Medical device 510(k) submission strategy

Alacrita’s client had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA. This was a complex submission that required careful planning in order to expedite the approval process while at the same time maximising its use over a number of potential measurement parameters.

Alacrita’s medical device regulatory consultant worked closely with the client’s product development and clinical teams to develop a strategy that balanced timelines and cost against the delivery of a marketable product that offered competitive advantages over existing products on the market.  The initial part of this process involved taking a Pre-Submission route in order to gain feedback from the FDA on the proposed strategy.

Alacrita’s lead regulatory consultant on this project has over 20 years’ experience operating in regulatory affairs across multiple medical device specialities. She has authored numerous successful FDA submissions including original PMA’s, a modular PMA, an HDE, several original IDE’s, pre-IDE’s, PMA and IDE Supplements and 510(k)s for novel products including implantable devices, multiple sensor monitoring tools and diagnostic devices. She has also worked on projects for clients with novel Class II and Class III IVD, diagnostic, therapeutic devices and drug device combination products.

Complex medical device supply chain strategy

Alacrita’s client had developed a novel medical device for the treatment of a condition that is becoming increasingly prevalent in the developed world.

The device was complex, incorporating high precision injection moulded parts, multi-layer extruded tubing, electronics and software. This led to a complex and geographically dispersed supply chain with vendors requiring quite unique expertise to manufacture the component and sub-assemblies of the device.  A consequence of this complexity was that the supply chain was difficult to manage and there were unacceptable delays in product supply. This prompted Alacrita’s client to develop a second generation device that was easier and less expensive to manufacture. This new device required a different set of manufacturing processes. At the same time the client made the decision to take more control over the supply chain and to contain it within relatively tight geographical boundaries.

Alacrita’s medical device consultants were asked if they could assist with the selection of new vendors for the second generation device. This involved reviewing a series of potential vendors against a long list of required capabilities and expertise, and using Alacrita’s broad network in medical device manufacturing to make recommendations on a way forward.

Developing a payer strategy for novel medical device

Alacrita’s client had developed a novel system for urinary drainage that provided a number of benefits for patients and caregivers over current systems. They believed that CE marking would be straightforward, and were designing a clinical trial to garner key opinion leader support for to support product uptake. They recognised that research was needed in order to help justify a significant premium in price over existing treatments and approached Alactrica to help identify what needed to be presented to payers to justify this premium price.

Alacrita’s medical device consultants recommended convening a small Payer Advisory Board consisting of ‘real payers’ who make pricing, reimbursement and formulary decisions at national and regional level. The objectives of the Board were to understand on which basis payers would evaluate the new device, to assess payers’ reaction to a proposed data package, to define a realistic price range and gain initial input on price sensitivity and to assess how payers might try to select/influence/restrict the target population for the product.

The Payer Advisory Board met to share knowledge and experience and planned a way forward that they believed would be successful in having the device adopted by the NHS at the premium price level.

Defining the value proposition of a drug packaging device

Alacrita’s client was reviewing an opportunity to commercialize a novel drug packaging device that had a number of advantages over existing systems. It was potentially safer to use and reduced errors in drug administration.

The client had a number of questions over how it would be disposed of in practice, that is in general waste or sharps waste, and how its means of disposal would influence the overall cost of its use.

Alacrita drew on the expertise of two of its medical device consultants, one of whom had previously spent a number of years working for medical disposables company Becton Dickinson and another who was an expert in healthcare operations management, to draw comparisons in the cost of disposal through the different routes. The project began by doing a risk assessment to ascertain how the device would be classified for disposal and what this would actually allow.

The picture was in reality quite complex and it led to recommendations being made for specific containment and modifications to the device to render it leak and tamper proof to allow disposal in general waste. This was expected to significantly reduce the cost of its use in practice.

Reality check on new biosensor technology

Alacrita’s client was considering investing in a new early stage biosensor technology for the measurement of blood pressure. This had a number of potential advantages over existing technologies. As its business activity was not in the healthcare sector it wished to draw on external expertise to help with its due diligence of the technology and device.

Alacrita conducted diligence work on four areas relating to this technology: market demand based on likely performance and cost; route to market including its sales plan; data – was this sufficient to convince regulators and potential partners of its future performance; execution – were the management team, advisors and non-executive directors sufficiently experienced to deliver against the business plan.

Alacrita formed an expert team with the experience necessary to address these four areas including  an Alacrita consultant who had been a lifescience investor and made numerous investments in new early stage companies. The team made suggestions for improving the business plan and highlighted areas where further data was required to convince the range of stakeholders in the business that this was an investable technology.

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