CleveMed Blogs

"You get what you pay for" – an idiom that has been around just about forever. It suggests that the quality of a product improves or increases with the amount of money one pays for that product. But for medical devices, quality products need to equate to more than a just a price tag.

Quality medical devices need to equate to a commitment – a commitment from top executive management that the products a company produces, not only meet “customer” requirements, but are safe and effective for their intended use. This commitment is to be communicated to all individuals at all levels of the organization who need to "buy–in" to it - and since this commitment is driven from the top down, employee resistance or "push back" should be reduced into the "slim to none" category!

Because they know their job functions best, employees need to become actively involved in the development of processes and procedures specific to their area of responsibility. These processes and procedures will evolve into the company’s "bible" or Quality System that guides and directs the operation.

"Customers" can be "internal" (engineering may be a customer of marketing, manufacturing may be a customer of sales) as well as external (regulatory agencies are customers of the Quality & Regulatory department, the end user or patient is a customer of sales or product support). A quality medical device is produced when customer requirements and specifications are translated into attainable and realistic design inputs. These inputs will develop into a finished medical device which, prior to being released to market, must go through extensive verification/validation testing to ensure the medical device functions according to specifications and is indeed safe and effective.

Consistency is paramount. Adhering to those employee developed processes and procedures such as purchasing items used in manufacturing only from pre-determined, experienced and competent suppliers are instrumental in maintaining the quality of a medical device.

Lastly, the commitment to quality cannot ever become stagnant. Customer requirements, customer feedback, processes and procedures used in product design and manufacturing as well as the infrastructure of the business itself must be continuously monitored, assessed, measured and improved upon if the medical device organization is to remain competitive, profitable and compliant with regulatory agencies.

Notice that throughout this blog cost was never mentioned? Sometimes you get a lot more than what you pay for!

Just in case you did not know: In CleveMed’s Movement Disorders Division we design and manufacture medical devices to help study movement disorders such as Parkinson’s disease. As an ongoing process in development, we’re always interested in receiving feedback to gain additional insight in movement disorders, especially from those using our devices. Some of you have participated in some of our research projects in the past (like one of our medical devices being currently developed with local hospitals, which uses a small wireless motion sensor placed on the finger to record symptoms of Parkinson’s disease).

CleveMed has established a Movement Disorder Focus Group for individuals diagnosed with Parkinson’s disease, and we are inviting you to join. As a participant, you’ll be in the know about future opportunities to get hands-on experience with our medical devices, test them out, and provide valuable feedback. Sessions are about an hour long, and allow you to learn more about how we are working to improve patient therapies. Lunch is always on us!

If you are interested in joining our Movement Disorder Focus Group call us at 216-361-5423 and ask for the focus group coordinator.

PS: CleveMed is located at 4415 Euclid Ave Cleveland, OH 44103. We look forward to seeing you at the CleveMed Movement Disorder Focus Group!

Sincerely,
Thomas Mera
Senior Biomedical Research Engineer

The Movement Disorders Division of CleveMed has primarily focused on monitoring motor symptoms associated with Parkinson’s disease (PD). A more common movement disorder is essential tremor (ET), which affects approximately 4% of the population over age 40 in the United States. In Parkinson’s disease, tremor (involuntary shaking) occurs primarily at rest, but essential tremor is mainly characterized by tremor of a moving limb.

Measuring Tremor

Subjective Rating: Tremor associated with essential tremor is traditionally rated by various subjective tremor rating scales. These scales all provide a discrete, subjective symptom rating at a discrete point in time. They require a clinician to visually assess the patient, and cannot capture complex fluctuations that occur throughout the day in response to interventions.

Objective Rating: Objectively capturing essential tremor symptoms continuously during daily activities, and using adaptive algorithms to both classify tremor types and severity, could help clinicians better adjust therapy to minimize symptom fluctuations, and expand care to rural and underserved populations. Therefore, CleveMed has recently begun development on a system to objectively monitor essential tremor.

CleveMed previously developed a compact wireless system, Kinesia™, to quantify Parkinson’s disease symptoms. In a clinical study, this system successfully demonstrated objective quantification of Parkinson’s disease motor symptoms. These promising results for Parkinson’s disease suggest the system may be adapted for quantifying tremor in essential tremor patients by developing specific ET algorithms. More continuous portable monitoring can capture the tremor fluctuations that can occur throughout the day. Using a combination of accelerometers and gyroscopes will provide a system with much greater sensitivity for tremor type discrimination and severity rating. (Existing systems contain only a single-axis accelerometer). Continuous ratings throughout the day can aid clinicians and researchers in therapy development and optimizing symptom management for patients with essential tremor.

Significant strides have been made in the management of Parkinson’s disease (PD) motor symptoms such as tremor, slowness of movement, and rigidity; however, treatment side effects pose a key therapeutic challenge. Upon initial onset of the disease, patients are typically prescribed levodopa, a drug taken orally several times a day to increase dopamine levels in the brain to alleviate motor symptoms.

As the disease progresses, changes in the body’s response to levodopa give rise to therapy complications such as delayed onset and decreased duration of motor symptom relief per dose. Chronic treatment can also lead to side effects such as dyskinesias, which can take on various debilitating forms: irregular brief rapid movements (chorea) during the “On” state at peak dose and sustained twisting movements (dystonia) during the “Off” state when the medication has worn off. Approximately 30% of patients diagnosed with PD exhibit levodopa-induced dyskinesia within 5 years of treatment^[1] and 59-100% by 10 years^[1-3]. Quality of life has been shown to be negatively impacted by dyskinesias^[4], specifically mobility^[5], activities of daily living^{[5, 6]}, communication^{[5, 6]}, and bodily discomfort^[6].

Figure 1: Blood Levodopa Concentration

Adjustments in medication to reduce drug side effects often sacrifice control of motor symptoms, and balancing this tradeoff poses a significant challenge for management of advanced PD. Alternate strategies to better control motor fluctuations have aimed efforts at developing drug administration methods to minimize swings in blood levodopa concentration. Figure 1 highlights the typical drug cycles that patients may experience throughout the day when taking levodopa in discrete intervals^[7]. Over time this approach shrinks the size of the “On” state window requiring higher doses to achieve the same effect and increasing the frequency and severity of dyskinesia. The ideal scenario would be to maintain levodopa concentration in the “On” state where levodopa is effective at alleviating motor symptoms without inducing dyskinesia. Studies have suggested that continuous drug administration may better mimic the normal physiological release of dopamine in the brain in order to attain more stable therapy benefits^{[8, 9].}