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6 Tips to Accelerate MedTech Time To Clinical Data

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Key Tech saved CoolTech, a startup MedTech company greater than $1 million in development costs and reduced the time required to get to clinical data by six months.

In our newest case study, we outline our expertise in driving speed to clinical data and reducing development costs and time substantially.

Published in: Engineering
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6 Tips to Accelerate MedTech Time To Clinical Data

  1. 1. For Your Toughest Product Development Challenges1 Case Study: CoolStat Development Program 6 Tips To Accelerate MedTech Time To Clinical Data
  2. 2. For Your Toughest Product Development Challenges2 For Your Toughest Technology & Product Development Challenges.
  3. 3. For Your Toughest Product Development Challenges3 How Key Tech Accelerated Product Development Times to Drive Speed to Clinical Data Speed to clinical data is most critical, particularly for novel devices such as therapeutic products – The therapy is the top risk! The primary focus should be on collecting human data safely, deferring some commercialization features and activities until after the trial. CoolTech saved 6 months in getting to clinical trials by following these methods for their product, CoolStat. This approach also saved $1M in development costs in getting to clinical studies. 1 2 3 4
  4. 4. For Your Toughest Product Development Challenges4 CoolStat Case Study
  5. 5. For Your Toughest Product Development Challenges5 Two Approaches to Launch Development Launch Trial Add Non-Safety, Commercial Features Key Tech’s Signature Speed to Clinical Data Methodology Development Trial Launch Vs… Traditional Approach: Product Development Time Saved: 6 Months
  6. 6. For Your Toughest Product Development Challenges6 Deliver air and water to the nasal turbinates to remove heat via evaporative cooling. CoolTech chose neurogenic fever as the first target market. Up to 37% of Traumatic Brain Injury survivors experience this sequela.
  7. 7. For Your Toughest Product Development Challenges7 Key Features of COOLSTAT
  8. 8. For Your Toughest Product Development Challenges8 When to start planning for a trial?
  9. 9. When to start planning for what goes into a clinical trial device? You have a product that you know will require clinical data for approvals You have a functional prototype developed pre-design control You have dosing models from previous work, e.g., preclinical testing You have fairly complete, albeit draft design documentation 1 2 3 4
  10. 10. Considerations for Speed What risks can you manage by monitoring with study personnel versus manage with device performance? Which features can you defer until after you’ve proven the product in trials?
  11. 11. For Your Toughest Product Development Challenges11 Where Key Tech Looks for Places to Accelerate Speed to Clinical Trials Product Design Product Testing Manufacturing Trial Method
  12. 12. For Your Toughest Product Development Challenges12 Key Tech Tip # 1 for Speed to Clinical Trials - Keep Device Disconnected Design Product Testing Manufacturing Trial Method • Connectivity was not critical for proving real-time that the therapy works in clinical trials • Deferred wireless functionality for future design configurations • Avoids cybersecurity concerns • Saves significant development and verification time, and simplifies the device in the trial
  13. 13. For Your Toughest Product Development Challenges13 Key Tech Tip # 2 - Design as a Platform for the Commercial Product Design Product Testing Manufacturing Trial Method • Architect for future commercial features such as connectivity and advanced algorithms • Battery is included in the trial device for backup only, not for primary power • Implemented wired data transfer, and data download option, but made them inaccessible on the trial device
  14. 14. For Your Toughest Product Development Challenges14 Key Tech Tip # 3 - Design for the Clinical Environment, Not Home Design Product Testing Manufacturing Trial Method • There are other indications of the therapy that would permit use at home • Stayed focused on design for the hospital environment, with trained users • Avoids 60601-1-11, requiring additional HF work and electrical safety design/testing
  15. 15. For Your Toughest Product Development Challenges15 Key Tech Tip # 4 - Limit Firmware Reviews to Safety Features Design Product Testing Manufacturing Trial Method • Followed 62304 Software Development Process • Completed ~30% of SW verification, focusing on patient risk areas • Limited white box verification for high risk modules • Skipped GUI verification
  16. 16. For Your Toughest Product Development Challenges16 Key Tech Tip # 5 - Build Clinical Trial Units at Design Firm Design Product Testing Manufacturing Trial Method • Building clinical trial units where design occurred saves time • No manufacturing transfer preserves overall schedule
  17. 17. For Your Toughest Product Development Challenges17 Key Tech Tip # 6 - Limit Process Validation on Device Builds Design Product Testing Manufacturing Trial Method • For the device assembly, no process validation was completed • Instead, black-box testing of clinical functionality and safety features was implemented • On the disposable, full manufacturing validation was established at a partner CM
  18. 18. For Your Toughest Product Development Challenges18 Path to Market FDA IDE Approval FDA DeNovo Submission Approved Add Non-Safety Commercial Features Launch Verify & Validate Regulatory Path Commercial Path IRB Clinical Trial There is much more to this methodology that we want to share with you. Contact us at andy@keytechinc.com to learn more about Key Tech’s expertise in Accelerating Time to Clinical Trials, and how we saved 6 months and $1M in product development costs for our client.
  19. 19. For Your Toughest Product Development Challenges19 Key Tech’s Expertise in Accelerating Speed to Clinical Trials Product Design Product Testing Manufacturing Trial Method There is an entire methodology that we can share with you. Contact at andy@keytechinc.com to learn more about Key Tech’s expertise in Accelerating Time to Clinical Trials, and how we saved 6 months and $1M in product development costs for our client.
  20. 20. The Key Tech Approach Risk mitigation is critical – Clinical efficacy is usually the biggest risk! Focus early on key requirements around patient safety to develop the optimal clinical trial device and get the clinical data quickly. Think of a clinical trial as a dry run of your product's commercial launch. Expect bugs & issues that can be refined post-trial for commercial launch. Have a plan to address gaps between trial devices & commercial launch. 1 2 3 4 There is an entire methodology that we can share with you. Contact us at andy@keytechinc.com to learn more about Key Tech’s expertise in Accelerating Time to Clinical Trials, and how we saved 6 months and $1M in product development costs for our client.
  21. 21. For Your Toughest Product Development Challenges21 Thank You www.keytechinc.com 40 East Cross St. Baltimore, MD 21230 This document contains work product that is confidential or proprietary to Key Tech and affiliated companies. Neither this document nor the material herein is to be reproduced, distributed, or disclosed in whole or in part, except as specifically authorized in writing. FORM REVISION 04/26/2018 Form F-0062 www.keytechinc.com andy@keytechinc.com

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