From specialty development, laboratory automation, and even IVD approval there options that abound
Here at Advances in Genome Biology and Technology 2019 (#AGB19) you come across plenty of companies new and old. On one floor of the exhibitor suites I counted 17 companies, and on the second floor there were probably another 8 or 10, and this morning I had the privilege of catching up with Cynthia Hendrickson, founder of Directed Genomics.
Directed Genomics develops and optimizes protocols as a service
Their specialized service is for vendors of reagents and protocols for NGS or other genetic analysis methods, or could be for an academic institution that is developing a unique assay for their own purposes (a laboratory-developed test for example). Do you need a buffer optimized but lack the people-power and equipment bandwidth to do so? Or an enzyme reaction optimized but wanting additional help in doing so?
In addition they also provide assistance with liquid handling automation of processes, which is a discipline all of itself. Speaking of which, if you are looking for a second source of specialized liquid handling automation outsourcing, you can also look into Arete Biosciences.
Argonaut manufactures kits for the life sciences research and clinical markets
On the way to breakfast the LaunchWorks people gave me a nice Rubiks Cube, labeled full of terms like ‘Package Testing’, ‘Companion Dx’, ‘Biopharmaceuticals’, ‘Temperature Verification’. At Singlera Genomics we are looking for a contract manufacturer so we do not have to handle box designs, tube labeling, and box labeling; we specific what needs to go where and in what format and temperature condition, and they handle all of it.
Another company, Argonaut Manufacturing Services is another option for contract manufacturing of kits and reagents. Formulation, mixing, dispensing, labeling, kitting and packaging, I have found them very responsive, in addition to offering a unique specialty of lyophilization of labile enzymes, allowing for room-temperature shipment. For any organization with global aspirations, offering a non-cold-chain product can pay for itself many times over the lifetime of the product. I am told they are expanding into specialty biologics manufacturing.
CSSi Life Sciences for In Vitro Diagnostics approvals
While wrestling with Singlera’s In Vitro Diagnostics FDA strategy and submission (along with attendant details like Quality Management and Regulatory Affairs), I came across CSSi Life Science CRO. Instead of hiring people with specific roles at a manager or director level for quality control and regulatory we could outsource the entire In Vitro Diagnostic process, from IVD strategy to biostatistics to pre-submission application to the FDA through the submission and clinical trial to IVD clearance. They have extensive capabilities for in-vitro diagnostics, in particular with ones that involve molecular diagnostics.
There are other in-vitro diagnostics advisory companies – NAMSA comes to mind – but CSSi Life Sciences is one you want to look into if you are going down the FDA 510(k), 510(k) de novo or Pre Market Authorization (PMA) pathways.
Outsourced Sales and Marketing BrainSpores
In a small company you are asked to wear multiple hats, asked to do a multitude of tasks, and often small companies may only consist of a few people, often only technical people as they develop a product for the market. And getting the first few precious customers may be limited by the breadth of their own personal network of connections, without the ability or resources to hire a full-time marketing or a full-time salesperson.
As an outsourced sales and marketing organization, BrainSpores is worth checking out. The founder James Gilmore has had a long and successful career in startups and Fortune 500 companies, and can offer a unique on-demand sales and marketing offering for your fledgling effort, regardless of how small it is.
Whether you need protocol development, help with automation, assistance with kit manufacturing, in-vitro diagnostics approval or sales and marketing, there are organizations out there that can help.