Web Document Management and Foundational Tools for Start-Up Medical Device Companies
Marci L. Crane
February 06, 2009
In a 'down' economy the medical device industry is fortunately 'sitting pretty,' or at the very least, keeping its head above water. Luckily for start-up medical device companies, the doors of opportunity are still open for progress and preparation for an inevitably competitive future is the name of the game.
Building a Foundation Now
With ideas and products that can make a difference, start-up medical device companies have a story to tell and are aren't afraid to tell it. Despite their brilliance, however, many start-up medical device companies frequently fail to create the basic foundation that is often required for the creation of an organization that 1) attracts potential mergers, or that 2) smoothly transitions into enterprise-level growth. This foundation, though simple in nature, often becomes a drag--a "boring" endeavor--clearly not enjoyed by engineering and/or most management executives.
Web Document Management as a Foundation for a Quality Management System Roll-Out
For start-up medical device companies that often exist without a quality management team or even for those who DO have a quality management representative, quality assurance is NOT a top priority. Quality controls are often implemented in order that a final product be deemed successful but quality assurance and its associated proofs, documentation, and pre-design documentation requirements are simply not feasible for a company in the race to market a first-time product.
A Question
What if, however, medical device start-up companies could effectively (and very quickly) set up the foundation for a complete FDA-compliant quality management system without spending a fortune or hiring a team of quality management professionals?
The answer is that with new technology enablers, start-up companies can do exactly that.
Enablers: Web Document Management, etc.
With the right web document management solution, start-up medical device companies can easily afford hosted web document management solutions that streamline, control, manage and effectively archive all documentation which will, upon subsequent growth of the company, be able to evolve into an effective quality management system (i.e., Design Control, Audits, Change Control, CAPA management, bill of materials management, supplier management, etc).
Searching for a Web Document Management System
Start-up companies should search for a web document management solution that not only provides document control and management but that can also be potentially rolled out into a complete quality management and/or product lifecycle management solution.
When searching for this type of web document management solution, medical device "shoppers" should consider the following potential features:
Conclusion
Most start-up medical device companies refuse to invest in ERP systems or pricy document management systems and are smart for doing so. Start-up medical device companies should consider the web document management and quality management solutions that grow as their company does.
Marci Crane is a marketing communication specialist at MasterControl in Salt Lake City, Utah. To learn more about web document management solutions for start-up medical device companies and web document management solutions for medium-enterprise level medical device companies, please feel free to contact a MasterControl representative.
Building a Foundation Now
With ideas and products that can make a difference, start-up medical device companies have a story to tell and are aren't afraid to tell it. Despite their brilliance, however, many start-up medical device companies frequently fail to create the basic foundation that is often required for the creation of an organization that 1) attracts potential mergers, or that 2) smoothly transitions into enterprise-level growth. This foundation, though simple in nature, often becomes a drag--a "boring" endeavor--clearly not enjoyed by engineering and/or most management executives.
Web Document Management as a Foundation for a Quality Management System Roll-Out
For start-up medical device companies that often exist without a quality management team or even for those who DO have a quality management representative, quality assurance is NOT a top priority. Quality controls are often implemented in order that a final product be deemed successful but quality assurance and its associated proofs, documentation, and pre-design documentation requirements are simply not feasible for a company in the race to market a first-time product.
A Question
What if, however, medical device start-up companies could effectively (and very quickly) set up the foundation for a complete FDA-compliant quality management system without spending a fortune or hiring a team of quality management professionals?
The answer is that with new technology enablers, start-up companies can do exactly that.
Enablers: Web Document Management, etc.
With the right web document management solution, start-up medical device companies can easily afford hosted web document management solutions that streamline, control, manage and effectively archive all documentation which will, upon subsequent growth of the company, be able to evolve into an effective quality management system (i.e., Design Control, Audits, Change Control, CAPA management, bill of materials management, supplier management, etc).
Searching for a Web Document Management System
Start-up companies should search for a web document management solution that not only provides document control and management but that can also be potentially rolled out into a complete quality management and/or product lifecycle management solution.
When searching for this type of web document management solution, medical device "shoppers" should consider the following potential features:
- A web document management solution that will manage and control all essential documentation agnostically (i.e., will accept all document types);
- Will remain in a price range that makes ROI possible within a short time period (i.e., not many years);
- Will be web-based and hosted;
- Can be easily rolled out into a full-scale quality management system;
- A web document management solution that will allow users to utilize their own design input templates;
- Will offer a functional user-interface via MS Word, Outlook or SharePoint;
- Will automatically route appropriate documents to a centralized DHF file location;
- Can be configured to route documents through a collaboration phase (i.e., a virtual meeting room);
- A web document management solution that will notify users (via email) when a document has been redlined;
- Will allow users to include attachments with routed documents;
- Will allow users to effectively manage the roles and rights of users;
- Will provide preconfigured reports and customizable report options;
- A web document management solution that will allow users (once they have their products on the market) to control documents such as SOPs, basic CAPAs, training records, etc.;
- Will allow users to determine their own approval process;
- Will require signatures (21 CFR Part 11);
- Will manage 3D drawings in a centralized archive (managed and routed as 2D renditions);
- Will provide the ROI information necessary to convince senior management that the solution is worth the effort.
PLUS…
PLUS…
PLUS…
Conclusion
Most start-up medical device companies refuse to invest in ERP systems or pricy document management systems and are smart for doing so. Start-up medical device companies should consider the web document management and quality management solutions that grow as their company does.
Marci Crane is a marketing communication specialist at MasterControl in Salt Lake City, Utah. To learn more about web document management solutions for start-up medical device companies and web document management solutions for medium-enterprise level medical device companies, please feel free to contact a MasterControl representative.
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