From the May 2016 issue of HealthCare Business News magazine
Keeping pace with scientific achievements
The scientists developing new therapeutic agents are specialists in chemistry, pharmacology, genetics and life sciences. They are making monumental inroads for successful treatment of disease. Treatments and even curative remedies are emerging for intractable illnesses and injuries such as nerve damage, genetic diseases, COPD and others. Delivering those treatments is another matter. Medical device developers — engineers, chemists, manufacturers — tackle different challenges.
These specialists design customized infusion devices with appropriate size, electronics, controls, power, monitors, metrics, physical properties, operation, maintenance and function. The FDA has rightfully added that more efforts must be made in the design phase to adequately study human factors. Medical device developers are putting more emphasis into designs that are intuitive for clinicians and patients, thus reducing or removing the risk of human error.
Medical drug researchers and biotech companies are responsible for testing the safety and effectiveness of the therapies they develop. They methodically test and confirm that the product meets all requirements to obtain regulatory approvals for these substances. Medical device companies assume responsibility for the safety and efficacy of the delivery mechanism while guiding it through testing and FDA approval. Some of these devices and drugs become a “combination device product," requiring the drug companies and device developers to work very closely to meet the demands of the “combination device” regulatory requirements.
Finally, there is the issue of cost. The technologies involved in making these infusion devices don’t come cheap, but leaders in the industry are always looking for ways to leverage their expertise with cost-effective technologies where possible. The number of people needing some of these treatments is high, and costs have been prohibitive for many. By making them more affordable, we can improve patient compliance.
The potential promised by new medical treatments is astonishing. As scientists come up with new therapeutic agents, the question of appropriate delivery mechanisms must be ad quantity and force of flow required. Different means of propelling the fluid are used for different solutions. CT scanning requires a relatively large, fast, forceful infusion of contrast medium. At the opposite extreme, some drugs are dispensed in miniscule doses, at a slow trickle. Either way, consistent and precise controls are necessary. Design and manufacturing approaches are modified to meet specific device requirements, ranging from sourcing next-generation power supply technologies to integrating advanced flow metering techniques, along with obtaining raw materials that are specified as demanded by the properties of the infusate.
