samedan logo
 
 
spacer
home > epc > winter 2017 > suggestions for success
PUBLICATIONS
European Pharmaceutical Contractor

Suggestions for Success

Many important medical innovations come from small companies and inventor-funded start-ups. CROs and consultancies play a significant role in bringing these innovations to market because start-ups and other small businesses typically lack the experience and resources necessary to successfully navigate the clinical and regulatory pathway on their own. With little or no revenue from existing products, small medical technology companies also have a compelling need to set a foundational strategy, gain market access and become financially viable – usually in the context of ambitious timelines and finite budget constraints.

Recent changes in the global economic and regulatory landscape have increased the time/cost burden of innovation for medical device companies. For instance, Europe's new regulations, slated to take full effect in 2020 in parallel with the recently revised quality system standard for medical devices (ISO 13485:2016), will reclassify many devices and tighten the requirements for clinical data, quality assurance and risk management (1-3).

In the US, the recently revised FDA user fees for medical device premarket submissions will increase by at least 33% for all application types, beginning in 2018, with further incremental costs added annually over the succeeding four years (4,5). The most significant increase pertains to De Novo requests, which refer to the FDA process for manufacturers to commercialise novel and cutting-edge products in the US. Previously free of charge, these will now cost $93,229 for large companies and $23,307 for small businesses with annual sales less than $100 million in 2018. However, the news is not all bad. The FDA, for its part, promises increased predictability and a faster review process. The average time taken to provide a final determination for De Novo requests is supposed to drop from 249 to 120 days after implementing the new user fees (6,7). Despite this, sweeping increases in the cost of registering new devices may strike a disproportionate blow to smaller medical device companies short on the knowledge, time or funds necessary to adapt.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Nuala Ronan is co-founder and managing partner of Databean, a collaborative research organisation supporting medical technology and biological technology start-ups. Her expertise in the clinical, regulatory and data management requirements, essential for successful execution of global clinical trials, stems from more than 20 years of leadership in academic and industry sponsored clinical research. Nuala holds a degree in nursing and pre-medical studies, and she can quickly assess the value of new technologies and works hard to bring them to fruition.

Deborah Arthur is Databean’s key regulatory strategist. Having served as Vice President of Regulatory and Quality for several medical device companies, including Cochlear Americas, MetaCure and Symphonix Devices, she has extensive experience with regulatory authorities around the world.

spacer
Nuala Ronan
spacer
spacer
spacer
Deborah Arthur
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Digital Manufacturing is a top priority for Life Sciences according to Zenith survey

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, recently conducted an industry survey that suggests the digital manufacturing is a top priority.
More info >>

White Papers

The Importance of Critical Temperatures in the Freeze Drying of Pharmaceutical Products

Biopharma Group

Every formulation has a critical temperature, below which it should be cooled for complete solidification and maintained below during primary drying in order to prevent processing defects. To design a freeze drying cycle on a rational basis such information should be identified.
More info >>

 
Industry Events

Digital Medicine & Medtech Showcase 2019

8-9 January 2019, Parc 55 San Francisco - a Hilton Hotel

The Digital Medicine and Medtech Showcase is the dedicated home for the digital health and medtech communities during Biotech Showcase™ and one of the healthcare industry’s biggest weeks. Taking place January 8–9, Digital Medicine & Medtech Showcase includes two days of networking opportunities, curated presentations, specialized sessions, one-to-one meetings scheduled by partneringONE®, and full access to Biotech Showcase.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement