Scientist loading sample plates into a liquid handling robot

Sectors · Longevity and preventive health

Longevity clinics and preventive health companies, from the blood test to the personal plan.

Blood tests, a biological age, wearable data and a personal plan, delivered through a test kit, a partner laboratory, a scoring engine, an app and a doctor's review. As the product grows, a score or a report can make the software a medical device in the EU or the US, and data from many sources has to stay correct and protected. We connect the parts, build the scoring and the app, and write down the regulatory status of each part, with the IEC 62304 documentation where a part is medical.

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Topics: Blood tests · biological age · wearables
Standards: IVDR · EU MDR · FDA · IEC 62304 · ISO 13485
First step: Free 30 minute call with engineering

The customer's path

From the test kit to the personal plan.

Test kit

Kit, sample logistics and app come from different suppliers, and samples are matched to customers by hand.

ImprovementKit, sample and result carry one identifier, so each result reaches the right customer.

Laboratory

Partner laboratories send results in their own formats and units.

ImprovementResults arrive in one data model, with the unit and the source next to every value.

Wearable data

Heart rate, sleep and activity come from several vendor platforms.

ImprovementReadings from every vendor arrive in the same model, labelled with their source.

Score and report

The score and its wording in the report may make the software IVD software in the EU or medical device software in the US.

ImprovementThe regulatory status of the score is written down before launch, and the report claims only what the software is documented to do.

Doctor and plan

The software drafts the plan, and it is not recorded who approved it.

ImprovementThe doctor's sign off is recorded, and the plan cannot reach the customer without it. In the EU the sign off does not change the regulatory status of the software that drafts the plan.

Data request

Customer data sits in several systems, so a data request means searching all of them.

ImprovementCustomer data sits in one model with access set by role, so a request is answered from one place.

The goal

Results customers can rely on, and a clear regulatory status.

For the company

A written regulatory status for each part of the product
Claims that match what the software is documented to do
An answer ready when an investor or a partner asks

For the doctors

Plans drafted by software, with the sign off recorded
Source and unit visible next to every value
Medical content and recommendations stay in their hands

For customers

A report that says clearly what a score means and what it does not
A plan a doctor has reviewed before it reaches them
Their data in one place, handed over when they ask

Problems and solutions

What we hear, and what we do about it.

We need the app, the scoring and the doctor's workflow built, and our team is small.

We develop the customer app, the backend, the scoring and report engine and the doctor's review workflow, and connect the test kit, the laboratory and the wearable platforms. Your team works with ours in your repositories, and the part with a medical purpose is built under IEC 62304 from the start.

Medical software development

Our score is built from dozens of laboratory values, and we need to know what we can claim with it.

We read the claims against Article 2(2) of the IVDR and the MDCG 2019-11 guidance (from the EU Medical Device Coordination Group), and against the FDA general wellness and clinical decision support guidance for the US market, and write the status down. If the score is IVD software, the IVDR asks for a classification under its Annex VIII, a notified body (the independent organisation that certifies a device under the EU regulations) from Class B upwards and a performance evaluation of scientific validity, analytical and clinical performance, and the software file is one part of it. We review the report and scoring code before the claims are extended.

IEC 62304 gap analysis

Test kit, laboratory and app come from three parties, and each part has a different regulatory status.

We map each part, its status and its interface in one document before launch. The part with a medical purpose is built and documented under IEC 62304, for the IVDR, the MDR or the FDA.

Medical software development

Wearable data from several vendors does not fit into one model.

We map the readings from each vendor to FHIR (a web standard for exchanging health records) Observation resources, with the unit and the source. Laboratory results go into the same model. Consumer wearables carry no medical accuracy claim, and the report says so where their data appears.

Interoperability

Customer health data sits in several systems, and we do not know how well it is protected.

We set access by role, log every access and test the protection the same way as for the data of a medical device. Health data falls under Article 9 of the GDPR, and HIPAA where it applies in the US. We prepare the data protection impact assessment with your data protection officer.

Medical device cybersecurity

An investor asked whether we are a medical device company.

We write a report on the claims, the code and the process, with a remediation plan in work packages.

IEC 62304 gap analysis

We are afraid of a project that never ends.

Each step is a separate contract with a written result. The first one can be the review of a single report or score.

How we work

Systems

The systems behind the customer's path, and the interfaces between them.

System	What it holds	Interface	Our work
Test kit and sample logistics	Kit, sample and result identifiers	Vendor API	One identifier across kit, sample and result, so each result reaches the right customer.
Partner laboratory	Biomarker panel results	HL7 v2 · FHIR	Results read into one model with LOINC codes and UCUM units, and the source and reference range next to every value.
Wearable platforms	Heart rate, sleep, activity	Vendor API · FHIR	Readings from every vendor in the same model, labelled with their source.
Scoring and report	Scores, reports, versions of the scoring logic	Internal API	Scoring code under version control and documented, with its regulatory status written down.
Clinic record	Doctor's notes, plans, sign off	FHIR · HL7 v2	Plans written back to the record with the doctor's sign off.
Customer app and portal	Reports, plans, data requests	REST API · single sign on	Access set by role and logged, under the GDPR in the EU and HIPAA where it applies in the US.

Fit

When we are the right partner.

Call us when

You want to know whether a report or a score has become IVD software in the EU or the US
You want the app, the scoring and the doctor's workflow built by one team
You want wearable data from several vendors in one record
You want a clear answer when an investor or partner asks for the regulatory status

Talk to us

Tell us about your product.

A biomarker report, a risk score, a test kit chain or wearable data. Write a few lines, or book a free 30 minute call with engineering.

Book a 30 minute technical call

FAQ

Frequently asked questions.

Is a biological age score a medical device?

Not while it is presented for general wellbeing without a disease claim. Once it estimates the risk of a disease or a predisposition from specimens, it is IVD software under the IVDR. We work from the MDCG 2019-11 guidance. When the score also uses wearable or questionnaire data, the IVDR applies if its intended purpose (what the manufacturer states the software is for) is driven mainly by the laboratory values, and the EU MDR otherwise. For the US market, we check the same score against the FDA rules for in vitro diagnostics and its general wellness guidance.

Does a home sample kit fall under the IVDR?

Yes, in part. The IVDR counts the specimen receptacle, the container in which the sample is collected and sent to the laboratory, as an in vitro diagnostic medical device.

Can wearable data appear in a medical report?

Yes. The report shows which device each value came from. Readings from a consumer wearable appear as wellness data, unless the wearable is itself CE marked or FDA authorized as a medical device.

How is customer data handled under the GDPR?

Health data falls under Article 9 of the GDPR. Data stays in your systems, access is set by role and logged, and we prepare the data protection impact assessment for a new system with your data protection officer. Silurus Software works as processor under a data processing agreement. In the US, HIPAA applies where the company is a covered entity or works for one, and we then work under a business associate agreement. Where HIPAA does not apply, the FTC Health Breach Notification Rule and state health data laws can.

What does a first project cost, and how fast can it start?

The 30 minute call is free. Each step after it is quoted individually, with scope, deliverable, duration and price agreed in writing. We reply within one business day. A gap analysis (a review of what is missing against the standard) can start within two weeks of the signed order, and an engineering team within two to three weeks of signature.

Related services and sectors.

IEC 62304 gap analysis Interoperability SaMD and digital health companies Laboratories Digital applications and wearable devices