Product Engineering, Quality and Design of the AffloVest
International Biophysics is an FDA-registered and ISO 13485 certified medical device manufacturer. We are a 26-year-old company that manufactures, and markets medical devices across the globe. What that means in terms of quality, for products such as the AffloVest, is that every product goes through a rigorous design and manufacturing process, inspection process, periodic audits by the FDA and other regulatory bodies to verify compliance with all the various regulations.
The New Gold Standard
When we look at new technologies and applications, we really focus on what we feel are disruptive technologies and not minor incremental improvements. In the example of the AffloVest, we saw a product category that did not have a lot of evolution over time, and we really wanted to develop something that really disrupts the market and results ultimately in improving patient care for the entire patient population that use HFCWO therapy, such as patients with Cystic Fibrosis, Bronchiectasis and other respiratory diseases.
The AffloVest was the first HFCWO Airway Clearance Vest on the market that uses mechanical oscillation technology as opposed to the traditional compressor-based vests. Now patients have two types of HFCWO devices to choose from; the traditional air bladder or compressor-based and mechanical motor based vests.
- Air bladder HFCWO is an older technology and more restrictive for the patient as far as ease of use and portability, things that people would expect in today’s world for something they use in their home.
- Mechanical oscillation vest therapy allows patients to get the same type of oscillation therapy but with full mobility during use and more flexibility, to promote compliance to the therapy.
Product Design and Development
The design of the AffloVest started with the patients and the users. We conducted interviews and gathered feedback about HFCWO devices; what’s lacking out in the current market and what the patients and clinicians themselves would like to see. The first step in the design process was to gather all that customer feedback, and then feed that into design process. We then bring the product back to the users and conduct additional surveys and interviews to make sure that what we’re delivering ultimately is what they are looking for.
Being in control of the design of the AffloVest allows us to respond quickly to patient and clinician feedback. We’re able to continuously improve the AffloVest product over time and deliver a better and better product.
We make sure to cover a broad range of patient and human factors heavily in the design phase. For example, the fact that there are many different patient sizes and anatomies led us to offer seven different sizes of the AffloVest, to make sure that we correctly fit every patient, regardless of their body type. This ensures that the motor placement on every size is anatomically correct to target the upper and lower lobes of the lungs with four motors on the front and four on the back.
We also take into consideration homecare environment factors such as weight, noise, ergonomics, comfort, ease-of-use and electromagnetic compatibility. As a result, the AffloVest is the lightest and quietest mobile HFCWO vest on the market and is well below published threshold limits for static magnetic field exposure for certain active implantable medical devices.
Other engineering driven features include patient flexibility in how they program and operate the AffloVest. There are 3 different operating modes that were designed to mimic hand CPT and provide choices to the patient, so they can customize their treatment into different sequences and save that based on their dialogue with their physician and what they feel ultimately is working best for them with airway clearance.