech #PharmaTech #SoftwareDevelopment

Y'all have heard me talk about how important a strong regulatory strategy is to the success of your submission. Some of you may have agreed, and adjusted your pitch deck accordingly. Some of you may have thought I was a half bubble off plumb, and ignored everything I said in favor of a shortened launch timeline and a happier C suite. But I'm not the only one making these statements anymore. This from a recent article on how to raise capital for your medical device startup: "𝘖𝘯𝘦 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘱𝘢𝘳𝘵𝘯𝘦𝘳 𝘢𝘨𝘳𝘦𝘦𝘥..𝘵𝘩𝘢𝘵 𝘵𝘩𝘦 𝘴𝘵𝘢𝘳𝘵𝘶𝘱 𝘩𝘢𝘥 𝘢 𝘳𝘦𝘮𝘢𝘳𝘬𝘢𝘣𝘭𝘦 𝘥𝘦𝘷𝘪𝘤𝘦 𝘸𝘪𝘵𝘩 𝘮𝘢𝘳𝘬𝘦𝘵 𝘰𝘱𝘱𝘰𝘳𝘵𝘶𝘯𝘪𝘵𝘺. 𝘉𝘶𝘵..𝘵𝘩𝘦 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘱𝘢𝘳𝘵𝘯𝘦𝘳..𝘥𝘪𝘥𝘯’𝘵 𝘵𝘩𝘪𝘯𝘬 𝘵𝘩𝘦 𝘴𝘵𝘢𝘳𝘵𝘶𝘱’𝘴 𝘵𝘦𝘢𝘮 𝘤𝘰𝘶𝘭𝘥 𝘦𝘹𝘦𝘤𝘶𝘵𝘦, 𝘴𝘱𝘦𝘤𝘪𝘧𝘪𝘤𝘢𝘭𝘭𝘺, 𝘪𝘯 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺." The potential investor didn't think the company had the right strategy - or maybe he thought they didn't have a strategy at all - and he pulled out because he didn't think the company would be successful with their submission. Well, I'll be. 😐 I've also talked about how important it is to implement your design controls from the start, and not just before (or after) your FDA submission. And I know that many of you - former clients included - thought I was two bricks short of a load for suggesting that it makes more business sense to implement ALL of your quality system from the start as opposed to doing it retrospectively. But as this next quote clearly shows, investors are becoming smarter and won't back a company or device that poses too much risk: "𝘐𝘯𝘷𝘦𝘴𝘵𝘰𝘳𝘴 𝘢𝘳𝘦 𝘮𝘰𝘳𝘦 𝘴𝘦𝘭𝘦𝘤𝘵𝘪𝘷𝘦, 𝘧𝘰𝘤𝘶𝘴𝘪𝘯𝘨 𝘰𝘯 𝘥𝘦𝘷𝘪𝘤𝘦𝘴 𝘸𝘪𝘵𝘩 𝘷𝘦𝘳𝘺 𝘤𝘭𝘦𝘢𝘳 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘢𝘯𝘥 𝘤𝘰𝘮𝘮𝘦𝘳𝘤𝘪𝘢𝘭 𝘱𝘢𝘵𝘩𝘸𝘢𝘺𝘴, 𝘰𝘳 𝘰𝘯𝘦𝘴 𝘵𝘩𝘢𝘵 𝘩𝘢𝘷𝘦 𝘷𝘦𝘳𝘴𝘪𝘰𝘯𝘴 𝘰𝘧 𝘥𝘦𝘷𝘪𝘤𝘦𝘴 𝘵𝘩𝘢𝘵 𝘢𝘳𝘦 𝘢𝘭𝘳𝘦𝘢𝘥𝘺 𝘤𝘰𝘮𝘮𝘦𝘳𝘤𝘪𝘢𝘭𝘭𝘺 𝘷𝘪𝘢𝘣𝘭𝘦. 𝘛𝘩𝘦𝘺 𝘱𝘳𝘦𝘧𝘦𝘳 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘸𝘪𝘵𝘩 𝘢 𝘩𝘪𝘨𝘩𝘦𝘳 𝘭𝘦𝘷𝘦𝘭 𝘰𝘧 𝘥𝘦-𝘳𝘪𝘴𝘬𝘪𝘯𝘨." Imagine that. 😉 Carry on with whatever strategy you and your executive team deem best. I'm just going to sit right here and enjoy my big ol' glass of I-told-you-so. 😁 #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA #riskmanagement #investor #startup

𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗪𝗮𝘁𝗲𝗿𝘀: 𝗧𝗵𝗲 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗳 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗣𝗼𝗹𝗶𝗰𝗶𝗲𝘀 𝗼𝗻 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗦𝘁𝗮𝗿𝘁𝘂𝗽𝘀 In the dynamic landscape of healthcare, startups are often the birthplace of groundbreaking innovations. However, the path to transforming these innovations into market-ready products is heavily influenced by regulatory policies. Understanding this impact is crucial for emerging healthcare ventures aiming to succeed in this regulated sector. ❔ Why Regulatory Policies Matter for Startups: Regulatory policies ensure safety, efficacy, and quality within the healthcare industry. For startups, these regulations can represent both significant challenges and vital opportunities: ⏳ Compliance Costs and Time: Compliance with regulatory standards, such as those set by the FDA or EMA, often requires significant investment in terms of both time and resources. For startups, these requirements can be daunting, as they may delay product launches and increase initial outlays. 💹 Market Access and Credibility: On the flip side, rigorous regulatory compliance boosts credibility and facilitates easier access to global markets. Adherence to stringent policies not only builds trust among consumers and investors but also enhances the startup’s profile against competitors. ❕ Strategic Tips for Startups: Early Engagement: Startups should engage with regulatory bodies early in the development process. Early dialogue can clarify requirements and provide guidance, reducing the risk of costly revisions later on. Expert Guidance: Leveraging expertise from regulatory professionals can streamline the compliance process. Consider hiring or consulting with experienced regulatory affairs specialists. Proactive Compliance Strategy: Develop a regulatory strategy that aligns with your business goals. This approach includes understanding the specific regulations that impact your product and integrating compliance into the business model from the outset. 🏁 Conclusion: For healthcare startups, regulatory policies are not just hurdles but stepping stones to wider acceptance and market success. By embracing these regulations and planning strategically, startups can enhance their market entry and establish a strong foundation for growth. 💬 Let’s Discuss: How has your startup navigated regulatory challenges? Share your experiences or tips for balancing innovation with compliance in the healthcare sector. Hashtags: #HealthcareStartups #RegulatoryCompliance #MedicalInnovation #StartupChallenges #HealthTech

**In a fast-paced world where speed often overshadows quality, are we compromising patient safety in the name of progress?** In the HealthTech and BioTech industries, numerous startups are eager to launch their products, neglecting the vital need for thorough software development. This rush can result in expensive mistakes, compliance challenges, and ultimately, a decline in trust from both patients and investors. **The solution?** - Emphasize a detailed software development approach that prioritizes quality assurance and user-focused design from the beginning. - By dedicating resources to comprehensive testing and iterative development, you can guarantee that your product not only complies with regulations but also effectively meets the needs of your users. **The major benefit?** - By focusing on quality, you will not only improve patient safety but also establish your startup as a reliable leader in the field, setting the stage for sustainable growth and innovation. #HealthTech #BioTech #MedTech #PharmaTech #SoftwareDevelopment

🚨 Start-ups 🚨 Ignoring compliance is costing you big time.. Regulatory isn't a roadblock - it's the path to success! Here's what you're missing out on: 💡 Steer clear of costly pitfalls with foresight. 🔗 Build a seamless bridge from development to market entry. ⏩ Slash time to market with streamlined regulatory strategies. 🌍 Gain the upper hand on international regulatory changes. 💰 Save time and money with well-prepared submissions. 📣 Enhance stakeholder communication with clear requirements. 🎯 Align development goals with regulatory frameworks. 🛡️ Safeguard your business from compliance risks. Don't let compliance be an afterthought, let Regulatory help drive innovation! #Startup #MedTech #Medicaldevice #Regulatory